Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR (POSTER)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Neoplasms
• Intervention / Treatment: Procedure: application of near infrared-indocyanine green imaging system; Procedure: Non-application of near infrared-indocyanine green imaging system

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 547
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhongtao Zhang, Professor; Phone Number: 13801060364; Email: zhangzht@medmail.com.cn
• Study Contact Backup: Name: Hongwei Yao, Professor; Phone Number: 13611015609; Email: yaohongwei@medmail.com.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital
      • Contact: Hongwei Yao, M.D.; Phone Number: +8613611015609; Email: yaohongwei@medmail.com.cn
  • Xicheng Dis
    • Beijing, Xicheng Dis, China, 100050
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Zhongtao Zhang, MD; Phone Number: 13801060364; Email: zhangzht@medmail.com.cn
      • Contact: Zhicheng Ge, MD; Phone Number: 13601032257; Email: gezhicheng2000@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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）;

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used during the surgeries.	Procedure: application of near infrared-indocyanine green imaging system; Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used to evaluate the anastomotic flood perfusion during the operation; The operator may decide whether to change the surgical programme based on the outcome of the evaluation.
Active Comparator: control group; Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience	Procedure: Non-application of near infrared-indocyanine green imaging system; Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic leakage	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.	within 30 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of surgical precedure	the change of intraoperative decision, including: (1) The change of the position of intestinal dissection; (2) Anastomotic stoma was removed and rebuilt or re-performed hartmann operation; (3) The performance of unplanned, preventive orifice, etc. due to ICG test results.	within the operation time

Collaborators and Investigators

• Sponsor: Zhongtao Zhang
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Changhai Hospital; Peking University People's Hospital; Fudan University; Peking Union Medical College Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Chinese PLA General Hospital; RenJi Hospital; Peking University Cancer Hospital & Institute; Ruijin Hospital; Beijing Chao Yang Hospital; Beijing Hospital; Guangdong Provincial People's Hospital; The First Hospital of Jilin University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Fujian Medical University Union Hospital; First Hospital of China Medical University; Southern Medical University, China; First Affiliated Hospital of Chongqing Medical University
• Investigators: Principal Investigator: Zhongtao Zhang, Professor, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: July 6, 2019
• First Submitted That Met QC Criteria: July 6, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Indocyanine Green; Rectal Neoplasms; Anastomotic Leakage
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: Poster

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No