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Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00222092
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 24, 2011
Sponsor:
Information provided by:
University of Ioannina

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 22, 2005
Last Update Posted Date August 24, 2011
Study Start Date September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers
Official Title Effect of Octreotide, Somatostatin, Pentoxyfilline or Placebo in the Prevention and the Course of Post-ERCP Pancreatitis and Study of Molecular Markers in Post-ERCP Pancreatitis
Brief Summary Octreotide, somatostatin and pentoxyfilline commercially available drugs that are used in various clinical situations. They are safe and known for years. Octreotide and somatostatin have been used in many studies for the prophylaxis and treatment of pancreatitis and post-ERCP pancreatitis, while pentoxyfilline has shown effect on patients with alcoholic hepatitis, obstructive vasculitis etc. The aim of the study is to evaluate the efficacy of any of those treatments for the prophylaxis and treatment of post-ERCP pancreatitis. In addition some molecular markers of acute and chronic inflammation will be measured before and after the endoscopic procedures according to the study protocol.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients undergoing endoscopic retrograde cholangiopancreatography
Condition Post-ERCP Acute Pancreatitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: August¬†23,¬†2011)
300
Original Enrollment Not Provided
Study Completion Date September 2006
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • patients undergoing endoscopic retrograde cholangiopancreatography

Exclusion Criteria:

  • children, pregnant or breastfeeding women
  • patients with coagulation disorders
  • inability to access the papilla of Vater due to technical difficulties (previous surgery, malignant obstruction)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT00222092
Other Study ID Numbers SIG-2005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor University of Ioannina
Collaborators Not Provided
Investigators
Principal Investigator: Dimitrios Sigounas, MD University of Ioannina
PRS Account University of Ioannina
Verification Date September 2005