Clinical trial NCT05422560: Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery
Official title: Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Embolism Mesenteric
Keywords: Colorectal surgery
Ischemic conditioning
Embolization
Inferior mesenteric artery
Anastomotic fistula
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier Mutualiste de Grenoble
name: University Hospital, Clermont-Ferrand
First posted: 2022-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Preoperative embolization of the inferior mesenteric artery in colorectal surgery (EPAMIR).

This is a prospective, monocentric, non-randomized study.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure of the Riolan arch (diameter in mm)
timeFrame: CT-TAP before embolization and CT-TAP between 3 and 4 weeks after embolization, before surgery.
Secondary outcomes:
measure: Evaluation of the rate of complications related to preoperative embolization of the inferior mesenteric artery
timeFrame: Between 21 and 30 days after embolization, before surgery.
measure: Evaluation of the rate of anastomotic fistulas after colo-rectal surgery
timeFrame: 30 days after colorectal surgery
measure: Evaluation of the rate of complications related to colorectal surgery
timeFrame: 30 days after colorectal surgery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste
city: Grenoble
country: France
facility: Grenoble Alpes University Hospital
Study officials:
affiliation: Grenoble Alpes University Hospital
name: Julien GHELFI, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ghelfi J, Brichon PY, Frandon J, Boussat B, Bricault I, Ferretti G, Guigard S, Sengel C. Ischemic Gastric Conditioning by Preoperative Arterial Embolization Before Oncologic Esophagectomy: A Single-Center Experience. Cardiovasc Intervent Radiol. 2017 May;40(5):712-720. doi: 10.1007/s00270-016-1556-2. Epub 2017 Jan 3.
citation: Manunga JM, Cragg A, Garberich R, Urbach JA, Skeik N, Alexander J, Titus J, Stephenson E, Alden P, Sullivan TM. Preoperative Inferior Mesenteric Artery Embolization: A Valid Method to Reduce the Rate of Type II Endoleak after EVAR? Ann Vasc Surg. 2017 Feb;39:40-47. doi: 10.1016/j.avsg.2016.05.106. Epub 2016 Aug 12.