Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adenoma, Villous
- Sponsor
- Professor Michael Bourke
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla is a safe and effective surgery sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the duodenum and ampulla.
Investigators
Professor Michael Bourke
Director of Gastrointestinal Endoscopy
Western Sydney Local Health District
Eligibility 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
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(14 days)