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Guideline Summary
Guideline Title
The role of endoscopy in the evaluation of suspected choledocholithiasis.
Bibliographic Source(s)
ASGE Standards of Practice Committee, Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. [106 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Choledocholithiasis (gallstones in the common bile duct)

Guideline Category
Diagnosis
Evaluation
Management
Risk Assessment
Technology Assessment
Clinical Specialty
Gastroenterology
Internal Medicine
Radiology
Surgery
Intended Users
Advanced Practice Nurses
Physician Assistants
Physicians
Guideline Objective(s)

To address the role of endoscopy in patients with suspected choledocholithiasis

Target Population

Patients with symptomatic cholelithiasis and suspected choledocholithiasis

Interventions and Practices Considered
  1. Initial evaluation with serum liver biochemical tests and transabdominal ultrasound (US)
  2. Non-endoscopic biliary imaging modalities, including magnetic resonance cholangiography (MRC), intraoperative cholangiography (IOC), laparoscopic US, and laparoscopic bile duct exploration
  3. Endoscopic biliary imaging modalities, including endoscopic US (EUS) and endoscopic retrograde cholangiography (ERC)
  4. Laparoscopic cholecystectomy
Major Outcomes Considered
  • Sensitivity and specificity of diagnostic tests
  • Morbidity
  • Mortality
  • Cost-effectiveness
  • Recovery time

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

A search of the medical literature 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 of 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 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
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

Weaker recommendations are indicated by phrases such as "The Practice Committee suggests," whereas stronger recommendations are typically stated as "The Practice Committee recommends."

Cost Analysis

Guideline developers reviewed published cost analyses.

An endoscopic ultrasound (EUS)-guided diagnostic strategy seems to be cost-effective for many patients with suspected choledocholithiasis. In a cost analysis associated with a prospective trial of EUS for suspected choledocholithiasis in more than 450 patients, an EUS-first strategy was cost-effective for patients with an estimated likelihood of common bile duct (CBD) stones of less than 61%, with the endoscopic retrograde cholangiography (ERC)-first strategy proving the dominant strategy for patients at higher risk. Similarly, a decision analysis assessing the roles of intraoperative cholangiography (IOC), ERC, and EUS in patients undergoing laparoscopic cholecystectomy found EUS to be cost-effective when the estimated risk of CBD stones was 11% to 55%. In both of these cost analyses, EUS and subsequent therapeutic ERC were performed on separate days; procedures performed in tandem with a single sedation may yield even greater savings.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

This document is a product of the American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee. This document was reviewed and approved by the Governing Board of the ASGE. This document was reviewed and endorsed by the Society of American Gastrointestinal and Endoscopic Surgeons Guidelines Committee and Board of Governors.

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.

  1. The Practice Committee recommends that the initial evaluation of suspected choledocholithiasis should include serum liver biochemical tests and a transabdominal ultrasound (US) of the right upper quadrant. (+++O) These tests should be used to risk-stratify patients to guide further evaluation and management.
  2. The Practice Committee recommends that patients with symptomatic cholelithiasis who are surgical candidates and have a low probability of choledocholithiasis proceed to cholecystectomy without additional biliary evaluation (see Figure 1 in the original guideline document). (+++O)
  3. The Practice Committee recommends that patients with an intermediate probability of choledocholithiasis undergo further evaluation with preoperative endoscopic ultrasound (EUS) or magnetic resonance cholangiography (MRC) or an intraoperative cholangiography (IOC) (see Figure 1 in the original guideline document). (+++O) In this group of patients, the Practice Committee suggests that endoscopic retrograde cholangiography (ERC) be deferred unless EUS, MRC, and IOC are unavailable, given the less favorable risk profile of ERC. (+++O)
  4. The Practice Committee recommends that patients with a high probability of choledocholithiasis undergo an evaluation of the bile duct with therapeutic capability, generally preoperative ERC (see Figure 1 in the original guideline document). (+++O) When available, laparoscopic bile duct exploration can serve as an alternative to ERC.
  5. The Practice Committee suggests that EUS or MRC be considered in the diagnostic evaluation of postcholecystectomy patients suspected of having choledocholithiasis when initial laboratory and US data are abnormal yet nondiagnostic. (++OO)
  6. The Practice Committee recommends against early ERC in the evaluation and management of patients with mild acute biliary pancreatitis (ABP) in the absence of clear evidence of a retained stone. (+++O)
  7. The Practice Committee recommends early ERC in patients with acute biliary pancreatitis and concomitant cholangitis, given the observed benefits in morbidity and mortality. (++++)
  8. The Practice Committee suggests that patients with acute biliary pancreatitis and clinical evidence of biliary obstruction be considered for early ERC. (++OO) The Practice Committee cannot recommend for or against early ERC in patients with predicted severe acute biliary pancreatitis in the absence of overt biliary obstruction or cholangitis, given the lack of consensus in the available data. (++OO)
  9. As patients with acute biliary pancreatitis are at least at intermediate risk for choledocholithiasis, the Practice Committee suggests that pre-operative EUS or IOC be considered for these patients when cholangitis or biliary obstruction are absent. (++OO)

Definitions:

GRADE 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

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)

A suggested management algorithm for patients with symptomatic cholelithiasis based on the degree of probability for choledocholithiasis is provided in the original guideline document.

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

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

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate use of endoscopic procedures in the evaluation of patients with suspected choledocholithiasis

Potential Harms

The risks of endoscopic retrograde cholangiography (ERC) include pancreatitis (1.3%-6.7%), infection (0.6%-5.0%), hemorrhage (0.3%-2.0%), and perforation (0.1%-1.1%) in prospective series of unselected patients. However, several patient variables (e.g., young age, female sex) have been identified that serve as risk factors for pancreatitis; similarly, coagulopathy increases bleeding risk and immunosuppression increases the risk of infection at ERC. Thus, risk estimates must be individualized to the patient.

Qualifying Statements

Qualifying Statements

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
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
ASGE Standards of Practice Committee, Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. [106 references] PubMed External Web Site Policy
Adaptation

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

Date Released
2010 Jan
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: John T. Maple; Tamir Ben-Menachem; Michelle A. Anderson; Vasundhara Appalaneni; Subhas Banerjee; Brooks D. Cash; Laurel Fisher; M. Edwyn Harrison; Robert D. Fanelli; Norio Fukami; Steven O. Ikenberry; Rajeev Jain; Khalid Khan; Mary Lee Krinsky; Laura Strohmeyer; Jason A. Dominitz (Chair)

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Endorser(s)
Society of American Gastrointestinal and Endoscopic Surgeons - Medical Specialty Society
Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the American Society for Gastrointestinal Endoscopy Web site External Web Site Policy.

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 27, 2011.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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