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

NCT ID: NCT01148693

Last Updated: 2011-09-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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gentamicin

adding 10mg gentamicin to every 10 ml of contrast media

Group Type ACTIVE_COMPARATOR

gentamicin

Intervention Type DRUG

10mg per 10ml of contrast media

Placebo

Identical placebo

Group Type PLACEBO_COMPARATOR

gentamicin

Intervention Type DRUG

10mg per 10ml of contrast media

Placebo

Intervention Type DRUG

Distilled water

Interventions

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gentamicin

10mg per 10ml of contrast media

Intervention Type DRUG

Placebo

Distilled water

Intervention Type DRUG

Other Intervention Names

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Brand name: Gentamicin

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Alireza Norouzi

gastroenterology fellow in DDRC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rasoul Sotudemanesh, MD

Role: STUDY_CHAIR

Tehran Medical University of Medical Science associate professor

Locations

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TUMS Digestive Disease Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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Norouzi A, Khatibian M, Afroogh R, Chaharmahali M, Sotoudehmanesh R. The effect of adding gentamicin to contrast media for prevention of cholangitis after biliary stenting for non-calculous biliary obstruction, a randomized controlled trial. Indian J Gastroenterol. 2013 Jan;32(1):18-21. doi: 10.1007/s12664-012-0208-y. Epub 2012 Oct 19.

Reference Type DERIVED
PMID: 23081843 (View on PubMed)

Other Identifiers

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DDRC-88/19

Identifier Type: -

Identifier Source: org_study_id

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