Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery

NCT05422560 | Unknown DMC

• 1 other identifier: 38RC21.0435
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Embolism Mesenteric

Keywords

Colorectal surgery; Ischemic conditioning; Embolization; Inferior mesenteric artery; Anastomotic fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of the rate of complications related to preoperative embolization of the inferior mesenteric artery

  Between 21 and 30 days after embolization, before surgery.

• Evaluation of the rate of anastomotic fistulas after colo-rectal surgery

  30 days after colorectal surgery

• Evaluation of the rate of complications related to colorectal surgery

  30 days after colorectal surgery

Study Arms (1)

Embolization of the inferior mesenteric artery

EXPERIMENTAL

Only one arm: Patient followed for sigmoid/rectal cancer 1. Pré-Selection Preoperative consultation, first information to the patient, Validation of IC / NIC, CT-TAP available 2. Selection Interventional radiology consultation: Consent collection + additional exams 3. Inclusion V1 - D0: 4. Follow-up visit V2 - D2: Phone call, pain assessment and analgesic treatments collection 5. Follow-up visit V3 - D7: Phone call, pain assessment and analgesic treatments collection 6. Follow-up visit V4 - D21-D30: CT-TAP 7. Follow-up visit V5 - D30: Digestive surgery consultation + additionnal exams 8. Surgery V6 - D0: Colic surgery + additional exams 9. Post-surgery visit V7 - D30: Last visit, additionnal exams

Procedure: Embolization of the inferior mesenteric artery

Interventions

Embolization of the inferior mesenteric artery PROCEDURE

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.

Embolization of the inferior mesenteric artery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Groupe Hospitalier Mutualiste de Grenoble: collaborator
• University Hospital, Clermont-Ferrand: collaborator

Study Sites (3)

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Groupe Hospitalier Mutualiste

Grenoble, 38000, France

RECRUITING

Grenoble Alpes University Hospital

Grenoble, 38043, France

RECRUITING

Related Publications (6)

• 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.

  PMID: 25220842 BACKGROUND

• 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.

  PMID: 23395398 BACKGROUND

• 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.

  PMID: 22954525 BACKGROUND

• 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.

  PMID: 17205202 BACKGROUND

• 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.

  PMID: 28050659 BACKGROUND

• 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.

  PMID: 27531083 BACKGROUND

Study Officials

• Julien GHELFI, MD

  Grenoble Alpes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marine FAURE

CONTACT

0476766872; MFaure6@chu-grenoble.fr

Pierre PITTET

CONTACT

0476766872; PPittet@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: September 6, 2022
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)