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

Cancer, Rectum Clinical Trial

— AMIREMBOL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628248
• Other study ID #: NIMAO/2017-02/JF-02
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: June 24, 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 24, 2021
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer, Rectum
• Cancer, Sigmoid
• Rectal Neoplasms
• Sigmoid Neoplasms

Intervention

Procedure:
• 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.
• Inferior mesenteric artery ligation
Endovascular ligation of Inferior mesenteric artery

Locations

Country	Name	City	State
France	CHU Nimes	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen saturation of the colon after inferior mesenteric artery ligation between groups	Digital oxymeter (%)	Prior to start of surgery
Primary	Arterial pressure after inferior mesenteric artery ligation between groups	Average (mmHg)	Prior to start of surgery
Primary	Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups	Rectal resistance index measured by Doppler	Prior to start of surgery
Primary	Oxygen saturation of the colon after inferior mesenteric artery ligation between groups	Digital oxymeter (%)	60 seconds after surgery
Primary	Oxygen saturation of the colon after inferior mesenteric artery ligation between groups	Digital oxymeter (%)	5 minutes after surgery
Primary	Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups	Average (mmHg)	60 seconds after surgery
Primary	Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups	Average (mmHg)	5 minutes after surgery
Primary	Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups	Rectal resistance index measured by Doppler	60 seconds after surgery
Primary	Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups	Rectal resistance index measured by Doppler	5 minutes after surgery
Secondary	Presence of post-embolization complications	Yes/No	Day 5 post-emoblization
Secondary	Presence of post-surgery complications	Yes/No	Hospital discharge (Day 7 after surgery)