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

Adenoma, Villous Clinical Trial

— OERDA  

Official title:

Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306603
• Other study ID #: HREC 2014/5/4.3 (3972)
• Status: Recruiting
• Start date: October 2014
• Est. completion date: April 2027

Study information

• Verified date: June 2023
• Source: Western Sydney Local Health District
• Contact: Kathleen Goodrick, BN
• Phone: 88905555
• Email: kathleen.goodrick[@]health.nsw.gov.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma, Villous

Intervention

Procedure:
• Endoscopic Mucosal Resection

Locations

Country	Name	City	State
Australia	Westmead Hospital Endoscopy Unit	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes		14 days
Secondary	Analysis of the costs of this procedure compared to previous treatments	Perform cost-utility analyses comparing different treatment approaches for duodenal and ampullary lesions	14 days