SEMINARS IN LIVER DISEASE-VOL. 10, NO.

3, 1990

Management of Bile Duct Stones

STUART SHERMAN, M.D., ROBERT H. HAWES, M.D., and
GLEN A. LEHMAN, M.D.

The management of bile duct stones has been evolving
over the past 15 years. Prior to that time, abdominal ex-
ploration with choledochotomy was the main therapeutic
recourse for the patient with common duct stones. Cur-
rently available alternative therapies' (Table I) allow the
physician to select the most appropriate therapy for a
given patient. Paralleling the development of alternative
therapies has been the advent of improved methods
to detect the presence of common duct stones (ex-
(ERCP), percutaneous transhepatic cholangiography (PTC),
computed tomography (CT) scan and ultrasound).
In this review, we will examine the methods to di-
agnose choledocholithiasis and the techniques available
for the successful removal of stones. Treatment methods
that are well established and whose techniques have not
changed significantly in recent years (surgery, ERCP-
sphincterotomy, T-tube tract extraction) will be covered
more concisely, whereas new techniques will be re-

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amples: endoscopic retrograde cholangiopancreatography viewed more thoroughly.

NATURAL HISTORY OF
TABLE 1. Management Alternatives for Bile CHOLEDOCHOLITHIASIS
Duct Stones
Irrigation Common bile duct stones can be classified into two
(via T-tube) types. Primary stones are formed directly in the bile
Extraction duct' and are composed predominantly of calcium bili-
ERCP-sphincteroto~~iy rubinate with variable amounts of cholesterol or fatty
Percutaneous
T-tube acid. Their pathogenesis appears to depend on the pres-
Transhepatic ence of biliary stasis (example, stricture) and bacterial
Surgical duct exploration infection.'.-' In contrast, secondary stones reflect the
Stenting composition of gallbladder stones (predominantly cho-
Temporary
Nasobiliary catheter
lesterol in 80% and black pigment in 20%) and are there-
Percutaneous fore believed to be of gallbladder origin'.' i.e., stones
Long-term are formed initially in the gallbladder and migrate into
Internal stent the ductal system. These differences in composition may
Fragmentation (lithotripsy) affect their response to therapy. For example, primary
Basket crushing (mechanical)
stones will not dissolve in lipid solvents.
Laser
Pulsed dye
Q switched
Electrohydraulic I
Extracorporeal shock waves
Dissolution
'! best via
mother-daughter system
About 15% of patients with cholelithiasis will have
choledocholithiasis at the time of surgery. Conversely,
of the patients with ductal stones, 95% also have con-
comitant gallbladder stones.' The cystic duct diameter
Oral agents appears to be an important determinant in stone migra-
Ursodeoxycholic acid (Actigall"") tion into the common bile duct. In a prospective study,
Chenodeoxcholic acid (Chenixob) Taylor and Armstrong7 evaluated 331 patients undergo-
Transcatheter ing cholecystectomy. It was found that stones present in
Monoctanoin (MoctaninW)
Methyl tert-butyl ether the gallbladder could be squeezed through the length of
Calcium solubolizing agents (e.g.. EDTA) the cystic duct in 60% of patients with common bile duct
Observation only stones, 67% with gallstone pancreatitis, but only 3% of
those with gallbladder stones alone. None of the gall-
bladder stones with diameters greater than the cystic duct
could be forced through it. Of course, large gallstones
From rhe Division of Ga.strornrerologyiHep~~foIogy,Indicmci unable to traverse the cystic duct may enter the common
Univer.sitv School of MedicYne.
Reprint address: Dr. Lehman, Department of Medicine, Divi-
duct through a fistula.
sion of GaatroenterologyiHepatoIogy,Indiana University School of The natural history of choledocholithiasis is vari-
Medicine, Bloomington, IN 47014. able. It is clear that there is a subpopulation of patients

Copyright 0 1990 by Thieme Medical Publishers. Inc., 381 Park Avenue South, New York. NY 10016. All rights reserved. 205
206 SEMINARS IN LIVER DISEASE-VOLUME
who remain asymptomatic for months to years."n an
autopsy series, 142 of 615 (23%) patients older than 60
years had cholelithiasis and Inore than half had asymp-
tomatic common duct stones." Simil;lrly, in another au-
topsy series, 24% of patients with cholelithiasis had
common duct stones but never came to clinical atten-
tion."' Millbourn" reported on 38 patients with choledo-
cholithiasis who were followed without operation either
because they refused surgery or were believed to be sur-
gically unfit. During the follow-up period of 6 months
to 13 years. 17 (45%) patients had nc further symptoms.
whereas the remaining 21 had one or more episodes of
colic, jaundice, or cholangitis. Common bile duct stones
may also pass into the duodenum and be evacuated in
the stool without producing symptoms. In one series.
stones were recovered in the stool in 11% of patients
with asymptomatic cholelithiasis." A second subpopu-
lation of patients manifest symptom:; directly related to
choledocholithiasis as their first sign of gallstone dis-
ease." This group often presents a therapeutic dilemma.
Although most agree that endoscopic sphincterotomy
(ES) is the initial procedure of choice for common bile
duct stones in high-risk surgical patients with an intact
gallbladder, the management of the average risk patient
is controversial." A final group of patients will have
symptomatic choledocholithiasis days to years after cho-
lecystectomy. Despite technical advances (examples, in-
traoperative cholangiography. ultrasonography, and cho-
ledochoscopy) retained calculi can be expected to occur
in 5 to 15% of patients following common duct explo-
ration.li It may be impossible to determine whether the
present stones were overlooked at the earlier operation
or have formed since.'" The longer the time interval from
cholecystectomy and common bile duct exploration, the
more likely the stones are newly formed. It is reasonable
to conclude, based on the pathogene:iis and composition
of primary and secondary common bile duct stones, that
cholesterol and black pigment stone:; usually have been
overlooked. Calcium bilirubinate stones also could have
been missed; however, if cholestasi:; and bactobilia are
present, it is more likely that the stone (calcium biliru-
binate) is new."
It is estimated that more than 75% of patients with
choledocholithiasis will ultimately become symptom-
atic. The incidence of common d ~ . c tstones increases
with age (similarly with gallbladder :;tones) and duration
of gallstone disease, suggesting that migration of gall-
stones into the common duct is time-dependent.'x
To summarize, choledocholithi;~sisusually (but not
always) results from passage of gallstones into the com-
mon duct. Bile duct calculi ultimately become symptom-
atic in the majority, but a significant proportion will
never manifest symptoms. It is most commonly a disease
of older patients, often presenting with complications as
the first evidence of calculus diseaie. Important ques-
tions in the natural history of common duct stones re-
main unanswered. When and which patients will become
symptomatic? What are the inciting factors to stone mi-
gration? What is the clinical course of patients in whom
common duct stones are left behind at the time of oper-
ation'? Answers to these questions may allow us to direct
our therapy before complications develop.
10, NUMBER 3, 1990
TABLE 2. Complications of Choledocholithiasis
Pancrcatitis
Cholansiti\ with or w ~ t h o u tsepsls
Chole\tasi\
Liver abscc\\
Secondary biliary cirrhosis
Iluct strictures
CLINICAL MANIFESTATIONS
Patients with choledocholithiasis may be asymp-
tomatic. More commonly they will present with one or
more of the following clinical manifestations: biliary
colic, jaundice, cholangitis, or pancreatitis" (Table 2).
The exact relationship between gallstones and pancrea-
titis remains an issue of contention. The bile reflux the-
ory proposes that obstruction of the papilla leads to ret-
rograde flow of bile into the pancreatic duct. Infected
bile and, perhaps, bile under high pressure can activate
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pancreatic enzymes resulting in pancreatitis.'" Propo-
nents of the common channel theory state that ampullary
obstruction by a stone blocks the pancreatic duct, result-
ing in pancreatitis.'? Anatomic features of the pancreatic
duct'" and stone characteristics (stones less than 3 mm
are frequently associated with pancreatitis)" appear to be
important modifying influences. Cholangitis results from
biliary tract obstruction with secondary infection. High
intraductal pressure seems to be a prerequisite for cho-
langitis as attempts to infect unobstructed ducts have
been u n s u ~ c e s s f u l . ~ ? . ? ~
The clinical features of cholangitis are variable,
though fever" and right upper quadrant pain" are seen
in more than 90%. Jaundice is present in up to 80% of
patients and correlates both with duration of obstruction
and mortality." Signs of sepsis and central nervous sys-
tem (CNS) depression are seen in 10% of patients. Char-
cot's triad (right upper quadrant pain, jaundice, and fe-
ver) is seen in 50 to 70% of cases.'5 Several authors
caution that elderly patients may not be febrile or com-
plain of pain.24.?5.27 Positive bile cultures are found in
most cases with bacteremia present in 25 to 40%.'%iver
abscess is a rare consequence of cholangitis. Secondary
biliary cirrhosis may result from long-standing biliary
tract obstruction. Elderly patients may present with
weight loss (with or without jaundice), anorexia, or
vague abdominal complaints suggesting an intra-abdom-
inal malignan~y.'~
LABORATORY FINDINGS
Hepatic and pancreatic chemistries may be normal
in patients with nonobstructing common bile duct
stones.' In assessing the biochemical features of 100
consecutive symptomatic patients during the first 3 days
of their illness, at least one abnormality was found in
99%" (Table 3). The most frequent abnormalities were
high gamma glutamyl transpeptidase (94%) and alkaline
phosphatase (AP, 9 1 %), with aspartate aminotransferase
(AST), alanine aminotransferase (ALT), and total bili-
MANAGEMENT O F BILE DUCT STONES-SHERMAN. HAWES. LEHMAN
TABLE 3. Levels of Serum Biologic Tests Performed During First Three Days Following Onset of Symptoms
of Choledocholithiasis (Mean & SD)*
Leuhocytosis (lO"1Iiter) 11.27 i 6 . 8 6
Total h~liruhtn( N < 17 p m o l l l ~ t e r ) 0 i 64
Gamma glutaniyl tran\peptitlase ( N < 35 IUilitcr) 372
Alkaline phosphatase ( N < X O IUlliter) 265
AS?' ( N < 3 0 lullitcr) 121
ALT ( N < 4 5 IUIliter) 1x3
Amylase ( N < 4 0 IUIliter) 45
."Adapted from Anciaux et al.'" Reprinted by perm~ssion.
-1-Group 1: 72 patient\ without prior cholecy\tectom).: s r o u p 2: 28 pattent\ with priot- cholecy\tectom)
rubin being elevated in 70 to 80%. The serum transam-
inases returned to normal levels within 10 days in the
majority of patients, despite the persistent presence of
common duct stones.
Direct-reacting bilirubin is most commonly in the 2
to 10 mgldl range, with higher values indicating associ-
ated liver disease or nearly complete obstruction. "' The
serum transaminase levels are modestly elevated in the
majority but can reach over 1000 IUIliter immediately
after a high-grade obstruction." The elevation in AP
may be transient (if the obstruction resolves) and its
height does not correlate with the degree of obstruction
or the level of bilirubin."' The white blood cell count
may be elevated with cholangitis or be depressed with
overwhelming sepsis." Over 90% of patients with bili-
ary pancreatitis have elevated serum amylase levels and
these values are, overall, higher than those observed in
patients with alcoholic pancreatitis."
SPECIAL DIAGNOSTIC TESTS
Intravenous cholangiography (IVC), formerly the
screening examination of choice for patients with sus-
pected choledocholithiasis, has a low diagnostic accu-
racy, especially when the bilirubin is greater than 2.5
mgidl, and is associated with serious allergic reactions.j4
The development of improved diagnostic techniques has
made IVC rarely necessary. Ultrasound is capable of de-
tecting gallbladder stones and dilated ducts with an ac-
curacy approaching 90%." However, it is able to iden-
tify common duct stones, per se, in only 15% of patients
subsequently proved to have choledocholithia~is.~ This
figure increased to 33% when patients were clinically
jaundiced." CT scans are also accurate in detecting bil-
iary dilation but, like ultrasound, are largely unsuccess-
ful in demonstrating common bile duct stones.3xDirect
cholangiography by ERCP or PTC are highly accurate in
establishing the cause of mechanical jaundice." The
choice of which test to perform should be based on the
local expertise and facilities. However, ERCP is gener-
ally preferable because it offers better associated thera-
peutic options without peritoneal soilage. ERCP also of-
fers the opportunity to visualize the pancreatic duct.'"."
Alternatively, if choledocholithiasis is highly suspected
at surgery, an intraoperative cholangiogram can be ob-
tained. Routine use of this technique has been shown to
207
10.93 t 4 Oh 11.18 -t 6 53
6X i X5 66 2 09
+ 321 491 i371 105 i 306
? 102 229 i 357 255 i 248
i 135 115 i 136 120 -+ 135
i 1x0 238 2 531 106 i 305
i 38 73 i XX 3X i 55
reduce the number of retained stones and decrease the
number of negative common bile duct exploration^.".^'^^
TREATMENT OF COMMON DUCT STONES
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The presence of a common duct stone is generally
an indication for its ren~oval.However, the timing, and
in many instances the method, of its removal remains
controversial. A spectrum of management options exists
(Table I ) , but therapy must be individualized. In gen-
eral, the greater the patient's risk for con~plicationsand
the more unstable he is, the greater the urgency of defin-
itive management.
Endoscopic Techniques
Since its inception in 1974. the indications for
ERCP and ES have been growing steadilyJi (Table 4).
Although controlled studies have not been performed,
ES is considered the procedure of choice for choledo-
cholithiasis after cholecystectomy and in poor surgical
risk patients with the gallbladder still present.'" Its role
as a therapeutic modality (to be discussed later) for the
treatment of common bile duct stones in the average risk
surgical patient with an intact gallbladder and as a rou-
tine procedure prior to cholecystectomy (to avoid com-
mon bile duct exploration) remain controversial.
This technique uses a side-viewing duodenoscope,
a sphincterotome, and electrodiathermy to incise the pa-
pilla and the sphincter muscles surrounding the ampulla
of Vater and a portion of the sphincter choledochus.'" By
enlarging the papillary orifice, a nasobiliary catheter, bil-
iary endoprosthesis, stone-retrieving balloon or basket,
or other equipment can be passed into the common duct.
The size of the endoscopic sphincterotomy should be tai-
lored to the size of the stone, but most often can be safely
extended to I0 to 15 mm in length. The average common
bile duct stone is 8 to 10 mm in diameter'x and in most
cases can be easily pulled into the duodenum using a
balloon catheter or Dormia basket.17 ES with clearance
of the biliary tree of stones is successful in 85 to 90% of
when performed by experienced endoscop-
ists.
Failure to achieve ES or duct clearance may occur
for a variety of reasons. Inability to cannulate the bile
208
TABLE 4. Indications for ERCP-Sphincterotomy
in Choledocholithiasis
I . Postcholecystectonly ( n o T-tube In)
2. Postcholecy\tectonly (T-tube in)
Syn~ptomaticpatient with immature T-t11betract
Failed T-tube extraction
3. Gallbladder in situ
Elderly patient
High operative risk patient
!' patients choosing nonoperative gallbl;idder stone manage-
nlent alternative
4 . Gall\tone pancreatit~s
duct deeply may occur, but precutting techniques have
largely bypassed this problem. Endos~x~pic access to the
papilla of Vater and subsequent cannulation and sphinc-
terotomv can be difficult in ~ a t i e n t swith Billroth 11 re-
sections. Successful cannulation has been achieved in 46
to 88% of such patientsi' and appears to be influenced
by the type of ana~tomosis.'~ In one series, ERCP was
successfully performed on 64% of patients with a retro-
colic gastroenterostorny and a short afferent limb but in
only 33% of patients with an antecolic gastroenteros-
tomy with a long afferent limb.'' More recently, sphinc-
tero;omy was c(impleted in 92% of patients with Bill-
roth I1 anastomosis using a "30-30" papillotome or by
creating a suprapapillary fi~tulotomy.'~ Successful can-
nulation in patients with a Roux-en-Y gastrojejunostomy
is rare. A transhepatically placed guide wire (combined
procedure) may help to bring the-endoscope to the pa-
pilla and therefore improve the chance of successful can-
nulation and sphincterotomy." Periampullary diverticula
are frequently associated with stone disease. especially
in elderly patients,5hand can be a cause for a failed can-
nulation when the papillary orifice is within the divertic-
ulum itself. If the papilla cannot be coaxed into view, a
transhepatically placed guide wire through the papillary
orifice will aid in successful cannulation and sphincter-
otomy.
More often. failure to perform IIS or clear the duct
is due to a large stone, impacted stone. or stone proximal
to a ductal or ampullary stricture. Until recently, the
large stone (usually defined as greater than 15 mm in
diameter) was often managed surgica.lly. Attempts to re-
move a large stone with a standard basket may result in
basket impaction. Currently, a nurrtber of nonsurgical
options exist for such "difficult" stones (discussed
later).
TABLE 5. Success and Conlplication Rates of Endoscopic Sphincterotomy Performed for Calculi*
Arter~rl~tc~tl
A~rrl~or- .S/)hirrc~te~1-~1to1rr1c~.s
Classen and Salrany 1975 59
Safrany 1978 3853
Cotton and Vallon 198 I 679
Siegel 1981 235
Cotton and Vallon I982 71
Neoptolcmos r~ (11. I984 100
Hatfield 1985 256
--
Total 5253
"Adapted from Johnson and Hosking.' Reprinted by permi\\ion
SEMINARS IN LIVER DISEASE-VOLUME 10, NUMBER 3, 1990
ES generally has a 6 to 10% major complication
rate and a 0.4 to 1.2% mortalitv rate."-5' However, se-
lected series of high-risk elderly patients had major com-
plication rates as high as 19% and mortality rates of
7.9%.h" These complications are bleeding, perforation,
infection, pancreatitis, and basket impactions. Approxi-
mately 20% of these events will require surgical inter-
vention. Because of its significant risk and the unknown
permanent effects of sphincter ablation, some authorities
have suggested that "small stones" be removed after
papillary balloon dilation, or the use of smooth muscle
relaxants (example, nitr~glycerin)."~."' Table 5 summa-
rizes the success and complication rates of ES performed
for bile duct ~ t o n e s . ~
Mechanical Lithotripsy
The simplest endoscopic adjunct for large stone
management is a mechanical lithotripter or "crushing
basket." In this technique, stones are captured in stan-
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dard fashion by a wire basket made of three or more
strong stainless steel wires that can stand a traction of
greater than 100 kg. By turning a screw, the wires en-
close the stone until it is crushed or the wires break."
a Because of the stiffness of the steel coil sheath, the early
models of mechanical lithotripters were difficult to insert
into the common bile duct. The more recent models are
provided with double sheaths made of a steel coil and a
Teflon tube."-' The basket with the Teflon sheath alone is
relatively easy to insert into the common bile duct. The
steel sheath (outer sheath) is then advanced over the in-
ner sheath to crush the stone grasped in the basket for-
ceps. Mechanical lithotripsy has proved efficient in the
majority of clinical investigations with fragmentation
rates between 27 and loo%, including "giant stones"
with maximal diameters up to 80 mm.h5-hxIn the largest
series reported, 209 patients required mechanical litho-
tripsy owing to stone size alone (80.4%). or in combi-
nation with common bile duct features such as an S-
shaped configuration (12.4%) or a stenosis below the
calculi (7.2%)."' The overall success rate for this series
was 87.6%, including 79.1% for common bile duct
stones 20 mm or larger and 67.6% for stones 25 mm or
larger. The introduction of stronger wire baskets with a
breaking strength of approximately 125 kg increased the
success^ rate of mechanical lithotripsy, especially for
large and "giant" common bile duct stones to 92.3% (20
mm or larger) and 85.7% (25 mm or larger), respec-
S~~c.c~c,s.\/irl O~.c,rtrllPrrc.rrrtergc,
Sl~lrirre~tc~roto~rric~s i ~ / ' f l ~ r c ~Cletrr-etl
t.s Morhitlir! Morttrlit\
50 84% 2% OR
36 1 8 90% 7% 1.4%
590 76% 8.5% IQ
230 97% 5%' 0.8%'
70 87% 6% 0R
98 9 1 %' 13% I %'
-24 1 85%
- -9.5% 0 0
4897 ( 9 3 % ) 88% 7% IR
MANAGEMENT OF BILE DUCT STONES-SHERMAN. HAWES, LEHMAN

tively. Failure to clear the stones occurred in 12.4% and

was due either to the inability to pass ( I 1.1 %) or to cap-
ture the stone with the basket (88.9%) because of its
size, common bile duct configuration, disproportion be-
tween stone size and common bile duct diameter, inad-
equate "unfolding" of the basket, or other technical
problems. Complications of mechanical extraction were
primarily related to ES.
The mechanical lithotripter has also been used suc-
cessfully to fragment and remove stones through an in-
tact papilla,"" although this application has been limited.
Mechanical lithotripsy is a safe. relatively effective.
and inexpensive technique. Where available. it is the
method of choice to remove most large stones (15 mm
or larger). However. because stones must be captured in
a basket to be fragmented, at least some of them will
escape destruction (usually stone size greater than
25 nim).

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Laser Lithotripsy
Laser fragmentation of ureteral stones is an estab-
lished technique. Similar applications for bile duct
stones and gallbladder stones have been reported. Stones
may be fragmented by: ( 1 ) frank heating and melting,
( 2 ) focal heating and induction of fracture lines, or ( 3 )
photoacoustic, essentially athermal methods."' In the ini-
tial report by Orii et a17' the continuous wave neo-
dymium: yttrium-aluminum-garnet (Nd:YAG) laser was
used. Although largely successful. the associated tissue
heating was thought to be prohibitive for general use of
this method. More recent reports using short duration
(nanosecond or microsecond) pulsed laser techniques
have shown its ability to fragment stones in vitro with
essentially no heat transfer to the stone o r surrounding
1nedia.7U 72.71 Although fragmentation may occur with
variable light wavelengths, wavelengths of approxi-
mately 500 nm appear to give optimal fragmentation
with low energy requirements. Stones of any composi-
tion can be fragmented by laser energy but pigment
stones require considerably less energy than cholesterol
stones. Calcium content appears to have little affect on
fragmentation. Fragmentation occurs much more readily
if the laser fiber and the stone are in an aqueous medium,
rather than air. Bile absorbs laser light and is therefore
detrimental to fragmentation, but helps to protect adja-
cent rnucosa.
Although numerous lasers have been tested, the
pulsed dye coumarin green laser (Candela Corporation,
Natick, M A ) is the only Food and Drug Ad~ninistration
(FDA) approved laser for biliary stones."." In Europe,
Q-switched Nd:YAG lasers (nanosecond pulse duration)
are also commercially available. Unfortunately, the stan-
dard commercially available continuous wave Nd:YAG
laser used for gastrointestinal tumor ablation and bleed-
ing cannot easily be modified fix delivery of short du-
ration pulses.
For bile duct work, laser energy is usually delivered
by 200 to 350 k m diameter quartz fibers that pass
through standard endoscopic channels. Via the duoden-
FIG. 1. Daughter endoscope passed up bile duct via the
mother endoscope to visualize common duct stones. A
laser fiber is passed through daughter endoscope for perfor-
mance of laser lithotripsy.
oscope, the laser fiber can be passed through a modified
stone retrieval balloon, modified Dormia basket, or the
mother-daughter endoscope system (see Fig. I ). Bal-
loons offer the simplest application but provide the least
certainty for laser fiber to stone approximation. Baskets
require capturing the stone but permit direct placement
of the fiber against the stone via the accessory lumen
within the basket sheath. The mother-daughter system
permits direct viewing and the most accurate fiber place-
ment but does require prior placement of a nasobiliary
tube for saline irrigation to wash away stone fragments
which quickly obscure the viewing area. Such saline
wash permits an optimal aqueous medium for transfer of
laser energy to the stone. These same techniques may be
applied through T-tube tracts or by percutaneous trans-
hepatic routes.
Ell et reported a series of nine patients with
common duct stones treated with the flash lamp pulsed
Nd:YAG laser. Eight of nine large (larger than 25 mm
diameter) stones were fragmented and in six of the nine
patients the duct was fully cleared of calculi. Failed pa-
tients were treated by surgery, internal drainage o r extra-
corporeal shock-wave lithotripsy (ESWL). In a prelimi-
nary report, Cotton et a17j treated 14 patients with the
pulsed dye laser. Treatments were applied by percuta-
neous tracts (n = 3), mother-daughter system ( n = 8), and
210 SEMINARS IN LIVER DISEASE-VOLUME
ERCP balloon technique (n = 3). Ninr: of 14 patients had
complete stone clearance. At the Indiana University
Medical Center, we have treated eight patients with large
bile duct calculi. Four were treated by percutaneous
transhepatic introduction of a small-caliber fiberscope
(Olympus BF type 3C10) and four were treated by ERCP
balloon or mother-daughter technique. Successful frag-
mentation and duct clearance occurred in six of the
eight cases. The failed cases were treated with internal
stents.
To date, complications have not been reported in
any of the series. However, therapy sessions commonly
require 1 to 3 hours (especially with the mother-daughter
technique) and are tedious for elderly patients. Kozarek
et a17' and Murray et a173both reported that small foci of
mucosal desiccation occur if the laser is fired directly
against the mucosa for several secontls. The pulsed dye
laser produces an easily audible (with stethoscope)
knocking sound and an endoscopically visible flash
when the laser fiber is fired against the stone. This helps
the operator to judge appropriate stone contact.
The comparative advantages of Iilser lithotripsy are:
(1) the relative availability of the pulsed dye laser (ap-
proximately 200 currently in hospitals in the United
States); (2) the relative safety, that is, lack of bile duct
injury; (3) the multiple routes and methods of applica-
tion; and (4) the relatively good success rate (approxi-
mately 70%) despite its use primarily with very large
stones. The relative disadvantages are: ( I ) the time and
manpower requirements to operate the mother-daughter
system; (2) the fragility of the baby scope; (3) the rela-
tively large costs of the lasers; and (4) the need for (gen-
erally) a large sphincterotomy and extraction of frag-
ments.
Overall, laser lithotripsy is still in its infancy.
Larger experience with various laser fibers and power
settings from multiple centers are needed. To make laser
lithotripsy cost effective, the laser must be used for other
areas, that is, kidney stones and gallbladder stones. Our
initial experience with the pulsed dye laser for fragmen-
tation of gallbladder stones by percutaneous approach
has been generally favorable, with s~~ccessful fragmen-
tation and gallbladder clearance in seven of nine pa-
tients.
Electrohydraulic Lithotripsy
Electrohydraulic lithotripsy depends on the princi-
ple that electrical sparks discharged in a liquid medium
emit steep hydraulic pressure waves. These acoustic
shocks are so energetic that concrernents can be frag-
mented but will leave elastic structures for the most part
uninjured.'" Intrabiliary lithotripsy can be performed us-
ing balloon-tipped probes that fit through the channel of
the therapeutic duodenoscope. Once in the duct, the bal-
loon must be inflated to keep the probe centered during
firing. This avoids injury to the bile duct wall.7bUsing
fluoroscopic guidance, multiple short bursts are admin-
istered, resulting in stone fragmentation. In animal stud-
ies using implanted human stones, fragmentation was
successful and duct in-jury did not o c c ~ r . ~In~ .two
~ ' se-
10. NUMBER 3, 1990
ries totaling 26 patients, successful fragmentation oc-
curred in 22 of 26 (85%) patient^.^".^" The only compli-
cation was pancreatitis in one patient, which resolved
with conservative treatment. Other authorities prefer to
use the small diameter electrohydraulic lithotripsy probe
under direct vision via per oral cholangioscopy ("baby
scope") to monitor more closely the direct contact be-
tween the spark discharge chamber and the stone." This
technique was used successfully to fragment large (larger
than 20 mm) common bile duct stones in four patients
without complication^.^'
Electrohydraulic lithotripsy has distinct advan-
tages when done under direct vision using the baby
scope, namely: ( 1 ) bile duct damage can probably be
avoided, (2) it is more economical than laser lithotripsy;
and (3) the unit is easily transportable. Although the ex-
perience with this technique is still limited, electrohy-
draulic lithotripsy appears to be a viable alternative
therapy when performed by experts using direct cholan-
gioscopy.
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Stents and Nasobiliary Drains
Long-term internal stenting is a good palliative
measure in old and high-risk patients with nonextractable
bile duct stones. In this technique, a stent is placed so
that one limb is above the stone and another in the duo-
denum. Although stents often clog within months, long-
term drainage is maintained because the stent prevents
stone impaction. Patency of the prosthesis is therefore
not important and stent changes are generally not re-
quired unless the stent spontaneously migrates out of the
duct. The latter may occur when a large sphincterotomy
has been performed in an attempt to remove the stone.
Most authors recommend double pigtail stents, although
Cotton had favorable experience with straight 10 F stents
placed well up into the intrahepatic duct^.^' If 7 F double
pigtail stents are used, placement of two stents will prob-
ably assure stent persistence better than one.
Siegel and Y a t t ~ , Foutch
'~ et aIx4and Cotton et alx'
reported series of 22, 10, and 17 patients, respectively,
with large common duct stones in which ERCP-sphinc-
terotomy had failed to remove the stones. Median fol-
low-up in these series was 18 to 39 months, with the
longest follow-up being 5 years. Although the size, num-
ber, and type of stents varied within the series, only 5 of
the 49 patients developed bile duct stone complications,
that is, stent dislodgement and/or cholangitis. These pa-
tients were managed surgically or by restenting. A few
patients had their stones extracted on a subsequent en-
doscopic attempt. These intermediate duration results
from stenting are encouraging and indicate that such
therapy is clearly appropriate for elderly and high-risk
patients. Long-term follow-up and additional studies will
be needed to answer questions concerning: (1) optimal
size, number, and shape of stents; (2) true long-term
complication rates; and (3) the role of combined use of
stents and oral bile salt dissolution therapy.
Preliminary data from Chung et alx' indicate that six
of seven patients with large bile duct stones treated with
stenting plus chenodeoxycholic acid had stone dissolu-
MANAGEMENT OF BILE DUCT STONES-SHERMAN,
tion or reduction in size to a degree to permit extraction.
This contrasted with only one of six patients treated with
a stent alone. In contrast, Cotton et alx' stated that none
of nine patients treated with ursodeoxycholic acid plus
stenting appeared to have benefited from the bile salt
therapy, although the dose and duration of therapy were
not reported. Overall, we believe the addition of bile salt
therapy to the use of stents appears attractive, although
the cost efficacy of such a recommendation clearly needs
further study.
A nasobiliary tube can be placed as a temporizing
measure if stones cannot be extracted e n d ~ s c o p i c a l l y . ~ ~tions appeared to be predominantly those of native gall-
This tube will prevent stone impaction and allow drain-
age while more definitive therapy is contemplated.
Moreover, the drain permits infusion of chemical disso-
lution agents (which appear to have limited efficacy with
large stones), allows for repeat cholangiographic assess-
ment of the common bile duct, and enables accurate fo-
cusing for such treatments as ESWL.
Extracorporeal Shockwave Lithotripsy
ESWL has been utilized for ductal stones in a fash-
ion similar to renal or gallbladder applications. Several
hundred patients have now been reported in the medical
literature. Most centers have used the first-generation re-
nal machines using fluoroscopic visualization by naso-
biliary or percutaneous (transhepatic, cholecystic, or T-
tube) contrast instillation. Access is generally from the
posterior in order to avoid a gas-filled bowel. Epidural,
general, or heavy intravenous anesthesia is usually re-
quired. Reports with more focused piezoelectric (essen-
~ ' . ~ ~ patients.
tially painless) machines are now a p p e a r i ~ ~ g . Anti-
biotic coverage appears necessary, as with any common
bile duct stone manipulation.
The usage of ESWL therapy has generally been re-
stricted to patients in whom endoscopic sphincterotomy
with or without mechanical lithotripsy or infusion of dis-
solving agents has failed to clear the ducts of the stones.
Additionally, patients with restricted access to the major
papilla via endoscopy (duodenal diverticula or gastroje-
junostomy) have been treated. A multicenter European
trialx"ound that 8.3% of patients referred for endoscopic
therapy ultimately were referred on for ESWL therapy.
Contraindications to such therapy are the presence of ex-
cessive air or bony structures, calcified vessels, renal
cysts, or vascular aneurysms in the path of the shock
wave, coagulopathy, significant cardiac arrhythmia, or
cardiac pacemaker. Twelve hundred to 2400 shocks in
one to two sessions have generally been given. In the
United States, none of the machines has yet been ap-
proved by the FDA for biliary use.
In 12 report^^'-^^ summarized from the literature a
total 374 patients with bile duct stones (includes com-
mon bile duct, common hepatic duct, and intrahepatic
duct stones) were treated by ESWL. Nearly all patients
had prior endoscopic sphincterotomy and a failed at-
tempt at stone removal. Although not all series separated
successful fragmentation from eventual duct clearance,
194 of 232 (84%) reported patients had successful frag-
mentation, whereas 296 of 374 (79%) patients had com-
HAWES, LEHMAN 21 1
plete clearance of all stones during initial follow-up,
although approximately 75% of patients required addi-
tional ERCP or percutaneous extraction of fragments.
Such success rates are remarkably high considering the
large diameters (commonly more than 20 mm) of stones
being treated.
Complications occurred in approximately one third
of patients, but consisted mainly of transient hemobilia
or hematuria and apparently clinically insignificant ar-
rhythmias or minimal fever. Serious complications were
reported in 13 of 374 (3.5%) patients. These complica-
stone disease, that is, biliary colic with or without cho-
lecystitis. Prophylactic antibiotics were not uniformly
given in these series. Other significant complications ap-
peared to be predominantly those of ERCP-ES and con-
sisted of basket impaction in two patients and duodenal
diverticulum perforations in two patients. Significant
pancreatitis was notably absent. Two deaths resulted
from major complications.
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The relative advantages of ESWL therapy include:
(1) the availability of many first-generation machines in
medical communities; (2) the minimal invasiveness of
the procedure; (3) the reported high success rate of stone
clearance even when applied to large stones; and (4) the
relatively low complication rate. The relative disadvan-
tages include: (1) the lack of FDA approval for use of
machines in the biliary tree; (2) high cost of such ma-
chines; (3) the need for a percutaneous or nasobiliary
tube for cholangiography, (4) the need for general, epi-
dural, or intravenous anesthesia; and (5) the need for ex-
traction of fragments (ERCP or percutaneous) in most
In summary, the application of ESWL for bile duct
stones is evolving. Where available, it appears as a good
"next approach" for patients in whom ERCP maneuvers
have failed to clear the ducts of stones. Additionally, this
therapy appears attractive to fragment stones, which then
may permit easier application of dissolving agents and1
or smaller sphincterotomies (with potentially lower com-
plication rates). FDA approval and additional experience
with second-generation machines, which require that
less analgesia be administered to patients, are awaited.
Further information about this technique will be found
in the review by Albert and Fromm elsewhere in this
issue of Seminars.
DISSOLUTION
Contact Dissolution
Bile duct stones are insoluble precipitates of
aqueous bile. Dissolving such stones via ductal irrigation
remains an attractive alternative. Unfortunately, search
for a rapidly effective, inexpensive, readily available
solvent remains elusive. Solvents may be instilled by
percutaneous transhepatic or cholecystic, T-tube, or na-
sobiliary routes. Complete dissolution is not required be-
cause smaller fragments may be flushed out or extracted.
Monoctanoin (Moctanin) is the only readily available,
212 SEMINARS IN LIVER DISEASE-VOLUME 10, NUMBER 3, 1990

FDA approved, agent for bile duct stone dissolution.
This agent is a reasonably effective cholesterol solvent
but requires prolonged stone and solvent contact time."
In a review of the published experience of 343 patients
treated with monoctanoin, partial or complete stone dis-
solution occurred in 5~4%."~'Dissolution therapy ap-
peared to be more successful with smaller stones. Aver-
age therapy duration was 7 days. Unfortunately, 67% of
patients experienced side effects, although most of these
were mild.'"' Such marginal efficacy of monoctanoin
largely limits its practical utilization to the early post-
operative setting via T-tube route (see Algorithm, Fig 2).
Unfortunately, large stones that fail ERCP-ES removal
are usually refractory to monoctanoin infusion.
Methyl tert-butyl ether (MTBE) is a powerful cho-
lesterol solvent."" The speed and efficacy of MTBE for
cholesterol gallstone dissolution is well documented.""
Its efficacy and toxicity for common bile duct stones are
more problematic. In summarizing 64 patients reported
in five published 18 patients had complete
stone dissolution and an additional 18 had partial disso-
lution, which then aided subsequent stone removal.
Overall, 56% of patients appeared to have benefited
from MTBE. As with monoctanoin, small stones dis-
solve more readily than large stones. The frequency of
complications varied in these series but, overall, approx-
imately half the patients had drowsiness, nausea, or ab-
dominal pain. Duodenitis may be observed on endos-

T-Tube in-situ

/
Stone 18mm diameter LAsympt~matic or
minor symptoms

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Very high risk
Saline flush Dissoivent patient (e.g.
+ sphincter infusions: long term
relaxants monoctanoin; anticoagulation)
methyl tertiary
fail butyl ether t- 7
(if available) Oral agent
dissolution

Significant
NolYes
symptomslcholangitis -- and stone
Endoscopic
Y/e) extractlon
Sphincterotomy
Failed
Ext raction
Failed
Walt 5-6 weeks Sphincterotomy
Very high risk patient
J
Endoscopic Access
Stent
+ oral
agent
dissolution
Good risk
patient Approach varies with
percutaneous YeslNo locallregional facilities
transhepatic and expertise
procedure

Percutaneous
Transhepat ic Mechanical
extractionlfragmentation Laser
dissolution or Electrohydraulic
DissoiutionlNaso-
biiiary tube
Surgical Bile Duct
Exploration

+
Lithotripsy

\
Above fails
or not
available
FIG. 2. Management of patients with postcholecystectomy bile duct stones as well as the elderly and high-risk
patients with gallbladder in situ.
MANAGEMENT OF BILE DUCT STONES-SHERMAN,
copy. Close contact between MTBE and the bile duct
stone is necessary for dissolution. Because of its low
specific gravity, MTBE will float on bile and may sepa-
rate from stones. Therefore the biliary tube must be ap-
propriately positioned for maximal contact. Aspiration
of bile before MTBE administration also facilitates con-
tact. In addition, the use of a balloon to block MTBE
flow into the duodenum will not only facilitate dissolu-
tion, but may help to prevent side effects.ln5Ether-resis-
tant balloons must be used.
Based on the information just given and the current
lack of FDA approval for this agent, it is unlikely that
MTBE will be widely used for ductal stones, although it
may have a role in the postoperative state with a T-tube
in place.
Most primary duct stones contain little or no lipid-
soluble material and therefore will not dissolve in lipid
solvents. Ethylene diaminetetraacetic acid (EDTA) so-
lutions with varying combinations of detergents are
being evaluated for dissolution of primary (calcium bi-
lirubinate) stones."" Leung and colleague^"'^ used 1%
EDTA bile duct irrigations in patients with large pigment
stones and recurrent cholangitis. It is unclear from their
data whether the success rate (50%) was due to simple
mechanical flushing and enhanced breaking up of stones
or was actually due to dissolution.""
Oral Agent Dissolution
Oral agents have been used in an attempt to dissolve
common duct stones. The results with chenodeoxycholic
acid have shown limited success, since only 10 to 44%
of stones completely disappeared. "0-"4 In a randomized
double-blind placebo-control study evaluating the effi-
cacy of ursodeoxycholic acid, 28 patients with common
duct stones, but no evidence of cholangitis or jaundice
(plasma bilirubin less than 2 mgidl), were entered.lI5
Fourteen patients were treated with ursodeoxycholic acid
at a dose of 12 mglkglday for up to 2 years. In the treated
group, the stones completely dissolved in seven and par-
tially in one (57.1%) while the stone size and number
remained unchanged in patients taking the placebo (p =
0.0003). Abdominal pain and biliary colic became less
frequent in the treatment group (p < 0.05) compared
with the placebo group. Moreover, three patients in the
placebo group developed complications requiring sur-
gery in contrast to only one in the treated group. Lirussi
et al"' reported the disappearance of intrahepatic stones
TABLE 6. Need for Cholecystectomy After Endoscopic Sphincterotomy with Gallbladder in Situ*
Series (Ref No. Av. Age Follow-up mos.
No.) Putients (vrJ (MeaniRanpeJ
*Adapted from Dowsett et al." Reprinted by permission
tMedian.
HAWES, LEHMAN 2 13
in three patients after 2 to 3 months of ursodeoxycholic
acid at 1.2 gmlday. In another study assessing the effi-
cacy of oral dissolution therapy, patients with radiolucent
common duct stones were treated with Rowachol (a ter-
pene preparation) alone, or in combination with cheno-
deoxycholic acid or ursodeoxycholic acid."' Forty-two
percent of patients treated with Rowachol achieved com-
plete stone disappearance within 3 to 48 months. When
Rowachol was combined with chenodeoxycholic acid or
ursodeoxycholic acid, 72% of patients achieved com-
plete dissolution within 18 months.
In summary, oral bile salt therapy appears attractive
for the small subpopulation of bile duct stone patients
who are only minimally symptomatic, not jaundiced,
and are at high risk for any intervention (such as hemo-
philiacs). Oral agents appear to be appropriate supple-
ments to ESWL or other fragmentation methods.
SPECIAL PROBLEMS
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Common Bile Duct Stones
with Gallbladder in Situ
Even in the absence of controlled trials comparing
surgery to ES for common bile duct stones, the wide-
spread favorable experience with ES has led to its pres-
ent ~ositionas the treatment of choice in most centers
for patients with choledocholithiasis who have had a
cholecy~tectomy."~ More recently, ES has now been
suggested as a viable alternative for patients with symp-
tomatic common duct stones with gallbladder in situ who
have an anticipated high operative risk. The incidence of
complications after surgical choledochotomy in patients
over 65 years old has been reported to be as high as
30%,"9,"0 with mortality rates varying between 2.9 and
4.4%"' and as high as 5 to 28%."'."3 These figures are
considerably higher than those generally reported with
ES, as already noted (6 to 10% and 0 . 4 to 1.2%, respec-
tively). The fear of doing an ES without removal of the
gallbladder is the subsequent development of gallbladder
and biliary complications ultimately requiring surgery.'24
Although long-term follow-up is not available in many
series, objections to this approach do not seem to be sup-
ported by current data (Table 6)45.'"'"' The incidence of
subsequent cholecystitis and biliary tract complications
are low. Those patients requiring urgent cholecystectomy
usually do so within the first year after ES. The risk of
No. Other
Operations Biliary Lute
Needed Svmntoms Deaths
214
TABLE 7. Results of a Prospective Randomized Trial of Conventional Treatment Versus ERCP
Suspected Acute Gallstone Pancreatitis*
Mild-conventional
GS. confirmed
GS, not confirmed
Mild-ERCPIES
GS. confirmed
GS. not confirmed
Severe-conventional
GS, confirmed
GS, not confirmed
Severe-ERCPIES
GS. confirmed
GS. not confirmed
'"Adapted from Neoptolemos and Carr-Locke."" Repr~ntedby pcrmissil
tGS: gall\tonea.
developing gallbladder symptoms requiring surgery ap-
pears greater for those with a blocked cystic duct at the
time of ERCP and those with ~ h o l e l i t h i a s i s . ' ~ ' - ~ "
The role of ES in patients with an intact gallbladder
who are a good surgical risk is more controversial. Be-
cause the mortality rate of common bile duct exploration
in patients less than 60 years old is 1 to 2% (similar to
ES),"'."" most young patients should probably undergo
surgery. However, with deve1opmr:nt of nonsurgical
techniques for treating gallbladder stones (example,
ESWL, chemical dissolution, laser lithotripsy), it may
be realistic for a patient to be treated solely by a non-
surgical regimen.
Acute Gallstone Pancreatitis
Most patients with gallstone pancreatitis have a
mild attack and can be treated conservatively. 1 3 ' . 1 ' J The
mortality rate from this disease overall is about 15%.13'
Early surgical treatment has been reported as benefi-
~ i a l , ' ~detrimental,137.'3%r
' of no harm. '3".'J0 Many of
these studies suffer from their use of retrospective data,
historical controls, and lack of definition of the severity
of pancreatitis. Because many studies have found that
urgent surgery (particularly for severe disease) is asso-
ciated with increased mortality, this approach has not
gained general acceptance. Since its introduction in 1978
for patients with acute gallstone pancreatitis, ERCP and
ES have proved to be safe and probably effective. 1'"-14J
Although these uncontrolled reports were encouraging,
studies varied in their methods of patient selection and
timing of ES in relation to the acute attack (many were
done in the postacute phase when surgery is also safe).
More recently, in a randomized prospective controlled
trial for acute biliary pancreatitis, 121 patients were en-
tered to receive either conventional therapy or to undergo
urgent (within 72 hours) ERCP with ES and stone ex-
traction (if stones were present in the common bile duct
at the time of the ERCP)."" Patients were stratified by
the predicted severity of their attack using the modified
Glasgow system. The results are seen in Table 7. The
four important findings are: (1) ERCP could be safely
SEMINARS IN LIVER DISEASE-VOLUME 10, NUMBER 3, 1990
+ ES in
Corri/~lic~titioi~s N o . Patients
with
done whether or not common bile duct stones were pres-
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ent; (2) there was a significant reduction in the major
complications of patients who underwent urgent ERCP
and ES (p = 0.03); (3) the reduction in morbidity was
only apparent in those with predicted severe attacks
(p = 0.007); (4) there was a significant reduction in hos-
pital stay for those with severe attacks treated with ur-
gent ERCP and ES (median 9.5 days versus 17 days,
p = 0.03).i4"Mortality, however, was not found to be
statistically different. This evidence leaves little doubt
that ES has an important role in the management of se-
vere gallstone pancreatitis. This therapy should also be
considered in patients with a mild attack who fail to im-
prove.
Role of Endoscopic Clearance of the Bile
Duct Prior to Cholecystectomy
In the surgically low-risk group of patients with
symptomatic common duct stones and gallbladder in
situ, it has been suggested that a preoperative ERCP and
ES be done.'47The hypothesis is that the combined risks
of ES and cholecystectomy are less than cholecystec-
tomy and common bile duct exploration.148In a random-
ized study testing this hypothesis, the overall complica-
tion rate (major plus minor) for the group treated by ES
and cholecystectomy was 32.7%, compared to 22% in
the group treated by surgery alone (not statistically dif-
ferent).'" Mortality was not different in the two groups,
but hospitalization was shorter for the combined
procedure group. The study was terminated after the
trend against preoperative endoscopic sphincterotomy
emerged. Of interest, most of the complications in the
ES group were in those who failed ES or stone extrac-
tion. As Cotton'4x points out, the use of a nasobiliary
tube or temporary stenting (not performed in this study
for patients who failed ES or stone extraction) probably
would have lowered the complication rate in these pa-
tients. In a nonrandomized study, the effects of endo-
scopic removal of common duct stones before elective
cholecystectomy was compared with cholecystectomy
and common bile duct exploration for patients with
MANAGEMENT O F BILE DUCT STONES-SHERMAN, HAWES, LEHMAN
symptomatic choledocholithiasis, but without "prohibi-
tive surgical risk."I5" In patients who underwent opera-
tive common duct stone removal, the complication rate
was 21.8%. This rate was reduced to 2.1% by preoper-
ative ERCP and stone extraction. The retained stone rate
(2.2 to 0.5%) and mortality rate (3.8 to 1%) was simi-
larly reduced by preoperative endoscopic stone removal.
The authors concluded that endoscopic removal of com-
mon bile duct stones before elective cholecystectomy is
a suitable approach to reducing the morbidity of biliary
tract surgery. The opposing results of these two studies
in part reflect different patient populations, different
study protocols, and perhaps varying expertise of the
surgeons and endoscopists. Additional prospective com-
parative studies are needed to clarify this issue.
PERCUTANEOUS METHODS TO
TREAT CHOLEDOCHOLITHIASIS
Mechanical extraction techniques using fluoro-
scopic guidance are routinely used to remove stones in
the common duct. 1 s 1 - 1 5The 7 commonest application of
these techniques is in the patient with retained common
duct stones after cholecystectomy when a T-tube remains
in place. Retained stones may occur in up to 15% of
patients after common bile duct e ~ p l o r a t i o n . " ~ Some '~".~~~
of these stones may pass, but in the majority. they will
have to be removed."" Further surgical exploration has
higher morbidity and mortality and is less successful
than the first With adequate experience,
the success rate of stone extraction via a T-tube should
approach 95%, with complications occurring in less than
5%.1".157Retained small common duct stones may also
be removed with a variable success rate of 25 to 50% by
saline flush with passage aided by coincident use of glu-
cagon, nitroglycerin, or ceruletide to relax the sphinc-
ter, 1 5 x . l This
~ ~ technique has the advantage of not requir-
ing 4 to 6 weeks for T-tube tract maturation. The use of
monoctanoin has met with variable success, as already
d e ~ c r i b e d . ' ~The
" experienced radiologist can employ
lithotripsy (mechanical, electrohydraulic, or laser) with
or without the aid of choledochoscopy if routine extrac-
tion methods fail.
Using mechanical extraction techniques when a T-
tube tract is not available requires that a percutaneous
transhepatic entry to the bile duct be made with a con-
comitant increase in invasiveness and complication
rate. I " I . I"' In general, mechanical extraction of bile duct
stones via a transhepatic approach should be reserved for
those patients in whom ES failed and who are considered
poor surgical c a n d i d a t e ~ . l " ~In. l ~a ~series of 50 patients formed if pigment stones are found."ntraoperative cho-
with symptomatic common duct stones, percutaneous
transhepatic removal was successful in 93%. ''"tones
fragments in the common duct were pushed (using a
Dormia basket) into the duodenum through a balloon-
dilated papilla or previously created sphincterotomy.
Monooctanoin (25 patients) or MTBE (four patients) was
used to reduce stone size or remove residual debris.
Complications occurred in 17%, with a mortality of 4%.
This complication and mortality rate compares favorably
to those of surgery (particularly since 22 patients were
2 15
believed to be high surgical risks), but are clearly higher
than that associated with ES and stone removal. It is
noteworthy that 32 patients referred for this procedure
had failed ES, refused ES, or had unfavorable anatomy
to perform a sphincterotomy (that is, patients had a cho-
ledochojejunostomy).
Transhepatic balloon dilation of the distal common
bile duct and ampulla of Vater is a relatively new tech-
nique. Using this method, Berkman and colleague^'^^
successfully pushed common bile duct calculi into the
duodenum in 17 patients without any significant compli-
cations or mortality. Eight of the 17 patients in this series
had failed to have their stones removed endoscopically.
A percutaneous transhepatic route for the introduc-
tion of a fiberoptic choledochoscope is an alternative
method to remove biliary stones. In a series from Tai-
wan, stones were successfully removed in 80% with only
one patient of 20 having a significant complication.
Stone removal is facilitated by initial fragmentation via
electrohydraulic or laser lithotripsy under direct vision
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through the c h o l e d o ~ h o s c o p e . ~ ~ ~
Combined percutaneous and endoscopic procedures
have been used successfully to treat choledocholithiasis
when endoscopic access to the biliary tree cannot be ac-
complished. 1h'.17"
SURGICAL TREATMENT OF COMMON
BILE DUCT STONES
Surgical therapy represented the only successful
treatment of common duct disease until 15 years ago.
Choledochotomy and choledocholithotomy were the
principal surgical therapies for common duct stones. If
surgery is performed primarily for cholelithiasis and
common bile duct stones are suspected, an intraoperative
cholangiogram should be performed via the cystic duct. I'
Intraoperative cholangiography has been shown to de-
crease the incidence of negative common duct explora-
tions (65 to 35%) and missed common duct stones (15
to 8%).".171 Absolute indications for exploring the com-
mon duct include a positive intraoperative cholangio-
gram, known choledocholithiasis, palpable common
duct stones, and active cholangitis.' During common
duct exploration, a drainage procedure (that is, sphinc-
teroplasty or choledochoduodenostomy) is generally in-
dicated for any of the following: previous common bile
duct exploration, distal stricture, multiple stones, or in-
ability to remove all Recent evidence demon-
strating a high incidence of bacteria within pigment
stones would suggest that a drainage procedure be per-
ledochoscopy has been shown to decrease the incidence
or of overlooked stones from 8-10% to 24%.".17' A
T-tube should be left in the common duct for cholangi-
ography prior to terminating the operation as well as af-
ter the procedure to check for residual stones and to fa-
cilitate biliary decompression. After 5 to 7 days of
gravity drainage, a cholangiogram should be done to
confirm the absence of stones or leak. The patient can
then be discharged to return for T-tube removal 7 to 14
days later.
216
TABLE 8. Morbidity and Mortality from Surgical Common Bile Duct Exploration* for Calculous Disease
Rqf: No. Stutlx
No. Ptrtic~~lt.s 1111c,rl~t1/
173 507 1978-1984
60 248 I981L19X5
174 102 1976- 1986
175 81 1981-1986
Total 938
*Includes biliary drainage procedure in selected patients
tCCX: simultaneous cholecystectomy.
As with surgery for any disease state, complications
of the disease or the surgery may occur in the operative
and postoperative intervals. The surgical complications
result from the consequences of the surgery itself and
more incidental events, such as myocardial infarction
and stroke. These adverse outcomes are usually tallied
through the first 30 days after surgery. In contrast, en-
doscopists and radiologists typically report only the di-
rectly related complications occurring in the immediate
postprocedure interval. Unfortunately, reported compli-
cations are often not separated as to major or minor
events. With these reservations, Table 8 summarizes the
morbidity and mortality rates associated with common
bile duct exploration for calculous disease. h".'73-'7' Of
the 938 patients summarized, 6 to 8.5% had major com-
plications and 2.2% died. Morbidity and mortality were
increased if patients were older than 65 years, jaundiced,
had acute cholangitis, or had significant systemic medi-
cal illness.
PATIENT MANAGEMENT ALGORITHM
There is a remarkable variety c~ftechniques avail-
able to attack the bile duct stone. Figure 2 outlines a
currently suggested sequential application of these tech-
niques for patients with bile duct stones postcholecystec-
tomy. Although patient management must be individu-
alized, most patients with a T-tube in place can have
their stones flushed out, dissolved, or extracted via the
T-tube tract. Eighty-five to 90% of patients without a
T-tube in place can have their bile duct stones success-
fully removed after ES using a balloon or Dormia basket.
The majority of the remaining 10 to 15% of symptomatic
patients may require more sophisticated endoscopic ap-
proaches using lithotripters or be managed by ESWL.
Although such expertise is not always available in a
given medical community, most patients can easily travel
to a facility where these techniques are available. The
patients failing to have their duct cleared of stones by
endoscopic methods may be treated by laparotomy and
common duct exploration if they are a good surgical risk.
Very poor surgical risk patients who have failed endo-
scopic extraction can usually be tided over with stenting
or percutaneous techniques.
SEMINARS IN LIVER DISEASE-VOLUME 10, NUMBER 3, 1990
CCX Co111l1lic.c1rio11.s Det1th.s
(R) (%i (%l
100% - 9 ( 1 .X%)
- Major: 21 (8.5%) 10 ( 4 % )
Minor: 35 (14%)
7.5'1 Total 35 (34%) I(I%)
94% Major 5 (6%) 1 (1.2%)
Minor 8 ( 10%)
21 (2.2%)
SPHINCTER OF ODD1 DYSFUNCTION
Commonly, the clinician will see patients with epi-
gastric or right upper quadrant abdominal pain with back
Downloaded by: University of Michigan. Copyrighted material.
radiation, strongly suggestive of biliary colic, yet appro-
priate evaluation shows no evidence of gallbladder dis-
ease or bile duct stones. Gastroesophageal reflux, peptic
ulcer disease, and pancreatitis should be considered. Ad-
ditionally, such patients may have sphincter of Oddi dys-
function. This entity has been previously termed papil-
lary stenosis, biliary dyskinesia, or postcholecystectomy
syndrome. Surgical wedge specimens from the sphincter
have identified adenomyosis, inflammation, muscular
hypertrophy, or fibrosis in approximately 70% of pa-
t i e n t ~ . " ~In
. ' ~addition
~ to pain, these patients may have
pancreatic or biliary ductal dilation as assessed by CT
scan or ultrasound and may have elevation of pancreatic
or hepatic enzymes.
Hogan et have diagnosed and categorized
sphincter of Oddi dysfunction based on ERCP, labora-
tory and clinical criteria (Table 9). Intraoperatively, sur-
geons have based the diagnosis on common bile duct
flow and pressure studies or resistance to passage of a
probe through the major papilla. More recently, ERCP
biliary manometry has been shown to have the highest
predictive value for sphincter of Oddi dysfunction. 17"
Sphincter of Oddi manometry is generally per-
formed using diazepam anesthesia with avoidance of
narcotics and anticholinergics. A triple lumen 5 F cath-
eter perfused by a low-compliance pneumohydraulic sys-
tem is used. A basal sphincter of Oddi pressure of 40
TABLE 9. Suspected Biliary Sphincter Dysfunction
Classification*
Criteria
A. Recurrent biliary-type pain
6 . Liver tests abnormalities?
C . Dilated common bile duct ( > l I nim)
D. Prolonged biliary drainage time (>45 minutes)
Type I = A + B + C + D
Type I1 = A + I or 2 o f B , C,or D
Type 111 = A (pain only)
*Adapted from Hogan et al"'. Reprinted by permission.
tAlkaline phosphatase, bilirubin, or transaminase twice normal
MANAGEMENT OF BILE DUCT STONES-SHERMAN.
mmHg or higher appears to be the most reliable indicator
of disease. We recommend use of sphincter of Oddi
manometry in patients with clinically significant, but
otherwise unexplained, pancreatobiliary pain or idio-
pathic pancreatitis to evaluate the sphincter for dysfunc-
tion more convincingly. In our own recent series of 128
patients with possible sphincter of Oddi dysfunction
studied by manometry, 70%, 51%, and 29% of types I,
11, and 111 patients, respectively, had abnormal mano-
metry.
Once sphincter dysfunction has been documented.
endoscopic ~phincterotomy"')-~~' or surgical sphinctero-
plasty~7fi.~77.~~'is generally recommended. Surgical
sphincteroplasty h a s the advantage of convincingly sev-
ering the biliary and the pancreatic sphincters. ES leaves
the pancreatic sphincter untouched but has the obvious
advantage of not requiring a laparotomy. Sphincter abla-
tion will give pain relief in approximately 75% of pa-
tients. Persistent symptoms, if present. may be due to
residual or recurrent sphincter stenosis. chronic pancrea-
titis, or concomitant other diseases, especially irritable
bowel syndrome. Treatment of patients with type 111
sphincter dysfunction is problematic. Such patients have
only pain and abnormal sphincter manometry. Whether
sphincter ablation is justified in this group or whether
more vigorous medical management with nitrates, cal-
cium channel blockers, or antich~linergics'~' in an at-
tempt to lower sphincter pressure are appropriate needs
further study. ~ r o s ~ e c t i vstudies
e currently are in prog-
ress at our institution comparing surgical sphinctero-
plasty, ES, and medical therapy for patients with sphinc-
ter of Oddi dysfunction.
CONCLUSION
Over the past 15 years there has been a virtual ex-
plosion of technical advances that have aided the man-
agement of bile duct stones and their complications.
Available treatment will depend on local facilities, ex-
perience, and expertise. Collaboration among the sur-
geon, interventional radiologist, and endoscopist offers
the patient the maximal opportunity for the successful
removal of bile duct stones with the least morbidity and
mortality.
The management of bile duct stones is still evolv-
ing. Changes and improvements in technology are likely
to occur. More widespread availability and application
of the new technologies is awaited. Safety and cost re-
main important considerations. Controlled trials will be
needed to answer many remaining questions. The diag-
nostic and therapeutic advancements made in gallstone
disease have highlighted this exciting era in medicine.
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