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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)

Primary Purpose

Cancer, Sigmoid, Cancer, Rectum

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
embolization of the inferior mesenteric artery
Inferior mesenteric artery ligation
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer, Sigmoid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Nimes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

embolization

No embolization

Arm Description

Outcomes

Primary Outcome Measures

Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Digital oxymeter (%)
Arterial pressure after inferior mesenteric artery ligation between groups
Average (mmHg)
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Rectal resistance index measured by Doppler
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Digital oxymeter (%)
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Digital oxymeter (%)
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
Average (mmHg)
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
Average (mmHg)
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Rectal resistance index measured by Doppler
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Rectal resistance index measured by Doppler

Secondary Outcome Measures

Presence of post-embolization complications
Yes/No
Presence of post-surgery complications
Yes/No

Full Information

First Posted
August 9, 2018
Last Updated
August 3, 2021
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03628248
Brief Title
Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
June 24, 2021 (Actual)
Study Completion Date
June 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Sigmoid, Cancer, Rectum

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
embolization
Arm Type
Experimental
Arm Title
No embolization
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
embolization of the inferior mesenteric artery
Intervention Description
proximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery.
Intervention Type
Procedure
Intervention Name(s)
Inferior mesenteric artery ligation
Intervention Description
Endovascular ligation of Inferior mesenteric artery
Primary Outcome Measure Information:
Title
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Description
Digital oxymeter (%)
Time Frame
Prior to start of surgery
Title
Arterial pressure after inferior mesenteric artery ligation between groups
Description
Average (mmHg)
Time Frame
Prior to start of surgery
Title
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Description
Rectal resistance index measured by Doppler
Time Frame
Prior to start of surgery
Title
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Description
Digital oxymeter (%)
Time Frame
60 seconds after surgery
Title
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Description
Digital oxymeter (%)
Time Frame
5 minutes after surgery
Title
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
Description
Average (mmHg)
Time Frame
60 seconds after surgery
Title
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
Description
Average (mmHg)
Time Frame
5 minutes after surgery
Title
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Description
Rectal resistance index measured by Doppler
Time Frame
60 seconds after surgery
Title
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Description
Rectal resistance index measured by Doppler
Time Frame
5 minutes after surgery
Secondary Outcome Measure Information:
Title
Presence of post-embolization complications
Description
Yes/No
Time Frame
Day 5 post-emoblization
Title
Presence of post-surgery complications
Description
Yes/No
Time Frame
Hospital discharge (Day 7 after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Bertrand, MD
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nimes
City
Nimes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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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

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