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)

NCT07098182 | Recruiting

• 2 other identifiers: PROICM 2025-03 REV2025-A01566-43
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Rectal Cancer; Colon Cancer; Ovarian Cancer

Outcome Measures

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.

  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 Outcomes (11)

• 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

  During the surgery

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

  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.

  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.

  Before the surgery. At the baseline

• Evaluation of the operative parameters (operating time).

  During the surgery

Other Outcomes (1)

• Determine the most appropriate measurement parameter to verify and quantify the vascularization of the descending colon among the following 4 methods

  During the surgery for the 15 first patient

Study Arms (1)

Single arm

OTHER

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

Interventions

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)

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Icm Val D'Aurelle

Montpellier, Herault, 34090, France

RECRUITING

Related Publications (20)

• 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.

  PMID: 34955158 BACKGROUND

• 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.

  PMID: 29501795 BACKGROUND

• 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.

  PMID: 37342851 BACKGROUND

• 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.

  PMID: 34303593 BACKGROUND

• 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.

  PMID: 34337371 BACKGROUND

• 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.

  PMID: 36163068 BACKGROUND

• 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.

  PMID: 23665058 BACKGROUND

• 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.

  PMID: 34942555 BACKGROUND

• 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.

  PMID: 22555105 BACKGROUND

• 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.

  PMID: 11748976 BACKGROUND

• 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.

  PMID: 26649151 BACKGROUND

• 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.

  PMID: 33377797 BACKGROUND

• 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.

  PMID: 33428000 BACKGROUND

• 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.

  PMID: 33409585 BACKGROUND

• 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.

  PMID: 776922 BACKGROUND

• Ahn HM, Son GM, Lee IY, Park SH, Kim NS, Baek KR. Optimization of indocyanine green angiography for colon perfusion during laparoscopic colorectal surgery. Colorectal Dis. 2021 Jul;23(7):1848-1859. doi: 10.1111/codi.15684. Epub 2021 May 11.

  PMID: 33894016 BACKGROUND

• Van den Hoven P, S Weller F, Van De Bent M, Goncalves LN, Ruig M, D Van Den Berg S, Ooms S, Mieog J, Ea Van De Bogt K, Van Schaik J, Schepers A, Vahrmeijer AL, Hamming JF, Van Der Vorst JR. Near-infrared fluorescence imaging with indocyanine green for quantification of changes in tissue perfusion following revascularization. Vascular. 2022 Oct;30(5):867-873. doi: 10.1177/17085381211032826. Epub 2021 Jul 28.

  PMID: 34320878 BACKGROUND

• Son GM, Kwon MS, Kim Y, Kim J, Kim SH, Lee JW. Quantitative analysis of colon perfusion pattern using indocyanine green (ICG) angiography in laparoscopic colorectal surgery. Surg Endosc. 2019 May;33(5):1640-1649. doi: 10.1007/s00464-018-6439-y. Epub 2018 Sep 10.

  PMID: 30203201 BACKGROUND

• Faber RA, Tange FP, Galema HA, Zwaan TC, Holman FA, Peeters KCMJ, Tanis PJ, Verhoef C, Burggraaf J, Mieog JSD, Hutteman M, Keereweer S, Vahrmeijer AL, van der Vorst JR, Hilling DE. Quantification of indocyanine green near-infrared fluorescence bowel perfusion assessment in colorectal surgery. Surg Endosc. 2023 Sep;37(9):6824-6833. doi: 10.1007/s00464-023-10140-8. Epub 2023 Jun 7.

  PMID: 37286750 BACKGROUND

• Pollmann L, Juratli M, Roushansarai N, Pascher A, Holzen JP. Quantification of Indocyanine Green Fluorescence Imaging in General, Visceral and Transplant Surgery. J Clin Med. 2023 May 18;12(10):3550. doi: 10.3390/jcm12103550.

  PMID: 37240657 BACKGROUND

Related Links

• cancer environnement
• colorectal cancer
• Related Info

MeSH Terms

Conditions

Rectal Neoplasms; Colonic Neoplasms; Ovarian Neoplasms

Interventions

Constriction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Aurore MOUSSION

CONTACT

467613102; aurore.moussion@icm.unicancer.fr

Pierre-Emmanuel COLOMBO, PHD

CONTACT

467612401; pierre-emmanuel.colombo@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 1, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)