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)

Официальное название

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)

Обзор

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.

Вмешательства

• Процедура 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 wi

Первичные конечные точки

• 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. [Срок оценки: During the surgery]

Вторичные конечные точки (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 [Срок оценки: During the surgery]
• Study of the anatomy of the lower mesenteric artery and its branches after arterial reconstruction of scanner performed preoperatively. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Before the surgery. At the baseline]
• Evaluation of the operative parameters (operating time). [Срок оценки: During the surgery]
• Evaluation of the operative parameters (duration of dissection of the inferior mesenteric artery). [Срок оценки: During the surgery]
• Evaluation of the operative parameters (duration of dissection of the left colic artery). [Срок оценки: During the surgery]
• Evaluation of the operative parameters (intraoperative bleeding). [Срок оценки: During the surgery]
• Evaluate postoperative parameters (within 30 days of surgery): rate of anastomotic leakage, rate of surgical recovery, duration of bowel function recovery. [Срок оценки: 30 days after the surgery]
• Number of resected lymph-nodes. [Срок оценки: 30 days after the surgery]
• Percentage of conservation of the colic artery. [Срок оценки: 30 days after the surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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,

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Icm Val D'Aurelle — Montpellier

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07098182 · PROICM 2025-03 REV · 2025-A01566-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗