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

Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148693
• Other study ID #: DDRC-88/19
• Status: Completed
• Phase: N/A
• First received: June 19, 2010
• Last updated: September 18, 2011
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cholangitis

Intervention

Drug:
• gentamicin
10mg per 10ml of contrast media
• Placebo
Distilled water

Locations

Country	Name	City	State
Iran, Islamic Republic of	TUMS Digestive Disease Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	72 hours	No