Colon Cancer, Ovarian Cancer, Rectal Cancer
Conditions
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.
Interventions
PROCEDUREClamping 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 with lights of the room switched off (laparotomy)
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | On the intraoperative Thoraco Abdomino Pelvis scanner, measure of the diameter in mm of the left colic artery. |
| Evaluation of the operative parameters (operating time). | During the surgery | operating time : in minutes: time between opening and closing of the skin |
| Evaluation of the operative parameters (duration of dissection of the inferior mesenteric artery). | During the surgery | inferior mesenteric artery dissection time : in minutes: time between the beginning of the dissection of the I and completion |
| Evaluation of the operative parameters (duration of dissection of the left colic artery). | During the surgery | left colic artery dissection time : in minutes:MA time between the beginning of the artery dissection and completion |
| Evaluation of the operative parameters (intraoperative bleeding). | During the surgery | intraoperative bleeding in mL: estimated total volume of blood, measured by aspiration and impregnated compresses. |
| Evaluate postoperative parameters (within 30 days of surgery): rate of anastomotic leakage, rate of surgical recovery, duration of bowel function recovery. | 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). |
| Number of resected lymph-nodes. | 30 days after the surgery | Total number of lymph nodes taken from the surgical specimen analysed in anatomopathology |
| Percentage of conservation of the colic artery. | 30 days after the surgery | Success Percentage of conservation of the colic artery among included patient in the study. |
Countries
France
Contacts
CONTACTAurore MOUSSION
CONTACTPierre-Emmanuel COLOMBO, PHD
Outcome results
None listed