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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alireza Norouzi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01148693
First received: June 19, 2010
Last updated: September 18, 2011
Last verified: July 2011
Results First Received: February 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Cholangitis
Interventions: Drug: gentamicin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between December 2009 and October 2010 all patients with non-calculus biliary obstructions including cholangiocarcinoma, pancreatic cancer, sclerosing cholangitis, postsurgical benign biliary strictures and biliary stenosis due to metastatic cancers to biliary tree who were candidate for palliative stenting, were included in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria were patients with biliary stones, patients who were candidate for surgical cure, and patients who were already febrile.

Reporting Groups
  Description
Gentamicin participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
Placebo participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography

Participant Flow:   Overall Study
    Gentamicin     Placebo  
STARTED     70     67  
COMPLETED     57     57  
NOT COMPLETED     13     10  
Attempts for cannulation were failed                 13                 10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gentamicin participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
Placebo participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
Total Total of all reporting groups

Baseline Measures
    Gentamicin     Placebo     Total  
Number of Participants  
[units: participants]
  70     67     137  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     40     39     79  
>=65 years     30     28     58  
Age  
[units: years]
Mean ± Standard Deviation
  62.59  ± 15.082     66.74  ± 14.145     64.62  ± 14.533  
Gender  
[units: participants]
     
Female     28     20     48  
Male     42     47     89  
Region of Enrollment  
[units: participants]
     
Iran, Islamic Republic of     70     67     137  



  Outcome Measures

1.  Primary:   Number of Participants With Cholangitis   [ Time Frame: 72 hours ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No limitation other than small sample size  


Results Point of Contact:  
Name/Title: Dr. Rasoul sotoudehmanesh
Organization: Tehran medical university of science
phone: (+98 21) 82414000 ext 82415000
e-mail: r.sotudemanesh@gmail.com


No publications provided by Tehran University of Medical Sciences

Publications automatically indexed to this study:

Responsible Party: Alireza Norouzi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01148693     History of Changes
Other Study ID Numbers: DDRC-88/19
Study First Received: June 19, 2010
Results First Received: February 18, 2011
Last Updated: September 18, 2011
Health Authority: Iran: Ministry of Health