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## Complete Summary

#### GUIDELINE TITLE

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

#### BIBLIOGRAPHIC SOURCE(S)

Mishkin D, Carpenter S, Croffie J, Chuttani R, Disario J, Hussain N, Liu
J, Somogyi L, Tierney W, Petersen BT. ASGE Technology Status Evaluation
Report: radiographic contrast media used in ERCP. Gastrointest
Endosc 2005 Oct;62(4):480-4. \[23 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16185956)

#### 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)

Mishkin D, Carpenter S, Croffie J, Chuttani R, Disario J, Hussain N, Liu
J, Somogyi L, Tierney W, Petersen BT. ASGE Technology Status Evaluation
Report: radiographic contrast media used in ERCP. Gastrointest
Endosc 2005 Oct;62(4):480-4. \[23 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16185956)

#### 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](http://www.asge.org/PublicationsProductsIndex.aspx?id=358).

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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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008