Ampulla of Vater Adenoma

2

Review clinical trials related to Ampulla of Vater Adenoma. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Duodenal Polyposis Classification in FAP

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.

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUpdated: Sep 30, 2025Locations: 2
Eligibility criteria

Confirmed germline diagnosis of FAP, as defined by genetic testing [+2]

Histological grading of duodenal polyps incomplete [+2]

Status: Not yet recruiting

Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy

Although ampullary tumors are rare (representing 0.6-0.8 % of all digestive cancers), their estimated incidence has increased in recent years (\<1 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. Nonetheless, 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/or 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.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Universidade do PortoUpdated: Oct 18, 2024
Eligibility criteria

lesions up to 30 mm (including with laterally spreading component) [+4]

intraductal extension [+5]