Clinical trial NCT01060826: Efficacy of Administration of Somatostatin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Pancreatitis
Keywords: acute pancreatits
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: The incidence of acute post-ERCP pancreatitis
timeFrame: One week
Secondary outcomes:
measure: Identify sub-groups of patients with high risk to develop post-ERCP pancreatitis
timeFrame: One week
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Endoscopy Unit Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Endoscopy Unit
name: Cristina Gómez
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.