- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00222092
Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers
August 23, 2011 updated by: University of Ioannina
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ioannina, Greece, 45110
- Hepato-Gastroenterology Unit, Medical School of Ioannina - Greece
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients undergoing endoscopic retrograde cholangiopancreatography
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dimitrios Sigounas, MD, University of Ioannina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Completion
September 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
August 24, 2011
Last Update Submitted That Met QC Criteria
August 23, 2011
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIG-2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.