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

Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cholangitis

Intervention: gentamicin (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Tehran University of Medical Sciences

Official(s) and/or principal investigator(s):
Rasoul Sotudemanesh, MD, Study Chair, Affiliation: Tehran Medical University of Medical Science associate professor

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Number of Participants With Cholangitis

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

TUMS Digestive Disease Research Center, Tehran 1411713135, Iran, Islamic Republic of
Additional Information

Starting date: December 2009
Last updated: September 18, 2011

Page last updated: August 23, 2015

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