Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversidade do Porto

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Endoscopic ampullectomy

Trial outcomes

Primary outcomes

1

Therapeutic success

\- Rate of adenoma recurrence after endoscopic resection of ampullary adenomas

Time frame
1 year
2

Safety outcomes

\- Rate of adverse events related to endoscopic resection of ampullary adenomas

Time frame
1 year

Secondary outcomes

1

Prophylaxis

\- Comparison of the post-ampullectomy acute pancreatitis incidence with different kinds of prophylaxis

Time frame
1 year
2

Risk factors

To perform a multivariate analysis of patient, lesion and procedure characteristics that correlate with the incidence of adverse events

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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