Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery

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

Detailed Description
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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.

Official Title
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Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery

Conditions
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Embolism Mesenteric

Intervention / Treatment
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* Procedure: Embolization of the inferior mesenteric artery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization of the inferior mesenteric artery<br>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 | Procedure: Embolization of the inferior mesenteric artery<br>* The procedure is performed in a dedicated angiography room. After local anesthesia, a common femoral arterial approach is performed according to the Seldinger technique with the placement of a 4 French valve introducer. Catheterization of the superior mesenteric artery with a Cobra 4F catheter and angiography to confirm patency of the border arcade. Catheterization of the inferior mesenteric artery with a 4F cobra/shepherd hook catheter and angiography. Microcatheterization of the artery with a 2.7F or 2.8F microcatheter and embolization with microcoil leaving the first centimeters of the IMA in order not to interfere with the surgery. Catheterization of the superior mesenteric artery and final angiography to confirm the reinjection of the inferior mesenteric by the border arcade. Removal of the material and manual compression of femoral access. Clinical monitoring for 6 hours and discharge the same day of the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the Riolan arch (diameter in mm) | Evaluation of the difference in size (diameter in mm) of the Riolan arch | CT-TAP before embolization and CT-TAP between 3 and 4 weeks after embolization, before surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the rate of complications related to preoperative embolization of the inferior mesenteric artery | Pain assessment, analgesic treatments collection, diarrhea, blood in the stool, hypertermia, Hematoma at the puncture site, occurence of adverse events. | Between 21 and 30 days after embolization, before surgery. | 
| Evaluation of the rate of anastomotic fistulas after colo-rectal surgery | CT-TAP, occurence of adverse events. | 30 days after colorectal surgery | 
| Evaluation of the rate of complications related to colorectal surgery | CT-TAP, occurence of adverse events. | 30 days after colorectal surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal surgery, Ischemic conditioning, Embolization, Inferior mesenteric artery, Anastomotic fistula