Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery (EPAMIR)

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Enrolling

Conditions

Embolism Mesenteric

Treatments

Procedure: Embolization of the inferior mesenteric artery

Study type

Interventional

Funder types

Other

Identifiers

NCT05422560
38RC21.0435

Details and patient eligibility

About

Preoperative embolization of the inferior mesenteric artery in colorectal surgery (EPAMIR). This is a prospective, monocentric, non-randomized study.

Full description

Colorectal surgery accounts for 60,000 acts per year in France. One of the feared complications after colorectal resection surgery is anastomotic leak (5-20% of cases), associated with significant morbidity and mortality. Ischemia of the colorectal or colo-anal anastomosis would be one of the main risk factors for the occurrence of a fistula (REF 1). During the operation, the inferior mesenteric artery is ligated and the remaining colon is vascularized only by Riolan's arch, the link between the networks of the inferior mesenteric artery and the superior mesenteric artery. Arterial ligation by operation is responsible for a transient drop in flow at the level of the anastomosis, while the arch develops. Preoperative ischemic conditioning by arterial embolization is a technique already used in esophageal surgery (REF 2). The objective is to embolize the arterial branches that will be ligated during surgery a few weeks before the resection procedure, in order to allow hypertrophy of the remaining branches to allow better vascularization of the anastomosis on the day of the intervention. The CHUGA is one of the motor centers of this technique. In our experience, embolization performed 3 to 4 weeks before esophageal surgery allows a reduction in the rate of fistulas (p=0.02). These results made it possible to aggregate other centers towards this technique, and a request for PHRC-K is in progress. In the context of ischemic conditioning before colorectal surgery, a proof of concept on 5 patients has just been completed by the University Hospital of Nîmes (REF 3) of which Dr Ghelfi (Radiologist) and Dr Trilling (Colorectal Surgeon) are investigators. The preliminary results seem suggested. The responsibility and safety of preoperative embolization of the inferior mesenteric artery have already been validated by meta-analyses of data from patients who received AMI embolization before placement of a covered aortic stent (REF 4). The objective of this study is to show that ischemic conditioning improves the vascular supply of the colon for risky procedures in colorectal surgery.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients
  • Patient to benefit from left colonic surgery or rectal surgery with upper ligation of the inferior mesenteric artery and colorectal or colo anastomosis
  • Person affiliated to or benefiting from social security
  • Person who has given written informed consent

Exclusion criteria

  • History of digestive resection or abdominal aorta surgery
  • Renal failure with GFR < 30 ml/min (MDRD)
  • History of severe allergy to iodine contrast medium
  • Pregnant, parturient, lactating women
  • Patient subject to a legal protection measure or unable to express his non-opposition (guardianship, curatorship)
  • Patient deprived of liberty by judicial or administrative decision

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Embolization of the inferior mesenteric artery
Experimental group
Description:
Only one arm: Patient followed for sigmoid/rectal cancer Pré-Selection Preoperative consultation, first information to the patient, Validation of IC / NIC, CT-TAP available Selection Interventional radiology consultation: Consent collection + additional exams Inclusion V1 - D0: Follow-up visit V2 - D2: Phone call, pain assessment and analgesic treatments collection Follow-up visit V3 - D7: Phone call, pain assessment and analgesic treatments collection Follow-up visit V4 - D21-D30: CT-TAP Follow-up visit V5 - D30: Digestive surgery consultation + additionnal exams Surgery V6 - D0: Colic surgery + additional exams Post-surgery visit V7 - D30: Last visit, additionnal exams
Treatment:
Procedure: Embolization of the inferior mesenteric artery

Trial contacts and locations

3

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Central trial contact

Pierre PITTET; Marine FAURE

Data sourced from clinicaltrials.gov

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