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临床试验/NCT04012645
NCT04012645招募中不适用

A Study Assessing Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR

Zhongtao Zhang2 个研究点 分布在 1 个国家目标入组 547 人开始时间: 2023年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
547
试验地点
2
主要终点
Anastomotic leakage

研究概览

简要总结

It is a multicenter, prospective, and randomized controlled clinical study of patients with mid- or low- rectal cancer who received laparoscopic TME surgery aims to explore whether the application of near infrared-indocyanine green imaging system can evaluate the anastomotic blood perfusion accurately, and optimize the surgical procedures, or even reduce the incidence rates of postoperative anastomotic leakage in mid- or low- rectal cancer patients.

详细描述

In total mesorectal excision of rectal cancer, accurate assessment of rectal anastomotic blood supply is crucial: for insufficient anastomotic blood supply is an important cause of postoperative anastomotic leakage, and once anastomotic leakage occurs, the perioperative mortality rate of patients is reportedly 16%. In the past, the assessment of anastomotic blood supply mainly depended on the experience of the surgeon and lacked objective and accurate assessment methods. In recent years, the application of near-infrared fluorescence laparoscopic imaging technology has provided a new way to accurately evaluate anastomotic perfusion. At present, the technology has been applied to evaluate anastomotic blood supply in colorectal cancer surgery worldwide, and its safety and reliability have been confirmed. However, whether the application of this technology can reduce the incidence of anastomotic leakage after total mesorectal excision for rectal cancer and thus benefit patients still needs high-level evidence-based medical evidence support with multi-centers and large samples.Thus, a multicenter, prospective, and randomized controlled clinical study of patients with mid- or low- rectal cancer who received laparoscopic TME surgery was intend to conduct to explore whether the application of near infrared-indocyanine green imaging system can evaluate the anastomotic blood perfusion accurately, and optimize the surgical procedures, or even reduce the incidence rates of postoperative anastomotic leakage in mid- or low- rectal cancer patients.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The age was over 18 years at the time of diagnosis;
  • Diagnosis of rectal carcinoma and was confirmed by preoperative pathology;
  • MRI was performed before operation, and the distance between the lower margin of tumor and the anal margin was no more than 10cm;
  • The colon-rectum or colon-anus anastomosis was performed by laparoscopic TME operation
  • The "spleen area" was not free during the operation
  • Baseline clinical tumor stage TNM Ⅰ-Ⅲ phase: cT1-4N0-2M0 (AJCC-8 version);

排除标准

  • Allergic to ICG or iodine;
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding who need emergency operation;
  • Patients requiring combined organ resection that the tumor involves adjacent organs;
  • Patients with recurrence of tumor or distant metastasis;
  • Patients with multiple colorectal cancer;
  • Patients with history of inflammatory bowel disease or familial adenomatous polyposis;
  • Patients who have participated in or are participating in other clinical trials in the past four weeks;
  • Patients that ASA level is larger than III;
  • Physical condition: Patients with KPS less than or equal to 60 points or ECOG larger than or equal to 2 points;
  • Patients with hepatic dysfunction and MELD larger than 12 points;
  • Patients with a history of serious mental illness;
  • Pregnant or lactating women;
  • Patients who are improper to participate in the study in the opinion of the researchers.

结局指标

主要结局

Anastomotic leakage

时间窗: within 30 days after operation

Anastomotic leakage occured within 30 days after operation. The diagnostic criteria for AL include: Flow of gas, abscess, or excrement from pelvic drainage tube, surgical incision or vagina; Accompanied by fever, peritonitis and other systemic symptoms; And AL confirmed by digestive tract radiography, CT scan or enteroscopy.

次要结局

  • the change of surgical precedure(within the operation time)

研究者

发起方
Zhongtao Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhongtao Zhang

Director of General Surgery of Beijing Friendship Hospital

Beijing Friendship Hospital

研究点 (2)

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