Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)

June 2, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Clinical Study Evaluating the Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)

Colorectal cancers and ovarian cancers are respectively the 2nd and 5th cause of cancer mortality in France.

Surgical resection is a crucial step in the therapeutic management of colorectal cancers. For advanced ovarian cancers, the objective of cytoreductive surgery is to obtain complete macroscopic resection with no visible residual disease. One or more digestive resections are often required to achieve this goal of complete surgery (usually a modified posterior pelvic exenteration with colorectal resection).

A ligation of the inferior mesenteric artery at its origin is classically performed in left colectomies and rectal resection for colorectal cancers. This allows the resection of the colorectal segment with a complete mesocolic lymphadenectomy until the origin of the inferior mesenteric artery and a good mobilization of the descending colon to allow its anastomosis to the underlying rectal stump. This ligation of the inferior mesenteric artery at its origin is also frequently performed in cases of modified posterior pelvic exenteration for ovarian cancer.

Recently, several studies suggest that arterial ligation of the inferior mesenteric artery could be performed below the emergence of the left colic artery. Its preservation requiring a meticulous vascular dissection would allow a better vascularization of the descending colon and of the colorectal anastomosis without affecting the carcinologic quality of the resection and the number of resected lymph-nodes. Indeed, the most feared complication during colorectal anastomosis is the anastomotic leakage whose rates are on average 15% in rectal cancer with low anastomosis and 6% in ovarian cancers.

Verifying the adequate vascularization of the descending colon before performing the colorectal anastomosis is a crucial step in reducing the risk of postoperative fistula. However, quantifying this vascularization is challenging, and several techniques can be used to assess it. The gold standard technique involves measuring arterial pressure using a catheter inserted into the marginal artery of the descending colon. Other non-invasive techniques also use Doppler studies to calculate pressure in the marginal artery or assess oxygen saturation using a sterile sensor.

Studies have shown that the use of indocyanine green in colorectal surgery, particularly to evaluate perfusion before the creation of an anastomosis, significantly reduces the rate of anastomotic leakage. Indocyanine green is a fluorescent dye that, after intravenous injection, binds to plasma proteins and allows tissue perfusion to be visualized using a fluorescence system.

The objective of this project is to show that the preservation of the left colic artery is possible and allows a better vascularization of the descending colon before colorectal anastomosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male/ female aged over 18 years,
  • Histologically proven left colon or rectal adenocarcinoma OR ovarian carcinoma (with potential colorectal resection),
  • Scheduled surgery for left colic or rectal carcinoma// Scheduled surgery for ovarian carcinoma with potential colorectal resection,
  • Surgical indication of colo-rectal resection validated in RCP and confirmed during the operative exploration (ovarian cancer,
  • WHO Status < 3
  • Patient who has given informed, written and express consent,
  • Patient (s) affiliated to a French social security.

Exclusion Criteria:

  • Contraindication to indocyanine green: thyroid adenoma, hyperthyroidism, hypersensitivity or allergy to one of the components, severe renal failure (GFR <30 ml/min/1.73m2),
  • Patient with a history of abdominal vascular surgery
  • Patient (e) not having left colic artery on vascular mapping of preoperative abdominal-pelvic scanners,
  • Patient whose regular follow-up is not possible for psychological, family, social or geographical reasons,
  • Patient (s) under guardianship, curatorship or safeguard of justice,
  • Pregnant and/or breastfeeding patient,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm

During surgery, on the same patient who received left or colorectal resection with ligation of the lower mesenteric artery below of the emergence of the left colic artery, the steps will be as follows:

  • Time 1: Clamping of the inferior mesenteric artery at its origin (resulting in clamping the left colic artery),

    1. Evaluation of the fluorescence intensity at the area of interest after Indocyanine green injection :
    2. Measurement of the blood pressure of the marginal artery of the descending colon via pressure sensor introduced in the artery and doppler
    3. Measurement of saturation via a saturation sensor
    4. Measurement of systemic blood pressure using a tension cuff
  • Time 2: after inferior mesenteric artery release restoring arterial blood flow in the artery and at least 10min since ICG injection of time 1 to obtain its clearance. same parameters mesured
Procedure: Clamping and restauration of arterial blood of the inferior mesenteric artery
  • Injection of Indocynianine green (INFRACYANINE 25mg diluted in 10 mL solvent, IV injection of 3ml at a concentration of 2.5 mg/mL or 7.5 mg), (excluding NaCl), purge 10ml NaCl,
  • Camera model (STORZ)
  • Camera/target distance: 5cm
  • Camera recording time (since Indocynianine green injection): 2 to 5 min with temporal identification of the injection time.

Extracorporeal evaluation (by mini laparatomy extraction in colorectal surgery minimally invasive, by laparotomy in case of ovarian cancer with lights of the room switched off (laparotomy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the variation in vascularization of the descending colon with or without clamping of the inferior mesenteric artery quantified by the method selected during the exploratory phase of the primary endpoint.
Time Frame: During the surgery

Measurement of vascularization at the end of the descending colon with and without clamping the inferior mesenteric artery at its origin (interrupting arterial flow in the left colic artery) according to the quantification method selected in the exploratory evaluation phase.

  • If Indocyanine green intraveinous injection: measurement of decrease in staining time and increase in intensity
  • If Blood Pressure by catheter, doppler or saturation: percentage increase all the measures will define the same measure, that is to say, the vascularization of the descending colon
During the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of blood pressure in the marginal artery of the colon descending after clamping of the IMA at its origin then without clamping of the left colic artery by the other three method
Time Frame: During the surgery
Measurement of blood pressure after catheterization of the marginal artery of the descending colon. Measurement of systemic blood pressure at the same time. The measurement will be performed using an arterial catheter.
During the surgery
Study of the anatomy of the lower mesenteric artery and its branches after arterial reconstruction of scanner performed preoperatively.
Time Frame: Before the surgery. At the baseline
On the intraoperative Thoraco Abdomino Pelvis scanner, measure of the diameter in mm of the left colic artery.
Before the surgery. At the baseline
Study of the anatomy of the lower mesenteric artery and its branches after arterial reconstruction of scanner performed preoperatively.
Time Frame: Before the surgery. At the baseline
On the intraoperative Thoraco Abdomino Pelvis scanner, measure the distance in mm between the origin of the inferior mesenteric artery.
Before the surgery. At the baseline
Study of the anatomy of the lower mesenteric artery and its branches after arterial reconstruction of scanner performed preoperatively.
Time Frame: Before the surgery. At the baseline
On the intraoperative Thoraco Abdomino Pelvis scanner, evaluate the presence of dividing branches.
Before the surgery. At the baseline
Evaluation of the operative parameters (operating time).
Time Frame: During the surgery
operating time : in minutes: time between opening and closing of the skin
During the surgery
Evaluation of the operative parameters (duration of dissection of the inferior mesenteric artery).
Time Frame: During the surgery
inferior mesenteric artery dissection time : in minutes: time between the beginning of the dissection of the I and completion
During the surgery
Evaluation of the operative parameters (duration of dissection of the left colic artery).
Time Frame: During the surgery
left colic artery dissection time : in minutes:MA time between the beginning of the artery dissection and completion
During the surgery
Evaluation of the operative parameters (intraoperative bleeding).
Time Frame: During the surgery
intraoperative bleeding in mL: estimated total volume of blood, measured by aspiration and impregnated compresses.
During the surgery
Evaluate postoperative parameters (within 30 days of surgery): rate of anastomotic leakage, rate of surgical recovery, duration of bowel function recovery.
Time Frame: 30 days after the surgery
Data recovery within 30 days of surgery: anastomotic leakage rate (number of patients with anastomotic leakages confirmed by scan within 30 days of surgery), surgical recovery rate (number of patients for whom a re-intervention was necessary following a postoperative complication) and duration of bowel recovery (in days, defined by the 1st gas/stool emission after the intervention, defined by a clinical assessment of the surgeon).
30 days after the surgery
Number of resected lymph-nodes.
Time Frame: 30 days after the surgery
Total number of lymph nodes taken from the surgical specimen analysed in anatomopathology
30 days after the surgery
Percentage of conservation of the colic artery.
Time Frame: 30 days after the surgery
Success Percentage of conservation of the colic artery among included patient in the study.
30 days after the surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the most appropriate measurement parameter to verify and quantify the vascularization of the descending colon among the following 4 methods
Time Frame: During the surgery for the 15 first patient
  • The measureof Blood pressure in the marginal artery of the colon with a pressure sensor introduced into the artery through a catheter.
  • Intraveinous ICG injection with the measure of duration between bolus and maximum opacification of the colon and semi-quantitative assessment of the intensity of the green. The measure will focus on the variation between the injection time and the maximum opacification (visual measurement) of the colon.
  • The measure of saturation in the marginal artery of the descending colon by a saturation sensor. The measure will be on the saturation variation in the artery.
  • The measure of BP in the marginal artery of the colon by Doppler. The measurement will be on the variation of pressure in the artery.

This first phase will establish the best method to observe an increase in revascularization between clamped and non-clamped time

all the measures will define the same measure, that is to say, the vascularization of the descending colon
During the surgery for the 15 first patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 11, 2025

First Submitted That Met QC Criteria

July 24, 2025

First Posted (Actual)

August 1, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2025-03 REV
  • 2025-A01566-43 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

IPD Sharing Time Frame

Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.

IPD Sharing Access Criteria

The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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