[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630353":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":47,"centralContacts":58,"locations":69,"responsibleParty":198,"collaborators":200,"id":208,"slug":209,"hasResults":210,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":210,"sex":215,"minAge":216,"maxAge":63,"enrollmentInfo":217,"targetDuration":63,"studyType":220,"phases":221,"briefSummary":223,"conditions":224,"keywords":228,"overallStatus":72,"whyStopped":63,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},{"fullName":5,"class":6},"Medisch Spectrum Twente","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm","EXPERIMENTAL","The intervention group will undergo preventive percutaneous transluminal angioplasty (PTA) and endovascular covered stenting for a ≥50% atherosclerotic SMA stenosis prior to elective colon surgery with primary anastomosis. All patients will receive mono antiplatelet therapy with carbasalate calcium (Ascal®).",[13,14,15],"Procedure: Percutaneous transluminal angiopasty and endovascular stenting of the superior mesenteric artery","Procedure: Colon surgery","Drug: Mono antiplatelet therapy with Ascal 80mg daily",{"label":17,"type":6,"description":18,"interventionNames":19},"Control Group","Control group will receive standard care for elective colon surgery with primary anastomosis, without preventive SMA PTA for a ≥50% atherosclerotic SMA stenosis. All patients will receive mono antiplatelet therapy with carbasalate calcium (Ascal®).",[14,15],[21,29,39],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","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.",[9],[27,28],"Endovascular Stenting","Percutaneous Angioplasty",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Colon surgery","Both groups are scheduled for elective colon resection with primary anastomosis. The intervention will remain unchanged and will follow standard care protocols.",[17,9],[34,35,36,37,38],"Ileocecal resection","Right hemicolectomy","Transverse colectomy","Left hemicolectomy","Sigmoid resection",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","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.",[17,9],[45,46],"Carbasalate Calcium","Ascal ®",[48,51,54],{"name":49,"affiliation":5,"role":50},"Bob H. Geelkerken, Prof. dr.","PRINCIPAL_INVESTIGATOR",{"name":52,"affiliation":53,"role":50},"Desiree van Noord, dr.","Franciscus",{"name":55,"affiliation":56,"role":57},"Koen J. Vree Egberts, MD, PhD Candidate","Medisch Spectrum Twente & Franciscus","STUDY_CHAIR",[59,65],{"name":60,"role":61,"phone":62,"phoneExt":63,"email":64},"Koen J. Vree Egberts, MD, PhD Candicate","CONTACT","+31 6 15247413",null,"koen.vreeegberts@mst.nl",{"name":66,"role":61,"phone":67,"phoneExt":63,"email":68},"Research Coordinator Surgery","+ 053 487 34 42","ALPrES2MA@mst.nl",[70,86,98,109,121,133,148,164,176,190],{"facility":71,"status":72,"city":73,"state":74,"zip":63,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Gelre ziekenhuis","RECRUITING","Apeldoorn","Gelderland","Netherlands","NL",{"type":78,"coordinates":79},"Point",[80,81],5.96944,52.21,{"lat":81,"lon":80},[84],{"name":85,"role":61,"phone":63,"phoneExt":63,"email":63},"Hessel Busscher",{"facility":87,"status":72,"city":88,"state":89,"zip":63,"country":75,"countryCode":76,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Zuyderland","Heerlen","Limburg",{"type":78,"coordinates":91},[92,93],5.98154,50.88365,{"lat":93,"lon":92},[96],{"name":97,"role":61,"phone":63,"phoneExt":63,"email":63},"Lee Bouwman",{"facility":99,"status":72,"city":100,"state":89,"zip":63,"country":75,"countryCode":76,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Maastricht Universitair Medisch Centrum (MUMC+)","Maastricht",{"type":78,"coordinates":102},[103,104],5.68889,50.84833,{"lat":104,"lon":103},[107],{"name":108,"role":61,"phone":63,"phoneExt":63,"email":63},"Tim Lubbers",{"facility":110,"status":72,"city":111,"state":112,"zip":63,"country":75,"countryCode":76,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Jeroen Bosch Ziekenhuis","'s-Hertogenbosch","North Brabant",{"type":78,"coordinates":114},[115,116],5.30417,51.69917,{"lat":116,"lon":115},[119],{"name":120,"role":61,"phone":63,"phoneExt":63,"email":63},"Jan Willem Hinnen",{"facility":122,"status":72,"city":123,"state":124,"zip":63,"country":75,"countryCode":76,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Noordwest Ziekenhuisgroep","Alkmaar","North Holland",{"type":78,"coordinates":126},[127,128],4.74861,52.63167,{"lat":128,"lon":127},[131],{"name":132,"role":61,"phone":63,"phoneExt":63,"email":63},"Wouter Hogendoorn",{"facility":134,"status":72,"city":135,"state":136,"zip":137,"country":75,"countryCode":76,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Ziekenhuisgroep Twente","Almelo","Overijsel","7609 PP",{"type":78,"coordinates":139},[140,141],6.6625,52.35667,{"lat":141,"lon":140},[144],{"name":145,"role":61,"phone":146,"phoneExt":63,"email":147},"Ian Faneyte, dr. MD","+31 88 708 52 31","researchverpleegkundigenheelkunde@zgt.nl",{"facility":5,"status":72,"city":149,"state":136,"zip":150,"country":75,"countryCode":76,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Enschede","7512KZ",{"type":78,"coordinates":152},[153,154],6.89583,52.21833,{"lat":154,"lon":153},[157,160,162],{"name":158,"role":61,"phone":159,"phoneExt":63,"email":68},"Koen Vree Egberts","+31534873442",{"name":161,"role":50,"phone":63,"phoneExt":63,"email":63},"Anneriet Dassen, dr. MD",{"name":163,"role":50,"phone":63,"phoneExt":63,"email":63},"Bob Geelkerken, Prof. dr. MD",{"facility":165,"status":72,"city":166,"state":167,"zip":63,"country":75,"countryCode":76,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Nij Smellinghe","Drachten","Provincie Friesland",{"type":78,"coordinates":169},[170,171],6.0989,53.11254,{"lat":171,"lon":170},[174],{"name":175,"role":61,"phone":63,"phoneExt":63,"email":63},"Floris Poelmann",{"facility":53,"status":72,"city":177,"state":178,"zip":179,"country":75,"countryCode":76,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Rotterdam","South Holland","3004 BA",{"type":78,"coordinates":181},[182,183],4.47917,51.9225,{"lat":183,"lon":182},[186],{"name":187,"role":61,"phone":188,"phoneExt":63,"email":189},"Desiree van Noord, dr. MD","+31 10 - 461 7430","D.Leemreis@franciscus.nl",{"facility":191,"status":72,"city":177,"state":178,"zip":63,"country":75,"countryCode":76,"cosmosGeoPoint":192,"geoPoint":194,"contacts":195},"Maasstad ziekenhuis",{"type":78,"coordinates":193},[182,183],{"lat":183,"lon":182},[196],{"name":197,"role":61,"phone":63,"phoneExt":63,"email":63},"Charles van Rossem",{"type":50,"investigatorFullName":158,"investigatorTitle":199,"investigatorAffiliation":5,"oldNameTitle":63,"oldOrganization":63},"MD",[201,202,204,206],{"name":134,"class":6},{"name":203,"class":6},"University of Twente",{"name":205,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":207,"class":6},"Franciscus Gasthuis","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":218,"type":219},360,"ESTIMATED","INTERVENTIONAL",[222],"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.",[225,226,227],"Mesenteric Vascular Disease","Colorectal Surgery","Preventive Intervention",[229,230,231,232,233,234],"Anastomotic leakage","Colorectal surgery","Preventive intervention","Superior Mesenteric Artery Stenosis","Percutaneous transluminal angioplasty","Endovascular stenting","2026-03-17",{"date":237,"type":238},"2026-03-20","ACTUAL",{"date":240,"type":238},"2026-02-01",{"date":242,"type":219},"2029-01-01",{"name":5,"class":6},10]