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Complete Summary

GUIDELINE TITLE

The role of endoscopy in ampullary and duodenal adenomas.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

COMPLETE SUMMARY CONTENT

 
SCOPE
 METHODOLOGY - including Rating Scheme and Cost Analysis
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
 CONTRAINDICATIONS
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

Ampullary and duodenal adenomas

GUIDELINE CATEGORY

Diagnosis
Evaluation
Management
Treatment

CLINICAL SPECIALTY

Colon and Rectal Surgery
Gastroenterology
Internal Medicine
Oncology

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

  1. Evaluation of lesions with endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasound (EUS)
  2. Biopsy of suspicious lesions
  3. Screening colonoscopy for patients with sporadic ampullary or duodenal adenomas

Management/Treatment

  1. Endoscopic removal of ampullary and duodenal adenomas
  2. Prophylactic pancreatic duct stenting during papillectomy
  3. Adjuvant ablative therapies
  4. Postprocedure inpatient observation
  5. 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

METHODOLOGY

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.

RECOMMENDATIONS

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

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified for each recommendation (see "Major Recommendations").

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE 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

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

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.

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Getting Better

IOM DOMAIN

Effectiveness

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2006 Dec

GUIDELINE DEVELOPER(S)

American Society for Gastrointestinal Endoscopy - Medical Specialty Society

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.

DISCLAIMER

NGC DISCLAIMER

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