Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting
- Registration Number
- NCT01148693
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- Patients with non-calculus biliary obstruction who need palliative treatment
- Fever (> 37.8 Celsius)
- Leukocytosis (WBC > 10,000 /mm3)
- Not candidate for surgical cure of obstruction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo gentamicin Identical placebo Placebo Placebo Identical placebo gentamicin gentamicin adding 10mg gentamicin to every 10 ml of contrast media
- Primary Outcome Measures
Name Time Method Number of Participants With Cholangitis 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
TUMS Digestive Disease Research Center
🇮🇷Tehran, Iran, Islamic Republic of