Informations générales (source: ClinicalTrials.gov)
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) (FLUOCOL-1)
Interventional
Phase 3
Centre Hospitalier Universitaire de Besancon (Voir sur ClinicalTrials)
septembre 2022
octobre 2025
21 septembre 2024
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.
Etablissements
Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
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HOPITAL NOVO | TRELLES | 14/02/2025 09:03:16 | Contacter | ||
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
AP-HP - Hôpital Cochin | Mahaut LECONTE | Contact (sur clinicalTrials) | |||
AP-HP - Hôpital Europeen Georges Pompidou | Gilles MANCEAU, MD | Contact (sur clinicalTrials) | |||
AP-HP - Hôpital Saint Antoine | Jérémie Lefèvre | Contact (sur clinicalTrials) | |||
CLCC INSTITUT GUSTAVE ROUSSY | Leonor Benhaim | Contact (sur clinicalTrials) | |||
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
Centre Georges François Leclerc - Dijon - France | David ORRY | Contact (sur clinicalTrials) | |||
Centre Hospitalier Bourgoin-Jallieu - 38302 - Bourgoin-Jallieu - France | Pierre Goubault | Contact (sur clinicalTrials) | |||
Centre Hospitalier de Tours - 37170 - Tours - France | Medhi Ouaissi | Contact (sur clinicalTrials) | |||
Centre Hospitalier Lyon-Sud - 69310 - Lyon - France | Eddy Cotte | Contact (sur clinicalTrials) | |||
Centre Hospitalier Universitaire Amiens-Picardie - 80054 - Amiens - France | Jean-Marc Regimbeau | Contact (sur clinicalTrials) | |||
Centre Hospitalier Universitaire de Besançon - 25000 - Besançon - France | Zaher Lakkis | Contact (sur clinicalTrials) | |||
Centre Hospitalier Universitaire de Grenoble - 38700 - La Tronche - France | Bertrand Trilling | Contact (sur clinicalTrials) | |||
Centre Hospitalier Universitaire de Lille - 59037 - Lille - France | Guillaume Piessen | Contact (sur clinicalTrials) | |||
Centre Hospitalier Universitaire de Rouen - 76000 - Rouen - France | Jean-Jacques Tuech | Contact (sur clinicalTrials) | |||
Centre Hospitalier Universitaire de Strasbourg - 67000 - Strasbourg - France | Benoit Romain | Contact (sur clinicalTrials) | |||
Centre lyonnais de chirurgie digestive - 69009 - Lyon - France | Benoit Gignoux | Contact (sur clinicalTrials) | |||
CH Annecy - Annecy - France | Olivier OULIE, MD | Contact (sur clinicalTrials) | |||
Ch Pontchaillou - Rennes - France | Veronique DESFOURNEAUX-DENIS, MD | Contact (sur clinicalTrials) | |||
CHU de Nancy - Nancy - France | Frédéric MARCHAL, MD PhD | Contact (sur clinicalTrials) | |||
CHU de Toulouse - 31400 - Toulouse - France | Etienne BUSCAIL, MD | Contact (sur clinicalTrials) | |||
Clinique TIVOLI - Toulouse - France | Quentin DENOST, MD PhD | Contact (sur clinicalTrials) | |||
Hôpiatl Européen - 13003 - Marseille - France | Régis Fara | Contact (sur clinicalTrials) | |||
Hôpital Bicêtre - 94275 - Paris - France | Stéphane BENOIST, MD | Contact (sur clinicalTrials) | |||
Hôpital La Timone - 13005 - Marseille - France | Diane Mege | Contact (sur clinicalTrials) | |||
Hôpital Nord AP-HM - 13015 - Marseille - France | Laura Beyer-Berjot | Contact (sur clinicalTrials) | |||
Hôpital Robert Debré - 51100 - Reims - France | Koceila Lamine AMROUN | Contact (sur clinicalTrials) | |||
Hôpital Saint Louis - 75010 - Paris - France | Leon Maggiori | Contact (sur clinicalTrials) | |||
Hôpital St Joseph Marseille - Marseille - France | Caroline ROSSI | Contact (sur clinicalTrials) | |||
Institut cancérologie de Lorraine - vandoeuvre les Nancy - France | Cécilia CERIBELLI, MD | Contact (sur clinicalTrials) | |||
Institut Paoli Calmettes - 13009 - Marseille - France | Cécile De Chaisemartin | Contact (sur clinicalTrials) | |||
Santé Atlantique - 44800 - Saint-Herblain - France | Antoine Sina | Contact (sur clinicalTrials) | |||
University Hospital of Dijon - 21000 - Dijon - France | Nathan Moreno-Lopez | Contact (sur clinicalTrials) |
Critères
Tous
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).
- 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).
- 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).