Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery - A Single-center Feasibility Pilot Study.

Centre Hospitalier Universitaire de Nīmes1 site in 1 country10 target enrollmentMarch 10, 2020

ConditionsCancer, Sigmoid Cancer, Rectum

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer, Sigmoid
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 10
Locations: 1
Primary Endpoint: Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 10, 2020

End Date

April 11, 2021

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

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).