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Using fluorescence imaging to prevent leaks in colorectal surgery

Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage: a Single-blind Phase III Multicenter Randomized Controlled Trial (Intergroup FRENCH-GRECCAR Trial)

PHASE3 · Centre Hospitalier Universitaire de Besancon · NCT05168839

This study is testing if a special imaging technique using a dye can help prevent leaks in the intestines after surgery for colorectal cancer.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1010 (estimated)
Ages18 Years and up
SexAll
SponsorCentre Hospitalier Universitaire de Besancon (other)
Locations32 sites (Amiens and 31 other locations)
Trial IDNCT05168839 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of intraoperative fluorescence angiography (IOFA) using indocyanine green (ICG) in reducing the rate of anastomotic leakage (AL) in patients undergoing elective left colectomy or high rectal resection for colorectal cancer. The study is a multicenter, single-blind, randomized, phase III trial that will compare outcomes between patients receiving the ICG intervention and those receiving standard care. The primary endpoint is the occurrence of AL within 90 days post-operation, assessed through imaging or surgical exploration. By addressing a significant complication in colorectal surgery, this trial seeks to improve patient outcomes and reduce healthcare costs associated with AL.

Who should consider this trial

Good fit: Ideal candidates for this study are adult patients over 18 years old scheduled for elective left colectomy or high rectal resection due to left-sided or high rectal cancer.

Not a fit: Patients undergoing emergency surgery, those with recurrent or locally advanced colorectal cancer, or those with a history of colectomy will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of anastomotic leakage, leading to better recovery and lower healthcare costs for patients undergoing colorectal surgery.

How similar studies have performed: While previous studies on IOFA with ICG have shown heterogeneous results, this trial is among the first randomized controlled trials specifically targeting anastomotic leakage in colorectal surgery.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adult patients (age \>18 years)
* Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis.
* Signed consent
* Affiliated to the French social security system (CMU included).

Exclusion Criteria:

* Emergent surgery.
* Rectal cancer requiring total mesorectal excision and anastomosis below the peritoneal reflexion.
* Colon cancer requiring total or subtotal colectomy defined as a right colectomy extended to the splenic flexure or more).
* Colon cancer requiring transverse colectomy.
* Recurrent colorectal cancer.
* Locally advanced colorectal cancer requiring multi-visceral excision.
* History of colectomy.
* Associated concomitant resection of other organ (liver, etc.).
* Previous pelvic radiotherapy for pathology unrelated to diagnosis with colon cancer e.g. treatment for prostate cancer.
* Inflammatory bowel disease.
* History of known allergy to indocyanine.
* Pregnant patients.
* Refusal to participate or inability to provide informed consent.
* Protected adults (individuals under guardianship by court order).

Where this trial is running

Amiens and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Colorectal Cancer, Anastomotic leakage, Colorectal surgery, fluorescence angiography, Indocyanine green, Colic surgery, Complication, Prevention

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.