Efficacy of Administration of Somatostatin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis (crepsmt1)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acute Pancreatitis |
Other: fisiologic serum Drug: somatostatin, intravenous bolus Drug: somatostatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- The incidence of acute post-ERCP pancreatitis [ Time Frame: One week ] [ Designated as safety issue: Yes ]
- Identify sub-groups of patients with high risk to develop post-ERCP pancreatitis [ Time Frame: One week ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 510 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Patients undergoing therapeutic endoscopic retrograde cholangiopancreatography (ERCP).
Exclusion Criteria:
- 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.
Contacts and Locations| Spain | |
| Hospital de la Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Cristina Gómez 620936011 cgomezo@santpau.cat | |
| Principal Investigator: Cristina Gómez | |
| Endoscopy Unit Hospital de la Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Carlos Guarner cguarner@santpau.cat | |
| Principal Investigator: Cristina Gómez | |
| Principal Investigator: | Cristina Gómez | Endoscopy Unit |
More Information
Additional Information:
No publications provided
| Responsible Party: | Cristina Gómez Oliva (principal investigator), Cristina Gómez |
| ClinicalTrials.gov Identifier: | NCT01060826 History of Changes |
| Other Study ID Numbers: | 2008-003338-41, 2008-003338-41 |
| Study First Received: | January 28, 2010 |
| Last Updated: | June 21, 2011 |
| Health Authority: | Spain: Spanish Agency of Medicines Spain: Ministry of Health and Consumption |
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
|
acute pancreatits |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatic Diseases Digestive System Diseases Somatostatin |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013