NCT05168839 Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage
| NCT ID | NCT05168839 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire de Besancon |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,010 participants |
| Start Date | 2022-09-26 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,010 participants in total. It began in 2022-09-26 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05168839 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05168839 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,010 participants.
Is NCT05168839 currently recruiting?
Yes, NCT05168839 is actively recruiting participants. Contact the research team at zlakkis@chu-besancon.fr for enrollment information.
Where is the NCT05168839 trial being conducted?
This trial is being conducted at Amiens, France, Annecy, France, Besançon, France, Bourgoin, France and 11 additional locations.
Who is sponsoring the NCT05168839 clinical trial?
NCT05168839 is sponsored by Centre Hospitalier Universitaire de Besancon. The trial plans to enroll 1,010 participants.
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