[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mesenteric-vascular-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mesenteric-vascular-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100630353","anastomotic-leakage-prevention-by-endovascular-stenting-of-the-superior-mesenteric-artery-100630353",false,"NCT07486570","Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery","ALPrES²MA","Inclusion Criteria:\n\n* Age \\>40 years.\n* 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).\n* Presence of an asymptomatic \\>50% atherosclerotic origin stenosis of the superior mesenteric artery (SMA)\n\nExclusion Criteria:\n\n* 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).\n* 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).\n* Simultaneous performed during the colon resection: a substantial abdominal organ resection, or T4b\u002FT4c colon tumour resection, or a second colon anastomosis or a diverting stoma\n* History of mesenteric revascularization, including endovascular stenting, thrombectomy, or bypass surgery involving any of the mesenteric arteries\n* Patients with a history of heparin induced thrombocytopenia-type 2 due to contraindication for VBX Stent Graft.\n* Patients with a contra-indication for mono antiplatelet therapy with Ascal due to comorbidities, allergy or intolerance.\n* Pregnancy","ALL","40 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23],"NA","Rationale:\n\nAnastomotic 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 \\\u003C .001).\n\nPrimary objective:\n\nThe ALPrES2MA study aims to evaluate whether preventive endovascular stenting of a \\>50% stenosed SMA origin reduces the risk of AL following colon surgery.\n\nSecondary objectives:\n\nClassification 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.\n\nStudy design: Nationwide multicentre randomized controlled trail with a 1:1 fashion\n\nStudy population:\n\nPatients, 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.\n\nIntervention:\n\nIntervention 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\n\nMain study parameters\u002Fendpoints:\n\nThe primary endpoint is the incidence of a clinically relevant AL within 90 days post-surgery. Secondary endpoints include AL classification\u002Fseverity, 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.",[26,27,28],"Mesenteric Vascular Disease","Colorectal Surgery","Preventive Intervention",[30,31,32,33,34,35],"Anastomotic leakage","Colorectal surgery","Preventive intervention","Superior Mesenteric Artery Stenosis","Percutaneous transluminal angioplasty","Endovascular stenting","RECRUITING","2026-03-17",{"date":39,"type":40},"2026-03-20","ACTUAL",{"date":42,"type":40},"2026-02-01",{"date":44,"type":20},"2029-01-01",{"name":46,"class":47},"Medisch Spectrum Twente","OTHER",10,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100628366","mesenteric-ischemia-markers-study-100628366","NCT07460700","Mesenteric Ischemia Markers Study","Mesenteric Ischemia Markers Study In The Presence Of Mesenteric Arteries Disease","MESMARK","Inclusion Criteria:\n\n* 18 years or older, all sex\n* Initial decision, the presence of angio-visualisation of the MA and suspicion of mesenteric arteries diseases\n* Patient's consent to participate in the study\n* No pregnancy, no history of major operations on MA, the gastrointestinal tract and digestive organs (except appendectomy, endoscopic polypectomy).\n\nExclusion Criteria:\n\n* Consent declined by patient or relatives\n* Failure to meet inclusion criteria",true,"18 Years",{"count":60,"type":20},120,[23],"Vascular bowel disease remains a socially significant and potentially fatal condition (if it develops into AMI), primarily due to delayed diagnosis. Blood biomarkers are theoretically ideal for early risk stratification (like troponins in myocardial infarction). However, the existing evidence base is characterized by low quality and high heterogeneity, which hinders their use in clinical practice. Therefore, there is an urgent and unmet clinical need for high-quality, methodologically rigorous research to validate biomarkers in MI. A current study (MESMARK) is to be undertaken to identify combinations of biomarkers that can reliably identify mesenteric ischemia (MI) and distinguish between non-transmural and transmural clinical relevant ischemia.",[26],[65,66,67],"Mesenteric arteries disease","Mesenteric Ischemia","Blood biomarkers","2026-03-04",{"date":70,"type":40},"2026-03-10",{"date":72,"type":40},"2025-12-22",{"date":74,"type":20},"2026-12-12",{"name":76,"class":47},"Belarusian State Medical University",1]