Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT06236633

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

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-12-04

30

Participants Needed

3

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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 CT scan.
  • Patients with occlusion of the inferior mesenteric artery on the extension scan.
  • Patients with systemic bleeding disorders or on anticoagulant therapy.
  • Patients taking corticosteroids or immunosuppressants posing high surgical risk.
  • Patients with renal insufficiency (clearance < 30 mL/min).
  • Patients allergic to iodine.
  • Patients treated for abdominal aorta or its branches.
  • Patients participating in another interventional study or in exclusion period.
  • Patients under court protection, guardianship, or curatorship.
  • Patients unable to give or receive informed consent.
  • Pregnant or breastfeeding patients.

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Hôpital Saint-Eloi

Montpellier, France, 34295

Actively Recruiting

2

Institut du Cancer de Montpellier

Montpellier, France, 34298

Actively Recruiting

3

CHU de Nîmes

Nîmes, France, 30029

Actively Recruiting

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Research Team

M

Martin BERTRAND, Professor

CONTACT

A

Anissa MEGZARI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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