[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100232663":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":20,"studyPopulation":21,"armGroups":22,"interventions":28,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":63,"collaborators":11,"id":67,"slug":11,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":11,"briefSummary":81,"conditions":82,"keywords":11,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Western Sydney Local Health District","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes",null,"14 days",[14],{"measure":15,"description":16,"timeFrame":12},"Analysis of the costs of this procedure compared to previous treatments","Perform cost-utility analyses comparing different treatment approaches for duodenal and ampullary lesions",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":18,"timePerspective":19,"maskingInfo":11},"COHORT","PROSPECTIVE","Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla is a safe and effective surgery sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the duodenum and ampulla.","Patients who have Duodenal and ampullary adenomas which are amendable to Endoscopic Mucosal Resection",[23],{"label":24,"type":11,"description":25,"interventionNames":26},"Endoscopic Mucosal Resection","Patients who are referred for Endoscopic Mucosal Resection of Duodenal and Ampullary Lesions will be included in this cohort.",[27],"Procedure: Endoscopic Mucosal Resection",[29],{"type":30,"name":24,"description":11,"armGroupLabels":31,"otherNames":11},"PROCEDURE",[24],[33],{"name":34,"affiliation":5,"role":35},"Michael J Bourke, MBBS","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":11,"email":41},"Michael Bourke, MBBS","CONTACT","88905555","michael@citywestgastro.com.au",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Westmead Hospital Endoscopy Unit","RECRUITING","Sydney","New South Wales","2145","Australia","AU",{"type":52,"coordinates":53},"Point",[54,55],151.20732,-33.86785,{"lat":55,"lon":54},[58,61],{"name":59,"role":39,"phone":40,"phoneExt":11,"email":60},"Clarence Kerrison, MBBS","clarence.kerrison@health.nsw.gov.au",{"name":34,"role":39,"phone":11,"phoneExt":11,"email":62},"westmeadendoscopyresearch@gmail.com",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Professor Michael Bourke","Director of Gastrointestinal Endoscopy","100232663",false,"NCT02306603","Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla","Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla","OERDA","Inclusion Criteria:\n\n\\* Duodenal and ampullary lesion \\> 10mm\n\n* Lesion limited to the mucosal and\u002For submucosal layer (T1 lesion)\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Lesion less than 10mm\n* Duodenal or ampullary lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)\n* Aged younger than 18 years","ALL","18 Years","99 Years",{"count":78,"type":79},200,"ESTIMATED","OBSERVATIONAL","This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.",[83],"Adenoma, Villous","2025-03-25",{"date":86,"type":87},"2025-03-27","ACTUAL",{"date":89,"type":11},"2014-10",{"date":91,"type":79},"2027-04",{"name":65,"class":6},1]