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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00222092
First Posted: September 22, 2005
Last Update Posted: August 24, 2011
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.
Information provided by:
University of Ioannina
  Purpose
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.

Condition Phase
Post-ERCP Acute Pancreatitis Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Ioannina:

Estimated Enrollment: 300
Study Start Date: September 2005
Estimated Study Completion Date: September 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing endoscopic retrograde cholangiopancreatography
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)
  Contacts and Locations
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): NCT00222092


Locations
Greece
Hepato-Gastroenterology Unit, Medical School of Ioannina - Greece
Ioannina, Greece, 45110
Sponsors and Collaborators
University of Ioannina
Investigators
Principal Investigator: Dimitrios Sigounas, MD University of Ioannina
  More Information

ClinicalTrials.gov Identifier: NCT00222092     History of Changes
Other Study ID Numbers: SIG-2005
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: August 24, 2011
Last Verified: September 2005

Keywords provided by University of Ioannina:
post-ERCP pancreatitis
prophylaxis
prognosis
natural course
molecular markers

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Octreotide
Somatostatin
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs