Tamura Takashi, Yamaue Hiroki, Itonaga Masahiro, Kawaji Yuki, Nuta Junya, Hatamaru Keiichi, Yamashita Yasunobu, Kitahata Yuji, Miyazawa Motoki, Hirono Seiko, Okada Ken-Ichi, Kawai Manabu, Shimokawa Toshio, Kitano Masayuki
Second Department of Internal Medicine.
Second Department of Surgery.
Medicine (Baltimore). 2020 Jan;99(3):e18718. doi: 10.1097/MD.0000000000018718.
Biliary obstruction can impair the effectiveness of neo-adjuvant chemotherapy. This study was designed to compare biliary stenting with covered self-expandable metal stents (FCSEMS) and plastic stents (PS) in patients with biliary obstruction caused by borderline resectable pancreatic cancer (BRPC) who were undergoing neo-adjuvant chemotherapy during preoperative biliary drainage.
This single-center, comparative, randomized, superiority study was designed to compare FCSEMS with PS for drainage of biliary obstruction of BRPC. Twenty two eligible patients providing informed consent will be randomized 1:1 by computer to either FCSEMS or PS for endoscopic retrograde biliary drainage (ERBD). All subsequent clinical interventions, including crossover to alternative procedures, will be at the discretion of the treating physician based on standard clinical care. The primary outcomes will be the rates and causes of stent dysfunction during preoperative biliary drainage. Other outcomes include time required for ERBD, adverse events related to ERBD, period from ERBD to surgery, percentage of patients able to undergo surgery, operation time, intraoperative bleeding volume, postoperative adverse events, and postoperative hospitalization. Subjects, treating clinicians, and outcome assessors will not be blinded to assignment.
This study is intended to determine whether FCSEMS or PS is the better biliary stent for ERBD for management of patients with biliary obstruction of BRPC, a common clinical dilemma that has not yet been investigated in randomized trials.
UMIN-CTR, Identifier: UMIN000030473. Registered July 10, 2017, Wakayama Medical University Hospital.
胆道梗阻会削弱新辅助化疗的效果。本研究旨在比较带膜自膨式金属支架（FCSEMS）和塑料支架（PS）在术前胆道引流期间接受新辅助化疗的交界可切除胰腺癌（BRPC）所致胆道梗阻患者中的应用效果。
本单中心、比较性、随机、优效性研究旨在比较FCSEMS和PS用于BRPC胆道梗阻引流的效果。22名提供知情同意的符合条件患者将通过计算机以1:1比例随机分为FCSEMS组或PS组，接受内镜逆行胆道引流（ERBD）。所有后续临床干预措施，包括交叉采用替代程序，均由治疗医师根据标准临床护理自行决定。主要结局将是术前胆道引流期间支架功能障碍的发生率和原因。其他结局包括ERBD所需时间、与ERBD相关的不良事件、从ERBD到手术的时间、能够接受手术的患者百分比、手术时间、术中出血量、术后不良事件以及术后住院时间。受试者、治疗临床医生和结局评估者不会对分组情况进行盲法处理。
本研究旨在确定FCSEMS或PS是否是用于ERBD治疗BRPC胆道梗阻患者的更好胆道支架，这是一个常见的临床难题，尚未在随机试验中进行研究。
UMIN-CTR，标识符：UMIN000030473。于2017年7月10日在和歌山县立医科大学医院注册。
