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Rectal CancerNCT07098182

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)

A study testing Clamping and restauration of arterial blood of the inferior mesenteric artery in people with Rectal Cancer and Colon Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer, Colon Cancer, Ovarian Cancer
What is being tested?
Clamping and restauration of arterial blood of the inferior mesenteric artery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
27 Nov 2025to Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Icm Val D'Aurelle

    Montpellier, Herault, 34090

    Pierre-Emmanuel COLOMBO, PHD, pierre-emmanuel.colombo@icm.unicancer.fr

    Recruiting

Other trials in France

About this study

Official 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)

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).

Read more

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.

Being tested
Clamping and restauration of arterial blood of the inferior mesenteric artery
Medical subject headings
Rectal Neoplasms, Colonic Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clamping and restauration of arterial blood of the inferior mesenteric arteryProcedure or surgery

    • 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)

Study groups in NCT07098182
Study groupRoleWhat they receive
Single armOtherDuring 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
Receives: Procedure: Clamping and restauration of arterial blood of the inferior mesenteric artery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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

    Measured: During the surgery

Secondary outcomes (11)
  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

    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.

    Measured: During the surgery

  2. Study of the anatomy of the lower mesenteric artery and its branches after arterial reconstruction of scanner performed preoperatively.

    On the intraoperative Thoraco Abdomino Pelvis scanner, measure of the diameter in mm of the left colic artery.

    Measured: Before the surgery. At the baseline

  3. Study of the anatomy of the lower mesenteric artery and its branches after arterial reconstruction of scanner performed preoperatively.

    On the intraoperative Thoraco Abdomino Pelvis scanner, measure the distance in mm between the origin of the inferior mesenteric artery.

    Measured: Before the surgery. At the baseline

  4. Study of the anatomy of the lower mesenteric artery and its branches after arterial reconstruction of scanner performed preoperatively.

    On the intraoperative Thoraco Abdomino Pelvis scanner, evaluate the presence of dividing branches.

    Measured: Before the surgery. At the baseline

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

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

    Measured: During the surgery

  6. Evaluation of the operative parameters (duration of dissection of the inferior mesenteric artery).

    inferior mesenteric artery dissection time : in minutes: time between the beginning of the dissection of the I and completion

    Measured: During the surgery

  7. Evaluation of the operative parameters (duration of dissection of the left colic artery).

    left colic artery dissection time : in minutes:MA time between the beginning of the artery dissection and completion

    Measured: During the surgery

  8. Evaluation of the operative parameters (intraoperative bleeding).

    intraoperative bleeding in mL: estimated total volume of blood, measured by aspiration and impregnated compresses.

    Measured: During the surgery

  9. Evaluate postoperative parameters (within 30 days of surgery): rate of anastomotic leakage, rate of surgical recovery, duration of bowel function recovery.

    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).

    Measured: 30 days after the surgery

  10. Number of resected lymph-nodes.

    Total number of lymph nodes taken from the surgical specimen analysed in anatomopathology

    Measured: 30 days after the surgery

  11. Percentage of conservation of the colic artery.

    Success Percentage of conservation of the colic artery among included patient in the study.

    Measured: 30 days after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study start27 Nov 2025
  3. Primary completionOct 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07098182
Sponsor's protocol ID
PROICM 2025-03 REV
Other IDs
2025-A01566-43
Status last verified
Jun 2026
First submitted
11 Jul 2025
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Classe JM, Joly F, Lecuru F, Morice P, Pomel C, Selle F, You B. Prise en charge chirurgicale du cancer epithelial de l'ovaire - premiere ligne et premiere rechute: Surgical management of epithelial ovarian cancer - first line and first relapse. Bull Cancer. 2021 Dec;108(9S1):S13-S21. doi: 10.1016/S0007-4551(21)00583-X.

    PubMed 34955158
  • Fan YC, Ning FL, Zhang CD, Dai DQ. Preservation versus non-preservation of left colic artery in sigmoid and rectal cancer surgery: A meta-analysis. Int J Surg. 2018 Apr;52:269-277. doi: 10.1016/j.ijsu.2018.02.054. Epub 2018 Mar 1.

    PubMed 29501795
  • Liu FC, Song JN, Yang YC, Zhang ZT. Preservation of left colic artery in laparoscopic colorectal operation: The benefit challenge. World J Gastrointest Surg. 2023 May 27;15(5):825-833. doi: 10.4240/wjgs.v15.i5.825.

    PubMed 37342851
  • Qu R, Li F, Zhou X, Fu W. Is the preservation of the left colic artery an ideal choice for patients undergoing colorectal cancer surgery? A meta-analysis. Asian J Surg. 2021 Oct;44(10):1347-1348. doi: 10.1016/j.asjsur.2021.07.001. Epub 2021 Jul 21. No abstract available.

    PubMed 34303593
  • Guidolin K, Covelli A, Chesney TR, Draginov A, Chadi SA, Quereshy FA. Apical lymphadenectomy during low ligation of the IMA during rectosigmoid resection for cancer. Surg Open Sci. 2021 Jun 23;5:1-5. doi: 10.1016/j.sopen.2021.06.002. eCollection 2021 Jul.

    PubMed 34337371
  • Li B, Wang J, Yang S, Shen J, Li Q, Zhu Q, Cui W. Left colic artery diameter is an important factor affecting anastomotic blood supply in sigmoid colon cancer or rectal cancer surgery: a pilot study. World J Surg Oncol. 2022 Sep 27;20(1):313. doi: 10.1186/s12957-022-02774-0.

    PubMed 36163068
  • Sabbagh C, Maggiori L, Panis Y. Management of failed low colorectal and coloanal anastomosis. J Visc Surg. 2013 Jun;150(3):181-7. doi: 10.1016/j.jviscsurg.2013.03.016. Epub 2013 May 9.

    PubMed 23665058
  • Valenti G, Vitagliano A, Morotti M, Giorda G, Sopracordevole F, Sapia F, Lo Presti V, Chiofalo B, Forte S, Lo Presti L, Tozzi R. Risks factors for anastomotic leakage in advanced ovarian cancer: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2022 Feb;269:3-15. doi: 10.1016/j.ejogrb.2021.12.007. Epub 2021 Dec 13.

    PubMed 34942555
  • Peiretti M, Bristow RE, Zapardiel I, Gerardi M, Zanagnolo V, Biffi R, Landoni F, Bocciolone L, Aletti GD, Maggioni A. Rectosigmoid resection at the time of primary cytoreduction for advanced ovarian cancer. A multi-center analysis of surgical and oncological outcomes. Gynecol Oncol. 2012 Aug;126(2):220-3. doi: 10.1016/j.ygyno.2012.04.030. Epub 2012 Apr 30.

    PubMed 22555105
  • Clayton RD, Obermair A, Hammond IG, Leung YC, McCartney AJ. The Western Australian experience of the use of en bloc resection of ovarian cancer with concomitant rectosigmoid colectomy. Gynecol Oncol. 2002 Jan;84(1):53-7. doi: 10.1006/gyno.2001.6469.

    PubMed 11748976
  • Rutegard M, Rutegard J. Anastomotic leakage in rectal cancer surgery: The role of blood perfusion. World J Gastrointest Surg. 2015 Nov 27;7(11):289-92. doi: 10.4240/wjgs.v7.i11.289.

    PubMed 26649151
  • Li Z, Zhou Y, Tian G, Liu Y, Jiang Y, Li X, Song M. Meta-Analysis on the Efficacy of Indocyanine Green Fluorescence Angiography for Reduction of Anastomotic Leakage After Rectal Cancer Surgery. Am Surg. 2021 Dec;87(12):1910-1919. doi: 10.1177/0003134820982848. Epub 2020 Dec 30.

    PubMed 33377797
  • Zhang W, Che X. Effect of indocyanine green fluorescence angiography on preventing anastomotic leakage after colorectal surgery: a meta-analysis. Surg Today. 2021 Sep;51(9):1415-1428. doi: 10.1007/s00595-020-02195-0. Epub 2021 Jan 11.

    PubMed 33428000
  • Pang HY, Chen XL, Song XH, Galiullin D, Zhao LY, Liu K, Zhang WH, Yang K, Chen XZ, Hu JK. Indocyanine green fluorescence angiography prevents anastomotic leakage in rectal cancer surgery: a systematic review and meta-analysis. Langenbecks Arch Surg. 2021 Mar;406(2):261-271. doi: 10.1007/s00423-020-02077-6. Epub 2021 Jan 7.

    PubMed 33409585
  • Landsman ML, Kwant G, Mook GA, Zijlstra WG. Light-absorbing properties, stability, and spectral stabilization of indocyanine green. J Appl Physiol. 1976 Apr;40(4):575-83. doi: 10.1152/jappl.1976.40.4.575.

    PubMed 776922

Questions about this trial

What is this clinical trial studying?

A study testing Clamping and restauration of arterial blood of the inferior mesenteric artery in people with Rectal Cancer and Colon Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aurore MOUSSION (467613102 ext. +33, aurore.moussion@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07098182, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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