Using near-infrared imaging to improve surgery for rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, randomized controlled clinical study investigates the effectiveness of a near-infrared indocyanine green imaging system during laparoscopic total mesorectal excision (TME) for patients with mid- or low-rectal cancer. The study aims to accurately assess anastomotic blood perfusion, which is critical for preventing postoperative complications such as anastomotic leakage. By comparing outcomes between patients who receive the imaging intervention and those who do not, the research seeks to provide high-level evidence on the technology's impact on surgical success and patient recovery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Friendship Hospital
  Beijing, Beijing, China Recruiting
• Beijing Friendship Hospital, Capital medical University
  Beijing, Xicheng Dis, China Recruiting

Study contacts

• Principal investigator: Zhongtao Zhang, Professor — Beijing Friendship Hospital
• Study coordinator: Zhongtao Zhang, Professor
• Email: zhangzht@medmail.com.cn
• Phone: 13801060364

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.