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

Tehran University of Medical Sciences

Status: Completed

Conditions: Cholangitis

Treatments: Drug: Placebo; Drug: gentamicin

Study type: Interventional

Funder types: Other

Identifiers

NCT01148693

DDRC-88/19

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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114 participants in 2 patient groups, including a placebo group

gentamicin

Active Comparator group

Description:

adding 10mg gentamicin to every 10 ml of contrast media

Treatment:

Drug: gentamicin

Placebo

Placebo Comparator group

Description:

Identical placebo

Treatment:

Drug: gentamicin

Drug: Placebo