General

Guideline Title

The role of endoscopy in the evaluation and treatment of patients with biliary neoplasia.

Bibliographic Source(s)

ASGE Standards of Practice Committee, Anderson MA, Appalaneni V, Ben-Menachem T, Decker GA, Early DS, Evans JA, Fanelli RD, Fisher DA, Fisher LR, Fukami N, Hwang JH, Ikenberry SO, Jain R, Jue TL, Khan K, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Shergill AK, Dominitz JA, Cash BD. The role of endoscopy in the evaluation and treatment of patients with biliary neoplasia. Gastrointest Endosc. 2013 Feb;77(2):167-74. [115 references] PubMed

Guideline Status

This is the current release of the guideline.

Recommendations

Major Recommendations

Definitions for the quality of the evidence (++++, +++O, ++OO, and +OOO) and for the strength of the recommendations (“recommends” or “suggests”) are provided at the end of the “Major Recommendations” field.

The Practice Committee recommends that endoscopic ultrasound (EUS) be performed in patients with suspected ampullary adenocarcinoma or cholangiocarcinoma if the EUS findings or positive fine needle aspiration (FNA) results would change management (+++O).
The Practice Committee recommends magnetic resonance cholangiography (MRC) to assess for resectability if a computed tomography (CT) scan suggests cholangiocarcinoma, particularly of the bifurcation. If the lesion is unresectable, endoscopic palliation of jaundice should be performed by using MRC as a guide for unilateral drainage to minimize the risk of cholangitis (++++).
The Practice Committee recommends endoscopic retrograde cholangiopancreatography (ERCP) to obtain tissue or facilitate further evaluation of indeterminate strictures (+++O).
The Practice Committee recommends that symptomatic patients with gallbladder polyp (GBP) undergo cholecystectomy (+++O).
The Practice Committee suggests that asymptomatic patients with a GBP larger than 10 mm undergo cholecystectomy (++OO).
The Practice Committee suggests that asymptomatic patients with a GBP 6 mm to 10 mm in size and without other risk factors for gallbladder cancer be followed by transabdominal ultrasound (TUS) every 12 months (++OO).
The Practice Committee recommends that the presence of any GBP should prompt cholecystectomy in patients with primary sclerosing cholangitis (PSC) (+++O).

Definitions:

GRADE (Grading of Recommendations, Assessment, Development and Evaluation) System for Rating the Quality of Evidence for Guidelines

Quality of Evidence	Definition	Symbol
High quality	Further research is very unlikely to change confidence in the estimate of effect.	++++
Moderate quality	Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate.	+++O
Low quality	Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate.	++OO
Very low quality	Any estimate of effect is very uncertain.	+OOO

Adapted from Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6.

Recommendation Strength

The strength of individual recommendations is based on both the aggregate evidence quality and an assessment of the anticipated benefits and harms. Weaker recommendations are indicated by phrases such as “the Practice Committee suggests,” whereas stronger recommendations are typically stated as “the Practice Committee recommends.”

Clinical Algorithm(s)

None provided

Scope

Disease/Condition(s)

Biliary neoplasia, including cholangiocarcinoma, gallbladder polyps, and adenocarcinoma of the gallbladder

Guideline Category

Diagnosis
Evaluation
Treatment

Clinical Specialty

Gastroenterology

Intended Users

Physicians

Guideline Objective(s)

To review the approach to the evaluation and treatment of the patient with suspected biliary neoplasia

Target Population

Adults with suspected biliary neoplasia

Interventions and Practices Considered

Endoscopic ultrasound (EUS)
Magnetic resonance cholangiography (MRC)
Endoscopic palliation of jaundice
Endoscopic retrograde cholangiopancreatography (ERCP)
Cholecystectomy
Transabdominal ultrasound (TUS)

Major Outcomes Considered

Sensitivity, specificity and predictability of diagnostic tests for diagnosis and classification
Safety and effectiveness of endoscopic procedures
Effectiveness of endoscopic approaches to treatment

Methodology

Methods Used to Collect/Select the Evidence

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

In preparing this guideline, a search of the medical literature for the years 1980 to 2012 was performed by using PubMed. Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When few or no data exist from well-designed prospective trials, emphasis is given to results from large series and reports from recognized experts.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Weighting According to a Rating Scheme (Scheme Given)

Rating Scheme for the Strength of the Evidence

GRADE (Grading of Recommendations, Assessment, Development and Evaluation) System for Rating the Quality of Evidence for Guidelines

Quality of Evidence	Definition	Symbol
High quality	Further research is very unlikely to change confidence in the estimate of effect.	++++
Moderate quality	Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate.	+++O
Low quality	Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate.	++OO
Very low quality	Any estimate of effect is very uncertain.	+OOO

Adapted from Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6.

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 at the time that the guidelines are drafted.

Rating Scheme for the Strength of the Recommendations

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 is a product of the Standards of Practice Committee. The document was reviewed and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy.

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the “Major Recommendations” field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate use of endoscopy in the evaluation and treatment of biliary neoplasia

Potential Harms

Risk of post-procedural cholangitis or pancreatitis
Complications related to procedures such as endoscopic retrograde cholangiopancreatography (ERCP). If the level of obstruction is at or above the hilum, extensive injection of contrast in ERCP should be avoided to minimize the risk of postprocedural cholangitis because the entire biliary tree may not drain adequately. Magnetic resonance cholangiography (MRC) can be helpful in defining ductal anatomy before ERCP to reduce the risk of this adverse event.

Qualifying Statements

Further controlled clinical studies may be needed to clarify aspects of this guideline. This guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice.
This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients. This guideline is not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions in any particular case involve a complex analysis of the patient’s condition and available courses of action. Therefore, clinical considerations may lead an endoscopist to take a course of action that varies from these guidelines.

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
Living with Illness
Staying Healthy

IOM Domain

Effectiveness
Patient-centeredness
Safety

Identifying Information and Availability

Bibliographic Source(s)

ASGE Standards of Practice Committee, Anderson MA, Appalaneni V, Ben-Menachem T, Decker GA, Early DS, Evans JA, Fanelli RD, Fisher DA, Fisher LR, Fukami N, Hwang JH, Ikenberry SO, Jain R, Jue TL, Khan K, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Shergill AK, Dominitz JA, Cash BD. The role of endoscopy in the evaluation and treatment of patients with biliary neoplasia. Gastrointest Endosc. 2013 Feb;77(2):167-74. [115 references] PubMed

Adaptation

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

Date Released

2013 Feb

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 : Michelle A. Anderson, MD; Vasu Appalaneni, MD; Tamir Ben-Menachem, MD; G. Anton Decker, MD; Dayna S. Early, MD; John A. Evans, MD; Robert D. Fanelli, MD; Deborah A. Fisher, MD; Laurel R. Fisher, MD; Norio Fukami, MD; Joo Ha Hwang, MD, PhD; Steven O. Ikenberry, MD; Rajeev Jain, MD; Terry L. Jue, MD; Khalid Khan, MD, NASPAGHAN Representative; Mary Lee Krinsky, DO; Phyllis M. Malpas, MA, RN, SGNA Representative; John T. Maple, DO; Ravi N. Sharaf, MD; Amandeep K. Shergill, MD; Jason A. Dominitz, MD, MHS ( Previous Chair ); Brooks D. Cash, MD ( Chair )

Financial Disclosures/Conflicts of Interest

The following author disclosed a financial relationship relevant to this publication: Dr D.A. Fisher, consultant to Epigemonics. The other authors disclosed no financial relationships relevant to this publication.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) 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 June 5, 2013.

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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