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

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.

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.

Study Overview

• Status: Completed
• Conditions: Cancer, Rectum; Cancer, Sigmoid
• Intervention / Treatment: Procedure: embolization of the inferior mesenteric artery; Procedure: Inferior mesenteric artery ligation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nimes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: embolization	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.; Procedure: Inferior mesenteric artery ligation; Endovascular ligation of Inferior mesenteric artery
Other: No embolization	Procedure: Inferior mesenteric artery ligation; Endovascular ligation of Inferior mesenteric artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups	Digital oxymeter (%)	Prior to start of surgery
Arterial pressure after inferior mesenteric artery ligation between groups	Average (mmHg)	Prior to start of surgery
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups	Rectal resistance index measured by Doppler	Prior to start of surgery
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups	Digital oxymeter (%)	60 seconds after surgery
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups	Digital oxymeter (%)	5 minutes after surgery
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups	Average (mmHg)	60 seconds after surgery
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups	Average (mmHg)	5 minutes after surgery
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups	Rectal resistance index measured by Doppler	60 seconds after surgery
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups	Rectal resistance index measured by Doppler	5 minutes after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of post-embolization complications	Yes/No	Day 5 post-emoblization
Presence of post-surgery complications	Yes/No	Hospital discharge (Day 7 after surgery)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Martin Bertrand, MD, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): June 24, 2021
• Study Completion (Actual): June 24, 2021

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Sigmoid Diseases; Colonic Neoplasms; Rectal Neoplasms; Sigmoid Neoplasms
• Other Study ID Numbers: NIMAO/2017-02/JF-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No