PMID- 25632802
OWN - NLM
STAT- MEDLINE
DCOM- 20160209
LR  - 20220408
IS  - 1542-7714 (Electronic)
IS  - 1542-3565 (Linking)
VI  - 13
IP  - 6
DP  - 2015 Jun
TI  - No benefit of endoscopic sphincterotomy before biliary placement of 
      self-expandable metal stents for unresectable pancreatic cancer.
PG  - 1151-8.e2
LID - S1542-3565(15)00094-4 [pii]
LID - 10.1016/j.cgh.2015.01.008 [doi]
AB  - BACKGROUND & AIMS: 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.
CI  - Copyright (c) 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.
FAU - Hayashi, Tsuyoshi
AU  - Hayashi T
AD  - Department of Medical Oncology and Hematology, Sapporo Medical University School 
      of Medicine, Sapporo, Japan. Electronic address: thayashi69@sapmed.ac.jp.
FAU - Kawakami, Hiroshi
AU  - Kawakami H
AD  - Department of Gastroenterology and Hepatology, Hokkaido University Graduate 
      School of Medicine, Sapporo, Japan.
FAU - Osanai, Manabu
AU  - Osanai M
AD  - Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Japan.
FAU - Ishiwatari, Hirotoshi
AU  - Ishiwatari H
AD  - Department of Medical Oncology and Hematology, Sapporo Medical University School 
      of Medicine, Sapporo, Japan.
FAU - Naruse, Hirohito
AU  - Naruse H
AD  - Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan.
FAU - Hisai, Hiroyuki
AU  - Hisai H
AD  - Department of Gastroenterology, Japan Red Cross Date General Hospital, Date, 
      Japan.
FAU - Yanagawa, Nobuyuki
AU  - Yanagawa N
AD  - Department of Gastroenterology, Asahikawa-Kosei General Hospital, Asahikawa, 
      Japan.
FAU - Kaneto, Hiroyuki
AU  - Kaneto H
AD  - Department of Gastroenterology, Muroran City General Hospital, Muroran, Japan.
FAU - Koizumi, Kazuya
AU  - Koizumi K
AD  - Division of Gastroenterology and Hematology/Oncology, Department of Medicine, 
      Asahikawa Medical University, Asahikawa, Japan.
FAU - Sakurai, Tamaki
AU  - Sakurai T
AD  - Department of Gastroenterology, Steel Memorial Muroran Hospital, Muroran, Japan.
FAU - Sonoda, Tomoko
AU  - Sonoda T
AD  - Department of Public Health, Sapporo Medical University School of Medicine, 
      Sapporo, Japan.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150126
PL  - United States
TA  - Clin Gastroenterol Hepatol
JT  - Clinical gastroenterology and hepatology : the official clinical practice journal 
      of the American Gastroenterological Association
JID - 101160775
SB  - IM
CIN - Clin Gastroenterol Hepatol. 2015 Jun;13(6):1159-61. PMID: 25737439
MH  - Aged
MH  - Aged, 80 and over
MH  - Biliary Tract Diseases/*surgery
MH  - Biliary Tract Surgical Procedures/adverse effects/*methods
MH  - Constriction, Pathologic/*surgery
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Pancreatic Neoplasms/*complications
MH  - Self Expandable Metallic Stents/*adverse effects
MH  - Sphincterotomy, Endoscopic/adverse effects/*methods
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adverse Event
OT  - Distal Biliary Stricture
OT  - Endoscopic Sphincterotomy
OT  - Pancreas
OT  - Self-Expandable Metallic Stent
EDAT- 2015/01/31 06:00
MHDA- 2016/02/10 06:00
CRDT- 2015/01/31 06:00
PHST- 2014/11/05 00:00 [received]
PHST- 2015/01/10 00:00 [revised]
PHST- 2015/01/13 00:00 [accepted]
PHST- 2015/01/31 06:00 [entrez]
PHST- 2015/01/31 06:00 [pubmed]
PHST- 2016/02/10 06:00 [medline]
AID - S1542-3565(15)00094-4 [pii]
AID - 10.1016/j.cgh.2015.01.008 [doi]
PST - ppublish
SO  - Clin Gastroenterol Hepatol. 2015 Jun;13(6):1151-8.e2. doi: 
      10.1016/j.cgh.2015.01.008. Epub 2015 Jan 26.