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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01060826

Acronym

crepsmt1

Enrollment

510

Registered

2010-02-02

Start date

2009-05-31

Completion date

2012-05-31

Last updated

2011-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis

Keywords

acute pancreatits

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.

Interventions

OTHERfisiologic serum

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

DRUGsomatostatin, intravenous bolus

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

DRUGsomatostatin

Intravenous bolus 250 micrograms

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
The incidence of acute post-ERCP pancreatitis	One week

Secondary

Measure	Time frame
Identify sub-groups of patients with high risk to develop post-ERCP pancreatitis	One week

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026