NCT05168839RecruitingPhase 4
FLUOCOL-1 : Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage
Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Jan 2026
Brief summary (registry, in English)
To demonstrate that the assessment of anastomotic perfusion using intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) will reduce AL in left-sided or high anterior resection with intraperitoneal anastomosis.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1010 (estimated)
- First submitted
- 19 Aug 2024
- Start date
- 10 Sept 2024
- Lead sponsor
- Centre Hospitalier Regional Universitaire
- Diseases
- Colorectal cancer
- NCT number
- NCT05168839
- EU CT number
- 2024-515118-42-00
- EudraCT number
- 2021-004814-21
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1010
- 29 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergent surgery
- 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
Other illness
- Inflammatory bowel disease
- History of known allergy to indocyanine
- 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
Other
- Pregnant patients
- Refusal to participate or inability to provide informed consent
- Protected adults (individuals under guardianship by court order).
Who the study is looking for
- Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis.
- Signed informed consent
- Affiliated to the French social security system (CMU included).
- Adult patients (age >18 years)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Recruiting |
| CHU Besancon Coordinator of this site? Confirm its status | Besancon Cedex | France | Recruiting |
| Clinique Tivoli-Ducos Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier William Morey Coordinator of this site? Confirm its status | Chalon Sur Saone Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Recruiting |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Clinique de La Sauvegarde Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hopital Europeen Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hôpital Saint Joseph Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| GIE Groupe hospitalier Paris Saint-Joseph/Vinci Coordinator of this site? Confirm its status | Paris Cedex 14 | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Hôpital NOVO Coordinator of this site? Confirm its status | Pontoise | France | Recruiting |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Pringy Cedex | France | Recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Recruiting |
| Sante Atlantique Coordinator of this site? Confirm its status | St Herblain | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Recruiting |
| Institut De Cancerologie De Lorraine Coordinator of this site? Confirm its status | Vandouvre Les Nancy | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.