NCT06236633Recruiting
Safety & Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Surgery for Tumors of Lower and Middle Rectum
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
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 24 Jan 2024
- Start date
- 2 Aug 2024
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Diseases
- Colorectal cancer
- NCT number
- NCT06236633
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 2 Aug 2024 to the primary completion date, 1 Aug 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk.
Other illness
- Patients with a history of colon cancer who has undergone colon resection surgery
- Patients with a systemic disorder responsible for haemostasis (haemophilia, Willebrand's disease, thrombocytopenia) and on anticoagulant therapy.
- Patients with an allergy to iodine.
Lab values
- Patients with renal insufficiency with clearance \< 30mL/min.
Other
- 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 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Saint Eloi Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Institut du Cancer de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.