Clinical trial NCT03628248: Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Sigmoid
Cancer, Rectum
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
timeFrame: Prior to start of surgery
measure: Arterial pressure after inferior mesenteric artery ligation between groups
timeFrame: Prior to start of surgery
measure: Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
timeFrame: Prior to start of surgery
measure: Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
timeFrame: 60 seconds after surgery
measure: Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
timeFrame: 5 minutes after surgery
measure: Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
timeFrame: 60 seconds after surgery
measure: Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
timeFrame: 5 minutes after surgery
measure: Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
timeFrame: 60 seconds after surgery
measure: Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
timeFrame: 5 minutes after surgery
Secondary outcomes:
measure: Presence of post-embolization complications
timeFrame: Day 5 post-emoblization
measure: Presence of post-surgery complications
timeFrame: Hospital discharge (Day 7 after surgery)
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Martin Bertrand, MD
role: PRINCIPAL_INVESTIGATOR
References: