FLUOCOL-1 : Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Universitaire

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]

Trial duration

10 Sep 2024 → ongoing

Decision date (initial)

2024-09-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

PHRC-K 2020

External identifiers

EU CT number

2024-515118-42-00

EudraCT number

2021-004814-21

ClinicalTrials.gov

NCT05168839

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

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.

Secondary objectives 8

1. To assess the effect of intraoperative fluorescence angiography with ICG on the incidence of change in planned anastomosis during surgery
2. To assess the rate of unplanned defunctioning or end stoma
3. To assess the operative and post-operative complications (according to Clavien-Dindo) within 90 days of operation
4. To assess: the length of post-operative hospital stay
5. To assess: the rate of reintervention within 90 days
6. To assess the Health-related quality of life at baseline (before surgery) and 90 days post-operation (using QLQ-C30 and QLQ-CR29 scales)
7. To assess: the medico-economic interest of IOFA with ICG use.
8. To assess: the rate of mortality within 90 days

Conditions and MedDRA coding

Colorectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis.
2. Signed informed consent
3. Affiliated to the French social security system (CMU included).
4. Adult patients (age >18 years)

Exclusion criteria 14

1. Emergent surgery
2. Rectal cancer requiring total mesorectal excision and anastomosis below the peritoneal reflexion
3. Colon cancer requiring total or subtotal colectomy defined as a right colectomy extended to the splenic flexure or more)
4. Colon cancer requiring transverse colectomy
5. Recurrent colorectal cancer
6. Locally advanced colorectal cancer requiring multi-visceral excision
7. History of colectomy
8. Associated concomitant resection of other organ (liver, etc.)
9. Previous pelvic radiotherapy for pathology unrelated to diagnosis with colon cancer e.g. treatment for prostate cancer
10. Inflammatory bowel disease
11. History of known allergy to indocyanine
12. Pregnant patients
13. Refusal to participate or inability to provide informed consent
14. Protected adults (individuals under guardianship by court order).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the occurrence of an anastomotic leakage 90-days post-operation. Anastomotic leakage 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

Secondary endpoints 8

1. Change in planned anastomosis during surgery defined as any decision change upon perfusion assessment such as modifying the initially planned transection level of the descending colon or refashioning anastomosis including the decision to undertake a permanent stoma rather than an anastomosis
2. Rate of defunctioning stoma
3. Overall 90-day postoperative morbidity, including all complications according to the Clavien-Dindo classification, and occurring within 90 days after surgery
4. Postoperative mortality, including all deaths occurring within 90 days after surgery
5. Duration of hospital stay, calculated from the day of surgery to the day of hospital discharge
6. Postoperative reintervention within 90 days
7. HRQoL using the QLQ-C30 and QLQ-CR29 at baseline and 90 days post-operation
8. Medico-economic interest of IOFA with ICG use

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Universitaire

Sponsor organisation

Centre Hospitalier Regional Universitaire

Address

2 Place Saint Jacques, Cs 51804 Cs 51804

City

Besancon Cedex

Postcode

25030

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire

Contact name

Zaher LAKKIS

Public contact point

Organisation

Centre Hospitalier Regional Universitaire

Contact name

Astrid POZET

Locations

1 EU/EEA country · 34 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications