Tsuyoshi Hayashi1, Hiroshi Kawakami2, Manabu Osanai3, Hirotoshi Ishiwatari4, Hirohito Naruse5, Hiroyuki Hisai6, Nobuyuki Yanagawa7, Hiroyuki Kaneto8, Kazuya Koizumi9, Tamaki Sakurai10, Tomoko Sonoda11. 1. Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan. Electronic address: thayashi69@sapmed.ac.jp. 2. Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan. 3. Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Japan. 4. Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan. 5. Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan. 6. Department of Gastroenterology, Japan Red Cross Date General Hospital, Date, Japan. 7. Department of Gastroenterology, Asahikawa-Kosei General Hospital, Asahikawa, Japan. 8. Department of Gastroenterology, Muroran City General Hospital, Muroran, Japan. 9. Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan. 10. Department of Gastroenterology, Steel Memorial Muroran Hospital, Muroran, Japan. 11. Department of Public Health, Sapporo Medical University School of Medicine, Sapporo, Japan.
Abstract
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.
RCT Entities:
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.
Authors: Timothy B Gardner; Chad C Spangler; Katerina L Byanova; Gregory H Ripple; Matthew J Rockacy; John M Levenick; Kerrington D Smith; Thomas A Colacchio; Richard J Barth; Bassem I Zaki; Michael J Tsapakos; Stuart R Gordon Journal: Gastrointest Endosc Date: 2016-03-10 Impact factor: 9.427
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