Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery

Condition(s) studied

Investigational drug(s) / intervention(s)

Percutaneous transluminal angiopasty and endovascular stenting of the superior mesenteric artery: The intervention group will recieve preventive percutaneous transluminal angiopasty and endovascular covered stenting of a ≥50% atherosclerotic SMA stenosis of the superior mesenteric artery. Stent graft that will be used is: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX stent graft), which is CE marked.

Colon surgery: Both groups are scheduled for elective colon resection with primary anastomosis. The intervention will remain unchanged and will follow standard care protocols.

Mono antiplatelet therapy with Ascal 80mg daily: Both groups will receive mono antiplatelet therapy with Ascal daily 80mg for atherosclerotic risk reduction throughout the study period. In the intervention group, the therapy will also be administered to maintain stent patency.

Study summary

Rationale:

Anastomotic leakage (AL) is a severe complication of colon surgery, with an incidence of 2.7-11.9%. It is associated with long-term increased mortality, reduced quality of life, and high healthcare costs due to reoperations and prolonged hospitalization. Among colon cancer patients, 5-year survival rates are 70% for those with AL compared to 81% for those without. A retrospective case-control study identified a \>50% stenosis of the Superior Mesenteric Artery (SMA) as a significant risk factor, increasing AL odds by six times (OR: 5.9, 95% CI: 2.7-12.6, p \< .001).

Primary objective:

The ALPrES2MA study aims to evaluate whether preventive endovascular stenting of a \>50% stenosed SMA origin reduces the risk of AL following colon surgery.

Secondary objectives:

Classification of severity of AL, incidence of delayed AL (\>90 days), Mesenteric Artery Calcification Score (MACS), surgical complications, hospital (re)admissions, Quality of life (including health related quality of life), healthcare and societal costs, cost-effectiveness (expressed as incremental costs per quality-adjusted life year gained), and budget impact. Additionally, the added value of quantitative fluorescence angiography (qFA) in predicting AL during surgery, in hospitals with suitable equipment and experience, will be explored. This will enhance surgeons' capabilities in preventing AL.

Study design: Nationwide multicentre randomized controlled trail with a 1:1 fashion

Study population:

Patients, 40 years and over, in the participating hospitals in the Netherlands with a \>50% SMA origin stenosis scheduled for elective colorectal resection with a primary anastomosis for malignant or benign colorectal pathology.

Intervention:

Intervention group will undergo preventive percutaneous transluminal angioplasty (PTA) and endovascular covered stenting of the SMA, within preferably two weeks prior to the colon resection. Control group will not undergo PTA and endovascular stenting of the \>50% SMA stenosis prior to the colon resection. Both groups will be treated with a mono antiplatelet therapy, i.e., carbasalate calcium (Ascal ®), for stent patency and atherosclerotic risk reduction. Intervention group has an indication for lifelong mono antiplatelet therapy and control group for at least 12 months

Main study parameters/endpoints:

The primary endpoint is the incidence of a clinically relevant AL within 90 days post-surgery. Secondary endpoints include AL classification/severity, calcification scores of aortic and mesenteric vessels, stenting complications, stent patency, intra-operative qFA measurements, operative duration, all causes of post-operative complications within 90 days, all reinterventions; surgical (including endovascular) and non-surgical within 90 days, duration of primary postoperative hospital stay and readmission within 12 months, 12 month mortality, patient-reported outcomes on month 0-3-6-12, cost-effectiveness budget impact analysis and stent patency. The total follow-up duration will be a total of 12 months.

Eligibility

Primary outcome measure(s)

• Incidence of anstomotic leakage (AL) after colon surgery with primary anastomosis — Anastomotic Leakage within 90 days following colon resection.
  The primary objective of this study is to compare the intervention and control group on the incidence of AL following elective colon resection with primary anastomosis in patients with an asymptomatic \>50% origin stenosis of the SMA.

Trial sites (18)

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