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

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ClinicalTrials.gov Identifier: NCT01148693
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : August 22, 2011
Last Update Posted : September 20, 2011
Sponsor:
Information provided by (Responsible Party):
Alireza Norouzi, Tehran University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cholangitis Drug: gentamicin Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparing Addition of Gentamicin vs. Placebo in Preventing Post ERCP Cholangitis in Non-calculus Stenting
Study Start Date : December 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: gentamicin
adding 10mg gentamicin to every 10 ml of contrast media
 Drug: gentamicin
10mg per 10ml of contrast media
Other Name: Brand name: Gentamicin
Placebo Comparator: Placebo
Identical placebo
 Drug: gentamicin
10mg per 10ml of contrast media
Other Name: Brand name: Gentamicin

Drug: Placebo
Distilled water


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Cholangitis [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148693


Locations
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Iran, Islamic Republic of
TUMS Digestive Disease Research Center
Tehran, Iran, Islamic Republic of, 1411713135
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Study Chair: Rasoul Sotudemanesh, MD Tehran Medical University of Medical Science associate professor
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alireza Norouzi, gastroenterology fellow in DDRC, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01148693    
Other Study ID Numbers: DDRC-88/19
First Posted: June 22, 2010    Key Record Dates
Results First Posted: August 22, 2011
Last Update Posted: September 20, 2011
Last Verified: July 2011
Keywords provided by Alireza Norouzi, Tehran University of Medical Sciences:
Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis
Additional relevant MeSH terms:
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Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Gentamicins
 Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action