Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery

NCT ID: NCT03628248

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2021-04-11

Brief Summary

The investigators hypothesize that a primary embolization, 3-4 weeks before surgery, would allow development of vascular collaterality, in particular for the marginal artery which will ensure a better colonic perfusion.

Conditions

Cancer, Sigmoid; Cancer, Rectum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

embolization

Group Type: EXPERIMENTAL

embolization of the inferior mesenteric artery

Intervention Type: PROCEDURE

proximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery.

Inferior mesenteric artery ligation

Intervention Type: PROCEDURE

Endovascular ligation of Inferior mesenteric artery

No embolization

Group Type: OTHER

Inferior mesenteric artery ligation

Intervention Type: PROCEDURE

Endovascular ligation of Inferior mesenteric artery

Interventions

embolization of the inferior mesenteric artery

proximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery.

Intervention Type: PROCEDURE

Inferior mesenteric artery ligation

Endovascular ligation of Inferior mesenteric artery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient is at least 18 years old and less than 80 years old
• Patient has rectal cancer or sigmoid colon cancer requiring surgical treatment

Exclusion Criteria

• The subject is participating in another study, or is in a period of exclusion determined by a previous study
• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• Patient has a history of abdominal surgery
• Patient suffers from a hemostasis disorder (hemophilia, von Willebrand disease, thrombocytopenia) and is on anticoagulant therapy.
• Patient whose general condition appears too precarious or is taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk.
• Renal insufficiency with clearance <45ml / min
• Known allergy to contrast media
• Patient who had treatment of the abdominal aorta or its branches Reported pregnancy (the existence of effective contraception will be verified for women of childbearing age).
• Anatomical variant at risk or absence of marginal artery highlighted at the time of arteriography.
• Abnormality of the superior mesenteric artery
• Historic occlusion of the inferior mesenteric artery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Bertrand, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

CHU Nimes

Nîmes, , France

Countries

France

References

Frandon J, Berny L, Prudhomme M, de Forges H, Serrand C, de Oliveira F, Beregi JP, Bertrand MM. Inferior mesenteric artery embolization ahead of rectal cancer surgery: AMIREMBOL pilot study. Br J Surg. 2022 Jul 15;109(8):650-652. doi: 10.1093/bjs/znac071.

Reference Type: RESULT

PMID: 35333313 (View on PubMed)

Other Identifiers

2017-A03527-46

Identifier Type: OTHER

Identifier Source: secondary_id

NIMAO/2017-02/JF-02

Identifier Type: -

Identifier Source: org_study_id