N/A
N=137
Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting
Cholangitis
Bottom Line
View on ClinicalTrials.gov: NCT01148693 ↗Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Number of Participants With Cholangitis — 5; 5 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- gentamicin (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Tehran University of Medical Sciences
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Cholangitis |
5; 5 | <0.05 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01148693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.