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Tests treatment safety and results for Cancer, Rectal
Official title Safety & Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Surgery for Tumors of Lower and Middle Rectum
ClinicalTrials.gov ID: NCT06236633
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
- Nîmes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France; Nîmes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.