Embolism MesentericEPAMIRNCT05422560
Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery
A study testing Embolization of the inferior mesenteric artery in people with Embolism Mesenteric, run by University Hospital, Grenoble at 3 sites in France.
Trial summary
Preoperative embolization of the inferior mesenteric artery in colorectal surgery (EPAMIR). This is a prospective, monocentric, non-randomized study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Embolism Mesenteric
- What is being tested?
- Embolization of the inferior mesenteric artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Sep 2022to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000
Anne DUBOIS, MD, a_dubois@chu-clermontferrand.fr
Brigitte GILLET, +33 4 73 75 52 26, bgillet@chu-clermontferrand.fr
- Recruiting
Groupe Hospitalier Mutualiste
Grenoble, 38000
Nicolas MOUGIN, MD, nicolas.mougin@avec.fr
Adrien MONARD, +33 4 76 70 70 22, adrien.monard@avec.fr
- Recruiting
Grenoble Alpes University Hospital
Grenoble, 38043
Julien GHELFI, MD, JGhelfi@chu-grenoble.fr
Marine FAURE, MFaure6@chu-grenoble.fr
About this study
Preoperative embolization of the inferior mesenteric artery in colorectal surgery (EPAMIR).
This is a prospective, monocentric, non-randomized study.
Read the 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.
- Conditions
- Embolism Mesenteric
- Being tested
- Embolization of the inferior mesenteric artery
- Keywords
- Colorectal surgery, Ischemic conditioning, Embolization, Inferior mesenteric artery, Anastomotic fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embolization of the inferior mesenteric arteryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Embolization of the inferior mesenteric artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the Riolan arch (diameter in mm)
Evaluation of the difference in size (diameter in mm) of the Riolan arch
Measured: 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
Pain assessment, analgesic treatments collection, diarrhea, blood in the stool, hypertermia, Hematoma at the puncture site, occurence of adverse events.
Measured: Between 21 and 30 days after embolization, before surgery.
Evaluation of the rate of anastomotic fistulas after colo-rectal surgery
CT-TAP, occurence of adverse events.
Measured: 30 days after colorectal surgery
Evaluation of the rate of complications related to colorectal surgery
CT-TAP, occurence of adverse events.
Measured: 30 days after colorectal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start6 Sep 2022
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Embolism MesentericStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Mutualiste de Grenoble, University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- Julien GHELFI, MD, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422560
- Sponsor's protocol ID
- 38RC21.0435
- Acronym
- EPAMIR
- Status last verified
- Nov 2023
- First submitted
- 13 Jun 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25220842van 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.
PubMed 23395398Snijders 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.
PubMed 22954525Posma 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.
PubMed 17205202Ghelfi 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.
PubMed 28050659Manunga 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.
PubMed 27531083
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT05422560
- Acronym / sponsor ID
- EPAMIR / 38RC21.0435
- Conditions
- Embolism Mesenteric
- Keywords
- Colorectal surgery, Ischemic conditioning, Embolization, Inferior mesenteric artery, Anastomotic fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Mutualiste de Grenoble, University Hospital, Clermont-Ferrand
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolization of the inferior mesenteric artery | Experimental | Procedure: Embolization of the inferior mesenteric arteryOnly 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embolization of the inferior mesenteric arteryThe 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. | Procedure or surgery | Embolization of the inferior mesenteric artery |
Primary outcome
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
3 secondary outcomes
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.
Evaluation of the rate of anastomotic fistulas after colo-rectal surgery
Time frame: 30 days after colorectal surgery
Evaluation of the rate of complications related to colorectal surgery
Time frame: 30 days after colorectal surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 25220842Ferlay 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.
- Background: PubMed 23395398van 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.
- Background: PubMed 22954525Snijders 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.
- Background: PubMed 17205202Posma 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.
- Background: PubMed 28050659Ghelfi 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.
- Background: PubMed 27531083Manunga 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.
- Individual participant dataSharing planned: No
Related trials for Embolism Mesenteric
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien GHELFI, MD principal investigator
Grenoble Alpes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization of the inferior mesenteric artery in people with Embolism Mesenteric, run by University Hospital, Grenoble at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marine FAURE (0476766872 ext. 66872, MFaure6@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05422560, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.