Long-term outcomes of removing lesions in the duodenum and ampulla
Official title: Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla
Run by Western Sydney Local Health District · NCT02306603 · Data updated 2026-11-12
This study is testing how well removing certain growths from the duodenum and ampulla helps patients feel better and stay healthy over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Western Sydney Local Health District Academic / other |
| Locations | 1 site (Sydney, New South Wales) |
| Status | Recruiting |
| Started | October 2014 |
| Main results expected | October 2026 |
| Study ends | April 2027 |
| Registry record updated | March 27, 2025 |
| Trial ID | NCT02306603 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 years or older with duodenal or ampullary lesions larger than 10mm that are confined to the mucosal or submucosal layers.
✕Probably not a fit
Patients with lesions smaller than 10mm or those that have invaded deeper layers of tissue may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research evaluates the long-term outcomes of endoscopic resection (ER) for superficial lesions in the duodenum and ampulla. The study aims to determine the effectiveness and safety of this surgical approach, which is often curative for dysplastic lesions and associated with minimal complications. Conducted at Westmead Hospital, the research seeks to document the experiences and results of patients who have undergone this procedure. The focus is on lesions larger than 10mm that are limited to the mucosal and submucosal layers.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of endoscopic resection for patients with duodenal and ampullary lesions.
How similar studies have gone: Other studies have shown promising results with endoscopic resection for similar lesions, indicating a potential for successful outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \* Duodenal and ampullary lesion \> 10mm * Lesion limited to the mucosal and/or submucosal layer (T1 lesion) * Aged 18 years or older Exclusion Criteria: * 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
Where it's running
-
Westmead Hospital Endoscopy Unit
Sydney, New South Wales, Australia Recruiting
Study contacts
- Principal investigator: Michael J Bourke, MBBS — Western Sydney Local Health District
- Study coordinator: Michael Bourke, MBBS
- Email: michael@citywestgastro.com.au
- Phone: 88905555
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.