Safety & Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Surgery for Tumors of Lower and Middle Rectum (AMIREMBOL_2)

November 27, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Recruiting

Conditions

Cancer, Rectal

Intervention / Treatment

Detailed Description

Anastomotic fistulas are the main cause of morbidity and mortality in colorectal surgery. They are responsible for septic complications, leading to increased mortality, local recurrence, repeat surgery and impaired sexual, urinary and digestive function. Fistulas are multifactorial; among the causes, colonic vascularization seems to be a major one. Ligation of the inferior mesenteric artery during rectal surgery has been shown to reduce intraoperative colonic perfusion flow. The left colon is then vascularized only by the colonic border arcade, perfused by the superior mesenteric artery. Ischemic pre-conditioning of the arterial network prior to surgery should ensure better vascularization by developing arterial collaterality and increasing perfusion flow in the colonic border arcade. In view of major advances in interventional radiology, this preconditioning could be achieved by endovascular ligation of the inferior mesenteric artery (IMA), based on the same principle as during surgery: proximal occlusion of the inferior mesenteric artery (IMA), using embolization material (plug or coils), 3 weeks before surgery, to allow the colonic border arcade to develop. We carried out a single-center pilot study (AMIREMBOL 1, NIMAO 2017; Frandon et al. 2022) to assess the feasibility of ischemic preconditioning of the colon for patients with rectal or sigmoid cancer. The study included 10 patients, randomized into two groups: the control group, with preoperative arteriography and standard management and the "embolization" group, with embolization of the IMA three weeks prior to surgery. IMA embolization was successfully performed in all 5 patients in the embolization group, with no major complications. The effect on colonic perfusion, measured by intraoperative Doppler directly on the border arch, with recording of resistance indexes (independent of measurement angle), showed a drop in resistance indexes in the control arm, after ligation of the IMA, which persisted after 5 minutes. In the "Embolization" arm, no drop in this index was reported during surgery, reflecting good development of vascular collaterality and at least relative acute ischemia of the colon after IMA ligation during surgery. Finally, in the "control" group, one anastomotic fistula was reported after surgery and required re-operation. There were no fistulas in the embolization group.

The present study (AMIREMBOL 2) will investigate the safety of IMA embolization prior to rectal surgery, according to IDEAL recommendations (Lancet 2009). Its aim is to assess the safety of endovascular embolization of the IMA prior to surgery in patients with rectal tumors, and to 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 (IMA) 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. The hypothesis is 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.

Study Type

Interventional

Enrollment (Estimated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Anissa MEGZARI
Phone Number: +33466684236
Email: drc@chu-nimes.fr

Study Contact Backup

Name: Martin BERTRAND, Professor
Phone Number: +336.43.50.35.22
Email: martin.bertrand@chu-nimes.fr

Study Locations

France
- - Montpellier, France, 34298
    - Recruiting
    - Institut Du Cancer de Montpellier
    - Contact:
      
      Philippe ROUANET, Pr
    - Principal Investigator:
      
      Philippe Rouanet, Pr
  - Montpellier, France, 34295
    - Recruiting
    - Hopital Saint-Eloi
    - Contact:
      
      Boris GUIU, Pr
    - Principal Investigator:
      
      Boris GUIU, Pr
  - Nîmes, France, 30029
    - Recruiting
    - CHU de Nîmes
    - Contact:
      
      Martin BERTRAND, Pr
    - Principal Investigator:
      
      Martin BERTRAND, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Ischemic preconditioning 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). Procedure: Arteriogram 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).

Participant Group / Arm

Intervention / Treatment

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.

Procedure: Ischemic preconditioning

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).

Procedure: Arteriogram

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of endovascular inferior mesenteric artery embolisation prior to surgical resection of the rectum in patients with tumours of the lower and middle rectum. Time Frame: Day 7 post embolization (performed 3 weeks before surgical resection of the 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 Outcome Measures

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender Time Frame: Day 0, on the day of inclusion	Male/Female	Day 0, on the day of inclusion
Age Time Frame: Day 0, on the day of inclusion	In years	Day 0, on the day of inclusion
Height Time Frame: Day 0, on the day of inclusion	In centimeters	Day 0, on the day of inclusion
Tumor stage Time Frame: Day 0, on the day of inclusion	Stage 0: Cancer cells are limited to the surface of the rectal lining. Stage I: Tumor has grown below the lining and possibly into the rectal wall. Stage II: Tumor has grown into the rectal wall and might extend into tissues around the rectum. Stage III: Tumor has invaded the lymph nodes next to the rectum and some tissues outside of the rectal wall. Stage IV: Cancer has spread to distant organs, such as the liver or lungs.	Day 0, on the day of inclusion
Tumor, Node and Metastasis staging (TNM) Time Frame: Day 0, on the day of inclusion	Tis:tumor in situ, only in mucosa.T1:tumor only in inner layer of bowel T2:tumor in muscle layer of the bowel wall T3:tumor in outer lining of bowel wall but not through it. T4a: tumor has gone through outer lining of bowel wall and into the peritoneum. T4b:tumor has grown through the bowel wall into nearby organs. N:cancer spread to lymph nodes? N0: no lymph nodes containing cancer cells. N1a:cancer cells in 1 nearby lymph node, N1b:cancer cells in 2 or 3 nearby lymph nodes,N1c:nearby lymph nodes do not contain cancer, but cancer cells in the tissue near the tumor. N2a:cancer cells in 4 to 6 nearby lymph nodes, N2b:cancer cells in >7 nearby lymph nodes. M:cancer in another part of the body (metastasis)? M0:cancer not spread to other organs, M1:cancer spread to elsewhere in the body. M1a: cancer spread to 1 distant site or organ, e.g. liver, but not to peritoneum, M1b:cancer spread to >2 distant sites, not to tissue lining the peritoneum M1c:cancer in distant organs and peritoneum.	Day 0, on the day of inclusion
Circumferential resection margin Time Frame: Week 3 or 4 on the day of surgery	In millimeters	Week 3 or 4 on the day of surgery
Distance from the lower pole of the tumor relative to the upper edge of the anal sphincter Time Frame: Week 3 or 4 on the day of surgery	In millimeters	Week 3 or 4 on the day of surgery
Bi-ischial diameter Time Frame: Week 3 or 4 on the day of surgery	In millimeters	Week 3 or 4 on the day of surgery
Bi-uterine diameter Time Frame: Week 3 or 4 on the day of surgery	In millimeters	Week 3 or 4 on the day of surgery
Mesorectal area Time Frame: Week 3 or 4 on the day of surgery	In square millimeters	Week 3 or 4 on the day of surgery
Type of surgery Time Frame: Week 3 or 4 on the day of surgery	Colorectal or anal anastomosis Mechanical or manual surgery Intersphincteric dissection Yes/ No, partial or total Delayed colo-anal anastomosis.	Week 3 or 4 on the day of surgery
Cardiovascular risk factors Time Frame: Day 0 on the day of inclusion	All cardiovascular risk factors will be recorded	Day 0 on the day of inclusion
Presence of the border arcade, occlusion of the mesenteric artery during arteriography. Time Frame: Day 0 on the day of inclusion	YES/NO	Day 0 on the day of inclusion
Operative data Time Frame: Week 3 or 4 on the day of surgery	Operative data: mobilisation of the colonic angle and ligation of the mesenteric vein.	Week 3 or 4 on the day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NIMAO/2022-1/MB-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Safety & Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Surgery for Tumors of Lower and Middle Rectum (AMIREMBOL_2)

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product