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

RecruitingNAAges 18 Years - 90 YearsAllCentre Hospitalier Universitaire de Nīmes
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In plain words

What the trial is, and whether it could suit you

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 po

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📋 Eligibility rules (as published)
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 branches. * Patients participating in an interventional study. * Patients in an exclusion period determined by another study. * Patients under court protection, guardianship or curatorship. * Patients unable to give consent. * Patients for whom it is impossible to provide informed information. * Pregnant or breast-feeding patients.
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What it tests

  • Ischemic preconditioning
  • Arteriogram
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Where

3 sites
Hôpital Saint-Eloi
Montpellier, France
Institut du Cancer de Montpellier
Montpellier, France
CHU de Nîmes
Nîmes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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