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

NCT03628248 | Completed

• 2 other identifiers: NIMAO/2017-02/JF-022017-A03527-46
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Sigmoid; Cancer, Rectum

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Presence of post-embolization complications

  Day 5 post-emoblization

• Presence of post-surgery complications

  Hospital discharge (Day 7 after surgery)

Study Arms (2)

embolization

EXPERIMENTAL

Procedure: embolization of the inferior mesenteric artery; Procedure: Inferior mesenteric artery ligation

No embolization

OTHER

Procedure: Inferior mesenteric artery ligation

Interventions

embolization of the inferior mesenteric artery PROCEDURE

proximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery.

embolization

Inferior mesenteric artery ligation PROCEDURE

Endovascular ligation of Inferior mesenteric artery

No embolization; embolization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• Frandon J, Berny L, Prudhomme M, de Forges H, Serrand C, de Oliveira F, Beregi JP, Bertrand MM. Inferior mesenteric artery embolization ahead of rectal cancer surgery: AMIREMBOL pilot study. Br J Surg. 2022 Jul 15;109(8):650-652. doi: 10.1093/bjs/znac071.

  PMID: 35333313 RESULT

MeSH Terms

Conditions

Sigmoid Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Sigmoid Diseases; Rectal Diseases

Study Officials

• Martin Bertrand, MD

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: March 10, 2020
• Primary Completion: April 11, 2021
• Study Completion: April 11, 2021
• Last Updated: December 4, 2025

Record last verified: 2021-08

Locations

FR (1)