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

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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

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

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