Safety & Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Surgery for Tumors of Lower and Middle Rectum

Condition(s) studied

Investigational drug(s) / intervention(s)

Ischemic preconditioning: Embolization performed via a common right femoral or radial approach, depending on the patient's conformation. Minor complications such as hematoma at the puncture site are rare in less than 1% of cases, and serious complications are exceptional. Proximal occlusion of the inferior mesenteric artery, before its dividing branches, using material adapted to arterial occlusion according to anatomical findings. Proximal occlusion during embolization is evaluated by intravascular injection into the inferior mesenteric artery, and resumption of vascularization of the distal inferior mesenteric artery is controlled by the border arcade injecting into the superior mesenteric artery. In the event of a high-risk anatomical variant, or absence of a border arcade, no embolization will be performed and the patient will be excluded from the study; this will represent no more than 1-2% of patients (surgical series describing 0.83% of ischemia in connection with absence of a border arcade).

Arteriogram: The interventional radiologist performs an arteriogram of the inferior and superior mesenteric arteries (IMA and SMA respectively) to check that the SMA is free of anomalies and that the IMA has a proximal trunk long enough for embolization. The radiologist also checks for the presence of a colonic border arcade. If this is absent, embolization will not be performed: the patient will be excluded from the study.This arteriogram is carried out under local anaesthetic specifically for research purposes, as follows: Common right femoral or radial approach and placement of a small introducer. Selective arteriogram of the inferior and superior mesenteric arteries to check perfusion of the border arcade.Arterial closure system or manual compression. Return to surgery or interventional radiology department. Patient discharged the same day after medical assessment (surgeon or interventional radiologist).Telephone check-up on Day1 (standard management) and Day 7 (added as part of the protocol).

Study 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 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 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 and/or the development of collateral vascularization.

Eligibility

Primary outcome measure(s)

• Safety of endovascular inferior mesenteric artery embolisation prior to surgical resection of the rectum in patients with tumours of the lower and middle rectum. — Day 7 post embolization (performed 3 weeks before surgical resection of the rectum)
  Percentage of patients with a complication (any grade) within 7 days after embolisation of the inferior mesenteric artery according to the classification of the International Society of Interventional Radiology assessed during the follow-up telephone consultation by the interventional radiologist. Complications will be classified as minor (Grades A and B) or Major (grades C to F). Grade A = No therapy, no consequence Grade B = Nominal therapy, no consequence. Includes overnight admission for observation only Grade C = Requires therapy, minor hospitalization (\<48 hours) Grade D = Requires major therapy. Unplanned increase in level of care. Prolonged hospitalization (\>48 hours) Grade E = Permanent adverse sequelae Grade F= Death

Trial sites (3)

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