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

NCT06236633 | Recruiting

• 1 other identifier: NIMAO/2022-1/MB-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cancer, Rectal

Keywords

Ischemic preconditioning surgery; Cancer, Rectal; Inferior Mesenteric Artery Embolus

Outcome Measures

Primary Outcomes (1)

• Safety of endovascular inferior mesenteric artery embolisation prior to surgical resection of the rectum in patients with tumours of the lower and middle rectum.

  Percentage of patients with a complication (any grade) within 7 days after embolisation of the inferior mesenteric artery according to the classification of the International Society of Interventional Radiology assessed during the follow-up telephone consultation by the interventional radiologist. Complications will be classified as minor (Grades A and B) or Major (grades C to F). Grade A = No therapy, no consequence Grade B = Nominal therapy, no consequence. Includes overnight admission for observation only Grade C = Requires therapy, minor hospitalization (\<48 hours) Grade D = Requires major therapy. Unplanned increase in level of care. Prolonged hospitalization (\>48 hours) Grade E = Permanent adverse sequelae Grade F= Death

  Day 7 post embolization (performed 3 weeks before surgical resection of the rectum)

Secondary Outcomes (96)

• Technical success of the embolization procedure

  Day 0, on the day of embolization

• Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade I

  Post-operative Day 30

• Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade II

  Post-operative Day 30

• Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IIIa

  Post-operative Day 30

• Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IIIb

  Post-operative Day 30

Other Outcomes (14)

• Gender

  Day 0, on the day of inclusion

• Age

  Day 0, on the day of inclusion

• Height

  Day 0, on the day of inclusion

Study Arms (2)

Control group

NO INTERVENTION

In the control group, patients will undergo standard management.

Ischemic preconditioning group

EXPERIMENTAL

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.

Procedure: Ischemic preconditioning; Procedure: Arteriogram

Interventions

Ischemic preconditioning PROCEDURE

Embolization performed via a common right femoral or radial approach, depending on the patient's conformation. Minor complications such as hematoma at the puncture site are rare in less than 1% of cases, and serious complications are exceptional. Proximal occlusion of the inferior mesenteric artery, before its dividing branches, using material adapted to arterial occlusion according to anatomical findings. Proximal occlusion during embolization is evaluated by intravascular injection into the inferior mesenteric artery, and resumption of vascularization of the distal inferior mesenteric artery is controlled by the border arcade injecting into the superior mesenteric artery. In the event of a high-risk anatomical variant, or absence of a border arcade, no embolization will be performed and the patient will be excluded from the study; this will represent no more than 1-2% of patients (surgical series describing 0.83% of ischemia in connection with absence of a border arcade).

Ischemic preconditioning group

Arteriogram PROCEDURE

The interventional radiologist performs an arteriogram of the inferior and superior mesenteric arteries (IMA and SMA respectively) to check that the SMA is free of anomalies and that the IMA has a proximal trunk long enough for embolization. The radiologist also checks for the presence of a colonic border arcade. If this is absent, embolization will not be performed: the patient will be excluded from the study.This arteriogram is carried out under local anaesthetic specifically for research purposes, as follows: Common right femoral or radial approach and placement of a small introducer. Selective arteriogram of the inferior and superior mesenteric arteries to check perfusion of the border arcade.Arterial closure system or manual compression. Return to surgery or interventional radiology department. Patient discharged the same day after medical assessment (surgeon or interventional radiologist).Telephone check-up on Day1 (standard management) and Day 7 (added as part of the protocol).

Ischemic preconditioning group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

Hôpital Saint-Eloi

Montpellier, 34295, France

RECRUITING

Institut du Cancer de Montpellier

Montpellier, 34298, France

RECRUITING

CHU de Nîmes

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Central Study Contacts

Martin BERTRAND, Professor

CONTACT

+336.43.50.35.22; martin.bertrand@chu-nimes.fr

Anissa MEGZARI

CONTACT

+33466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the type of intervention and the design of the study, the patient and the referring caregivers cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot exploratory descriptive prospective bicentric study to evaluate the safety and efficacy of an innovative procedure: inferior mesenteric artery embolization prior to rectal cancer surgery involving 2 groups: one with standard treatment and the other with inferior mesenteric artery embolization.

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: August 2, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

FR (3)