About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
lesions up to 30 mm (including with laterally spreading component)
with low-grade or high-grade dysplasia on preprocedural histology
with no intraductal extension
with no evidence of invasive malignancy on endoscopic assessment (including endoscopic features including hard consistency, friable or ulcera:ve surface and spontaneous bleeding)
Disqualifiers
intraductal extension
evidence of invasive malignancy
other non-adenomatous lesions
Patients who underwent endoscopic resection or surgical ampullectomy prior to enrollment
Trial population
Consecutive adult patients submihed to endoscopic resection of an ampullary adenoma in each of the participating center (ULS de Santo António - Porto; ULS São João - Porto)
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Therapeutic success
\- Rate of adenoma recurrence after endoscopic resection of ampullary adenomas
Safety outcomes
\- Rate of adverse events related to endoscopic resection of ampullary adenomas
Secondary outcomes
Prophylaxis
\- Comparison of the post-ampullectomy acute pancreatitis incidence with different kinds of prophylaxis
Risk factors
To perform a multivariate analysis of patient, lesion and procedure characteristics that correlate with the incidence of adverse events
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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