Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06236633
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-24
Brief Title:
Safety Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Surgery for Tumors of Lower and Middle Rectum
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Oncologic Surgery for Tumors of the Lower and Middle Rectum Bicentric Exploratory Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMIREMBOL_2
Brief Summary:
The present study will investigate the safety of inferior mesenteric artery embolization prior to rectal surgery according to IDEAL recommendations Lancet 2009 It aims to assess the safety of endovascular embolization of the inferior mesenteric artery prior to surgery in patients with rectal tumors and estimate the potential benefits in terms of time to surgery and the occurrence of post-operative fistulasThe study will also assess the impact of subacute ischemia induced by IMA embolization on colonic vasculature remodeling colonic ischemic suffering altered hemostasis and initiation of neo-angiogenesis through blood sampling kineticsThe hypothesis is that ischemic preconditioning by inferior mesenteric artery embolization prior to rectal cancer resection surgery is safe and will result in a decrease in acute relative colon ischemia and a reduction in the rate of fistulas and post-surgical complications Indeed we believe that the beneficial effects of the ischemic preconditioning of IMA will be due to better blood perfusion of the colon at 3 weeks which is apparently linked to remodeling andor the development of collateral vascularization
Detailed Description:
Anastomotic fistulas are the main cause of morbidity and mortality in colorectal surgery They are responsible for septic complications leading to increased mortality local recurrence repeat surgery and impaired sexual urinary and digestive function Fistulas are multifactorial among the causes colonic vascularization seems to be a major one Ligation of the inferior mesenteric artery during rectal surgery has been shown to reduce intraoperative colonic perfusion flow The left colon is then vascularized only by the colonic border arcade perfused by the superior mesenteric artery Ischemic pre-conditioning of the arterial network prior to surgery should ensure better vascularization by developing arterial collaterality and increasing perfusion flow in the colonic border arcade In view of major advances in interventional radiology this preconditioning could be achieved by endovascular ligation of the inferior mesenteric artery IMA based on the same principle as during surgery proximal occlusion of the inferior mesenteric artery IMA using embolization material plug or coils 3 weeks before surgery to allow the colonic border arcade to develop We carried out a single-center pilot study AMIREMBOL 1 NIMAO 2017 Frandon et al 2022 to assess the feasibility of ischemic preconditioning of the colon for patients with rectal or sigmoid cancer The study included 10 patients randomized into two groups the control group with preoperative arteriography and standard management and the embolization group with embolization of the IMA three weeks prior to surgery IMA embolization was successfully performed in all 5 patients in the embolization group with no major complications The effect on colonic perfusion measured by intraoperative Doppler directly on the border arch with recording of resistance indexes independent of measurement angle showed a drop in resistance indexes in the control arm after ligation of the IMA which persisted after 5 minutes In the Embolization arm no drop in this index was reported during surgery reflecting good development of vascular collaterality and at least relative acute ischemia of the colon after IMA ligation during surgery Finally in the control group one anastomotic fistula was reported after surgery and required re-operation There were no fistulas in the embolization group
The present study AMIREMBOL 2 will investigate the safety of IMA embolization prior to rectal surgery according to IDEAL recommendations Lancet 2009 Its aim is to assess the safety of endovascular embolization of the IMA prior to surgery in patients with rectal tumors and to estimate the potential benefits in terms of time to surgery and the occurrence of post-operative fistulas
The study will also assess the impact of subacute ischemia induced by IMA embolization on colonic vasculature remodeling colonic ischemic suffering altered hemostasis and initiation of neo-angiogenesis through blood sampling kinetics
The hypothesis is that ischemic preconditioning by inferior mesenteric artery IMA embolization prior to rectal cancer resection surgery is safe and will result in a decrease in acute relative colon ischemia and a reduction in the rate of fistulas and post-surgical complications The hypothesis is that the beneficial effects of the ischemic preconditioning of IMA will be due to better blood perfusion of the colon at 3 weeks which is apparently linked to remodeling andor the development of collateral vascularization
The present study AMIREMBOL 2 will investigate the safety of IMA embolization prior to rectal surgery according to IDEAL recommendations Lancet 2009 Its aim is to assess the safety of endovascular embolization of the IMA prior to surgery in patients with rectal tumors and to estimate the potential benefits in terms of time to surgery and the occurrence of post-operative fistulas
The study will also assess the impact of subacute ischemia induced by IMA embolization on colonic vasculature remodeling colonic ischemic suffering altered hemostasis and initiation of neo-angiogenesis through blood sampling kinetics
The hypothesis is that ischemic preconditioning by inferior mesenteric artery IMA embolization prior to rectal cancer resection surgery is safe and will result in a decrease in acute relative colon ischemia and a reduction in the rate of fistulas and post-surgical complications The hypothesis is that the beneficial effects of the ischemic preconditioning of IMA will be due to better blood perfusion of the colon at 3 weeks which is apparently linked to remodeling andor the development of collateral vascularization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None