[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ampulla-of-vater-adenoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ampulla-of-vater-adenoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":34,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100608251","duodenal-polyposis-classification-in-fap-100608251",false,"NCT07199127","Duodenal Polyposis Classification in FAP","Novel Endoscopic Classification for Duodenal Polyposis in Individuals With Familial Adenomatous Polyposis","DRACO","Inclusion Criteria:\n\n* Confirmed germline diagnosis of FAP, as defined by genetic testing\n* Two or more upper gastrointestinal endoscopies\n* Complete documentation of all Spigelman classification variables at each endoscopic evaluation\n\nExclusion Criteria:\n\n* Histological grading of duodenal polyps incomplete\n* Follow-up data were unavailable\n* Duodenal surgery before study baseline endoscopy","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","Duodenal cancer is the leading cause of cancer-related mortality in patients with familial adenomatous polyposis (FAP), yet the current Spigelman staging system provides limited predictive accuracy for advanced neoplasia. The DRACO study (Duodenal Risk Assessment in adenomatous polyposis Coli -Oncogene) is a multicenter, STROBE- and CONSORT-compliant cohort study that analyzes upper endoscopies from genetically confirmed FAP patients across independent cohorts to develop, validate, and externally test two multivariable risk models.",[25,26,27,28,29,30,31,32,33],"Duodenum Cancer","Familial Adenomatous Polyposis","Duodenal Polyposis","Ampulla of Vater Adenoma","FAP Gene Mutation","FAP","Duodenal Neoplasms","Duodenal Adenoma","Ampulla of Vater Cancer",[35,27],"Spigelman","RECRUITING","2025-09-22",{"date":39,"type":40},"2025-09-30","ACTUAL",{"date":42,"type":40},"2018-02-02",{"date":44,"type":21},"2030-01-15",{"name":46,"class":47},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":66,"locationsCount":4},"100565943","predictors-of-therapeutic-success-and-adverse-events-in-endoscopic-ampullectomy-100565943","NCT06648746","Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy","Inclusion Criteria:\n\n* Adult patients (≥18 years) submitted to endoscopic resection of an ampullary adenoma with the following features were included:\n\n  * lesions up to 30 mm (including with laterally spreading component)\n  * with low-grade or high-grade dysplasia on preprocedural histology\n  * with no intraductal extension\n  * with no evidence of invasive malignancy on endoscopic assessment (including endoscopic features including hard consistency, friable or ulcera:ve surface and spontaneous bleeding)\n* A minimum follow-up period of one year afer endoscopic ampullary resection.\n\nExclusion Criteria:\n\n* Patients with lesions with the following features were excluded:\n\n  * intraductal extension\n  * evidence of invasive malignancy\n  * other non-adenomatous lesions\n* Patients who underwent endoscopic resection or surgical ampullectomy prior to enrollment\n* Patients with a follow-up of less than a year after endoscopic ampullary resection\n* Patients with pancreas divisum.",{"count":55,"type":21},100,"Although ampullary tumors are rare (representing 0.6-0.8 % of all digestive cancers), their estimated incidence has increased in recent years (\\\u003C1 per 100 000 per year). Most noninvasive ampullary tumors of the major papilla occur as sporadic and asymptomatic lesions, detected during conventional upper endoscopy performed for another indication.\n\nNonetheless, they can present with jaundice (17%), pain (14%), pancreatitis (4%), cholangitis (1%), and can be associated with common bile duct stones (up to 38%). Resection of ampullary adenomas is warranted to prevent malignant progression. The most recent European Society of Gastrointestinal Endoscopy (ESGE) recommend endoscopic ampullectomy as the standard of care approach for ampullary adenomas without intraductal extension, due to excellent outcomes of technical and clinical success (high complete and curative resection rates of 94% and 87%, respectively), with lower morbidity and recurrence rates. This procedure as a low rate of mortality (of 0.4%), but the rate of adverse events can exceed 20%. The most frequent adverse events are acute pancreatitis (12%), intraprocedural and\u002For delayed bleeding (11%), perforation (3%), cholangitis (3%), ampullary stenosis (2.5%). Also there is a high recurrence rate of up to one third after endoscopic resection; up to two thirds are identified at the first follow-up endoscopy, requiring additional endoscopic resection or surgery.",[28,58],"Ampulla of Vater Disease (Benign\u002FMalignancy)","NOT_YET_RECRUITING","2024-10-16",{"date":62,"type":40},"2024-10-18",{"date":64,"type":21},"2024-12",{"date":64,"type":21},{"name":67,"class":47},"Universidade do Porto"]