Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting

Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary strictures and stenosis is one of important risk factors for post-ERCP cholangitis. Adding antibiotics to contrast media has proposed in some studies for prevention of cholangitis but remains controversial. In this study we compare effect of adding gentamicin versus placebo in preventing cholangitis in patients who undergone endoscopic stenting for non-calculus strictures and stenosis.

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Key information

Conditions

Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholestasis Digestive System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TUMS Digestive Disease Research Center

Tehran, Tehran Province, 1411713135, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with non-calculus biliary obstruction who need palliative treatment

Exclusion criteria

Fever (> 37.8 Celsius)
Leukocytosis (WBC > 10,000 /mm3)
Not candidate for surgical cure of obstruction

Treatment and study plan

Gentamicin

Drug

10mg per 10ml of contrast media

Other names: Brand name: Gentamicin

Placebo

Drug

Distilled water

Primary outcomes

Number of Participants With Cholangitis

Time frame: 72 hours

After Endoscopic Retrograde CholangioPancreatography (ERCP) in 3 following days we check all participants for syptoms of cholangitis (fever, chills, right upper qudrant (RUQ) pain, leukocytosis) and ruling out other diagnoses than cholangitis

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Comparing Addition of Gentamicin vs. Placebo in Preventing Post ERCP Cholangitis in Non-calculus Stenting

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jun 22, 2010
Registry last updated: Sep 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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