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Recruiting NCT06236633

Safety & Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Surgery for Tumors of Lower and Middle Rectum

Trial Parameters

Condition Cancer, Rectal
Sponsor Centre Hospitalier Universitaire de Nīmes
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 90 Years
Start Date 2024-08-02
Completion 2026-08-01
Interventions
Ischemic preconditioningArteriogram

Brief Summary

The present study will investigate the safety of inferior mesenteric artery embolization prior to rectal surgery, according to IDEAL recommendations (Lancet 2009). It aims to assess the safety of endovascular embolization of the inferior mesenteric artery prior to surgery in patients with rectal tumors, and estimate the potential benefits in terms of time to surgery and the occurrence of post-operative fistulas.The study will also assess the impact of subacute ischemia induced by IMA embolization on colonic vasculature remodeling, colonic ischemic suffering, altered hemostasis and initiation of neo-angiogenesis through blood sampling kinetics.The hypothesis is that ischemic preconditioning by inferior mesenteric artery embolization prior to rectal cancer resection surgery is safe and will result in a decrease in acute relative colon ischemia and a reduction in the rate of fistulas and post-surgical complications. Indeed, we believe that the beneficial effects of the ischemic preconditioning of IMA will be due to better blood perfusion of the colon at 3 weeks, which is apparently linked to remodeling and/or the development of collateral vascularization.

Eligibility Criteria

Inclusion Criteria: * Patients with rectal cancer eligible for surgery with ligation at the origin of the inferior mesenteric artery. * Patients with free, informed consent. * Patients affiliated to or benefiting from a health insurance plan. Exclusion Criteria: * Patients with a history of colon cancer who has undergone colon resection surgery * Patients with occlusion of the superior mesenteric artery or stenosis of more than 50%, visible on the CT scan performed as part of conventional management during extension workup. * Patients with occlusion of the IMA on the extension scan. * Patients with a systemic disorder responsible for haemostasis (haemophilia, Willebrand's disease, thrombocytopenia) and on anticoagulant therapy. * Patients taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk. * Patients with renal insufficiency with clearance \< 30mL/min. * Patients with an allergy to iodine. * Patients who has had treatment of the abdominal aorta or its

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