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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)

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ClinicalTrials.gov Identifier: NCT03628248
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment Phase
Cancer, Sigmoid Cancer, Rectum Procedure: embolization of the inferior mesenteric artery Procedure: Inferior mesenteric artery ligation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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.
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

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

No embolization Procedure: Inferior mesenteric artery ligation
Endovascular ligation of Inferior mesenteric artery




Primary Outcome Measures :
  1. Oxygen saturation of the colon after inferior mesenteric artery ligation between groups [ Time Frame: Prior to start of surgery ]
    Digital oxymeter (%)

  2. Arterial pressure after inferior mesenteric artery ligation between groups [ Time Frame: Prior to start of surgery ]
    Average (mmHg)

  3. Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups [ Time Frame: Prior to start of surgery ]
    Rectal resistance index measured by Doppler

  4. Oxygen saturation of the colon after inferior mesenteric artery ligation between groups [ Time Frame: 60 seconds after surgery ]
    Digital oxymeter (%)

  5. Oxygen saturation of the colon after inferior mesenteric artery ligation between groups [ Time Frame: 5 minutes after surgery ]
    Digital oxymeter (%)

  6. Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups [ Time Frame: 60 seconds after surgery ]
    Average (mmHg)

  7. Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups [ Time Frame: 5 minutes after surgery ]
    Average (mmHg)

  8. Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups [ Time Frame: 60 seconds after surgery ]
    Rectal resistance index measured by Doppler

  9. Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups [ Time Frame: 5 minutes after surgery ]
    Rectal resistance index measured by Doppler


Secondary Outcome Measures :
  1. Presence of post-embolization complications [ Time Frame: Day 5 post-emoblization ]
    Yes/No

  2. Presence of post-surgery complications [ Time Frame: Hospital discharge (Day 7 after surgery) ]
    Yes/No



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628248


Contacts
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Contact: Julien Frandon, MD 06.42.54.79.51 julien.frandon@chu-nimes.fr

Locations
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France
CHU Nimes Not yet recruiting
Nimes, France, 30029
Contact: Anissa Megzari    +33 (0)4.66.68.42.36    drc@chu-nimes.fr   
Sub-Investigator: Julien Frandon, MD         
Principal Investigator: Martin Bertrand, MD         
Sub-Investigator: Michel Prudhomme, MD         
Sub-Investigator: Jean-Paul Beregi, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Martin Bertrand, MD CHU Nimes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03628248     History of Changes
Other Study ID Numbers: NIMAO/2017-02/JF-02
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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

Additional relevant MeSH terms:
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Rectal Neoplasms
Sigmoid Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Neoplasms
Colonic Diseases
Sigmoid Diseases