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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01566-43 | Other Identifier | ID-RCB |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clamping and restauration of arterial blood of the inferior mesenteric artery | Procedure |
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) |
| 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. | 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.
| During the surgery |
| 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 | 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. |
| 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 |
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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurore MOUSSION | Contact | 467613102 | +33 | aurore.moussion@icm.unicancer.fr |
| Pierre-Emmanuel COLOMBO, PHD | Contact | 467612401 | +33 | pierre-emmanuel.colombo@icm.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icm Val D'Aurelle | Recruiting | Montpellier | Herault | 34090 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34955158 | Background | 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. | |
| 29501795 |
| Label | URL |
|---|---|
| cancer environnement | View source |
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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.
Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
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.
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|
| During the surgery |
| 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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. | 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. | 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. | Success Percentage of conservation of the colic artery among included patient in the study. | 30 days after the surgery |
| During the surgery for the 15 first patient |
| 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. |
| 37342851 | 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. |
| 34303593 | 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. |
| 34337371 | 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. |
| 36163068 | 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. |
| 23665058 | 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. |
| 34942555 | 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. |
| 22555105 | 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. |
| 11748976 | 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. |
| 26649151 | 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. |
| 33377797 | 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. |
| 33428000 | 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. |
| 33409585 | 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. |
| 776922 | 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. |
| 33894016 | 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. |
| 34320878 | 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. |
| 30203201 | 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. |
| 37286750 | 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. |
| 37240657 | 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. |
| colorectal cancer | View source |
| Related Info | View source |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D003250 | Constriction |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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