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

Overview

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.

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Diagnostic
  • Masking: Double (Participant, Outcomes Assessor)
• Study Primary Completion Date: December 1, 2023

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.

Interventions

• 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.
• 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

Arms, Groups and Cohorts

• Experimental: experimental group
  • Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used during the surgeries.
• 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

Clinical Trial Outcome Measures

Primary Measures

• Anastomotic leakage
  • Time Frame: 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.

Secondary Measures

• the change of surgical precedure
  • Time Frame: within the operation time
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Zhongtao Zhang
• Collaborator
  • Peking Union Medical College Hospital
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Zhongtao Zhang, Director of General Surgery of Beijing Friendship Hospital – Beijing Friendship Hospital
• Overall Official(s)
  • Zhongtao Zhang, Professor, Principal Investigator, Beijing Friendship Hospital
• Overall Contact(s)
  • Zhongtao Zhang, Professor, 13801060364, zhangzht@medmail.com.cn