[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636036":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Shaare Zedek Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Budesonide arm","EXPERIMENTAL","Patients will take budesonide gel (1mg\u002F8mL) 250mcg orally twice daily for 12 weeks from the first dilatation.",[13],"Drug: Budesonide intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","NO_INTERVENTION","Patients will not receive any treatment following their dilations.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Budesonide intervention","Patients will receive budesonide gel (1mg\u002F8mL) 250mcg orally twice daily for 12 weeks from the first dilatation.",[9],[26],{"name":27,"affiliation":5,"role":28},"Oren Leder, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Oren Ledder, Dr","CONTACT","+972-2-6666743","orenl@szmc.org.il",[36],{"facility":37,"status":18,"city":38,"state":18,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":18},"Shaare Zedek Medical Centre","Jerusalem","91031","Israel","IL",{"type":43,"coordinates":44},"Point",[45,46],35.21633,31.76904,{"lat":46,"lon":45},{"type":28,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Oren Ledder, MD","Dr. Oren Ledder, Principal Investigator",[52],{"name":53,"class":6},"European Society of Pediatric Gastroenterology, Hepatology and Nutrition","100636036","budesonide-following-endoscopic-dilatation-of-esophageal-strictures-in-children-100636036",false,"NCT07560462","Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.","Single-blinded, Randomized Controlled Trial of Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.","Inclusion Criteria:\n\n* Infants and children \\\u003C 12 years old with an anastomotic esophageal stricture following repair of congenital esophageal atresia \u002F tracheoesophageal fistula\n* Dysphagia score ≥1\n* Parental consent\n\nExclusion Criteria:\n\n* Additional stricture\u002Fs besides anastomotic stricture eg. Congenital stricture\n* Complicated stricture - including length \\>2cm, significant angulation or irregularity\n* Neurological impairment or other cause of expected limitation to oral intake\n* Previous anastomotic dilatations\n* Complicated surgical course including need for re-operation, re-fistularization or surgical anastomotic leak\n* Suspected or verified thoracic vascular anomaly affecting esophageal patency or function\n* Verified co-diagnosis of eosinophilic esophagitis\n* Any contraindication to EBD according to treating physician's planned treatment course","ALL","12 Years",{"count":64,"type":65},32,"ESTIMATED","INTERVENTIONAL",[68],"NA","Endoscopic balloon dilatation (EBD) is a common therapeutic procedure performed for esophageal strictures. While the etiologies of esophageal strictures are numerous - including congenital strictures, caustic injuries and eosinophilic esophagitis (EoE) -anastomotic strictures following esophageal atresia and trachea-esophageal fistula repairs is reported as the most frequent cause in children.\n\nStricture dilatation is usually performed under direct endoscopic vision, with graduated balloon dilatation, utilizing increasing balloon diameters deployed until reaching a pre-determined, age-based, dilatation target. Balloon dilatation is repeated every 2-4 weeks until the target is reached. Success is defined as prolonged restoration of effective swallow with no dysphagia or dietary restrictions. Dilatation is repeated if clinical resolution is not obtained, or if symptoms return after initial resolution.\n\nIn children, a stricture is considered refractory when the age-appropriate esophageal lumen is not achieved with five dilatations within 5 months, or if despite ≥7 dilatations overall an age-appropriate esophageal lumen was not maintained.\n\nSeveral interventions have been studied to improve the efficacy of balloon dilatation, including injecting corticosteroids at the dilatation site, topical Mitomycin C following dilatation, or pre-dilatation endoscopic incisions of the anastomotic scar tissue. All these interventions are performed endoscopically at the time of the dilatation, require advanced endoscopic skills and may potentially have associated additional risk.\n\nIn this study the investigators aim to test the efficacy and safety of topical budesonide gel following EBD for anastomotic esophageal strictures in a single-blinded, randomized controlled study of children.",[71],"Esophageal Stricture",[73,74,75],"EBD","esophageal stricture","Oral viscous budesonide","NOT_YET_RECRUITING","2026-04-27",{"date":79,"type":80},"2026-05-01","ACTUAL",{"date":79,"type":65},{"date":83,"type":65},"2029-05-01",{"name":5,"class":6},1]