title: Somatostatin for prevention of post-ERCP pancreatitis: a randomized, double-blind trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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. The main indications for ERCP were choledocholithiasis (62 %), and biliary malignant stricture (31 %). Post-ERCP pancreatitis occurred in 19 patients (7.5 %) in the somatostatin group and 17 patients (6.7 %) in the placebo group (relative risk [RR] 1.12, 95 % confidence interval [95 %CI] 0.59 - 2.1; P = 0.73). The number of cases of moderate or severe acute pancreatitis was similar in the somatostatin (2.4 %) and the placebo (3.5 %) groups (RR 0.67, 95 %CI 0.24 - 1.85, P = 0.43). 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.
authors: Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Mar
authors: M
authors: Concepción-Martín
authors: Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Cristina
authors: C
authors: Gómez-Oliva
authors: Pharmacology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Ana
authors: A
authors: Juanes
authors: Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Xavier
authors: X
authors: Díez
authors: Musculoskeletal Epidemiology Unit, NDORMS, University of Oxford, Oxford, United Kingdom.
authors: Daniel
authors: D
authors: Prieto-Alhambra
authors: Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Xavier
authors: X
authors: Torras
authors: Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Sergio
authors: S
authors: Sainz
authors: Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Cándido
authors: C
authors: Villanueva
authors: Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Antoni
authors: A
authors: Farre
authors: Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Carlos
authors: C
authors: Guarner-Argente
authors: Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Carlos
authors: C
authors: Guarner
mesh_terms: D015746:Abdominal Pain / Q000209:etiology; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006728:Hormones / Q000627:therapeutic use*; D006801:Humans; D034321:Hyperamylasemia / Q000209:etiology; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D012720:Severity of Illness Index; D013004:Somatostatin / Q000627:therapeutic use*
chemical_list: D006728:Hormones; D013004:Somatostatin