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

Tehran University of Medical Sciences114 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

114

Conditions

Cholangitis

Interventions

gentamicinDRUG

10mg per 10ml of contrast media

PlaceboDRUG

Distilled water

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

TUMS Digestive Disease Research Center

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

Number of Participants With Cholangitis

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

Time frame: 72 hours

Data from ClinicalTrials.gov

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