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Complete Summary

GUIDELINE TITLE

ASGE technology status evaluation report: radiographic contrast media used in ERCP.

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
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

Pancreatic or hepatobiliary diseases including gallstones, cancers and pancreatitis

GUIDELINE CATEGORY

Diagnosis
Evaluation
Technology Assessment

CLINICAL SPECIALTY

Gastroenterology
Radiology

INTENDED USERS

Physicians

GUIDELINE OBJECTIVE(S)

  • To promote the appropriate use of new or emerging endoscopic technologies and those technologies that impact practice
  • To review the use of contrast media (CM) in endoscopic retrograde cholangiopancreatography (ERCP), including its relation to image quality, the likelihood for systemic absorption, and the risk for, and means of, reducing adverse reactions

TARGET POPULATION

Patients with known or suspected pancreatic or hepatobiliary diseases undergoing endoscopic retrograde cholangiopancreatography (ERCP)

INTERVENTIONS AND PRACTICES CONSIDERED

  1. Endoscopic retrograde cholangiopancreatography (ERCP)
  2. In patients at high risk for contrast media (CM)-related reactions:
    • Steroid pretreatment
    • Substitution of low osmolality contrast media (LOCM) during ERCP

Note: Routine addition of antibiotics to CM was considered but not recommended.

MAJOR OUTCOMES CONSIDERED

Serious adverse events

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

NUMBER OF SOURCE DOCUMENTS

Not stated

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Not stated

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

METHODS USED TO ANALYZE THE EVIDENCE

Review

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

COST ANALYSIS

A formal cost analysis was not performed and published cost analyses were not reviewed.

METHOD OF GUIDELINE VALIDATION

Not stated

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not applicable

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

The safety data derived from studies of the intravascular use of low osmolality contrast media (LOCM) cannot be translated to endoscopic retrograde cholangiopancreatography (ERCP) in view of their low incidence of serious adverse events with nonvascular use. The evidence is lacking to support LOCM as a method for decreasing ERCP complications.

There is no justification for the routine use of LOCM during ERCP. In patients considered at high risk for contrast media (CM)-related reactions (i.e., those with a prior serious anaphylactoid reaction to intravascular CM), premedication and/or substitution of LOCM may be considered as an option based on the above-mentioned theoretical considerations.

The low frequency of sepsis after adequate biliary and pancreatic drainage at ERCP and the lack of data argue against the practice of routinely adding antibiotics to CM. Additional data are needed regarding the use of antibiotics in contrast media for those disease states in which optimal drainage cannot be accomplished.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically stated.

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

Prevention of serious adverse reactions to intravascular administration of contrast media for endoscopic retrograde cholangiopancreatography

POTENTIAL HARMS

  • Systemic adverse reactions to contrast media (CM) used in endoscopic retrograde cholangiopancreatography (ERCP) have been documented, but their true incidence is unknown. Adverse reactions can be characterized as idiosyncratic or nonidiosyncratic, based on their proposed mechanisms. In general, nonidiosyncratic reactions are most likely dose and osmolality related, whereas idiosyncratic (anaphylactoid) reactions usually occur immediately. Acute CM reactions can be subdivided into minor, intermediate/moderate, and severe (see Table 1 "Categories of acute reactions" in the original guideline document).
  • No statistical difference in the risk of clinical post-ERCP pancreatitis with the use of high osmolality contrast media (HOCM) vs. low osmolality contrast media (LOCM); however, high osmolar contrast was associated with an increased incidence of asymptomatic elevations of pancreatic enzymes.

QUALIFYING STATEMENTS

QUALIFYING STATEMENTS

To promote the appropriate use of new or emerging endoscopic technologies and those technologies that impact on endoscopic practice, the American Society for Gastrointestinal Endoscopy Technology Assessment Committee has developed a series of status evaluation papers. This process presents relevant information about these technologies to practicing physicians for the education and the care of their patients. In many cases, data from randomized controlled trials are lacking and only preliminary clinical studies are available. Practitioners should continue to monitor the medical literature for subsequent data about the efficacy, the safety, and the socioeconomic aspects of these technologies.

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

Safety

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

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

DATE RELEASED

2005 Oct

GUIDELINE DEVELOPER(S)

American Society for Gastrointestinal Endoscopy - Medical Specialty Society

SOURCE(S) OF FUNDING

American Society for Gastrointestinal Endoscopy

GUIDELINE COMMITTEE

Technology Assessment Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Daniel Mishkin, MD; Steven Carpenter, MD; Joseph Croffie, MD; Ram Chuttani, MD; James DiSario, MD; Nadeem Hussain, MD; Julia Liu, MD; Lehel Somogyi, MD; William Tierney, MD; Bret T. Petersen, 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 on May 1, 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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