Using near-infrared imaging to improve surgery for rectal cancer

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

This study is testing if using special near-infrared imaging during surgery for rectal cancer can help improve healing and reduce complications for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 547 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Friendship Hospital (Academic / other)
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT04012645 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with mid- or low-rectal cancer who are undergoing laparoscopic TME surgery.

Not a fit: Patients with allergies to indocyanine green, those requiring emergency surgery for intestinal issues, or those with advanced disease stages may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the rates of postoperative anastomotic leakage in rectal cancer surgeries, improving patient outcomes.

How similar studies have performed: Previous studies have shown promising results with near-infrared imaging in colorectal surgeries, indicating potential for success in this novel application.

Eligibility criteria

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 this trial is running

Beijing, Beijing and 1 other locations

• 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

Conditions Rectal Neoplasms; Indocyanine Green; Anastomotic Leakage