title: No benefit of endoscopic sphincterotomy before biliary placement of self-expandable metal stents for unresectable pancreatic cancer.
abstract: OBJECTIVE
  Endoscopic sphincterotomy (ES) is performed routinely before self-expandable metallic stents (SEMS) are placed in malignant distal biliary strictures to prevent postprocedural pancreatitis. However, it is not clear whether ES actually prevents pancreatitis or affects other adverse events (AEs). We conducted a noninferiority trial to examine the necessity of ES before SEMS placement.
  
  
  METHODS
  Two hundred patients with distal biliary strictures caused by unresectable pancreatic cancer were assigned randomly to groups that received ES or did not receive ES (non-ES) before SEMS placement, at 25 hospitals in Hokkaido, Japan, from August 2010 through November 2012. The primary outcome was early AEs (≤30 d) specifically related to the presence or absence of ES (pancreatitis, bleeding, or perforation). Secondary outcomes measured included the effect of ES omission on time to SEMS dysfunction and patient survival times.
  
  
  RESULTS
  The proportions of patients with early AEs were 9.2% in the non-ES group and 10.4% in the ES group (a difference of 1.2%, noninferior). The median times to SEMS dysfunction was longer than 594 days in the non-ES group and 541 days in the ES group (P = .88). The median overall survival times were 202 in the ES group vs 255 days in the non-ES group; P = .20).
  
  
  CONCLUSIONS
  ES before SEMS does not affect the incidence of AEs, SEMS patency, or patient survival times. Our data provide no evidence for a benefit of ES to patients undergoing SEMS placement for a biliary stricture caused by pancreatic cancer. UMIN clinical trials registry number: 000004044.
authors: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan. Electronic address: thayashi69@sapmed.ac.jp.
authors: Tsuyoshi
authors: T
authors: Hayashi
authors: Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors: Hiroshi
authors: H
authors: Kawakami
authors: Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Japan.
authors: Manabu
authors: M
authors: Osanai
authors: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors: Hirotoshi
authors: H
authors: Ishiwatari
authors: Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan.
authors: Hirohito
authors: H
authors: Naruse
authors: Department of Gastroenterology, Japan Red Cross Date General Hospital, Date, Japan.
authors: Hiroyuki
authors: H
authors: Hisai
authors: Department of Gastroenterology, Asahikawa-Kosei General Hospital, Asahikawa, Japan.
authors: Nobuyuki
authors: N
authors: Yanagawa
authors: Department of Gastroenterology, Muroran City General Hospital, Muroran, Japan.
authors: Hiroyuki
authors: H
authors: Kaneto
authors: Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.
authors: Kazuya
authors: K
authors: Koizumi
authors: Department of Gastroenterology, Steel Memorial Muroran Hospital, Muroran, Japan.
authors: Tamaki
authors: T
authors: Sakurai
authors: Department of Public Health, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors: Tomoko
authors: T
authors: Sonoda
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001660:Biliary Tract Diseases / Q000601:surgery*; D001662:Biliary Tract Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D003251:Constriction, Pathologic / Q000601:surgery*; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000150:complications*; D000069322:Self Expandable Metallic Stents / Q000009:adverse effects*; D016717:Sphincterotomy, Endoscopic / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome
keywords: Adverse Event; Distal Biliary Stricture; Endoscopic Sphincterotomy; Pancreas; Self-Expandable Metallic Stent