search
Back to results

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

Primary Purpose

Embolism Mesenteric

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Embolization of the inferior mesenteric artery
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Embolism Mesenteric focused on measuring Colorectal surgery, Ischemic conditioning, Embolization, Inferior mesenteric artery, Anastomotic fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Grenoble Alpes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Embolization of the inferior mesenteric artery

Arm 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

Outcomes

Primary Outcome Measures

Measure of the Riolan arch (diameter in mm)
Evaluation of the difference in size (diameter in mm) of the Riolan arch

Secondary Outcome Measures

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.
Evaluation of the rate of anastomotic fistulas after colo-rectal surgery
CT-TAP, occurence of adverse events.
Evaluation of the rate of complications related to colorectal surgery
CT-TAP, occurence of adverse events.

Full Information

First Posted
June 13, 2022
Last Updated
September 2, 2022
Sponsor
University Hospital, Grenoble
Collaborators
Groupe Hospitalier Mutualiste de Grenoble
search

1. Study Identification

Unique Protocol Identification Number
NCT05422560
Brief Title
Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery
Acronym
EPAMIR
Official Title
Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Groupe Hospitalier Mutualiste de Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embolism Mesenteric
Keywords
Colorectal surgery, Ischemic conditioning, Embolization, Inferior mesenteric artery, Anastomotic fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Embolization of the inferior mesenteric artery
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Embolization of the inferior mesenteric artery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure of the Riolan arch (diameter in mm)
Description
Evaluation of the difference in size (diameter in mm) of the Riolan arch
Time Frame
CT-TAP before embolization and CT-TAP between 3 and 4 weeks after embolization, before surgery.
Secondary Outcome Measure Information:
Title
Evaluation of the rate of complications related to preoperative embolization of the inferior mesenteric artery
Description
Pain assessment, analgesic treatments collection, diarrhea, blood in the stool, hypertermia, Hematoma at the puncture site, occurence of adverse events.
Time Frame
Between 21 and 30 days after embolization, before surgery.
Title
Evaluation of the rate of anastomotic fistulas after colo-rectal surgery
Description
CT-TAP, occurence of adverse events.
Time Frame
30 days after colorectal surgery
Title
Evaluation of the rate of complications related to colorectal surgery
Description
CT-TAP, occurence of adverse events.
Time Frame
30 days after colorectal surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marine FAURE
Phone
0476766872
Ext
66872
Email
MFaure6@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre PITTET
Phone
0476766872
Ext
66872
Email
PPittet@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien GHELFI, MD
Organizational Affiliation
Grenoble Alpes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble Alpes University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien GHELFI, MD
Email
JGhelfi@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Julien GHELFI, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25220842
Citation
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.
Results Reference
background
PubMed Identifier
23395398
Citation
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.
Results Reference
background
PubMed Identifier
22954525
Citation
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.
Results Reference
background
PubMed Identifier
17205202
Citation
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.
Results Reference
background
PubMed Identifier
28050659
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.
Results Reference
background
PubMed Identifier
27531083
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.
Results Reference
background

Learn more about this trial

Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery

We'll reach out to this number within 24 hrs