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NCT Number: NCT02306603

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

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.

Recruiting

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Key information

Conditions

Adenoma, Villous Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital Endoscopy Unit

Sydney, New South Wales, 2145, Australia

Location status: Recruiting

Location contact

Clarence Kerrison, MBBS

CONTACT

[email protected]

88905555

Michael J Bourke, MBBS

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic mucosal resection

Procedure

Primary outcomes

  1. Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes

    Time frame: 14 days

Secondary outcomes

  1. Analysis of the costs of this procedure compared to previous treatments

    Time frame: 14 days

    Perform cost-utility analyses comparing different treatment approaches for duodenal and ampullary lesions

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Bourke, MBBS

CONTACT

[email protected]

88905555

Sponsors and collaborators

Lead sponsor

Professor Michael Bourke

Other

Registry information

Official study title

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

Acronym: OERDA

Important dates

Study start
2014
Primary completion
2026
Study completion
2027
First posted
Dec 3, 2014
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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