An open-label, non-randomized clinical study of the development of an intraoperative detection system for bile leakage after hepatectomy with indocyanine green

Hanaki Takehiko0 个研究点目标入组 85 人开始时间: 2021年10月13日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•[Study drug treatment group]
•1) Patients undergoing hepatectomy as scheduled surgery for primary hepatic cancer, metastatic hepatic cancer, and benign hepatic tumor, regardless of laparotomy or laparoscopic surgery
•2) ECOG-PS<=1
•3) Male and female over 20 years old at the time of consent form
•4) Patients without serious complications
•[Historical control group]
•1) Patients who underwent hepatectomy and drained for primary hepatic cancer, metastatic hepatic cancer, and benign hepatic tumor before July 2020, regardless of laparotomy or laparoscopic surgery
•2) ECOG-PS<=1
•3) Male and female over 20 years old at the time of surgery
•4) Patients without serious complications

•[Study drug treatment group]
•1) Patients undergoing emergency surgery
•2) Patients with a history of hypersensitivity to ICG components
•3) Patients with a history of iodine hypersensitivity
•4) Pregnant women or patients who may be pregnant
•5) Lactating patients
•6) Patients who participated in other clinical studies within 3 months before registration
•[Historical control group]
•1) Patients undergoing emergency surgery
•2) Patients who received ICG at the time of surgery

发起方

Hanaki Takehiko