Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery
NCT ID: NCT05422560
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2022-09-06
2025-05-31
Brief Summary
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This is a prospective, monocentric, non-randomized study.
Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Embolization of the inferior mesenteric artery
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
Embolization of the inferior mesenteric artery
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.
Interventions
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Embolization of the inferior mesenteric artery
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Groupe Hospitalier Mutualiste de Grenoble
OTHER
University Hospital, Clermont-Ferrand
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Julien GHELFI, MD
Role: PRINCIPAL_INVESTIGATOR
Grenoble Alpes University Hospital
Locations
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Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, , France
Groupe Hospitalier Mutualiste
Grenoble, , France
Grenoble Alpes University Hospital
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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38RC21.0435
Identifier Type: -
Identifier Source: org_study_id