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NCT Number: NCT07098182

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.

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Key information

Conditions

Rectal Cancer Adnexal Diseases Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Rectal Diseases Rectal Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icm Val D'Aurelle

Montpellier, Herault, 34090, France

Location status: Recruiting

Location contact

Pierre-Emmanuel COLOMBO, PHD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Clamping and restauration of arterial blood of the inferior mesenteric artery

Procedure
  • 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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Evaluation of the operative parameters (operating time).

    Time frame: During the surgery

    operating time : in minutes: time between opening and closing of the skin

  6. 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

  7. 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

  8. 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.

  9. 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).

  10. 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

  11. 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.

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore MOUSSION

CONTACT

[email protected]

467613102 ext. +33

Pierre-Emmanuel COLOMBO, PHD

CONTACT

[email protected]

467612401 ext. +33

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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