A Prospective, Multi-center, Single-blind, Parallel, Randomized Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the LED Light Source System for Endoscope During Ureter Transillumination.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Visualization rate of extrahepatic bile duct.
研究概览
简要总结
This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).
This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period.
详细描述
The prospective, multi-center, single-blind, parallel, randomized controlled non-inferiority trial design is adopted to evaluate the safety and effectiveness of the real-time endoscopic near infrared fluorescence image provided by the LED light source system for endoscope by evaluating at least one main extrahepatic bile duct (common bile duct and ductuli hepaticus communis). The trial will be carried out in 5 centers, with the competitive grouping mode adopted. Totally 220 patients to receive laparoscopic cholecystectomy will be involved (110 patients for each of the control group and the test group). The subjects, after signing the informed consent form approved by the Ethics Committee, will be screened by the investigators. Qualified subjects who meet all the inclusion criteria and do not meet any of the exclusion criteria will be randomly divided into the control group or the test group. For the subjects in the control group, the Pinpoint Endoscopic Fluorescence Imaging System commercially available will be used for operation. For subjects of the test group, the LED light source system for endoscope will be used for operation. On the operation date, investigators will evaluate the display performance of the device by judging whether at least one main extrahepatic bile duct (common bile duct and ductuli hepaticus communis) is displayed. During the follow-up period, the investigators will evaluate the safety of the device based on the results of vital signs, physical examination, blood routine examination, routine urine examination, blood biochemistry and 12-lead ECG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
In this trial, single-blind method will be used, which means that the investigators know about the device used for treatment of the subjects while the subjects know nothing about it.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who should receive laparoscopic cholecystectomy on a selected day Symptoms of such subjects include gallstone, cholecystitis, or gallbladder polyp≥0.8 cm
- •Aged between 18 and 75
- •All subjects voluntarily participate in the clinical trial and are asked to sign the informed consent form
排除标准
- •Subjects suffering acute cholecystitis and cholangitis
- •Subjects requiring laparotomy
- •Women during pregnancy or lactation
- •Subjects expected to give birth to a child within 3 months after the trial
- •Subjects suffering liver cirrhosis
- •Subjects allergic to ICG or iodine
- •Subjects with cardiopulmonary insufficiency and those intolerant of surgery
- •Subjects with abnormal renal and liver function: ①Aspartate aminotransferase AST or alanine aminotransferase ALT exceeding 3 times of the upper limit of the normal range; ② Serum creatinine > 2.0 mg/dL or ≥ 176.8 μmol/L
- •Subjects with history of malignant cancer or subjects with malignant cancer
- •Subjects currently engaged in other clinical trials
- •Subjects deemed by the investigators as unsuitable for the trial
结局指标
主要结局
Visualization rate of extrahepatic bile duct.
时间窗: During the operation
Note: The visualization rate of extrahepatic bile duct refers to the visualization rate of at least one extrahepatic bile duct (the ductuli hepaticus communis and common bile duct) after dissection of the calot's triangle (the images are taken respectively before unfolding the anatomical structure, during dissection and after complete unfolding of the triangular structure).
次要结局
- Time of operation(During the operation)
- Intraoperative blood loss(During the operation)
- the occurrence rate of complications(Postoperative follow-up period was up to 7 days)
- Device failure rate(During the operation)