Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | August 23, 2011 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00222092 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients undergoing endoscopic retrograde cholangiopancreatography |
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| Condition ICMJE | Post-ERCP Acute Pancreatitis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | September 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Greece | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00222092 | ||||
| Other Study ID Numbers ICMJE | SIG-2005 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Ioannina | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Ioannina | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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