Embolization of the Inferior Mesenteric Artery before Rectal Surgery
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
This study tests if blocking a specific artery before rectal surgery can help people with tumors recover better and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 3 sites (Montpellier and 2 other locations) |
| Trial ID | NCT06236633 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of embolizing the inferior mesenteric artery prior to surgery for tumors of the lower and middle rectum. The approach aims to induce ischemic preconditioning, which may enhance vascularization and reduce complications such as postoperative fistulas. By performing this embolization three weeks before surgery, the study seeks to improve colonic blood flow and overall surgical outcomes. The research will also evaluate the impact of this procedure on colonic vasculature and postoperative recovery.
Who should consider this trial
Good fit: Ideal candidates are patients with cancer of the lower or middle rectum who are eligible for surgical treatment requiring ligation of the inferior mesenteric artery.
Not a fit: Patients with significant vascular occlusions, systemic disorders affecting hemostasis, or those on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rate of postoperative complications and improve recovery for patients undergoing rectal cancer surgery.
How similar studies have performed: Previous studies have shown promising results with similar ischemic preconditioning approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Montpellier and 2 other locations
- Hôpital Saint-Eloi — Montpellier, France (Recruiting)
- Institut du Cancer de Montpellier — Montpellier, France (Recruiting)
- CHU de Nîmes — Nîmes, France (Recruiting)
Study contacts
- Study coordinator: Martin BERTRAND, Professor
- Email: martin.bertrand@chu-nimes.fr
- Phone: +336.43.50.35.22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.