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

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Cancer, Rectum
Cancer, Sigmoid

Treatments

Procedure: Inferior mesenteric artery ligation
Procedure: embolization of the inferior mesenteric artery

Study type

Interventional

Funder types

Other

Identifiers

NCT03628248
2017-A03527-46 (Other Identifier)
NIMAO/2017-02/JF-02

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

10 participants in 2 patient groups

embolization
Experimental group
Treatment:
Procedure: embolization of the inferior mesenteric artery
Procedure: Inferior mesenteric artery ligation
No embolization
Other group
Treatment:
Procedure: Inferior mesenteric artery ligation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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