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

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

Status and phase: Unknown; Phase 3

Conditions: Acute Pancreatitis

Treatments: Other: fisiologic serum; Drug: somatostatin, intravenous bolus; Drug: somatostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01060826

2008-003338-41 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 510 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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510 participants in 2 patient groups, including a placebo group

somatostatin, intravenous bolus

Experimental group

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.

Treatment:

Drug: somatostatin, intravenous bolus

Drug: somatostatin

Placebo, intravenous bolus

Placebo Comparator group

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.

Treatment:

Other: fisiologic serum