MENTORING, EDUCATION, AND TRAINING CORNER

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Prateek Sharma, Section Editor
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3 62
4 How to Approach a Patient with Ampullary Lesion 63
5 64
6 Q7 Jennis Kandler and Horst Neuhaus 65
7 66
8 Department of Internal Medicine, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany 67
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T umors involving
the major
duodenal papilla are
high rates of morbidity (transduodenal ampullectomy,
20%–30%; pancreaticoduodenectomy, 25%–50%) and
mortality (transduodenal ampullectomy, 0%–6%; pan-
71
72
14 rare in the general creaticoduodenectomy, 3%–9%).6 Despite the overall good 73
15 population with re- results of the endoscopic approach, relevant procedure- 74
16 ported prevalence related adverse events (AEs) occur in approximately 75
17 rates from autopsy 20%–35%, even in specialized centers.6,7 Thus, to 76
18 series of 0.04%– ensure the greatest efficacy and safety for the patient, EP 77
19 0.12%,1 occurring should be performed in tertiary centers by endoscopists 78
20 most commonly in trained in advanced endoscopic retrograde chol- 79
21 patients of 50–70 angiopancreatography—and endoscopic resection— 80
22 years of age. Never- techniques. In addition, for the appropriate management of 81
23 theless, sporadic AEs, ready access to the full spectrum of pancreaticobiliary 82
24 papillary tumors are surgery and interventional radiology support should be 83
25 more frequently diagnosed with aging population and granted.8 84
26 increasing use of upper gastrointestinal endoscopy, mostly 85
27 incidentally in early asymptomatic stages, although they can 86
28 cause typical symptoms owing to their location, such as Preprocedural Assessment 87
29 obstructive jaundice and pancreatitis. Most of these papil- A thorough pretherapeutic assessment is necessary to 88
30 lary tumors are of neoplastic origin, with a majority of ad- identify patients who are likely to benefit from the endo- 89
31 enomas, following the adenoma to carcinoma sequence scopic approach. Therefore, the estimated risk of LNM must 90
32 similar to colorectal adenocarcinoma.2 In addition, other be negligible and the entire lesion accessible to resection. 91
33 neoplastic, nonadenomatous lesions such as neuroendocrine Lesions with low-grade and high-grade dysplasia with an 92
34 tumors, adenomyomas, or gangliocytic paragangliomas intraductal tumor extension (ITE) of <10 mm are regarded 93
35 occur in this region as well.3 as suitable for EP.5,9,10 Even if the lesion is largely spreading 94
36 to the duodenal wall, between 40 and 60 mm in diameter, 95
37 named laterally spreading tumors of the papilla (LST-P; 96
38 Figure 5A), cure can be achieved by endoscopic treatment Q5 97
39
Treatment Options 98
Owing to the potential cancer progression of most of (EP combined with endoscopic mucosal resection) at rates
40 comparable with lesions confined to the papilla.11 If malig- 99
41 these papillary lesions, with an estimated incidence of ma- 100
lignant transformation ranging from 26% to 65% for spo- nancy is expected, patients usually should be referred to
42 surgery, even in early T1 cancers (tumor limited to Vater’s 101
43 radic adenomas,4 therapy is mandatory in most cases, 102
especially if symptoms are present. As with all neoplasms, ampulla or sphincter of Oddi), owing to high rates of lym-
44 phovascular invasion (LVI; 56.7%) with coexisting LNM 103
45 patient-, lesion- and procedure-related factors like age, 104
comorbidities, anticipated life expectancy, tumor stage (18%).6,12 Otherwise, endoscopic cure of selected low-risk
46 T1 carcinomas is feasible and has been demonstrated in 105
47 (especially risk of lymph node metastases [LNM]) and pro- 106
cedure related risk need to be considered, determining the small series.13–16 If complete resection (R0) was achievable
48 and tumors were well-differentiated without evidence of 107
49 individualized therapeutic approach for each patient. 108
For early, noninvasive tumors, endoscopic resection, also submucosal or LVI, EP was curative in 100% of cases.14
50 For patients with advanced age or major comorbidities, 109
51 known as endoscopic papillectomy (EP), is an effective and 110
safe therapeutic option, showing long-term cure rates of who do not suffer from tumor-related symptoms like jaun-
52 dice with itching or pancreatitis, observation alone may be 111
53 approximately 80% with recurrence rates of about 33% 112
and low morbidity and mortality rates (9.7%–20% and appropriate because the majority of papillary tumors are
54 slowly progressive and the procedure-related risk 113
55 0.09%–0.3%, respectively),3–6 making it a viable alternative 114
56 therapy to surgery. In comparison, the 2 surgical proced- 115
57 ures, the transduodenal ampullectomy, which also can leave 116
© 2018 by the AGA Institute
58 behind residual adenomatous tissue in 13%–100% of cases, 0016-5085/$36.00 117
59 and the more radical pancreaticoduodenectomy, carry https://doi.org/10.1053/j.gastro.2018.11.010
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132 Figure 1. Algorithmic 191
133 approach to a patient with 192
134 ampullary lesion. CT, 193
135 contrast-enhanced multi- 194
136 detector computed to- 195
mography; CTx,
137 chemotherapy; EP, endo- 196
138 scopic papillectomy; EUS, 197
139 endoscopic ultrasound; F- 198
140 up, follow-up; ITE, intra- 199
141 ductal tumor extension; 200
142 LVI, lymphovascular 201
invasion; MRCP, magnetic
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resonance chol-
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144 angiopancreatography; R1, 203

145 histologically confirmed 204
146 incomplete resection; RFA, 205
147 radiofrequency ablation; 206
148 SEMS, self-expandable 207
149 metal stent; SMI, submu- 208
cosal invasion.
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154 substantial. Figure 1 gives an overview of the management Role of Biopsies 213
155 algorithm for patients with ampullary lesions. Biopsies have a limited diagnostic accuracy of between 214
156 45% and 80%, with a high rate of false-negative results 215
157 (16%–60%)3 and carry the risk of inducing pancreatitis.19 216
158 Role of Endoscopy Therefore, only in cases suspicious for cancer, biopsy sam- 217
159 An ampullary lesion is best assessed endoscopically pling is recommended (Figure 1B), because LVI or poor dif- 218
160 with a side-viewing duodenoscope for optimal visualiza- ferentiation might lead to surgery. To minimize the risk of 219
161 tion of the papilla. But how to distinguish adenomas and pancreatitis in these selected cases, biopsies should be taken 220
162 low-risk T1 carcinomas from advanced carcinomas? There from the 9 to 1 o’clock area, far away from the pancreatic 221
163 are no well-established endoscopic criteria predicting orifice. If suspected malignancy cannot be confirmed by bi- 222
164 early neoplasia of the papilla like in other regions of the opsy, and EP is considered to be feasible and safe, resection as 223
165 gastrointestinal tract such as Kudo- or JNET-classification a diagnostic-therapeutic step is appropriate (Figure 1D). 224
166 for characterization of early colorectal neoplasia. Magni- 225
167 fication and optical enhancements like narrow band im- 226
168 aging may be helpful to delineate the lesions extent, Role of Imaging 227
169 especially for LST-P, and to estimate the histologic Preinterventional imaging is not obligatory, especially 228
170 grade17,18; however, this method has not been widely for small lesions (<2 cm), but advantageous to assess ITE, 229
171 adopted. If the lesion is slightly elevated or sessile with the presence of pancreatic duct anatomic variants, such as 230
172 regular surface appearance, soft, movable and non- pancreas divisum, and in cases suspicious for cancer, for 231
173 ulcerated, benign disease seems likely (Figure 2A, local tumor and nodal staging. Because the only main 232
174 Figure 3A). If the lesion is firm, not movable and/or ul- predictor of invasion in ampullary adenomas is size,20 233
175 cerated with spontaneous bleeding, malignancy appears to imaging is recommended for lesions 2 cm or those 234
176 be obvious (Figure 4B). In case of doubt, biopsies should suspicious for cancer3 (Figure 1C). For this purpose, 235
177 be taken (Figure 1B) or even EP as diagnostic-therapeutic endoscopic ultrasound imaging, magnetic resonance 236
178 step be performed (Figure 1D). imaging/magnetic resonance cholangiopancreatography 237
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260 Figure 2. Endoscopic simple snare papillectomy. A, Endo- 319
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scopic view of an adenoma limited to the major duodenal
262 papilla. B, Resection with a standard polypectomy snare 321
without prior submucosal injection. C, Endoscopic view of the
263 resection site with the orifices of common bile duct (CDB) at
322
264 11 o’clock and main pancreatic duct (MPD) at 5 o’clock, 323
265 surrounded by fibers of sphincter of Oddi (SO). D, Guidewire 324
266 inside the MPD for stent placement. 325
267 Figure 3. Endoscopic papillectomy (EP) of ampullary ade- 326
268 noma (A–G) and endoscopic mucosal resection (EMR) of 327
269 and contrast-enhanced multidetector computed tomogra- oppositely located duodenal adenoma (H–J). Procedure (A–J) 328
and long-term results (K, L). A, Endoscopic view of a papillary
270 phy, endoscopic retrograde cholangiopancreatography, and
lesion in the upper part of the picture with a large vertical 329
271 intraductal ultrasound imaging are used complementarily,
extension and only small laterally spreading component. In 330
272 because no test has proven to be definitive. Despite the the lower part, a slightly elevated (Paris 0-IIa) laterally 331
273 high diagnostic accuracy concerning T staging and ITE,21,22 spreading adenoma. B, Selective submucosal injection of the 332
274 the application of intraductal ultrasound imaging is limited extrapapillary component. C, En bloc resection of the entire 333
275 in clinical practice owing to its limited availability, expense lesion with a polypectomy snare (white starlet). D, Endo- 334
scopic view of the resection area. E, Cannulation of the
276 and the linked risks (eg, pancreatitis). 335
pancreatic orifice with a standard catheter. F, Pancreatic
277 Tables 1–3 provide an overview of the role of
guidewire in place. G,. Plastic 10F biliary and 5F pancreatic 336
278 endoscopic ultrasound imaging, computed tomography, stents have been placed. H, Duodenal adenoma with sub- 337
279 magnetic resonance imaging, endoscopic retrograde chol- mucosal injection and partial resection of the lateral portion. I, 338
280 angiopancreatography, and intraductal ultrasound imaging Completed EMR with mild ongoing bleeding. J, Several clips 339
281 in preinterventional imaging, with corresponding overall have been placed. K, L., Surveillance endoscopy at 4 years. 340
282 accuracies. Bland scar of the papilla (K) and the opposite duodenal wall 341
(L) with no recurrence.
283 342
284 343
285 Role of EP as Diagnostic-Therapeutic Step 344
286 In uncertain borderline cases, in which no definitive How to Perform EP 345
287 diagnosis or prediction of curative resectability is possible With EP, neoplastic tissue from the papilla, more precisely 346
288 by endoscopy, biopsy, and imaging, and en bloc resection the mucosa and submucosa of the duodenal wall, can be 347
289 seems to be feasible and safe, EP can provide accurate his- removed endoscopically, and therefore the term “endoscopic 348
290 tology, as well as grading, T and LVI staging in cases of papillectomy” is a more appropriate term than “endoscopic 349
291 malignancy. If high-risk features for LNM like LVI or poor ampullectomy,” although the two often are used inter- 350
292 differentiation are encountered, subsequent surgical man- changeably in clinical practice. Ampullectomy refers to the 351
293 agement is not hampered by prior EP (Figure 4). Lesions surgical removal of the entire ampulla of Vater and consists of 352
294 considered to be eligible for this approach are 20 mm in circumferential resection of the papilla with reinsertion of 353
295 diameter and feature 10 mm lateral extension, because the common bile duct and the main pancreatic duct into the 354
296 these conditions enable en bloc resection with a low duodenal wall, which necessitates longitudinal duodenotomy 355
297 procedure-related risk.25 and partial resection of pancreatic head tissue.26 356
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Figure 5. Endoscopic papillectomy (EP) and endoscopic
369 mucosal resection (EMR) of a large laterally spreading tumor 428
370 of the papilla (LST-P). A, Late recurrence of LST-P in an 429
371 elderly patient after surgical ampullectomy, presenting with 430
372 obstructive jaundice, unfit for repeat surgery. B, Resection 431
373 area with a biliary fully covered self-expandable metal stent 432
374 (FC-SEMS) in place. 433
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376 435
377 locating the pancreatic orifice for stent placement after 436
378 resection can be facilitated by adding methylene blue to 437
379 contrast medium, minimizing the risk for post-EP pancrea- 438
380 titis.27 Occasionally, cannulation may be difficult or even 439
381 impossible, especially with large lesions, because the tumor 440
382 may obscure the ductal orifices. In this case, especially if a 441
383 magnetic resonance cholangiopancreatography has been 442
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384 done, excessive attempts at cannulation should be avoided 443

385 to minimize the risk of post-EP pancreatitis.28,29 For this 444
386 reason, rectal nonsteroidal anti-inflammatory drugs, like 445
387 indomethacin or diclofenac, should be applied before EP, as 446
388 well.3,28 In cases of failed cannulation before resection, 447
389 Figure 4. Endoscopic papillectomy (EP) of ampullary T1
cholangiogram and pancreatogram should be obtained 448
390 carcinoma as diagnostic-therapeutic step. A, Magnetic
after EP. 449
391 resonance cholangiopancreatography of a patient with pain- 450
392 less jaundice and assumed small filling defect (yellow circle) 451
393 at the distal common bile duct (CDB), suspicious for intra- Resection 452
394 ductal tumor extension (ITE) of <1 cm. B, Endoscopic view of To minimize the risk of recurrence and enable accurate 453
an ulcerated tumor arising from the major duodenal papilla. histologic assessment, complete en bloc resection of the
395 454
Biopsy revealed well-differentiated adenocarcinoma without entire lesion should be the goal and is usually feasible for
396 lymphovascular invasion (LVI). Imaging (endoscopic ultra- 455
397 lesions 20 mm in diameter and  10mm lateral exten- 456
sound, computed tomography) showed T1 stage and no ITE,
398 sion.6,25,30 For these kind of lesions, EP without prior sub- 457
lymph node (LNM), or distant metastases (not shown). C,
399 Endoscopic retrograde cholangiography excluded ITE (yellow mucosal injection (simple snare papillectomy [SSP]; 458
400 arrow). D, En bloc resection of the tumor with a polypectomy Figure 2) may be a simpler and primarily recommendable 459
401 snare (white arrow) without prior submucosal injection. E, technique, as submucosal injection papillectomy (SIP) 460
Endoscopic view of the resection site. F, Plastic 5F straight showed no advantage over SSP in terms of achieving com-
402 461
stent inside main pancreatic duct and 10F pigtail stent (black plete resection (SIP 50% vs SSP 81%) or decreasing the
403 starlet) inside the CDB. Histology revealed submucosal and 462
404 frequency of postpapillectomy AEs, such as bleeding (SIP 463
lymphovascular invasion. The patient was referred to surgery,
405 pancreaticoduodenectomy was performed without detection
36% vs SSP 27%) and pancreatitis (SIP 25% vs SSP 15%), 464
406 of residual carcinoma but 1 LNM; therefore, adjuvant although the recurrence rate was similar (SSP 12% vs SIP 465
407 chemotherapy was conducted. 10%).31 To capture the lesion, the tip of a snare is anchored 466
408 above the superior part of the papilla. As the snare is 467
409 carefully opened, it is drawn down over the lesion, while the 468
410
Cholangiography and Pancreatography tip of the snare maintains its contact with the mucosa and 469
411 After thorough endoscopic inspection of the lesion con- the duodenoscope is gently pushed inferiorly into the duo- 470
412 cerning extent and malignancy and before resection, fluo- denum. This maneuver has been termed the “fulcrum 471
413 roscopic evaluation of the distal common bile duct and main technique”8 (Figure 2B). The snare is closed maximally and 472
414 pancreatic duct is recommended, with particular attention the mobility of the papilla is assessed. If the entrapped tis- 473
415 paid to filling defects that may suggest ITE or coexisting sue is independently mobile relative to the duodenal wall, it 474
416 neoplastic changes of the ducts (Figure 4C). Furthermore, is transected by application of electrocautery (Endocut Q, 475
476
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 MENTORING, EDUCATION, AND TRAINING CORNER
477 Table 1.Evaluation of Intraductal Tumor Extension 536
478 Endoscopic Ultrasound Endoscopic Retrograde Intraductal Ultrasound 537
479 Imaging Cholangiopancreatography Imaging 538
480 539
481 Accuracy 91%23 84%23 90%22 540
482 541
483 542
484 543
485 effect 3, ERBE VIO 300D, Tübingen, Germany). Standard rectal nonsteroidal anti-inflammatory drugs should be 544
486 braided polypectomy snares, as well as thin wire snares can applied before EP as mentioned.28 545
487 be used, because there is no evidence of superiority of 1 546
488 type of snare over another.3 However, some authors 547
Biliary Stenting/Sphincterotomy
489 recommend the use of thin wire snares, because they may 548
Routine biliary stenting and sphincterotomy are gener-
490 maximize current density for swift transection, probably 549
ally not necessary; the evidence for this approach is weak
491 minimizing inadvertent injury to the pancreatic orifice, 550
and cholangitis as well as papillary stenosis after EP are
492 increasing the risk of late stenosis.25 The first concern after 551
rare.3,6 In patients with EP and extensive piecemeal re-
493 successful resection is to retrieve the specimen to prevent 552
sections of LST-P and, thus, a high risk for delayed bleeding
494 distal migration. For this purpose, the snare should be used 553
with consecutive ascending cholangitis from haemobilia as
495 to lift the specimen above the papilla to drop into the 554
well as papillary stenosis, prophylactic biliary stenting is
496 duodenal bulb. 555
recommended.11 If the bile duct is not dilated, plastic stents
497 In lesions with a large vertical extension and only a small 556
are appropriate.6 Fully covered self-expandable metal stents
498 laterally spreading component, selective submucosal injec- 557
(Figure 5B) may have some beneficial effects, theoretically,
499 tion should be used only to elevate the extrapapillary 558
regarding the closure of unanticipated microperforations at
500 component with the goal to perform en bloc resection of the 559
the resection site, prevention of delayed bleeding, and
501 entire lesion25 (Figure 3). In case of LST-P (Figure 5, Video 560
dilation therapy of the distal common bile duct, which may
502 1), standard duodenal endoscopic mucosal resection tech- 561
facilitate subsequent direct endoscopic assessment and
503 niques are used to remove the laterally spreading compo- 562
treatment of residual tissue in case of ITE. However, evi-
504 nent, first aiming to isolate the papilla for en bloc resection 563
dence for these indications is lacking.8
505 at the end.6 In this case, submucosal injection of the adjacent 564
506 mucosa should be performed cautiously, to avoid a papilla, 565
507 buried between the lifted mucosa. Ablative Therapies 566
508 Limited data suggest that EP and intraductal ablative 567
509 therapies like radiofrequency ablation may effectively treat 568
510 Pancreatic Stenting ITE of ampullary neoplasms, even >1 cm and, therefore, 569
511 As a second priority after resection, pancreatic stent may be appropriate in selected patients, particularly when 570
512 placement should be performed if possible, because it may the main treatment alternative is surgery.10,34 For final 571
513 decrease the risk of post-EP pancreatitis.27,32 Patients with recommendations concerning this matter, prospective, ran- 572
514 complete pancreas divisum on magnetic resonance chol- domized controlled trials are needed. 573
515 angiopancreatography are of course excluded from this 574
516 recommendation. The pancreatic orifice is usually identified 575
517 at the 5 o’clock position of the papillectomy site and should AEs 576
518 be cannulated wire guided28 (Figure 2C, D). If methylene Procedure-related AEs occur in approximately 20%– 577
519 blue has been added to contrast medium before resection, 35% and mainly include, with decreasing incidence, 578
520 identification of the pancreatic orifice might be facilitated.27 pancreatitis (4%–20%), bleeding (2%–30%), perforation 579
521 However, whether or not pancreatic stent placement can (0%–4%), and cholangitis (1%–2%) as early complications 580
522 Q3 decrease the rate of PEP remains controversial, because and papillary stenosis (1%–2%) as a late complication.6 581
523 some studies have shown no significant benefit.33 In case of Almost all of these complications can be managed endo- 582
524 difficult pancreatic duct cannulation after EP, excessive at- scopically/conservatively, and even selected cases of 583
525 tempts at cannulation should be avoided because it in- perforation, which is usually retroperitoneal, do not require 584
526 creases the risk of post EP pancreatitis.29 For this reason, surgical intervention and may be managed with gut rest, 585
527 586
528 587
529 Table 2.T Staging 588
530 Endoscopic Ultrasound Computed Magnetic Resonance Intraductal Ultrasound 589
531 Imaging Tomography Imaging Imaging 590
532 591
533 Accuracy 63%–90%22–24 26.1%24 53.8%24 78%–88.9%21, 22
592
534 593
535 594
595
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596 Table 3.N Staging EP is a highly effective albeit complex procedure with 655
597 relevant procedure-related risks, although relatively low 656
Endoscopic Magnetic when compared with surgery. A thoroughly multimodal
598 Ultrasound Computed Resonance 657
599 pretherapeutic assessment is required to identify the indi- 658
Imaging Tomography Imaging
600 vidualized approach for each patient, especially because 659
601 Accuracy 66.7%24 43.5%24 76.9%24 most affected patients are elderly, often with relevant 660
602 comorbidities, and the majority of papillary tumors are 661
slowly progressive. Q6
603 662
604 663
antibiotics, and close surgical involvement.35 The manage-
605 Supplementary Material 664
ment of EP-associated complications has been described in
606 665
detail elsewhere.8,25 Note: To access the supplementary material accompanying
607 this article, visit the online version of Gastroenterology at 666
608 www.gastrojournal.org, and at https://doi.org/10.1053/ 667
609 Postprocedural Care and Follow-up j.gastro.2018.11.010. 668
610 Owing to the frequency and possible severity of pro- 669
611 cedure related risks,7 we perform all our EP procedures as 670
612 an inpatient procedure, which is in accordance with Amer- References 671
613 ican Society for Gastrointestinal Endoscopy guidelines.3 Af- 1. Shapiro PF, Lifvendahl RA. Tumors of the extrahepatic 672
614 ter EP, patients remain fasting for 3–4 hours and then bile-ducts. Ann Surg 1931;94:61–79. 673
615 receive first clear and later nonclear liquids, usually for 3–4 2. Fischer HP, Zhou H. Pathogenesis of carcinoma of the 674
616 days. Furthermore, all patients receive intravenously proton papilla of Vater. J Hepatobiliary Pancreat Surg 2004; 675
617 pump inhibitors twice a day. 11:301–309. 676
618 Pancreatic stent removal should be carried out within 2 3. ASGE Standards of Practice CommitteeChathadi KV, 677
619 weeks after EP to minimize the risk of ductal injuries and is Khashab MA, et al. The role of endoscopy in ampullary 678
620 mostly undertaken 3 days after EP in our unit. This timing and duodenal adenomas. Gastrointest Endosc 2015; 679
621 offers the chance to evaluate the resection site before pa- 82:773–781. 680
622 tient discharge. Endoscopic surveillance of the resection 4. Gaspar JP, Stelow EB, Wang AY. Approach to the 681
623 area with a side viewing duodenoscope (Figure 3K) is per- endoscopic resection of duodenal lesions. World J 682
624 formed at 3-month intervals for 1 year. If residual adenoma Gastroenterol 2016;22:600–617. 683
625 is found, it is usually easily excised or ablated. After this, 5. Aiura K, Imaeda H, Kitajima M, et al. Balloon-catheter- 684
626 subsequent follow-up endoscopies are repeated every 6 assisted endoscopic snare papillectomy for benign tu- 685
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628 However, endpoints for surveillance in these patients have 2003;57:743–747. 687
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633 Sporadic ampullary lesions are rare but more frequently papillectomy for early ampullary tumors: long-term re- 692
634 diagnosed and feature substantial progression to cancer, sults from a large multicenter prospective study. 693
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639 lectomy safe for ampullary adenomas with high-grade 698
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ITE, and trointest Endosc 2010;71:967–975.
648 707
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650 tion be applied for early stage ampulla of Vater cancer? 709
651 CT, computed tomography; EUS, endoscopic ultrasound; Gastrointest Endosc 2006;63:783–788. 710
652 IDUS, intraductal ultrasound; MRCP, magnetic resonance 13. Salmi S, Ezzedine S, Vitton V, et al. Can papillary carci- 711
653 cholangiopancreatography; MRI, magnetic resonance nomas be treated by endoscopic ampullectomy? Surg 712
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