Guideline:
Bibliographic Source(s)
- Standards of Practice Committee Adler DG Qureshi W Davila R Gan SI Lichtenstein D Rajan E Shen B Zuckerman MJ Fanelli RD Van Guilder T Baron TH. The role of endoscopy in ampullary and duodenal adenomas. Gastrointest EndoscĀ 2006 Dec;64(6):849-54. [50 references] PubMed
Guideline Status
This is the current release of the guideline.
Guideline Category
Diagnosis
Evaluation
Management
Treatment
Intended Users
Physicians
Guideline Objective(s)
To discuss the use of gastrointestinal endoscopy for the evaluation and treatment of ampullary and duodenal adenomas
Target Population
Patients with ampullary and duodenal adenomas
Interventions and Practices Considered
Diagnosis/Evaluation/Prevention
- Evaluation of lesions with endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasound (EUS)
- Biopsy of suspicious lesions
- Screening colonoscopy for patients with sporadic ampullary or duodenal adenomas
Management/Treatment
- Endoscopic removal of ampullary and duodenal adenomas
- Prophylactic pancreatic duct stenting during papillectomy
- Adjuvant ablative therapies
- Postprocedure inpatient observation
- Periodic surveillance endoscopy for detection and treatment of recurrence
Note: The following procedures were considered but not recommended due to insufficient data or lack of consensus:
- Submucosal injection
- Pancreatic or biliary sphincterotomy
Major Outcomes Considered
- Effectiveness of endoscopic resection of ampullary and duodenal adenomas
- Accuracy of endoscopic tests
- Complications of endoscopic therapies
Methods Used to Collect/Select Evidence
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
In preparing this guideline MEDLINE and PubMed databases were used to search publications through the last 15 years related to ampullary and duodenal adenomas by using the keyword(s) "ampullary adenoma" and each of the following: "ampullectomy" "duodenal adenoma" and "familial adenomatous polyposis." The search was supplemented by accessing the "related articles" feature of PubMed with articles identified on MEDLINE and PubMed as the references. Pertinent studies published in English were reviewed. Studies or reports that described fewer than 10 patients were excluded from analysis if multiple series with greater than 10 patients addressing the same issue were available.
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Rating Scheme for the Strength of the Evidence
Not applicable
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus.
Rating Scheme for the Strength of the Recommendations
Grades of Recommendation*
| Grade of Recommendation | Clarity of Benefit | Methodologic Strength of Supporting Evidence | Implications |
|---|---|---|---|
| 1A | Clear | Randomized trials without important limitations | Strong recommendation; can be applied to most clinical settings |
| 1B | Clear | Randomized trials with important limitations (inconsistent results nonfatal methodologic flaws) | Strong recommendation; likely to apply to most practice settings |
| 1C+ | Clear | Overwhelming evidence from observational studies | Strong recommendation; can apply 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 important limitations | Intermediate-strength recommendation; best action may differ depending on circumstances or patients' or societal values |
| 2B | Unclear | Randomized trials with important limitations (inconsistent results nonfatal methodologic flaws) | Weak recommendation; alternative approaches may be better under 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 Jaeschke R Schunemann H Pauker S. Moving from evidence to action: grading recommendations—a qualitative approach. In: Guyatt G Rennie D eds. Users' guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608.
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation
This document was reviewed and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy.
Major Recommendations
Recommendations were graded on the strength of the supporting evidence (Grades 1A–3). Definitions of the recommendation grades are presented at the end of the "Major Recommendations" field.
Summary
- Ampullary and duodenal adenomas have the potential for malignant transformation and require appropriate diagnostic evaluation. (1C)
- Both endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) are important tools in the evaluation and staging of ampullary adenomas and can assist in selecting candidates for endoscopic or surgical therapy. (1C)
- Techniques of endoscopic removal of ampullary neoplasms are not standardized and should be performed by experienced endoscopists. (2C)
- Patients undergoing endoscopic removal of ampullary and duodenal neoplasms should undergo postprocedure surveillance to ensure complete tissue removal and lack of disease recurrence. (2C)
- Endoscopy is useful for evaluation and resection of sporadic duodenal adenomas using techniques similar to those used during polypectomy. (2C)
- Patients with sporadic ampullary or duodenal adenomas are at increased risk for colon polyps and should be offered screening colonoscopy. (2C)
Definitions:
Grades of Recommendation*
| Grade of Recommendation | Clarity of Benefit | Methodologic Strength of Supporting Evidence | Implications |
|---|---|---|---|
| 1A | Clear | Randomized trials without important limitations | Strong recommendation; can be applied to most clinical settings |
| 1B | Clear | Randomized trials with important limitations (inconsistent results nonfatal methodologic flaws) | Strong recommendation; likely to apply to most practice settings |
| 1C+ | Clear | Overwhelming evidence from observational studies | Strong recommendation; can apply 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 important limitations | Intermediate-strength recommendation; best action may differ depending on circumstances or patients' or societal values |
| 2B | Unclear | Randomized trials with important limitations (inconsistent results nonfatal methodologic flaws) | Weak recommendation; alternative approaches may be better under 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 Jaeschke R Schunemann H Pauker S. Moving from evidence to action: grading recommendations—a qualitative approach. In: Guyatt G Rennie D eds. Users' guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608.
Clinical Algorithm(s)
None provided
Type of Evidence supporting the Recommendations
The type of supporting evidence is identified for each recommendation (see "Major Recommendations").
Potential Benefits
Appropriate utilization of gastrointestinal endoscopy in the evaluation and treatment of patients with ampullary and duodenal adenomas
Potential Harms
- Early complications after endoscopic papillectomy are similar in nature to other complications of endoscopic retrograde cholangiopancreatography (ERCP) and include pancreatitis perforation bleeding sedation complications and cholangitis. Late complications include the development of pancreatic or biliary stenosis. Death after papillectomy is rare but has been reported.
- Complications after endoscopic resection of duodenal adenomas are similar in nature to complications of colonoscopic polypectomy and include perforation bleeding and complications related to sedation.
- Piecemeal resection may produce electrocautery-related injury to tissue fragments sent for pathologic analysis.
- If a pancreatic duct stent is placed before papillectomy is performed it may prevent en bloc removal of the lesion although en bloc resection may make subsequent pancreatic duct stent placement difficult.
Contraindications
Contraindications to Endoscopic Resection
The failure of a lesion to manifest a "lift sign" is associated with malignancy and is considered a contraindication to attempts at complete endoscopic resection (although further endoscopic therapy could be performed as a form of palliation in a poor operative candidate).
Qualifying Statements
Further controlled clinical studies are needed to clarify aspects of this statement and revision may be necessary as new data appear. Clinical consideration may justify a course of action at variance to these recommendations.
Description of Implementation Strategy
An implementation strategy was not provided.
IOM Care Need
Getting Better
IOM Domain
Effectiveness
Bibliographic Source(s)
- Standards of Practice Committee Adler DG Qureshi W Davila R Gan SI Lichtenstein D Rajan E Shen B Zuckerman MJ Fanelli RD Van Guilder T Baron TH. The role of endoscopy in ampullary and duodenal adenomas. Gastrointest EndoscĀ 2006 Dec;64(6):849-54. [50 references] PubMed
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
American Society for Gastrointestinal Endoscopy
Guideline Committee
Standards of Practice Committee
Composition of Group that Authored the Guideline
Committee Members: Douglas G. Adler MD; Waqar Qureshi MD; Raquel Davila MD; S. Ian Gan MD; David Lichtenstein MD; Elizabeth Rajan MD; Bo Shen MD; Marc J. Zuckerman MD; Robert D. Fanelli MD FACS (SAGES Representative); Trina Van Guilder RN (SGNA Representative); Todd H. Baron MD (Chair)
Financial Disclosures/Conflicts of Interest
Not stated
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available from the American Society for Gastrointestinal Endoscopy Web site.
Print copies: Available from the American Society for Gastrointestinal Endoscopy 1520 Kensington Road Suite 202 Oak Brook IL 60523
Availability of Companion Documents
None available
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI Institute on May 30 2007.
COPYRIGHT STATEMENT
This NGC summary is based on the original guideline which is subject to the guideline developer's copyright restrictions.
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