search
Back to results

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

Primary Purpose

Cholangitis

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
gentamicin
Placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholangitis focused on measuring Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • TUMS Digestive Disease Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

gentamicin

Placebo

Arm Description

adding 10mg gentamicin to every 10 ml of contrast media

Identical placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 19, 2010
Last Updated
September 18, 2011
Sponsor
Tehran University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01148693
Brief Title
Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting
Official Title
Comparing Addition of Gentamicin vs. Placebo in Preventing Post ERCP Cholangitis in Non-calculus Stenting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangitis
Keywords
Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gentamicin
Arm Type
Active Comparator
Arm Description
adding 10mg gentamicin to every 10 ml of contrast media
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical placebo
Intervention Type
Drug
Intervention Name(s)
gentamicin
Other Intervention Name(s)
Brand name: Gentamicin
Intervention Description
10mg per 10ml of contrast media
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Distilled water
Primary Outcome Measure Information:
Title
Number of Participants With Cholangitis
Description
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
Time Frame
72 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasoul Sotudemanesh, MD
Organizational Affiliation
Tehran Medical University of Medical Science associate professor
Official's Role
Study Chair
Facility Information:
Facility Name
TUMS Digestive Disease Research Center
City
Tehran
ZIP/Postal Code
1411713135
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23081843
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs