title: Effect of octreotide administration in the prophylaxis of post-ERCP pancreatitis and hyperamylasemia: A multicenter, placebo-controlled, randomized clinical trial.
abstract: OBJECTIVE
  Since the introduction of endoscopic retrograde cholangiopancreatology (ERCP) in clinical use, pancreatitis has become a common complication of ERCP. Octreotide is an inhibitor of pancreatic enzyme secretions. Several studies have evaluated the effect of octreotide on the incidence of clinical pancreatitis after ERCP, but with different results. The aim was to determine the efficacy of prophylactic administration of octreotide for the prevention of post-ERCP pancreatitis (PEP) and hyperamylasemia.
  
  
  METHODS
  In this study, patients with scheduled ERCP were randomized to receive either octreotide (0.3 mg) via intramuscular injection or a placebo. The study was conducted in 12 digestive endoscopic units in China. Patients were randomized into two groups: an octreotide group (N = 414) and a control group (N = 418). In the octreotide group, octreotide (0.3 mg) was dissolved in 500 mL of 0.9% saline solution and administered by continuous intravenous infusion, beginning 1 h before endoscopic examination and continued for 6 h thereafter; 0.1 mg of octreotide was injected subcutaneously at 6 and 12 h after the intravenous injection was stopped. The control group was given a placebo intravenously. The end point was the development of acute pancreatitis.
  
  
  RESULTS
  The overall incidence of acute pancreatitis was 3.85%; this included 2.42% (10/414) in the octreotide group and 5.26% (22/418) in the control group (P = 0.046). The overall incidence of hyperamylasemia was 14.9%; 12.32% (51/414) in the octreotide group and 17.46% (73/418) in the control group (P = 0.041). No side effects were found.
  
  
  CONCLUSIONS
  The results indicate that octreotide can prevent PEP and hyperamylasemia.
authors.affiliation: Department of Gastroenterology, Changhai Hospital, SMMU, Shanghai, China.
authors.forename: Zhao-Shen
authors.initials: ZS
authors.lastname: Li
authors.forename: Xue
authors.initials: X
authors.lastname: Pan
authors.forename: Wen-Jun
authors.initials: WJ
authors.lastname: Zhang
authors.forename: Biao
authors.initials: B
authors.lastname: Gong
authors.forename: Fa-Chao
authors.initials: FC
authors.lastname: Zhi
authors.forename: Xue-Gang
authors.initials: XG
authors.lastname: Guo
authors.forename: Pei-Ming
authors.initials: PM
authors.lastname: Li
authors.forename: Zhi-Ning
authors.initials: ZN
authors.lastname: Fan
authors.forename: Wen-Sheng
authors.initials: WS
authors.lastname: Sun
authors.forename: Yun-Zhi
authors.initials: YZ
authors.lastname: Shen
authors.forename: Shu-Ren
authors.initials: SR
authors.lastname: Ma
authors.forename: Wei-Fen
authors.initials: WF
authors.lastname: Xie
authors.forename: Min-Hu
authors.initials: MH
authors.lastname: Chen
authors.forename: Yan-Qing
authors.initials: YQ
authors.lastname: Li
mesh_terms: D002681:China / Q000453:epidemiology; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D034321:Hyperamylasemia / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000627:therapeutic use*; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*; D010919:Placebos; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D010919:Placebos; D015282:Octreotide