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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01060826
First received: January 28, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Acute Pancreatitis
Other: fisiologic serum
Drug: somatostatin, intravenous bolus
Drug: somatostatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • The incidence of acute post-ERCP pancreatitis [ Time Frame: One week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Identify sub-groups of patients with high risk to develop post-ERCP pancreatitis [ Time Frame: One week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 510
Study Start Date: May 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01060826

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Cristina Gómez    620936011    cgomezo@santpau.cat   
Principal Investigator: Cristina Gómez         
Endoscopy Unit Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Carlos Guarner       cguarner@santpau.cat   
Principal Investigator: Cristina Gómez         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Cristina Gómez Endoscopy Unit
  More Information

Additional Information:
No publications provided

Responsible Party: Cristina Gómez Oliva (principal investigator), Cristina Gómez
ClinicalTrials.gov Identifier: NCT01060826     History of Changes
Other Study ID Numbers: 2008-003338-41, 2008-003338-41
Study First Received: January 28, 2010
Last Updated: June 21, 2011
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ministry of Health and Consumption

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
acute pancreatits

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014