Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage
FLUOCOL-1
1 other identifier
interventional
1,010
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Sep 2022
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2021
CompletedFirst Posted
Study publicly available on registry
December 23, 2021
CompletedStudy Start
First participant enrolled
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedSeptember 19, 2024
September 1, 2024
3.1 years
December 9, 2021
September 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anastomotic leakage 90 days after surgery
The primary outcome is the occurence of an anastomotic leakage during the 90 days following surgery. Anastomotic leakage is defined as any clinical signs of leakage diagnosed by radiological examination or surgical exploration, or as any isolated pelvic organ infection without leakage evidence, as defined by the International Rectal Cancer Study Group.
90 days after surgery
Secondary Outcomes (9)
Change in planned anastomotic site.
During surgery
Rate of patients with a defunctioning stoma.
Surgery time.
Overall 30-day postoperative morbidity.
30 days after surgery.
Overall 90-day postoperative morbidity.
90 days after surgery.
Mortality rate.
90 days after surgery.
- +4 more secondary outcomes
Study Arms (2)
FLUO+
EXPERIMENTALExperimental arm = surgery with IOFA. In the experimental arm, cancer resection and anastomosis will be performed after assessment of descending colon perfusion using intravenous injection of indocyanine green 0.1ml/kg.
FLUO-
NO INTERVENTIONControl arm = Surgery without IOFA. In the control arm, cancer resection and anastomosis will be performed without intraoperative fluorescence angiography.
Interventions
In the experimental arm (FLUO+), at least one 0.1mg/kg Infracyanine® bolus will be injected intravenously by the anesthesiologist. The detection of indocyanine green in the proximal colon segment will be done open or intracorporeally using a dedicated infrared camera. A surgical film describing the injection technique and fluorescence detection will be presented during the study set-up visits. An additional injection is allowed at the surgeon's discretion if necessary (change of anastomosis site). The time from injection to indocyanine green detection and any adverse events will be recorded.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Centre Hospitalier Universitaire Amiens-Picardie
Amiens, 80054, France
CH Annecy
Annecy, France
Centre Hospitalier Universitaire de Besançon
Besançon, 25000, France
Centre Hospitalier Bourgoin-Jallieu
Bourgoin, 38302, France
University Hospital of Dijon
Dijon, 21000, France
Centre Georges François Leclerc
Dijon, France
Centre Hospitalier Universitaire de Grenoble
La Tronche, 38700, France
Centre Hospitalier Universitaire de Lille
Lille, 59037, France
Centre lyonnais de chirurgie digestive
Lyon, 69009, France
Centre Hospitalier Lyon-Sud
Lyon, 69310, France
Hôpiatl Européen
Marseille, 13003, France
Hôpital La Timone
Marseille, 13005, France
Institut Paoli Calmettes
Marseille, 13009, France
Hôpital Nord AP-HM
Marseille, 13015, France
Hôpital St Joseph Marseille
Marseille, France
CHU de Nancy
Nancy, France
Hôpital Saint Louis
Paris, 75010, France
Hôpital Saint Antoine
Paris, 75012, France
Hôpital Cochin
Paris, 75014, France
Hôpital Bicêtre
Paris, 94275, France
Hôpital Européen Georges Pompidou
Paris, France
Centre Hospitalier de Pontoise
Pontoise, 95300, France
Hôpital Robert Debré
Reims, 51100, France
Ch Pontchaillou
Rennes, France
Centre Hospitalier Universitaire de Rouen
Rouen, 76000, France
Santé Atlantique
Saint-Herblain, 44800, France
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, 67000, France
CHU de Toulouse
Toulouse, 31400, France
Clinique TIVOLI
Toulouse, France
Centre Hospitalier de Tours
Tours, 37170, France
Institut cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Gustave Roussy
Villejuif, 94805, France
Related Publications (1)
Wojcik M, Doussot A, Manfredelli S, Duclos C, Paquette B, Turco C, Heyd B, Lakkis Z. Intra-operative fluorescence angiography is reproducible and reduces the rate of anastomotic leak after colorectal resection for cancer: a prospective case-matched study. Colorectal Dis. 2020 Oct;22(10):1263-1270. doi: 10.1111/codi.15076. Epub 2020 May 18.
PMID: 32306516BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2021
First Posted
December 23, 2021
Study Start
September 26, 2022
Primary Completion
October 31, 2025
Study Completion
October 31, 2025
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share