Somatostatin for prevention of post-ERCP pancreatitis: a randomized, double-blind trial.
Endoscopy
; 46(10): 851-6, 2014 Oct.
Article
em En
| MEDLINE
| ID: mdl-24977398
ABSTRACT
BACKGROUND AND STUDY AIMS:
Meta-analyses suggest that an intravenous bolus or a high dose continuous infusion of somatostatin reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). Clinical guidelines, however, do not recommend this prophylaxis. The aim of this randomized, double-blind clinical trial was to evaluate the effect of somatostatin on the incidence of post-ERCP pancreatitis. PATIENTS ANDMETHODS:
Patients undergoing ERCP at a single center were randomized to either intravenous bolus of somatostatin followed by a short (4-hour) continuous infusion, or to a similar placebo regimen. The primary outcome was post-ERCP pancreatitis, defined as abdominal pain with an amylase level at least three times higher than the upper limit of normality 24 hours after the ERCP and requiring admission for at least 2 days.RESULTS:
A total of 510 patients were enrolled (255 patients per group) and all completed follow-up.âThe main indications for ERCP were choledocholithiasis (62â%), and biliary malignant stricture (31â%). Post-ERCP pancreatitis occurred in 19 patients (7.5â%) in the somatostatin group and 17 patients (6.7â%) in the placebo group (relative risk [RR] 1.12, 95â% confidence interval [95â%CI] 0.59â-â2.1; Pâ=â0.73). The number of cases of moderate or severe acute pancreatitis was similar in the somatostatin (2.4â%) and the placebo (3.5â%) groups (RR 0.67, 95â%CI 0.24â-â1.85, Pâ=â0.43). No side effects were observed related to the use of somatostatin.CONCLUSIONS:
Administration of an intravenous bolus of somatostatin followed by a short continuous infusion does not reduce the incidence of post-ERCP pancreatitis. Clinical Trials.gov number NCT01060826.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pancreatite
/
Somatostatina
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Colangiopancreatografia Retrógrada Endoscópica
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Hormônios
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Guideline
Limite:
Aged
/
Aged80
/
Female
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Humans
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Male
/
Middle aged
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article