The Role of Endoscopy in Ampullary and Duodenal Adenomas

GUIDELINE

The role of endoscopy in ampullary and duodenal adenomas

This is one of a series of statements discussing the use and mortality rates ranging from 1% to 9%,1,5-7 although of gastrointestinal endoscopy in common clinical situa- complication rates tend to be related to surgical case tions. The Standards of Practice Committee of the Amer- volume. ican Society for Gastrointestinal Endoscopy prepared this Endoscopic approaches for the evaluation and treat- text. In preparing this guideline, MEDLINE and PubMed ment of ampullary adenomas now represent a viable alter- databases were used to search publications through the native to surgical therapy. last 15 years related to ampullary and duodenal adenomas by using the keyword(s) ‘‘ampullary adenoma’’ and Evaluation of ampullary lesions before each of the following: ‘‘ampullectomy,’’ ‘‘duodenal endoscopic therapy adenoma,’’ and ‘‘familial adenomatous polyposis.’’ Ampullary adenomas cannot always be distinguished The search was supplemented by accessing the ‘‘related from ampullary carcinomas or nonadenomatous polyps articles’’ feature of PubMed with articles identified on (carcinoid tumors, gangliocytic paragangliomas, etc) on MEDLINE and PubMed as the references. Pertinent studies the basis of endoscopic appearance alone. Suspicious am- published in English were reviewed. Studies or reports pullary lesions should be biopsied before endoscopic re- that described fewer than 10 patients were excluded section is attempted. Brush cytology may offer additional from analysis if multiple series with greater than 10 information to biopsy for the detection of malignancy in patients addressing the same issue were available. selected cases.8 Recommendations were made on the basis of the re- There is no consensus on which ampullary adenomas viewed studies and were graded as to the strength of the should be kept under surveillance and which lesions ( ). supporting evidence Table 1 should be removed endoscopically or surgically. An inci- Guidelines for appropriate use of endoscopy are based dental, small ampullary adenoma may not require further on a critical review of the available data and expert con- evaluation or therapy, depending on the clinical context. sensus. Further controlled clinical studies may be needed Lesions with high-grade dysplasia often warrant therapy to clarify aspects of this statement, and revision may because they may harbor malignancy missed on biopsy be necessary as new data appear. Clinical considera- and to prevent progression to malignancy.9 tion may justify a course of action at variance to these Several authors have advocated that endoscopic re- . recommendations section should only be performed in patients without evidence of invasive cancer.10-12 Although endoscopic re- AMPULLARY ADENOMAS moval of ampullary adenocarcinoma has been described, it cannot be endorsed for routine management.13,14 The Adenomas of the major duodenal papilla, also known finding of high-grade dysplasia is not a contraindication as ampullary adenomas, can occur sporadically or in the to endoscopic removal, but it should prompt removal of context of genetic syndromes such as familial adenoma- the lesion by either endoscopic or surgical means rather tous polyposis (FAP). These lesions have the potential to than management by surveillance on the basis of health 15 undergo malignant transformation to ampullary cancer.1 status. Ampullary adenomas have historically been treated surgi- There are no definitive guidelines as to the size or cally. Surgical options include pancreaticoduodenectomy diameter above which endoscopic removal of ampullary (Whipple’s procedure) or transduodenal ampullectomy adenomas should not be attempted. Many authors recom- R (which can occasionally leave behind residual adenoma- mend that lesions 4 to 5 cm not be treated endoscopi- tous tissue).2-4 Surgical management often allows complete cally, although there are reports of successful endoscopic 10-12,16 removal but carries morbidity, including anastomotic dehis- resection of ampullary lesions of greater size. The cence and fistulae in 9% and 14% of patients, respectively, size of the lesion, however, can affect the endoscopic approach to resection, as discussed below. Endoscopic features such as firmness, ulceration, non- Copyright ª 2006 by the American Society for Gastrointestinal Endoscopy lifting with attempted submucosal injection to create 0016-5107/$32.00 a submucosal fluid cushion, and friability suggest possible doi:10.1016/j.gie.2006.08.044 malignancy and such lesions should be considered for www.giejournal.org Volume 64, No. 6 : 2006 GASTROINTESTINAL ENDOSCOPY 849 The role of endoscopy in ampullary and duodenal adenomas

TABLE 1. Grades of recommendation*

Grade of Methodologic strength recommendation Clarity of benefit of supporting evidence Implications

1A Clear Randomized trials without Strong recommendation; can be important limitations applied to most clinical settings 1B Clear Randomized trials with important Strong recommendation; likely to limitations (inconsistent results, apply to most practice settings nonfatal methodologic flaws)

1Cþ Clear Overwhelming evidence from Strong recommendation; can apply observational studies to most practice settings in most situations 1C Clear Observational studies Intermediate-strength recommendation; may change when stronger evidence is available 2A Unclear Randomized trials without Intermediate-strength important limitations recommendation; best action may differ depending on circumstances or patients’ or societal values 2B Unclear Randomized trials with important Weak recommendation; alternative limitations (inconsistent results, approaches may be better under nonfatal methodologic flaws) some circumstances 2C Unclear Observational studies Very weak recommendation; alternative approaches likely to be better under some circumstances

3 Unclear Expert opinion only Weak recommendation; likely to change as data become available

*Adapted from Guyatt G, Sinclair J, Cook D, et al. Moving from evidence to action. Grading recommendationsda qualitative approach. In: Guyatt G, Rennie D, editors: Users’ guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608.

surgical resection even in the absence of malignancy on curate imaging study with an accuracy superior to that of biopsy specimens.12 EUS.22 Role of endoscopic retrograde cholangiopancrea- There is disagreement as to whether all patients with tography and endoscopic ultrasound. ERCP and EUS ampullary adenomas should undergo EUS before therapy, provide useful information in the assessment of ampullary with some experts proposing that lesions less than 1 cm in adenomas. EUS and intraductal US (IDUS) have emerged diameter or those that do not have suspicious signs of ma- as useful techniques to assess the depth of involvement in lignancy (ulceration, induration, bleeding) do not require patients with ampullary neoplasms. These modalities al- ultrasonographic evaluation before endoscopic removal.23 low the assessment and extent of intraductal extension If available, EUS examination should be considered before and extension beyond the muscularis propria and can al- endoscopic or surgical resection is performed. low evaluation of periampullary lymph nodes in those pa- ERCP with both biliary and pancreatic duct evaluation tients suspected of having cancer. EUS or IDUS of lesions should be performed at the time of endoscopic resection that appear suspicious for harboring cancer may help to to assess for evidence of extension into either ductal sys- select which patients can be considered candidates for en- tem. Several authors have used evidence of intraductal doscopic versus surgical therapy and for guiding the surgi- extension as a criterion for surgical referral.24-26 Other in- cal therapy. EUS has been shown to be superior to CT, vestigators have shown that less than 1 cm of extension magnetic resonance imaging, or transabdominal ultraso- into the common bile duct or pancreatic duct does not nography for tumor staging.17-21 Magnetic resonance im- preclude endoscopic therapy because tissue invading to aging has been found to be superior to EUS for nodal this level may be endoscopically exposed and ablated.27,28 staging in this setting, whereas CT scans and positron emission tomographic scans can detect metastases not Endoscopic resection techniques seen on EUS or IDUS.19,20 One prospective study compar- Techniques of endoscopic removal of ampullary ade- ing EUS, IDUS, and CT scan favored IDUS as the most ac- nomas remain unstandardized, likely because of the

850 GASTROINTESTINAL ENDOSCOPY Volume 64, No. 6 : 2006 www.giejournal.org The role of endoscopy in ampullary and duodenal adenomas relatively small number of formal investigations into this reported using a combination of en bloc and piecemeal practice. Importantly, the term ‘‘ampullectomy’’ refers to resection techniques as the types of lesions treated were removal of the entire ampulla of Vater and is a surgical of mixed size and architecture.10,25,33,37-39 term for procedures that require surgical reimplantation Electrocautery settings. There is no consensus as to of the distal common bile duct and pancreatic duct within which type of current should be used during endoscopic the duodenal wall. Technically, when endoscopic resec- papillectomy. Both pure cutting current and blended cur- tions of lesions at the major papilla are performed, only rent have been used and neither has been proven to be tissue from the papilla can be removed endoscopically, superior over the other at this time. Power settings are and thus the term ‘‘papillectomy’’ is more appropriate also not standardized.10,24-26,38,40 than the term ‘‘ampullectomy,’’ although the two are of- Pancreatic or biliary sphincterotomy. Given the ten used interchangeably in the literature.29 potential for significant tissue injury to the pancreatic Submucosal injection. Several authors have advo- and biliary orifices during endoscopic removal of ampul- cated the use of submucosal injection immediately before lary adenomas, pancreatic or biliary sphincterotomies endoscopic papillectomy in a manner similar to that used are frequently performed during the procedure. Pancre- before performing endoscopic mucosal resection for colo- atic or biliary sphincterotomy may assist in providing rectal polyps. The failure of a lesion to manifest a ‘‘lift pancreaticobiliary drainage after papillectomy, simplify sign’’ is associated with malignancy and is considered attempts to access the common bile duct and pancreatic a contraindication to attempts at complete endoscopic re- duct for stent placement, and assist in postprocedure section (although further endoscopic therapy could be surveillance. There is no consensus as to whether these ma- performed as a form of palliation in a poor operative can- neuvers should be performed at all, much less before or didate).27 Fluids injected into the submucosa have in- after the papillectomy.23,26,27,30,38,41 cluded saline solution, epinephrine, methylene blue, and Pancreatic or biliary stenting. Endoscopic papillec- viscous materials such as hydroxypropyl methylcellu- tomy is associated with an increased risk for postproce- lose.27,30-35 Volumes of injected fluid are not standardized dural pancreatitis. Several studies have shown that and vary widely. Some authors have not used submucosal placement of a prophylactic pancreatic duct stent reduces injection, and there are insufficient data to conclude that the risk of post-ERCP pancreatitis.42 It has been implied this is a necessary step in the procedure.23-25 then that placement of a pancreatic stent during endoscopic papillectomy may also minimize the risk of stenosis Endoscopic resection of the pancreatic duct orifice and may also allow safer use Endoscopic papillectomy is performed by use of endo- of adjunctive coagulative therapies, but this theory is un- scopic snares and electrocautery. In most reports standard proven.12,16,25,30,40 Other authors have suggested that pan- ‘‘braided’’ polypectomy snares have been used, although creatic duct stents should only be used if pancreatic duct fine-wire snares specifically designed for ampullary resec- drainage is deemed suboptimal or if the pancreatic duct is tion are available.24,30,32 There is no evidence document- difficult to cannulate after the procedure.10,26,27 If a pan- ing the utility of one type of snare over another. Snare creatic duct stent is placed before papillectomy is per- position during papillectomy is also not standardized, formed, it may prevent en bloc removal of the lesion, with investigators describing successful papillectomy although en bloc resection may make subsequent pancre- with snares oriented in both a cephalad to caudal orienta- atic duct stent placement difficult. tion and a caudal to cephalad orientation; the majority of The only prospective, randomized, controlled trial to published series have not specifically commented on the evaluate the role of prophylactic pancreatic duct stent- orientation of the snare during the procedure.23,24,27,36 ing for the reduction of post-ERCP pancreatitis after en- If the lesion can be completely ensnared, en bloc doscopic papillectomy showed a statistically significant resection with electrocautery can be performed. En bloc decrease in the rate of postprocedure pancreatitis in resection has the advantages of potentially shortening the stent group.41 On the basis of these data, prophylac- the procedure time, requiring less electrocautery, and pro- tic pancreatic duct stenting during papillectomy is viding a complete tissue sample for pathologic evaluation. recommended to reduce the risk of postprocedural Piecemeal resection (with electrocautery) is often pancreatitis. performed for lesions larger than 2 cm or in cases where Prophylactic biliary stenting to reduce the risk of post- an attempt at en bloc resection has left visible neoplastic procedural cholangitis has not been widely performed and tissue in place. Piecemeal resection may produce cannot be uniformly recommended at this time unless electrocautery-related injury to tissue fragments sent there is concern for inadequate biliary drainage after the for pathologic analysis. Piecemeal snare resection may papillectomy.10,12,30 require repeated submucosal injections over time to Ablative therapies. Although they are not routinely achieve sustained elevation of the adenomatous tissue. used as primary therapy for ampullary adenomas, ablative Larger lesions may require multiple endoscopic proce- therapies (argon plasma coagulation, laser therapy, mo- dures to be completely removed. Most published series nopolar or bipolar electrocoagulation) are useful to www.giejournal.org Volume 64, No. 6 : 2006 GASTROINTESTINAL ENDOSCOPY 851 The role of endoscopy in ampullary and duodenal adenomas destroy residual or recurrent adenomatous tissue not re- incorporating degree of dysplasia and evidence of intra- moved during attempts at primary snare resection. Argon ductal involvement into the decision-making process. plasma coagulation is the most frequently used modality, given its widespread availability and superficial depth of tissue destruction.10,12,24,25,27,30,33,37,39 Unfortunately, tis- Role of papillectomy in FAP sue treated in this manner is not available for pathologic The precise role of endoscopic papillectomy in patients analysis and any suspicious area should be biopsied before with FAP remains unclear because the natural history of ablation. the disease and overall outcome in these patients is de- Postprocedure evaluation. Endoscopic removal of pendent on the entire duodenal carcinogenic risk rather ampullary adenomas is considered a ‘‘high-risk’’ proce- than that of the ampullary lesion alone.1 Natural history dure for complications. A period of postprocedure inpa- studies in patients with FAP suggest slow histologic pro- tient observation should be considered for the detection gression of proximal lesions over time and a relatively and treatment of any immediate or early delayed compli- low risk for development of cancer.44 Of note, patients cations, especially after extensive removal and treatment who have undergone proctocolectomy are still at high of large lesions, in patients with comorbid medical ill- risk for development of ampullary lesions and should un- nesses, those who do not have ready access to medical dergo periodic surveillance for duodenal and ampullary care, and those without support measures. adenoma and carcinoma.26

Results of endoscopic therapy Clinical success. Data on the clinical success of en- NONAMPULLARY DUODENAL ADENOMAS doscopic papillectomy are largely based on retrospective, heterogeneous case series. Successful papillectomy rates Adenomas of the duodenum that do not involve the range from 46% to 92%, although multiple procedures major duodenal papilla can occur sporadically or in the were often required to completely remove all adenoma- 10,12,16,24,25,30,37 context of genetic syndromes such as FAP or Peutz-Jeghers tous tissue. Larger lesions are more likely syndrome and have the potential to undergo malignant to be incompletely excised at the initial endoscopic transformation to duodenal cancer. Management of pa- procedure. tients with FAP, Peutz-Jeghers syndrome, and other related Complications. Early complications after endoscopic conditions is discussed in another guideline.1 The remain- papillectomy are similar in nature to other complications der of this guideline will focus on the management of spo- of ERCP and include pancreatitis, perforation, bleeding, radic duodenal adenomas. sedation complications, and cholangitis. Late complications include the development of pancreatic or biliary stenosis. Reported complication rates derived from data from Evaluation of nonampullary duodenal lesions large, tertiary care referral centers and experienced thera- before endoscopic therapy peutic endoscopists are as follows: pancreatitis 8% to 15%, The endoscopic appearance of duodenal adenomas perforation 0% to 4%, bleeding 2% to 13%, cholangitis 0% may be indistinguishable from nonadenomatous polyps to 2%, and papillary stenosis 0% to 8%.10,12,16,24,25,30,37 such as Brunner’s gland tumors, inflammatory polyps, Death after papillectomy is rare but has been reported.27 carcinoid tumors, and hamartomas. Suspicious lesions should be biopsied before attempted endoscopic resec- Surveillance for residual or recurrent tion. Before endoscopic resection of a duodenal polyp, neoplastic tissue it is important to ensure that the polyp does not involve It is recommended that all patients who have under- the ampulla because the pancreaticobiliary systems need gone endoscopic papillectomy undergo surveillance en- to be addressed as discussed above. Examination with doscopy for the detection of recurrent neoplastic tissue. a side-viewing endoscope or EUS can be helpful in making Reported surveillance intervals have varied but, in general, this distinction. have included an initial surveillance examination 1 to 6 Role of EUS. The precise role of EUS in the manage- months after the index procedure followed by repeat ex- ment of duodenal adenomas is unclear. EUS can establish aminations with a duodenoscope every 3 to 12 months the relationship of the lesion to the pancreaticobiliary tree thereafter for a period of at least 2 years with periodic ex- when this is uncertain after forward and side-viewing ex- aminations thereafter.10,16,25,30,32,33,37,39 Lesions found to aminations and can obviate the need for ERCP. EUS can contain areas of high-grade dysplasia may need to be fol- also allow determination of endoscopic resectability lowed more closely. Endpoints for surveillance have not when biopsy specimens have shown high-grade dysplasia been established. One reasonable approach for sporadic and endoscopic findings are suspicious for malignancy, (non-FAP) ampullary polyps is to adopt a surveillance and it may be useful for evaluation of polyps larger than policy similar to that of patients with flat colonic polyps,43 2 cm.45,46

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Endoscopic resection techniques definitive data are available, it is reasonable to offer Techniques of endoscopic removal of duodenal adeno- screening colonoscopy to all patients who have duodenal mas are not standardized, although the general approach or ampullary adenomas. is similar to that of colonic polyps, particularly those of the right colon because of the thinness of the duodenal wall. A submucosal injection to create a submucosal fluid cush- SUMMARY ion may be useful for removal of flat polyps. The lack of lifting during injection suggests underlying malignancy, d Ampullary and duodenal adenomas have the potential as previously mentioned. Endoscopic mucosal resection for malignant transformation and require appropriate techniques have also been described in the removal of du- diagnostic evaluation. (1C) odenal lesions.45 Adjuvant ablative therapies such as the d Both ERCP and EUS are important tools in the evalua- use of argon plasma coagulation or electrocoagulation tion and staging of ampullary adenomas and can assist may be used to destroy residual or recurrent adenoma- in selecting candidates for endoscopic or surgical ther- tous tissue not removed during attempts at primary snare apy. (1C) resection.47 Small or flat lesions may sometimes be com- d Techniques of endoscopic removal of ampullary neo- pletely removed with ablative methods alone such as ar- plasms are not standardized and should be performed gon plasma coagulation, neodymium:yttrium-aluminum- by experienced endoscopists. (2C) garnet laser, or electrocautery. d Patients undergoing endoscopic removal of ampullary and duodenal neoplasms should undergo postprocedure surveillance to ensure complete tissue removal Results of endoscopic resection for sporadic and lack of disease recurrence. (2C) duodenal adenoma d Endoscopy is useful for evaluation and resection of spo- Data on the clinical success of resection of duodenal radic duodenal adenomas using techniques similar to adenoma in patients with sporadic polyps are based on those used during polypectomy. (2C) a few small case series. In one series of 21 patients with d Patients with sporadic ampullary or duodenal adenomas lesions of a median size of 27.5 mm (range 8-50 mm), are at increased risk for colon polyps and should be of- the success rate for endoscopic removal after a 3-month fered screening colonoscopy. (2C) interval was 55%. After a median follow-up period of 71 months, local recurrences developed in 25%, which were re-treated endoscopically. No patients had carcinoma during the follow-up period.47 REFERENCES Generally, larger lesions are more difficult to remove, 1. Hirota WK, Zuckerman MJ, Adler DG, et al. 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Endoscopic papillectomy for adenomas of the major Waqar Qureshi, MD duodenal papilla (with video). Gastrointest Endosc 2006;63:292-301. Raquel Davila, MD 30. Desilets DJ, Dy RM, Ku PM, et al. Endoscopic management of tumors S. Ian Gan, MD of the major duodenal papilla: refined techniques to improve out- David Lichtenstein, MD come and avoid complications. Gastrointest Endosc 2001;54:202-8. Elizabeth Rajan, MD 31. Park SW, Song SY, Chung JB, et al. Endoscopic snare resection for Bo Shen, MD tumors of the ampulla of Vater. Yonsei Med J 2000;41:213-8. Marc J. Zuckerman, MD 32. Cheng CL, Sherman S, Fogel EL, et al. Endoscopic snare papillectomy for Robert D. Fanelli, MD, FACS, SAGES Representative tumors of the duodenal papillae. Gastrointest Endosc 2004;60:757-64. Trina Van Guilder, RN, SGNA Representative 33. Charton JP, Deinert K, Schumacher B, et al. Endoscopic resection for Todd H. Baron, MD, Chair neoplastic diseases of the papilla of Vater. J Hepatobiliary Pancreat Surg 2004;11:245-51. This document is a product of the Standards of Practice Committee. This 34. Conio M, Rajan E, Sorbi D, et al. Comparative performance in the por- document was reviewed and approved by the Governing Board of the cine esophagus of different solutions used for submucosal injection. American Society for Gastrointestinal Endoscopy on August 30, 2006. Gastrointest Endosc 2002;56:513-6.

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