Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery (EPAMIR)
Preoperative embolization of the inferior mesenteric artery in colorectal surgery (EPAMIR).
This is a prospective, monocentric, non-randomized study.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marine FAURE
- Phone Number: 66872 0476766872
- Email: MFaure6@chu-grenoble.fr
Study Contact Backup
- Name: Pierre PITTET
- Phone Number: 66872 0476766872
- Email: PPittet@chu-grenoble.fr
Study Locations
-
-
-
Clermont-Ferrand, France, 63000
- Not yet recruiting
- Centre Hospitalier Universitaire de Clermont-Ferrand
-
Contact:
- Anne DUBOIS, MD
- Email: a_dubois@chu-clermontferrand.fr
-
Principal Investigator:
- Anne Dubois, MD
-
Contact:
- Brigitte GILLET
- Phone Number: +33 4 73 75 52 26
- Email: bgillet@chu-clermontferrand.fr
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Sub-Investigator:
- Pascal CHABROT, MD PHD
-
Sub-Investigator:
- Karine POIROT, MD
-
Sub-Investigator:
- Louis BOYER, MD PHD
-
Grenoble, France, 38000
- Recruiting
- Groupe Hospitalier Mutualiste
-
Contact:
- Nicolas MOUGIN, MD
- Email: nicolas.mougin@avec.fr
-
Contact:
- Adrien MONARD
- Phone Number: +33 4 76 70 70 22
- Email: adrien.monard@avec.fr
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Principal Investigator:
- Nicolas MOUGIN, MD
-
Sub-Investigator:
- David VOIRINS
-
Grenoble, France, 38043
- Recruiting
- GRENOBLE ALPES UNIVERSITY HOSPITAL
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Contact:
- Julien Ghelfi, MD
- Email: jghelfi@chu-grenoble.fr
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Principal Investigator:
- Julien GHELFI, MD
-
Sub-Investigator:
- Bertrand TRILLING, MD
-
Contact:
- Marine FAURE
- Email: MFaure6@chu-grenoble.fr
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Sub-Investigator:
- Christian SENGEL, MD
-
Sub-Investigator:
- Yann TEYSSIER, MD
-
Sub-Investigator:
- Eliott MATHIEU, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Embolization of the inferior mesenteric artery
Only one arm: Patient followed for sigmoid/rectal cancer
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure of the Riolan arch (diameter in mm)
Time Frame: CT-TAP before embolization and CT-TAP between 3 and 4 weeks after embolization, before surgery.
|
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
Time Frame: Between 21 and 30 days after embolization, before surgery.
|
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.
|
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Evaluation of the rate of anastomotic fistulas after colo-rectal surgery
Time Frame: 30 days after colorectal surgery
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CT-TAP, occurence of adverse events.
|
30 days after colorectal surgery
|
|
Evaluation of the rate of complications related to colorectal surgery
Time Frame: 30 days after colorectal surgery
|
CT-TAP, occurence of adverse events.
|
30 days after colorectal surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julien GHELFI, MD, GRENOBLE ALPES UNIVERSITY HOSPITAL
Publications and helpful links
General Publications
- Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- van der Pas MH, Haglind E, Cuesta MA, Furst A, Lacy AM, Hop WC, Bonjer HJ; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013 Mar;14(3):210-8. doi: 10.1016/S1470-2045(13)70016-0. Epub 2013 Feb 6.
- Snijders HS, Wouters MW, van Leersum NJ, Kolfschoten NE, Henneman D, de Vries AC, Tollenaar RA, Bonsing BA. Meta-analysis of the risk for anastomotic leakage, the postoperative mortality caused by leakage in relation to the overall postoperative mortality. Eur J Surg Oncol. 2012 Nov;38(11):1013-9. doi: 10.1016/j.ejso.2012.07.111. Epub 2012 Sep 3.
- Posma LA, Bleichrodt RP, van Goor H, Hendriks T. Transient profound mesenteric ischemia strongly affects the strength of intestinal anastomoses in the rat. Dis Colon Rectum. 2007 Jul;50(7):1070-9. doi: 10.1007/s10350-006-0822-9.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC21.0435
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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