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Completed

NCT Number: NCT02305290

Upper GI Outcomes Following EMR

The purpose of this study is to evaluate the long-term outcomes of Endoscopic Resection (ER) of superficial lesions of the Upper Gastrointestinal Tract(UGIT)

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

About this study

Endoscopic resection (ER) of superficial lesions of the upper gastrointestinal tract 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 UGIT.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • UGIT lesion > 10mm
  • Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
  • Aged 18 years or older

Exclusion criteria

  • Lesion less than 10mm
  • Gastric 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

    Time frame: 14 days

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes

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 UGIT lesions

Sponsors and collaborators

Lead sponsor

Professor Michael Bourke

Other

Registry information

Official study title

Outcomes of Endoscopic Resection in the Upper Gastrointestinal Tract

Acronym: UGI-EMR

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Dec 2, 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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