title: Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial.
abstract: OBJECTIVE
  Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) remains the most common complication of ERCP. Somatostatin may inhibit pancreatic secretion and has been tested for PEP prophylaxis. However, the results of previous studies are inconsistent. The aim of the current study was to investigate whether somatostatin can reduce the incidence of PEP.
  
  
  METHODS
  The study was a multicenter, open-label, randomized controlled trial. A total of 908 patients with normal amylase levels who were undergoing ERCP were randomized to receive somatostatin 250 μg bolus injection before ERCP and 250 μg/hour intravenous infusion for 11 hours after ERCP (somatostatin group) or no somatostatin treatments (control group). The incidences of PEP and hyperamylasemia were compared in the two groups.
  
  
  RESULTS
  The full analysis set included 900 patients (445 in the somatostatin group, 455 in the control group). PEP developed in 34 patients (7.5 %) in the control group (95 % confidence interval [CI] 5.4 % - 10.3 %) and in 18 patients (4.0 %) in the somatostatin group (95 %CI 2.6 % - 6.3 %; P = 0.03). Hyperamylasemia occurred in 46 patients (10.1 %) in the control group (95 %CI 7.7 % - 13.2 %) and in 27 patients (6.1 %) in the somatostatin group (95 %CI 4.2 % - 8.7 %; P = 0.03). No perforation or death occurred during the study.
  
  
  CONCLUSIONS
  This study showed that somatostatin was effective and safe for the prevention of PEP and hyperamylasemia in ERCP patients.(ClinicalTrials.gov number, NCT01431781).
authors.affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Bai
authors.affiliation: Department of Gastroenterology, Heilongjiang Province Hospital, Harbin, China.
authors.forename: Xu
authors.initials: X
authors.lastname: Ren
authors.affiliation: Department of Gastroenterology, First People's Hospital of Hangzhou, Hangzhou, Zhejiang, China.
authors.forename: Xiao-Feng
authors.initials: XF
authors.lastname: Zhang
authors.affiliation: Department of Gastroenterology, First Affiliated Hospital, Nan Chang University, Jiangxi, China.
authors.forename: Nong-Hua
authors.initials: NH
authors.lastname: Lv
authors.affiliation: Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.
authors.forename: Xue-Gang
authors.initials: XG
authors.lastname: Guo
authors.affiliation: Department of Gastroenterology, First People's Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
authors.forename: Xin-Jian
authors.initials: XJ
authors.lastname: Wan
authors.affiliation: Department of Gastroenterology, Urumchi General Hospital, Lanzhou Command, PLA, China.
authors.forename: Zhan-Guo
authors.initials: ZG
authors.lastname: Nie
authors.affiliation: Gastrointestinal Endoscopy Center, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, Jiangsu, China.
authors.forename: Shu-Tang
authors.initials: ST
authors.lastname: Han
authors.affiliation: Department of Gastroenterology, Southwest Hospital, Third Military Medical University, Chongqing, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Bie
authors.affiliation: Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: De-An
authors.initials: DA
authors.lastname: Tian
authors.affiliation: Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Ji
authors.affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Zhao-Shen
authors.initials: ZS
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000681:Amylases / Q000097:blood; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D005260:Female; D006728:Hormones / Q000627:therapeutic use*; D006801:Humans; D034321:Hyperamylasemia / Q000209:etiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D013004:Somatostatin / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D006728:Hormones; D013004:Somatostatin; D000681:Amylases