Evaluation of the Safety and Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Oncologic Surgery for Tumors of the Lower and Middle Rectum. Bicentric Exploratory Pilot Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Patients with cancer of the lower or middle rectum, eligible for surgical treatment requiring ligation at the origin of the inferior mesenteric artery.

• Patients with free, informed consent.

• Patients affiliated to or benefiting from a health insurance plan.

Locations
Other Locations
France
Hôpital Saint-Eloi
RECRUITING
Montpellier
Institut du Cancer de Montpellier
RECRUITING
Montpellier
CHU de Nîmes
RECRUITING
Nîmes
Contact Information
Primary
Martin BERTRAND, Professor
martin.bertrand@chu-nimes.fr
+336.43.50.35.22
Backup
Anissa MEGZARI
drc@chu-nimes.fr
+33466684236
Time Frame
Start Date: 2024-08-02
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 30
Treatments
No_intervention: Control group
In the control group, patients will undergo standard management.
Experimental: Ischemic preconditioning group
In the experimental group, patients will undergo preoperative arteriography and ischemic preconditioning One blood sample will be taken before and two samples taken after embolization of the IMA.~These patients will receive a phone call on Day 7 post embolization. A blood sample will also be taken at the time of surgery.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nīmes

This content was sourced from clinicaltrials.gov