A multicenter, randomized, controlled trial to reveal the efficacy of low axial force designed Dumbbell head shaped SEMS (self-expandable metallic stent) for malignant biliary obstruction caused by unresectable pancreatic cancer (fully covered vs. uncovered)(confirmatory trial) - LPAC Study

Takenaka Mamoru0 个研究点目标入组 300 人开始时间: 2021年6月2日最近更新: 2023年10月17日

研究概览

暂无简介。

•(1)Unresectable pancreatic cancer (UR-LA,UR-M) causing distal biliary obstruction
•(2)Pathologically confirmed diagnosis or patients with suspected pancreatic cancer who are scheduled to undergo a pathological examination(It does not matter whether it is by cytology or histology)
•(3)Patients aged 20 and over who have given sufficient explanation about the content of the study and have proved informed consent created by the patient's will based on the understanding of the content. (In principle, cancer notification shall be given.)

•(1)Cases with Performance status of 4
•(2)Cases with serious complications in other organs.such as ASA classification 3 or higher (Subject who is dialysis also excluded)
•(3)Cases with hilar biliary obstruction
•(4)Cases with bordeline resectable pancreatic cancer (BR), hilar biliary obstruction associated with lymphadenopathy
•(5)Cases where informed consent cannot be obtained
•(6)Cases with Uncontrollable cholangitis
•(7)Cases with an expected prognosis of less than 3 months
•(8)Cases where the condition worsens after the first biliary drainage
•(9)Cases judged by the investigator (in-charge doctor) to be inappropriate as a subject

发起方

Takenaka Mamoru