Efficacy of Administration of Somatostatin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis (crepsmt1)

June 21, 2011 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Randomized, Double-blind Study to Evaluate the Efficacy of Administration With Intravenous Bolus Followed by a Continuous Infusion of Somatostatin in the Prevention of Post-ERCP Pancreatitis

Acute pancreatitis is the most frequent (5-10%) and severe complication after endoscopic retrograde cholangiopancreatography (ERCP), that could require of surgical intervention and lead to death. A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. The main aim of this study will be the incidence of acute post-ERCP pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. The study will include 510 patients submitted to an ERCP during a period of 3 years.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. The main aim of this study will be the incidence of acute post-ERCP pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. The study will include 510 patients submitted to an ERCP during a period of 3 years.

Study Type

Interventional

Enrollment (Anticipated)

510

Phase

  • Phase 3

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

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Principal Investigator:
          • Cristina Gómez
        • Contact:
      • Barcelona, Spain, 08025
        • Recruiting
        • Endoscopy Unit Hospital de la Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Cristina Gómez

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

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Patients undergoing therapeutic endoscopic retrograde cholangiopancreatography (ERCP).

Exclusion Criteria:

  1. Pregnancy or history of allergy to somatostatin.
  2. Acute myocardial infarction within 3 months of the procedure.
  3. Acute pancreatitis in patients undergoing early ERCP in the acute phase of the disease.
  4. Previous sphincterotomy.
  5. Chronic pancreatitis.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: somatostatin, intravenous bolus
A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo.
Drug: somatostatin, intravenous bolus
250 microgramos bolus intravenous in 3 minutes and continuous infusion for 4 hours after endoscopic
Drug: somatostatin
Intravenous bolus 250 micrograms
Placebo Comparator: Placebo, intravenous bolus
A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo.
Other: fisiologic serum
250 microgramos bolus intravenous during 3 minutes and continuous infusion for 4 hours after endoscopic procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of acute post-ERCP pancreatitis
Time Frame: One week
One week

Secondary Outcome Measures

Outcome Measure
Time Frame
Identify sub-groups of patients with high risk to develop post-ERCP pancreatitis
Time Frame: One week
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Principal Investigator: Cristina Gómez, Endoscopy Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

May 1, 2009

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-003338-41 (EudraCT Number)

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.

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