NCT05168839: FLUOCOL-1

Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage

Recruiting now Phase 3 Last updated 19 September 2024

What this trial tests

Phase 3 trial testing FLUO+ : Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG). in Colorectal Cancer in 1,010 participants. Currently enrolling.

Timeline

26 September 2022

Primary endpoint
31 October 2025

31 October 2025

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Besancon
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,010
Start date	26 September 2022
Primary completion	31 October 2025
Estimated completion	31 October 2025
Sites	32 locations across France

Drugs / interventions tested

• FLUO+ : Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG). — full drug profile →

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Centre Hospitalier Universitaire de Besancon

Who can join

18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world and the third in France. Its incidence is steadily rising in developing nations. Anastomotic leak (AL) is a major problem in colorectal surgery affecting at least 7% of patients operated on for left colonic cancer. It is the most feared complication after colorectal anastomosis, associated with mortality, prolonged hospitalization, impaired health related quality of life (HRQoL) and increased health care costs. Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) may help preventing AL. Available studies on the effects of IOFA with ICG are heterogeneous and randomized controlled trial are scarce. Our aim is to demonstrate that IOFA with ICG could lead to a reduction of AL rate after left-sided or low anterior resection with anastomosis for CRC.

The FLUOCOL-1 study is the first national, multicenter, single blind, randomized, 2-arm, phase III superiority clinical trial. The primary endpoint is the occurrence of an AL 90 days post-operation. AL is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer.

The study population will be made of adult patients with left-sided or high rectal cancer scheduled to undergo elective left colectomy or high rectal resection (by open, laparoscopy or robotic surgery) and with expected stapled or hand-sewn intraperitoneal anastomosis. The exclusion criteria are mainly an emergent surgery; rectal cancer requiring total mesorectal excision and anastomosis expected below the peritoneal reflection; CRC requiring total or subtotal colectomy; CRC requiring transverse colectomy; recurrent CRC and locally advanced colorectal cancer requiring multi-visceral excision.

A total of 1010 patients will be necessary (39 patients in each centre during 36 months). An interim analysis for efficacy and futility is scheduled when half of the participants will have been recruited.

In case of positive results favoring IOFA, this study would define the use of IOFA as a standard of care in colorectal surgery. At the patient level, a significantly lower rate of AL will reduce hospital stay and stoma rate, and will ensure improved postoperative recovery, faster return to normal activity and better long-term oncologic outcomes.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of fluorescence angiography on anastomotic leak and complication rate in colorectal surgery: A systematic review and meta-analysis of randomized controlled trials.
   Balaphas A, Sleiman MJ, Meurette G, Liot E, et al · · 2025 · cited 3× · PMID 41031406 · DOI 10.1111/codi.70236
2. Indocyanine Green Fluorescence Imaging for Colorectal Surgery: A Health Technology Assessment.
   Ontario Health (Quality) . · · 2025 · cited 1× · PMID 40727261
3. Intraoperative indocyanine green fluorescence angiography in colorectal surgery to prevent anastomotic leakage: A single-blind phase III multicentre randomized controlled trial (FLUOCOL-01/FRENCH 21/GRECCAR 19 intergroup trial).
   Pretalli JB, Vernerey D, Evrard P, Pozet A, et al · · 2025 · cited 1× · PMID 40415381 · DOI 10.1111/codi.70119