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

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01060826
• Collaborator: (none)
• Enrollment: 510
• Locations: 2
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 255
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Acute Pancreatitis	Other: fisiologic serum; Drug: somatostatin, intravenous bolus; Drug: somatostatin	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 510 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: May 1, 2009
• Anticipated Primary Completion Date: May 1, 2012
• Anticipated Study Completion Date: May 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The incidence of acute post-ERCP pancreatitis [One week]

Secondary Outcome Measures

1. Identify sub-groups of patients with high risk to develop post-ERCP pancreatitis [One week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Endoscopy Unit Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025
2	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Cristina Gómez, Endoscopy Unit

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• preventing post-therapeutic ERCP pancreatitis

Publications

• 1. Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383-93. 2. Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc 2004;59:845-64. 3. Bordás JM et al. Effects of bolus somatostatin in preventing pancreatitis after endoscopic pancreatography: results of a randomized study. Gastrointest Endosc 1998;47:230-4. 4. Poon RT, Yeung C, Liu CL, et al. Intravenous bolus somatostatin after diagnostic cholangiopancreatography reduces the incidence of pancreatitis associated with therapeutic endoscopic retrograde cholangiopancreatography procedures: a randomized controlled trial. Gut 2003;52:1768-73. 5. Andriulli A et al. Pharmacologic treatment can prevent pancreatic injury after ERCP: a meta-analysis. Gastrointest Endosc. 2000;5:1-7.

• ClinicalTrials.gov Identifier: NCT01060826
• Other Study ID Numbers: 2008-003338-41; 2008-003338-41
• First Posted: Feb 2, 2010
• Last Update Posted: Jun 22, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: acute pancreatits
• Additional relevant MeSH terms: Pancreatitis; Somatostatin

Study Results

No Results Posted as of Jun 22, 2011