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

This study has been completed.
Sponsor:
Information provided by:
University of Ioannina
ClinicalTrials.gov Identifier:
NCT00222092
First received: September 13, 2005
Last updated: August 23, 2011
Last verified: September 2005
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00222092     History of Changes
Other Study ID Numbers: SIG-2005
Study First Received: September 13, 2005
Last Updated: August 23, 2011
Health Authority: Greece: University of Ioannina - Greece

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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014