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

Professor Michael Bourke

Status: Enrolling

Conditions: Adenoma, Villous

Treatments: Procedure: Endoscopic Mucosal Resection

Study type: Observational

Funder types: Other

Identifiers

NCT02306603

HREC 2014/5/4.3 (3972)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Endoscopic Mucosal Resection

Description:

Patients who are referred for Endoscopic Mucosal Resection of Duodenal and Ampullary Lesions will be included in this cohort.

Treatment:

Procedure: Endoscopic Mucosal Resection