Long-term outcomes of removing lesions in the duodenum and ampulla
Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Western Sydney Local Health District Academic / other |
| Locations | 1 site (Sydney, New South Wales) |
| Trial ID | NCT02306603 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with lesions smaller than 10mm or those that have invaded deeper layers of tissue may not benefit from this study.
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 performed: Other studies have shown promising results with endoscopic resection for similar lesions, indicating a potential for successful outcomes.
Eligibility criteria
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 this trial is running
Sydney, New South Wales
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.