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

NCT01060826 | Unknown Phase 3 DMC

• 1 other identifier: 2008-003338-41
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Pancreatitis

Keywords

acute pancreatits

Outcome Measures

Primary Outcomes (1)

• The incidence of acute post-ERCP pancreatitis

  One week

Secondary Outcomes (1)

• Identify sub-groups of patients with high risk to develop post-ERCP pancreatitis

  One week

Study Arms (2)

somatostatin, intravenous bolus

EXPERIMENTAL

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; Drug: somatostatin

Placebo, intravenous bolus

PLACEBO COMPARATOR

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

Interventions

fisiologic serum OTHER

250 microgramos bolus intravenous during 3 minutes and continuous infusion for 4 hours after endoscopic procedure

Placebo, intravenous bolus

somatostatin, intravenous bolus DRUG

250 microgramos bolus intravenous in 3 minutes and continuous infusion for 4 hours after endoscopic

somatostatin, intravenous bolus

somatostatin DRUG

Intravenous bolus 250 micrograms

somatostatin, intravenous bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing therapeutic endoscopic retrograde cholangiopancreatography (ERCP).

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Endoscopy Unit Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Related Publications (2)

• 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.

  BACKGROUND

• Concepcion-Martin M, Gomez-Oliva C, Juanes A, Diez X, Prieto-Alhambra D, Torras X, Sainz S, Villanueva C, Farre A, Guarner-Argente C, Guarner C. Somatostatin for prevention of post-ERCP pancreatitis: a randomized, double-blind trial. Endoscopy. 2014 Oct;46(10):851-6. doi: 10.1055/s-0034-1377306. Epub 2014 Jun 30.

  PMID: 24977398 DERIVED

Related Links

• preventing post-therapeutic ERCP pancreatitis

MeSH Terms

Conditions

Pancreatitis

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Cristina Gómez

  Endoscopy Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: February 2, 2010
• Study Start: May 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 22, 2011

Record last verified: 2011-06

Locations

ES (2)