Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla

ConditionAdenoma, Villous

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-99

SponsorProfessor Michael Bourke

About this trial

This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Lesion limited to the mucosal and/or submucosal layer (T1 lesion)

Aged 18 years or older

Disqualifiers

Lesion less than 10mm

Duodenal or ampullary lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)

Aged younger than 18 years

Trial population

Patients who have Duodenal and ampullary adenomas which are amendable to Endoscopic Mucosal Resection

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Endoscopic Mucosal Resection
Procedure/Surgery

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: Endoscopic Mucosal Resection1 intervention

Trial outcomes

Primary outcomes

Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes

Time frame

14 days

Secondary outcomes

Analysis of the costs of this procedure compared to previous treatments

Perform cost-utility analyses comparing different treatment approaches for duodenal and ampullary lesions

Time frame

14 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Professor Michael Bourke

Lead sponsor

Western Sydney Local Health District

Sponsor institution

Source ClinicalTrials.gov

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