https://doi.org/10.1016/j.hpb.2017.10.

012 HPB

ORIGINAL ARTICLE

Proposed standards for reporting outcomes of treating

biliary injuries
Jai Young Cho1, Todd H. Baron2, David L. Carr-Locke3, William C. Chapman4, Guido Costamagna5,
Eduardo de Santibanes6, Ismael Dominguez Rosado7, O. James Garden8, Dirk Gouma9,
Keith D. Lillemoe10, Miguel Angel Mercado7, Daniel K. Mullady11, Robert Padbury12, Daniel Picus13,
Henry A. Pitt14, Stuart Sherman15, Richard Shlansky-Goldberg16, Bjorn Tornqvist17 &
Steven M. Strasberg18
1
Department of Surgery, Seoul National University, Bundang Hospital, Seoul National University College of Medicine, Seongnam, 82,
Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam-si 13620, Republic of Korea, 2Division of Gastroenterology and Hepatology,
Department of Medicine, University of North Carolina, 130 Mason Farm Road CB 7080, Chapel Hill, NC 27599, 3The Center for
Advanced Digestive Care, Weill Cornell Medicine, New York Presbyterian Hospital, 1305 York Avenue, 4th Floor, New York, NY 10021,
4
Section of Transplantation, Department of Surgery, Washington University in St Louis, 1 Barnes Hospital Plaza, St Louis, MO 63110,
USA, 5Digestive Endoscopy Unit, Catholic University of the Sacred Heart, Gemelli Hospital, Largo Agostino Gemelli, 8, Roma, RM
00168, Italy, 6Department of Surgery, Hospital Italiano de Buenos Aires, Juan D. Peron 4190, C1181ACH CABA, Buenos Aires,
Argentina, 7Department of Surgery, National Institute of Medical Sciences and Nutrition, Vasco de Quiroga 15 Col. Seccion XVI, Tlalpan
C.P. 14000, Mexico City, Mexico, 8Clinical Surgery, University of Edinburgh, Royal Infirmary, 51 Little France Crescent, Edinburgh
EH16 4SA, UK, 9Department of Surgery, Faculty of Medicine AMC, University of Amsterdam, Sweelincklaan 15, 1217 CK, Hilversum,
The Netherlands, 10Department of Surgery, White 506, 55 Fruit Street, Massachusetts General Hospital, Boston, MA 02114,
11
Washington University in St Louis, Department of Medicine, Division of Gastroenterology, Campus Box 8124 660 S Euclid Ave, St
Louis, MO 63110, USA, 12Department of Surgery, Flinders Medical Centre and Flinders University, Flinders Dr, Bedford Park SA 5042,
Australia, 13Mallinckrodt Institute of Radiology, Washington University School of Medicine, 510 South Kingshighway Blvd, St Louis,
MO 63110, 14Department of Surgery, Lewis Katz School of Medicine at Temple University, 3509 N. Broad Street, Boyer Pavilion, E 938,
Philadelphia, PA 19140, 15Department of Medicine, Division of Digestive and Liver Disorders, Indiana University Health-University
Hospital, 550 North University Blvd, Suite 1634, Indianapolis, IN 46202, 16Division of Interventional Radiology, Perelman School of
Medicine at the University of Pennsylvania, Hospital of the University of Pennsylvania, Silverstein 1st floor, 3400 Spruce Street,
Philadelphia, PA 19104, USA, 17Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden, and
18
Section of HPB Surgery, Washington University in St Louis, 1 Barnes Hospital Plaza, St Louis, MO 63110, USA

Abstract
Background: There is no standard nor widely accepted way of reporting outcomes of treatment of
biliary injuries. This hinders comparison of results among approaches and among centers. This paper
presents a proposal to standardize terminology and reporting of results of treating biliary injuries.
Methods: The proposal was developed by an international group of surgeons, biliary endoscopists and
interventional radiologists. The method is based on the concept of “patency” and is similar to the
approach used to create reporting standards for arteriovenous hemodialysis access.
Results: The group considered definitions and gradings under the following headings: Definition of
Patency, Definition of Index Treatment Periods, Grading of Severity of Biliary Injury, Grading of Patency,
Metrics, Comparison of Surgical to Non Surgical Treatments and Presentation of Case Series.
Conclusions: A standard procedure for reporting outcomes of treating biliary injuries has been pro-
duced. It is applicable to presenting results of treatment by surgery, endoscopy, and interventional
radiology.

Received 28 July 2017; accepted 21 October 2017

Correspondence
Steven M. Strasberg, Section of HPB Surgery, Washington University in St Louis, 1 Barnes Hospital Plaza,
St Louis, MO 63110, USA. E-mail: strasbergs@wustl.edu

Biliary injuries are usually complications of laparoscopic chole- evolved to treat them and many reports of such treatment out-
cystectomy and are both morbid and costly. Effective surgical, comes are available. However, there is no standard or widely
endoscopic and interventional radiologic techniques have accepted way of reporting outcomes. This hinders comparison of

HPB 2017, -, 1–9 © 2017 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Cho JY, et al., Proposed standards for reporting outcomes of treating biliary injuries, HPB (2017), https://doi.org/10.1016/
j.hpb.2017.10.012
2 HPB
results among approaches and among centers. Furthermore,
heterogeneity among studies represents a major challenge in
assessment of outcomes because of non-standard reporting
methods. Adoption of standardized reporting of outcomes
should allow determination of the degree of clinical heteroge-
neity that exists among studies and improve the ability to
compare studies of biliary injuries.
The following is a proposal to standardize terminology and
reporting of results of treating biliary injuries. The proposal is
largely focused on the outcome of primary repairs of bile duct
injuries. However there is a discussion on how the approach may
be also used for evaluating patients who have had prior failed
attempts at repair.
Methods
The proposal was developed by an international group of nine-
teen surgeons, biliary endoscopists and interventional radiolo-
gists. The method is based on the concept of “patency” and is
similar to the approach used to create reporting standards for
arteriovenous hemodialysis access.1,2 The schema was developed
in an iterative fashion in which a series of plans and questions
were emailed to participants for comment over a period of 18
months. Based on feedback the proposal was modified until this
final document was produced.
The group considered recommendations under the headings:
Definition of Patency, Definition of Index Treatment Periods,
Grading of Severity of Biliary Injury, Grading of Patency, Metrics,
Comparison of Surgical to Non Surgical Treatments and Pre-
sentation of Case Series.
Results
Definition of patency
The purpose of treating biliary injuries is to restore continuity of
the biliary tree and bring patients into a state of cure that will be
referred to as “patency”. Patients may stay in a state of cure or
patency or fall out of that state temporarily or permanently.
What is evaluated is how effectively “patency” is attained and
conserved after treatment of a biliary injury, and if it is lost how
effectively it is restored.
Patency is defined as an open functional biliary tree, free of
stents,a and free of the need for invasive interventions, in a pa-
tient who following completion of treatment has no episodes of
cholangitis, liver abscess, jaundice or external biliary fistula. The
biliary tree must be both open and functional to be in a state of
“patency”. Although uncommon, a repair may be anatomically
patent but nonetheless associated with cholangitis, liver abscess,
a
The word stent is used throughout to indicate any tube placed in the
biliary tree. This includes short tubes that are entirely within the body and
those that exit from the body and which sometimes are called drainage
catheters.
HPB 2017, -, 1–9 © 2017 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Cho JY, et al., Proposed standards for reporting outcomes of treating biliary injuries, HPB (2017), https://doi.org/10.1016/
j.hpb.2017.10.012
jaundice, or external biliary fistula. This type of result is not
considered patency. Therefore, patency means not only anatomic
but functional patency.
Primary patency: If the definition of patency is fulfilled after
the completion of the index surgical or non-surgical treatment of
a biliary injury then the patient is considered to have entered a
state of “primary patency”. If after primary patency is attained an
invasive intervention is required either by surgery, endoscopy or
by interventional radiologic techniques then primary patency is
lost. Similarly, if after primary patency is attained cholangitis,
liver abscess, jaundice or external biliary fistula occur, then pri-
mary patency is lost. The duration of primary patency is the
interval between attainment of patency and loss. Primary
patency is the ideal outcome. A patient who does not achieve
patency at the end of the index treatment period never attains
primary patency. Abdominal pain alone i.e., in the absence of
jaundice, cholangitis, liver abscess, or bile fistula is not consid-
ered to represent a loss of patency.
Secondary patency is a state that may be achieved in a patient
who has either not attained primary patency at the end of the
index treatment period or who has subsequently lost primary
patency. In the former case, if patency is achieved after the
treatment or, in the latter case, restored after additional treat-
ment then the patient is considered to have entered a state of
“secondary patency”. If during the period of secondary patency, a
need for an invasive intervention develops or cholangitis, liver
abscess, jaundice or external biliary fistula occur then secondary
patency is lost. Secondary patency can be lost and regained more
than once. The duration of secondary patency is the interval
between achievement and loss.
It is common for surgical case series to include primary repairs
and re-repairs of failed primary repairs, which are often called
secondary repairs. The term “secondary repair” is undesirable as
it may be confused with “secondary patency” and if two re-
repairs are performed it would be necessary to refer to “ter-
tiary” or more repairs. The term re-repair is suggested and can be
used as first re-repair, second re-repair, and so on.
Definition of index treatment periods
Index treatment period
The index treatment period is the time during which a definitive
attempt is made to obtain patency in an injured biliary tree by
surgical, endoscopic or radiologic means. Surgical treatments
differ from endoscopic or interventional radiologic (IR) pro-
cedures in that surgical repairs are usually accomplished in one
procedure. The most common surgical procedure involves the
formation of one or more biliary-enteric anastomoses. The
surgical procedure is followed by a recovery period. Non-surgical
treatments often require more than one intervention and these
are commonly performed over several months. Recognizing that
the treatments are fundamentally different in this manner the
Index Treatment Period will be different for surgical and non-
surgical treatments.
HPB
Index treatment period for surgical repairs (surgical
treatment and recovery period)
The Index Treatment Period for surgical repair takes into ac-
count the operation and the recovery period which follows. The
total treatment period in which primary patency can be obtained
is fixed at 90 days in duration. If at the end of 90 days, the patient
is alive and free of cholangitis, liver abscess, jaundice, and
external biliary fistula and the biliary tree is free of stents or other
devices, then primary patency has been attained and the clock
starts on duration of primary patency. Stated otherwise, the
follow-up period for primary patency begins at 90 days after the
operative repair. The use of stents or performance of endoscopic
or IR procedures during the 90 day interval does not affect the
achievement of primary patency provided the biliary tree is free
of stents at the end of that time interval. The occurrence of
cholangitis, liver abscess, jaundice, bile collections, or external
biliary fistula within the 90 day period do not affect the
achievement of primary patency but these must be absent at 90
days. However, if during the 90 day recovery period from the
primary bile duct reconstruction, a bile duct re-repair, a liver
resection or a liver transplant is performed, or death occurs, then
primary patency cannot be obtained.
The index treatment period for endoscopic or IR
procedures
The Index Treatment Period for endoscopic or IR procedures is
not a fixed period like the index treatment period for surgical
repair. Rather it is determined by the length of time stents or
other devices are in the biliary tree. The duration of treatment
may be less than a month or as long as 12 months but it cannot
exceed 12 months for primary patency to be attained. The clock
on duration of primary patency starts when treatment is
completed as evidenced by removal of all stents or other devices.
This may be at any time up to 12 months. The occurrence of
cholangitis, liver abscess, jaundice, bile collections, or external
biliary fistula during the index treatment period do not affect the
attainment of primary patency provided that the patient is free of
these at the completion of treatment. Conversion to surgical
treatment or death while under treatment may occur and of
course represents failure to obtain primary patency. Importantly,
reinsertion of stents within the 12 month period in a patient who
became intentionally stent free, before 12 months have elapsed
also constitutes loss of primary patency.
The periods for achieving primary patency i.e. 90 days after
surgery and 12 months after start of endoscopic or IR procedures
are based on standard practice and literature. 90 days is an
accepted standard for reporting postoperative morbidity and
mortality after major surgical procedures. It is also a reasonable
marker for postoperative healing. The presence of a persistent
stricture after 12 months of endoscopic therapy has been used to
define treatment failure3 Also it is commonly the time that pa-
tients are referred for surgery after attempted endo/IR treat-
ments. Surgical and endo/IR treatments are treated equally in
HPB 2017, -, 1–9 © 2017 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Cho JY, et al., Proposed standards for reporting outcomes of treating biliary injuries, HPB (2017), https://doi.org/10.1016/
j.hpb.2017.10.012
3
respect to events during the index treatment period. Cholangitis
may occur early after surgical repair in which a temporary stent is
left in place or due to edema at the anastomosis or there may be a
temporary biliary fistula. Cholangitis may also occur in endo/IR
treatments due to stent blockage or dislodgement. Cholangitis
due to these causes of any severity or frequency is not considered
loss of patency if it is cured at 90 days or 12 months respectively
and has not led to death or a surgical re-repair or repair. This
avoids subjective judgements about what constitutes treatment
versus treatment failure. However, this does not mean that such
events should go unreported. They should be reported as pro-
cedural or postprocedural complications – but not a failure to
achieve primary patency.
Grading of severity of biliary injury
Since there is a wide spectrum in the severity of biliary injuries
ranging from cystic duct leak to transection of multiple bile
ducts, comparison between treated groups requires use of a
severity grading system when comparisons are made. Such a
system should be simple and rational.
The proposed grading of biliary injuries is based on a publi-
cation by Strasberg et al., in 1995 (Fig. 1).4
Severity Grade 1 (SG1): Type A and D injuries (lateral injuries
which do not result in discontinuity of the biliary tract)
Severity Grade 2 (SG2): Type B, C, E1, E2, E3. (Axial injuries
which result in single discontinuity of the biliary tree)
Severity Grade 3 (SG3): Type E4, E5. (Axial injuries which
result in two or more discontinuities of the biliary tree)
Most SG1 injuries will be treated by non-surgical means
whereas most SG3 injuries will be treated surgically. The main
area for comparison of between surgical and non-surgical
treatments will likely be for SG2 injuries.
Grading of patency
The grading of patency is based on whether primary patency is
achieved, the durability of primary patency, whether secondary
patency is achieved and maintained, and the type and number of
procedures needed to achieve secondary patency.
The criteria are similar but necessarily different for surgical
methods (Table 1) and endoscopic/interventional radiologic
methods (Table 2). There are 4 grades. Grade A is primary
patency. Grades B–D are for patients who failed to achieve
primary patency in the index treatment period or who sub-
sequently lose patency. Such patients may be brought or
restored to secondary patency by additional treatment. These
levels differ by degree of patient morbidity, ie duration or type
of additional treatment or reason for loss of patency. Grade D
also includes patients who never achieve patency or lose it
permanently. Development of cirrhosis is also classified as
grade D. Cholangitis is one of the criteria for grading and its
diagnosis is based on criteria given in the Tokyo Guidelines
2013 (Tokyo guidelines will be revised in 2017 and published
in 2018).5
4 HPB
Figure 1 Proposed grading of biliary injuries into 3 categories of severity
Metrics
The metrics are:
Per Cent of Patients Attaining Primary Patency;
Actuarial Primary Patency Rate (Grade A);
Grade B, C and D Secondary Patency Rates;
Actuarial Secondary Patency Rates after Surgical Re-
Repairs.
1) Per cent of patients attaining primary patency
This metric measures the success of initial treatment. The
denominator represents all patients who entered treatment and
the numerator all patients who attained primary patency by the
end of the index treatment period expressed as a percentage.
2) Actuarial primary patency rate (Grade A outcome)
This is the most important metric in evaluating outcome. It is
calculated as a Kaplan–Meier survival curve. It has the advan-
tages of having time as a continuous variable and the ability to
account for variable follow-up periods. It also incorporates the
metric for Per Cent of Patients Attaining Primary Patency.
The time plot starts at the completion of treatment. Patients
who did not achieve primary patency within the index treatment
period are treated as having “died at day zero” similar to an
operative death in a survival curve. As an example, if 5% of
patients fail to attain primary patency by the completion of the
index treatment period then the zero time, Actuarial Primary
Patency Rate, would be plotted at 95%.
HPB 2017, -, 1–9 © 2017 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Cho JY, et al., Proposed standards for reporting outcomes of treating biliary injuries, HPB (2017), https://doi.org/10.1016/
j.hpb.2017.10.012
Those patients who attain and maintain primary patency are
treated as being “alive” for the period from the date of completion
of the index treatment to the time of follow-up. Patients who lose
primary patency are treated as having “died” at the time that
primary patency is lost. Patients lost to follow-up are censored at
the time of last follow-up. Patients still within the index treatment
period are not plotted in the curve. Other appropriate aspects of
Kaplan–Meier curve plotting should be respected including an
indication of “at risk” patients and discontinuance of the plot
when fewer than 10% of patients are at risk.
As with cancer survival curves, several metrics may be derived
from the curve. The most useful metrics for comparative pur-
poses are likely to be the per cent of patients who attain primary
patency (as above), and 1, 3, 5 and 10 year actuarial primary
patency rates.
An example of a primary patency curve is shown in Fig. 2. The
curve is derived from recently published data from Washington
University in St Louis.6
3) B, C and D results and secondary patency rates (Grade
B–D outcomes)
These outcomes are measured as actual rather than actuarial
rates.
Per cent of patients in whom secondary patency is attained
or restored by procedures listed under Grade B and
measured at 3, 5 and 10 years from completion of
treatment.
HPB 5

Table 1 Classification of patency after primary treatment of bile duct injuries by surgery

Grade A result: primary patency attained within the 90 day surgical treatment period and maintained thereafter
 Biliary tree is free of stents and other devices at completion of treatment.
 Cholangitis, liver abscess, jaundice, and external biliary fistula do not occur after completion of treatment.
 No invasive interventions of the biliary tree are required after completion of treatment.
 Second bile duct reconstruction, liver resection or transplantation do not take place within the 90 day treatment period.
Grade B result: primary patency not achieved or lost. Secondary patency achieved and maintained by any one of the following:
 Stents or other devices are retained for up to 18 months from the day of surgery.
 Endoscopic or IR treatment of the biliary tree or liver is required after the 90 day treatment period in a patient who achieved primary patency and
treatment is completed within one year after commencement of that treatment.
 Only one or two episodes of cholangitis have occurred as defined by Tokyo Guidelines 2013 and have been successfully treated.
 Liver abscess has occurred once and successfully treated.
 Bile fistula has occurred and healed within one year of onset.
Grade C result: primary patency not achieved or lost. Secondary patency achieved and maintained by any one of the following:
 Stents or other devices are retained for more than 18 but fewer than 24 months from the day of surgery.
 Endoscopic or IR treatment of the biliary tree or liver is required after the 90 day treatment period in a patient who achieved primary patency and
treatment is completed more than one year after commencement of that treatment.
 More than one temporary loss of patency after surgical repair requiring treatment by endoscopic or percutaneous means.
 Three or more episodes of cholangitis have occurred as defined by Tokyo Guidelines 2013.
 Liver abscess has occurred on more than one occasion at least 3 months apart.
 Bile fistula has occurred and healed within two years.
 A second surgical bile duct reconstruction is performed.
Grade D result:
 Indwelling stent present for more than 24 months from the day of surgery.
 A third surgical bile duct reconstruction is performed.
 Liver resection or liver transplantation is needed for unreconstructable biliary tree after the index surgical biliary reconstruction.
 Bile fistula present for more than 2 years.
 Development of cirrhosis.

This metric determines how frequently patients who failed to
achieve primary patency in the index treatment period or who
subsequently lost patency were brought or restored to patency
according to Grade B criteria (Tables 1 and 2). The denominator
comprises all patients. The numerator is all patients who failed to
attain or lost primary patency and who then attained secondary
patency by the use of procedures outlined under Grade B with
results expressed as a percent.
Per cent of patients in whom secondary patency is attained
or by procedures listed under Grade C and measured at 3,5
and 10 years from completion of treatment.
This metric determines how frequently patients who failed to
achieve primary patency in the index treatment period or who
subsequently lost patency were brought or restored to patency
according to Grade C criteria (Tables 1 and 2). The denominator
is all patients. The numerator is all patients who failed to attain
or lost primary patency and who then attained secondary
patency by the use of procedures outlined under Grade C with
results expressed as a percent.
Per cent of patients with a Grade D result.
This metric determines how frequently patients who failed to
achieve primary patency in the index treatment period or who
subsequently lost patency were brought or restored to patency
according to Grade D criteria or who permanently lost patency
(Tables 1 and 2). The denominator comprises all patients. The
numerator is all patients who failed to attain or lost primary
patency and who then attained secondary patency by the use of
procedures outlined under Grade D or who permanently lost
patency with results expressed as a percent.
4) Actuarial secondary patency rates after surgical re-repairs
Re-repairs should not be included with primary repairs in
reports as the operative conditions and operations are different
and such reporting can lead to heterogeneity among studies.
However results of re-repairs may be plotted as a separate sur-
vival curve using the same criteria as for the actuarial primary
patency rate with the time plot beginning 90 days after the
operative re-repair. Failure to obtain functional patency by 90
days after re-repair should be presented in the curve as described
for actuarial primary repair curves (i.e. as “died at day zero” in a
survival curve). Using these methods actuarial primary patency
rates for the initial repair and actuarial secondary patency rates
for the first or later re-repair may be correctly compared.
Comparison of surgical to non surgical treatments
and presentation of data within a case series
Under certain conditions, a patient may be a candidate only for a
surgical treatment or only for a non-surgical treatment. In other
circumstances a patient may be ineligible for either surgical
treatment or non-surgical treatment. The main contraindication
to surgical treatment is a patient who is unfit for the required
surgical procedure as a result of variables such as advanced age or
comorbid conditions. The main contraindication to non-surgical

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Please cite this article in press as: Cho JY, et al., Proposed standards for reporting outcomes of treating biliary injuries, HPB (2017), https://doi.org/10.1016/
j.hpb.2017.10.012
6 HPB

Table 2 Classification of patency after primary treatment of bile duct injuries: endoscopic or percutaneous treatments

Endoscopic or percutaneous treatments

Grade A result: primary patency attained at the latest by 12 months after initiation of treatment and maintained thereafter
 Biliary tree is free of stents and other devices at completion of treatment.
 Cholangitis, liver abscess, jaundice, and external biliary fistula do not occur after completion of treatment.
 No invasive interventions of the biliary tree are required after completion of treatment.
 No conversion of treatment to bile duct reconstruction, liver resection or transplantation while under non-surgical treatment.
Grade B result: primary patency not achieved or lost. Secondary patency achieved and maintained by any one of the following:
 Stents or other devices are retained for up to 18 months after initiation of treatment.
 Endoscopic or IR treatment of the biliary tree or liver is required after in a patient who achieved primary patency and treatment is completed
within one year after commencement of that treatment.
 One or two episodes of cholangitis have occurred as defined by Tokyo Guidelines 2013 and have been successfully treated.
 Liver abscess has occurred and successfully treated.
 Bile fistula has occurred and healed within one year.
Grade C result: primary patency not achieved or lost. Secondary patency achieved and maintained by any one of the following:
 Stents or other devices are retained for greater than 18 months but less than 24 after initiations of treatment.
 Endoscopic or IR treatment of the biliary tree or liver is required after in a patient who achieved primary patency and treatment is not completed
within one year after commencement of that treatment.
 More than one temporary loss of patency after repair requiring treatment by endoscopic or percutaneous means.
 Three or more episodes of cholangitis have occurred as defined by Tokyo Guidelines 2013.
 Liver abscess has occurred on more than one occasion at least 3 months apart.
 Bile fistula has occurred and not healed within one year.
 A surgical bile duct reconstruction is performed.
Grade D result:
 Stents or other devices are retained for greater than 24 months after initiation of treatment.
 A second surgical bile duct reconstruction is performed.
 Liver resection or liver transplantation is needed.
 Bile fistula present for more than 2 years.
 Development of cirrhosis.

Figure 2 Example of actuarial primary patency curve. Data provided by authors of reference 6. 122 patients had surgical bile duct repair. Eight
patients (6.6%) did not achieve primary patency within the 90 day index treatment period. Therefore the per cent of patients attaining primary
patency was 93.6%. Two patients lost primary patency in the first year and none thereafter. The long term 5 and 10 year primary patency rate
was 91.8%. First year data are enlarged in the inset

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Please cite this article in press as: Cho JY, et al., Proposed standards for reporting outcomes of treating biliary injuries, HPB (2017), https://doi.org/10.1016/
j.hpb.2017.10.012
HPB
approaches is the inability to place a stent through a stenosis or
bridge a gap between the upper and lower biliary tree. Some
patients may also be too frail or medically unstable to undergo
non-surgical procedures.
The outcome of a patient who is eligible only for surgical
treatment may be reported in surgical case series and the
outcome of a patient who is only eligible for non-surgical
treatment may be reported in case series of patients treated
endoscopically or by IR methods. However, it is inappropriate to
include such patients in studies comparing surgical to non-
surgical techniques. The latter does not lessen the appreciation
that there are complex injuries treatable only by surgery and that
there are patients who, although not surgical candidates, may be
treated successfully by non-surgical means. However, inclusion
of such patients in comparative studies would make the results
uninterpretable.
Patients are frequently prepared for surgery by the placement
of stents which are not intended as definitive treatment of the
injury but as a bridge to surgical repair. Often it is difficult to
ascertain in the early post-injury phase whether stenting may or
may not have a chance of successfully treating an injury.
Consequently the following guidelines are proposed.
1. Patients who are not candidates for surgery should not be
included in studies comparing surgical to non-surgical
techniques.
2. Patients whose injury cannot be repaired by non-surgical
techniques should not be included in studies comparing
surgical to non-surgical techniques.
3. Patients who have stents placed only to facilitate a surgical
repair should not be considered to have been treated by non-
surgical techniques in studies comparing surgical to non
surgical techniques. This is also true in regard to placement of
IR drains.
4. The continued presence of stents for greater than 4 months
after injury in a patient who is fit for surgery is an attempt at
treatment by non-surgical means as opposed to preparation
for surgery.
5. Results will be evaluated by intention to treat. Patients who fail
non-surgical treatment then undergo surgical repair will be
evaluated in the non-surgical group and patients who fail
surgical treatment and then undergo non-surgical treatment
will be evaluated in the surgical group.
6. Patients who have had attempts to repair injuries by non-
surgical methods at facilities outside the study facility(s)
should not be included in comparative studies but should be
included in surgical case series of primary repairs.
7. Patients who have had attempts to repair injuries by non-
surgical methods in a study institution(s) should be included
both in comparative studies and in surgical case series.
8. Operative and postoperative complications related or unre-
lated to patency and the grade of complications need to be
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7
reported in all studies as do procedural complications of
endoscopic and IR procedures.
Discussion
Various investigators report on outcome of repairs of biliary
injuries. However, it is rather difficult to compare outcomes
because of the lack of standard definitions and metrics to express
results. In multiple papers, the main outcome criteria which have
been used in the past are liver function tests,7–16 postoperative
clinical manifestations such as cholangitis,13,17–19 need for
additional treatment to address loss of patency,7,13,17,20–22 and
quality of life.11,14,15,23–25
The method chosen herein is based on the concept of
"patency" and is similar to the approach used to create reporting
standards for arteriovenous hemodialysis access.1,2 Like biliary
injuries arteriovenous hemodialysis access involves surgeons,
internists and radiologists who may use different methods to
create or maintain hemodialysis access. However, although
arteriovenous hemodialysis access was used as a guide it should
be noted that some terms are used differently in this proposal.
The usual surgical procedure employed in repair of a biliary
injury is biliary-enteric anastomosis. However very uncommonly
liver resection is used as the method to recreate functional
patency by removing part or all of the biliary tree. Such re-
sections, including liver transplantation, may be considered
primary repairs at the discretion of authors because the aim is to
recreate functional patency of the biliary tree just as in biliary-
enteric anastomosis.
This proposed schema for grading the severity of biliary injury
is not as nuanced as possible. For instance, vasculobiliary injuries
are not included as a subcategory. However, increased granularity
resulting in multiple levels of severity is undesirable since it
would establish the need for very large numbers of patients to be
able to make statistically valid comparisons. Type D injuries
present a particular problem for a severity classification since
there is a range of injuries within the D category ranging from a
small clean lateral laceration to a laceration that is greater than
50% of circumference or a thermal injury whose full extent may
be difficult to determine initially. Fortunately, the more severe
Type D injuries comprise a very small per cent of biliary injuries
overall. Also as noted in the 1995 classification of biliary injuries,
Type D injuries may evolve into bile duct strictures4 ie Type E
which is a Grade 2 severity. Otherwise stated, injuries classified
initially as a Type D that evolve into circumferential stricture
should be re-classified as a Type E injury and acquire Grade 2
severity status.
Long term stenting (eg 12 months), after biliary reconstruc-
tion of very high injuries involving multiple small ducts may be
beneficial. In the current schema such treatment allows attain-
ment of only secondary patency. Data supporting long term use
of stents after surgical repair are needed to clarify this issue. A
8 HPB
similar remark can be made about longer-term use of stents in
non-surgical treatments.
Liver function tests are not considered in the grading of out-
comes in the present proposal. Mild but persistent abnormalities
of liver function tests are frequent in asymptomatic patients for
years after biliary reconstruction.26 Occasionally, more severe
abnormalities of liver function tests may occur in the absence of
symptoms. These abnormalities may be associated with new or
increasing ductal dilation detected by imaging. To include liver
function test abnormalities and/or ductal dilation as diagnostic
for loss of patency would require setting thresholds for liver
function test abnormalities and/or ductal dilation at which loss
of patency is declared. Also, asymptomatic obstruction of a part
of the biliary tree (even a small part) may cause abnormal liver
function tests, especially alkaline phosphatase, as well as local
ductal dilation. In practice, the decision to perform an invasive
procedure in an asymptomatic patient is based on a complex
clinical judgement that takes multiple factors into account. Thus
in the current proposal loss of patency occurs when liver func-
tion test abnormalities and/or ductal dilation result in the clinical
decision that an invasive procedure is required (and performed).
Stated otherwise, at present it is considered less subjective to rely
on global clinical judgement that an invasive procedure is
required than attempt to stipulate exact criteria for liver function
test abnormalities and/or ductal dilation at which an invasive
procedure is indicated in an asymptomatic patient. Also the
presence of underlying liver disease may occasionally be present
in patients who sustain a bile duct injury and this needs to be
considered.
There is a need to not only adopt a universal set of standards
for reporting but also to adopt a standardized system of follow
up. Comparisons of therapeutic methods of treating bile duct
injury with respect to short term and long term patency will only
be meaningful if patients are followed in systematic way. The
current standard of followup for reporting outcomes of treat-
ment of malignancies should be a useful guide.
There are limitations to the proposed reporting method. The
criteria for Grades A–D are indicative of progressive morbidity
and are based generally on the invasiveness of treatment required
to correct a problem as has been done for reporting of compli-
cations.27–29 However, they are not based on data derived from
the opinion of patients or experts or the cost of interventions.
Furthermore, the reporting system does not include quality of
life or Patient Related Outcome Measures (PROMS) as an
endpoint. Refinement of metrics, inclusion of quality of life
criteria, and determination of relation of grades to quality of life
are future goals of the study group. The same is true of cost. The
reporting method does not include postoperative complications
other than those related directly to patency. The reader is referred
to a recent paper on Standardized Tabular Reporting of biliary
injuries which deals with reporting of complications using
MAGS (Modified Accordion Grading System) and other aspects
of reporting of biliary injuries.6
HPB 2017, -, 1–9 © 2017 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Cho JY, et al., Proposed standards for reporting outcomes of treating biliary injuries, HPB (2017), https://doi.org/10.1016/
j.hpb.2017.10.012
Conflicts of interest
None declared.
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