Superior Meseteric Artery Origin Stenosis, Mesenteric Artery stenosis Stenosis of a gastrointestinal artery
Conditions
Interventions
The intervention group will undergo percutaneous transluminal angioplasty (PTA) with placement of a covered stent in the superior mesenteric artery (equal to, or more than 50% stenosis) within two wee
Sponsors
Medisch Spectrum Twente (MST)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >40 years.Patient scheduled for elective colon resection above the recto-sigmoid junction with a primary anastomosis (side-to-side, side-to-end, or end-to-end).Presence of an asymptomatic >50% atherosclerotic origin stenosis of the superior mesenteric artery (SMA)
Exclusion criteria
Exclusion criteria: All patients with symptomatic chronic or acute mesenteric ischemia (i.e., mesenteric artery stenosis in combination with symptoms as postprandial abdominal pain, fear of eating, altered eating patterns, weight loss, diarrhoea, nausea, or exercise-induced abdominal pain).Presence of a >50% stenosis of the celiac artery, regardless of the underlying pathology (i.e., intra-articular atherosclerosis, intra articular thrombus or external compression by the median accurate ligament).Simultaneous performed during the colon resection: a substantial abdominal organ resection, or T4b/T4c colon tumour resection, or a second colon anastomosis or a diverting stoma. History of mesenteric revascularization, including endovascular stenting, thrombectomy, or bypass surgery involving any of the mesenteric arteries. Patients with a history of heparin induced thrombocytopenia-type 2 due to contraindication for VBX Stent Graft.Patients with a contra-indication for mono antiplatelet therapy with Ascal due to comorbidities, allergy or intolerance.End Stage Kidney Disease (ESKD)Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ALPrES2MA study aims to evaluate whether preventive endovascular stenting of a 50% or more stenosed SMA origin reduces the risk of AL following colon surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Classification of severity of AL, prevalence 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. | — |
Countries
Netherlands
Contacts
Public ContactK.J. Vree Egberts
Medisch Spectrum Twente (MST)
Outcome results
None listed