[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esophageal-stricture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esophageal-stricture":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,73,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":19,"type":20},32,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Esophageal Stricture",[28,29,30],"EBD","esophageal stricture","Oral viscous budesonide","NOT_YET_RECRUITING","2026-04-27",{"date":34,"type":35},"2026-05-01","ACTUAL",{"date":34,"type":20},{"date":38,"type":20},"2029-05-01",{"name":40,"class":41},"Shaare Zedek Medical Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100482367","phase-3-paclitaxel-coated-balloon-for-the-treatment-of-chronic-benign-stricture--esophagus-100482367","NCT05561114","Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus","PATENT-E","Inclusion Criteria:\n\n1. Age ≥ 22 years\n2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations\n3. Ogilvie Dysphagia Score of ≥2\n4. Minimum esophageal lumen diameter \\\u003C13 mm\n5. Willing and able to complete protocol required follow-up visits\n6. Willing and able to provide written informed consent\n7. Strictures ≤5cm in total length\n8. Target benign esophageal stricture etiologies include:\n\n   1. Peptic stricture,\n   2. Schatzki's ring,\n   3. Stricture due to prior infection,\n   4. Post-procedural (e.g. ESD\u002FEMR\u002FRFA\u002FCryo) stricture\n   5. Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy\n\nExclusion Criteria:\n\n1. Two or more clinically significant (e.g. non-traversable) strictures with total length \\>5cm or unable to be treated with a single balloon.\n2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months\n3. Contraindication to endoscopy, anesthesia or deep sedation\n4. Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head\u002Fneck cancer treatment.\n5. History of diagnosis of eosinophilic esophagitis (EoE)\n6. Signs or suspicion of a malignant esophageal stricture NOTE: If stricture is suspicious for malignancy based on clinical or endoscopic presentation, malignancy must be excluded by biopsy prior to enrollment. Subjects with a history of invasive esophageal cancer should have recurrence excluded by advanced imaging (e.g. CT\u002FPET scan) and biopsy within 6 months of enrollment.\n7. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the neck or thoracic region NOTE: A prior diagnosis of esophageal cancer is acceptable if considered in remission and recurrence has been excluded by advanced imaging and biopsy within 6 months of enrollment.\n8. Suspected perforation of gastrointestinal tract\n9. Inability to pass guidewire across stricture\n10. Active systemic infection\n11. Allergy to paclitaxel or structurally related compounds\n12. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure\n13. Chronic systemic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use\n14. Received steroid injections into target stricture in the last 8 weeks.\n15. Stricture not amenable to endoscopic dilation to ≥ 18 mm in the opinion of the investigator\n16. Current use of nasal or oral feeding tube unless tube is removed prior to baseline assessments and subject maintains normal swallowing function.\n17. Acute stricture condition that requires emergent procedure (e.g. immediate dilation)\n18. Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc\n19. Life expectancy of less than 24 months\n20. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, ongoing infection, etc\n21. Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint.\n22. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, etc.\n23. Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy.\n24. Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility.\n25. Intolerant to effective acid suppression medication (e.g. proton pump inhibitors, H2 receptor antagonists)\n26. Concurrent gastric and\u002For duodenal obstruction","22 Years",{"count":52,"type":20},198,[54],"PHASE3","To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.",[26],[29,58,59,60],"drug coated balloon","DCB","paclitaxel coated balloon","RECRUITING","2025-06-19",{"date":64,"type":35},"2025-06-25",{"date":66,"type":35},"2023-12-01",{"date":68,"type":20},"2031-04",{"name":70,"class":71},"GIE Medical","INDUSTRY",34,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100565554","phase-2-tranilast-vs-steroids-to-prevent-esophageal-stricture-tapes-after-endoscopic-resection-for-superficial-neoplasms-100565554","NCT06643689","Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) After Endoscopic Resection for Superficial Neoplasms","Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) Following Circumferential Endoscopic Submucosal Dissection (cESD) for Superficial Neoplasms","TAPES","Inclusion Criteria:\n\n1. age\\>18 and proficient in Mandarin.\n2. underwent cESD treatment for superficial esophageal neoplasms.\n3. agree to sign an informed consent form.\n\nExclusion Criteria:\n\n1. allergic to tranilast.\n2. with severe comorbid conditions.\n3. pregnant or breastfeeding.","18 Years",{"count":83,"type":20},394,[85],"PHASE2","The goal of this clinical trial is to learn if tranilast works to prevent esophageal stricture after circumferential endoscopic submucosal dissection (cESD) in adults. It will also help us learn more about the safety of tranilast. The main questions it aims to answer are: 1. Does tranilast reduce the occurence of esophageal stricture in participants after cESD? 2. What medical problems do participants have when taking tranilast.\n\nResearchers will compare tranilast to prednisone (a steroid used in clinical practice with potential defects) to see if tranilast works well to prevent esophageal stricture.\n\nParticipants will: 1. Take tranilast or prednisone every day for 8 weeks. 2. Attend visit (at clinic or phone) once every 2 weeks for checkups and tests until 16 weeks. 3. Keep a diary of their symptoms and let researchers know during the 16 weeks follow up.",[26,88],"Esophageal Neoplasms",[90,88,91,92,93],"Tranilast","Steroids","Esophageal stricture","Circumferential Endoscopic Submucosal Dissection","2024-11-12",{"date":96,"type":35},"2024-11-14",{"date":98,"type":20},"2025-01-01",{"date":100,"type":20},"2028-12-31",{"name":102,"class":41},"Second Affiliated Hospital, School of Medicine, Zhejiang University",3,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":42},"100555591","role-of-topical-steroid-injection-with-refractory-benign-esophageal-stricture-endoscopic-dilatation-in-children-100555591","NCT06514079","Role of Topical Steroid Injection With Refractory Benign Esophageal Stricture Endoscopic Dilatation in Children","ISIs","Inclusion Criteria:\n\n* Pediatric patients aged less than 14 years\n* with refractory benign esophageal strictures\n* received a dilatation therapy without triamcinolone injections\n\nExclusion Criteria:\n\n* failure to pass a guide wire secondary to pharyngeal stenosis\n* tracheo-esophageal fistula\n* those who received triamcinolone injections at early dilatation","2 Years","14 Years",{"count":114,"type":20},21,[23],"This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.",[118,119,26],"Pediatric Disorder","Esophageal Diseases",[92,121,122],"Steroid injection","Esophageal dilatation","2024-07-22",{"date":125,"type":35},"2024-07-23",{"date":127,"type":35},"2022-03-02",{"date":129,"type":20},"2024-08-20",{"name":131,"class":41},"Mohammad Daboos"]