[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100387907":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":221,"collaborators":24,"id":223,"slug":224,"hasResults":225,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":225,"sex":231,"minAge":232,"maxAge":233,"enrollmentInfo":234,"targetDuration":24,"studyType":237,"phases":238,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":81,"whyStopped":24,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},{"fullName":5,"class":6},"Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"EBD group","EXPERIMENTAL","* Post-procedural admission in the Short Stay Unit (SSU).\n* Superficial sedation by endoscopist or anesthesiologist depending on the center.\n* Pneumatic balloon type CRE Boston scientific®; diameter of the balloon at the endoscopist's discretion.\n* A maximum of 2 dilations will be performed with a minimum interval of 15-30 days between each dilation.\n* Dilation failure will be considered if \\> 2 dilations are required.",[13],"Procedure: Surgical resection",{"label":15,"type":10,"description":16,"interventionNames":17},"SEMS group","* Post-procedural admission in the Short Stay Unit (SSU).\n* Superficial sedation by endoscopist or anesthesiologist depending on the center.\n* Fully coated, self-expanding Tae Woong medical®-type metal prostheses; size of the prostheses at the discretion of the endoscopist\n* Clips can be placed at the distal end of the prosthesis at the endoscopist's discretion.\n* Removal time of the prosthesis 4 weeks.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Surgical resection","The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Carme Loras","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Anna Casas","CONTACT","635 899 553","secretariacientifica2@geteccu.org",{"name":36,"role":32,"phone":24,"phoneExt":24,"email":37},"Eugeni Domènech","eugenidomenech@gmail.com",[39,56,67,79,92,104,116,127,135,145,156,168,180,188,196,213],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hospital Germans Trias i Pujol","NOT_YET_RECRUITING","Badalona","Barcelona","08916","Spain","ES",{"type":48,"coordinates":49},"Point",[50,51],2.24741,41.45004,{"lat":51,"lon":50},[54],{"name":55,"role":28,"phone":24,"phoneExt":24,"email":24},"Ingrid Marin, MD",{"facility":57,"status":41,"city":58,"state":43,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Hospital Universitario de Bellvitge","L'Hospitalet de Llobregat",{"type":48,"coordinates":60},[61,62],2.10028,41.35967,{"lat":62,"lon":61},[65],{"name":66,"role":28,"phone":24,"phoneExt":24,"email":24},"Joan Gonals, MD",{"facility":68,"status":41,"city":69,"state":43,"zip":70,"country":45,"countryCode":46,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Althaia, xarxa assistencial universitaria de Manresa","Manresa","08243",{"type":48,"coordinates":72},[73,74],1.82399,41.72815,{"lat":74,"lon":73},[77],{"name":78,"role":28,"phone":24,"phoneExt":24,"email":24},"Empar Sainz, MD",{"facility":80,"status":81,"city":82,"state":43,"zip":83,"country":45,"countryCode":46,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Consorci Corporació Sanitària Parc Taulí","RECRUITING","Sabadell","08208",{"type":48,"coordinates":85},[86,87],2.10942,41.54329,{"lat":87,"lon":86},[90],{"name":91,"role":28,"phone":24,"phoneExt":24,"email":24},"Albert Villoria, MD",{"facility":93,"status":41,"city":94,"state":43,"zip":95,"country":45,"countryCode":46,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Hospital Moisès Broggi","Sant Joan Despí","08970",{"type":48,"coordinates":97},[98,99],2.0574,41.36718,{"lat":99,"lon":98},[102],{"name":103,"role":28,"phone":24,"phoneExt":24,"email":24},"Mercè Navarro, MD",{"facility":105,"status":81,"city":106,"state":43,"zip":107,"country":45,"countryCode":46,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Hospital Mutua de Terrassa","Terrassa","08221",{"type":48,"coordinates":109},[110,111],2.01667,41.56667,{"lat":111,"lon":110},[114],{"name":115,"role":28,"phone":24,"phoneExt":24,"email":24},"Carme Loras, MD",{"facility":117,"status":81,"city":118,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Hospital Universitario de Cáceres","Cáceres",{"type":48,"coordinates":120},[121,122],-6.37224,39.47649,{"lat":122,"lon":121},[125],{"name":126,"role":28,"phone":24,"phoneExt":24,"email":24},"Carmen Dueñas, MD",{"facility":128,"status":41,"city":129,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":130,"geoPoint":134,"contacts":24},"Clínica Girona","Girona",{"type":48,"coordinates":131},[132,133],2.82493,41.98311,{"lat":133,"lon":132},{"facility":136,"status":41,"city":129,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":137,"geoPoint":139,"contacts":140},"Hospital Josep Trueta",{"type":48,"coordinates":138},[132,133],{"lat":133,"lon":132},[141,143],{"name":142,"role":32,"phone":24,"phoneExt":24,"email":24},"Xavier Aldeguer, Dr",{"name":144,"role":28,"phone":24,"phoneExt":24,"email":24},"David Busquets, MD",{"facility":146,"status":41,"city":147,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Hospital de Inca","Inca",{"type":48,"coordinates":149},[150,151],2.91093,39.7211,{"lat":151,"lon":150},[154],{"name":155,"role":28,"phone":24,"phoneExt":24,"email":24},"José Reyes, MD",{"facility":157,"status":81,"city":158,"state":24,"zip":159,"country":45,"countryCode":46,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Hospital Universitari Arnau de Vilanova","Lleida","25198",{"type":48,"coordinates":161},[162,163],0.62218,41.61674,{"lat":163,"lon":162},[166],{"name":167,"role":28,"phone":24,"phoneExt":24,"email":24},"Ferran Gonzalez-Huix, MD",{"facility":169,"status":41,"city":170,"state":24,"zip":171,"country":45,"countryCode":46,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Hospital Universitario La Paz","Madrid","28046",{"type":48,"coordinates":173},[174,175],-3.70256,40.4165,{"lat":175,"lon":174},[178],{"name":179,"role":28,"phone":24,"phoneExt":24,"email":24},"Mariló Martín, MD",{"facility":181,"status":41,"city":170,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":182,"geoPoint":184,"contacts":185},"Hospital Universitario Ramon y Cajal",{"type":48,"coordinates":183},[174,175],{"lat":175,"lon":174},[186],{"name":187,"role":28,"phone":24,"phoneExt":24,"email":24},"Paco Mesonero, MD",{"facility":189,"status":41,"city":106,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":190,"geoPoint":192,"contacts":193},"Hospital de Terrassa",{"type":48,"coordinates":191},[110,111],{"lat":111,"lon":110},[194],{"name":195,"role":28,"phone":24,"phoneExt":24,"email":24},"David Monfort, MD",{"facility":197,"status":41,"city":198,"state":24,"zip":199,"country":45,"countryCode":46,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Hospital Clínico de Valencia","Valencia","46010",{"type":48,"coordinates":201},[202,203],-0.37966,39.47391,{"lat":203,"lon":202},[206,208,211],{"name":207,"role":28,"phone":24,"phoneExt":24,"email":24},"MÍGUEL MÍNGUEZ PÉREZ, MD",{"name":209,"role":210,"phone":24,"phoneExt":24,"email":24},"Maia Boscó, MD","SUB_INVESTIGATOR",{"name":212,"role":210,"phone":24,"phoneExt":24,"email":24},"Vicente Sanchiz, MD",{"facility":214,"status":81,"city":198,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":215,"geoPoint":217,"contacts":218},"Hospital Universitari La Fe",{"type":48,"coordinates":216},[202,203],{"lat":203,"lon":202},[219],{"name":220,"role":28,"phone":24,"phoneExt":24,"email":24},"Elena Cerrillo, MD",{"type":222,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100387907","prospective-multicenter-randomized-comparative-study-of-the-treatment-of-de-novo-stenosis-in-chrons-disease-100387907",false,"NCT04330846","Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.","Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Crohn's Disease. Endoscopic Treatment (Self-expanding Metal Prosthesis\u002FBallon Dilation) vc Surgical Resection (ENDOCIR STUDY)","ENDOCIR","Inclusion Criteria:\n\n* 18-80 years of age.\n* Crohn's disease with predominantly de novo fibrotic stenosis\\* confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy).\n* Patients with known stenosis previously treated with stenting and\u002For dilation performed over one year before the date of inclusion.\n* Symptomatology of intestinal occlusion-subocclusion.\n* Refractoriness to conventional medical treatment (non-response to the usual accelerated step-up therapeutic approach).\n* Stenosis length \\\u003C 10 cm.\n* Maximum of 2 stenoses.\n* Informed consent from patient.\n\nExclusion Criteria:\n\n* No informed consent from the patient.\n* Complicated stenosis with abscess, fistula or significant activity associated with CD not limited to the area of the stenosis.\n* Patients with known stenosis previously treated with stenting and\u002For dilation performed \\\u003C 1 year before the date of inclusion.\n* Pregnancy or lactation.\n* Any clinical situation that prevents the performance of endoscopy or surgery.\n* Stenosis not accessible by endoscopy.\n* Asymptomatic patient.\n* Stenosis length ≥ 10 cm.\n* Presents with \\> 2 stenoses.\n* Severe coagulation disorders (platelets \\\u003C 70000; INR \\> 1.8).","ALL","18 Years","80 Years",{"count":235,"type":236},40,"ESTIMATED","INTERVENTIONAL",[239],"NA","Stenosis is one of the most frequent complications in patients with Crohn's disease (CD), causing greater morbidity and increasing the probability of repeated surgery and short bowel syndrome (1-3). Endoscopic balloon dilation (EBD) is clearly the treatment of choice for short stenoses located at the anastomosis of previous surgeries (4-6). However, there is no scientific evidence for determining the most appropriate treatment for de novo stenosis less than 10 cm in length (surgical versus endoscopic treatment), both in terms of efficacy and complications. Neither has it been established which of these two approaches has a greater impact on the quality of life of patients and on costs.",[242],"Crohn Disease",[244],"crohn","2025-08-18",{"date":247,"type":248},"2025-08-19","ACTUAL",{"date":250,"type":248},"2022-11-29",{"date":252,"type":236},"2027-04-01",{"name":5,"class":6},16]