[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653156":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":11,"studyPopulation":24,"armGroups":11,"interventions":11,"overallOfficials":11,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":11,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Western Sydney Local Health District","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"To evaluate the recurrence rate of endoscopic resection of mucosal and submucosal lesions in the duodenum and papilla",null,"From enrolment to final surveillance endoscopy (generally 5 years after index procedure)",{"measure":14,"description":11,"timeFrame":12},"To assess duodenal and ampulla endoscopic resection procedure adverse event rates",{"measure":16,"description":11,"timeFrame":12},"To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy.",[18],{"measure":19,"description":20,"timeFrame":12},"Requirements for surgery","Rate of surgery",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":22,"timePerspective":23,"maskingInfo":11},"COHORT","RETROSPECTIVE","This study will be conducted at a tertiary referral centre specialising in endoscopic therapy in the duodenum and ampulla.\n\nIdentifying patients:\n\nParticipants will be sourced through the current electronic documentation system, utilising the following methods:\n\nProvation (endoscopic reporting software) key search for key terms related to:\n\n* Duodenal polyp(s)\n* Duodenal lesion\n* Duodenal SEL\n* Duodenal submucosal lesion\n* Duodenal EMR\n* Duodenal ESD\n* Papillectomy\n* Ampullectomy\n\nElectronic referral pathway for endoscopic retrograde cholangiopancreatogram (ERCP) at Westmead Hospital for indications showing:\n\n* Duodenal polyp(s)\n* Duodenal lesion\n* Duodenal EMR\n* Duodenal ESD\n* Papillectomy\n* Ampullectomy",[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Clarence Kerrison, MBChB, MBiomedSc, FRACP","CONTACT","+61413361347","clarence.kerrison@health.nsw.gov.au",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":11,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Westmead Endoscopy, Westmead hospital, Western Sydney Local Health District","RECRUITING","Sydney","New South Wales","Australia","AU",{"type":40,"coordinates":41},"Point",[42,43],151.20732,-33.86785,{"lat":43,"lon":42},[46],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Professor Michael Bourke","Professor","100653156","analysis-of-long-term-outcomes-of-endoscopic-resection-of-duodenal-and-ampullary-mucosal-and-submucosal-lesions-100653156",false,"NCT07781137","Analysis of Long-term Outcomes of Endoscopic Resection of Duodenal and Ampullary Mucosal and Submucosal Lesions","Retrospective Analysis of Long-term Outcomes of Endoscopic Resection of Duodenal and Ampullary Mucosal and Submucosal Lesions","DuoP-ER","Inclusion Criteria:\n\n* Age greater than 18\n* Mucosal or submucosal lesion in the duodenum or ampulla with endoscopic resection performed at Westmead hospital Endoscopic resection occurred between January 2010 to March 2025\n\nExclusion Criteria:\n\n* Age less than 18","ALL","18 Years",{"count":62,"type":63},1000,"ESTIMATED","OBSERVATIONAL","Mucosal and submucosal lesions of the duodenum represent a diverse group of pathologies, ranging from benign adenomas to lesions with significant malignant potential. Endoscopic resection has emerged as a minimally invasive approach; however, the success rates, recurrence patterns, and long-term outcomes remain poorly defined due to the heterogeneity of these lesions. This study aims to retrospectively evaluate the endoscopic management and long-term outcomes of patients who underwent endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla over a 15-year period. The investigators aim to assess key procedural outcomes, including complete resection rates, recurrence, complication rates, recurrence and morbidity and mortality of duodenal or ampullary malignancy. By analysing these factors, the investigators hope to better understand the role of endoscopic therapy in managing these challenging lesions and identify predictors of long-term success. This data will help guide future practice and optimize surveillance strategies for patients undergoing endoscopic resection in this complex anatomical region.\n\nPrimary Objective\n\n1. To evaluate the effectiveness of endoscopic resection of mucosal and submucosal lesions (MSML) in the duodenum and ampulla.\n2. To assess the safety profile of the procedure.\n3. To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy.\n\nSecondary Objectives\n\n1. Diagnostic yield of endoscopic surveillance post endoscopic resection\n2. Requirements for surgery",[67,68,69,70,71],"Duodenal Adenoma","Duodenal Carcinoma","Papillary Adenoma","Papillary Adenocarcinoma","Endoscopic Mucosal Resection","2026-08-18",{"date":74,"type":75},"2026-08-24","ACTUAL",{"date":77,"type":75},"2025-05-23",{"date":79,"type":63},"2030-01",{"name":5,"class":6},1]