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Recruiting

NCT Number: NCT05804331

The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study

To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions

Recruiting

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Key information

Conditions

Cancer of Stomach Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms GI Cancer GIST Gastric Adenocarcinoma Gastric Cancer Gastric Neoplasm Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Oesophageal Cancer Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location status: Recruiting

Location contact

Clarence Kerrison

CONTACT

[email protected]

About this study

To collect prospective observational data on patients undergoing ESD, EFTR or STER for UGI neoplastic lesions

  • Lesion characteristics including histology
  • Procedural outcomes
  • Safety Outcomes
  • Efficacy outcomes

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • UGI neoplastic lesions > 10mm
  • Lesions for ESD limited to the mucosal and/or submucosal layer OR
  • Lesions for EFTR limited to the muscularis propria layer OR
  • Lesions for STER limited to the submucosal and/or muscularis propria layer
  • Aged 18 years or older

Exclusion criteria

  • Age less than 18
  • Unable to give informed consent
  • Pregnant or lactating patients
  • Patients with bleeding diathesis or who cannot discontinue ADP blockers (e.g. clopidogrel, prasugrel) or antithrombotics (e.g. warfarin, dabigatran) periprocedurally

Treatment and study plan

Primary outcomes

  1. Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection

    Time frame: 2 weeks

    Determined based on clear margins in histology review

  2. Safety: intra and post procedural; bleeding; perforation; anaesthetic

    Time frame: 30 day

    Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome

  3. Long term outcomes: recurrent and residual disease

    Time frame: 3 years

    Determined at subsequent procedures

Secondary outcomes

  1. Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives

    Time frame: 6 months

    Determined after follow up procedure to confirm no recurrence

  2. Need for more than one endoscopic therapy

    Time frame: 3 years

    Determined after follow up procedures

  3. Need for surgery

    Time frame: 2 months

    Determined after follow up procedures, histological review

  4. Post ESD, EFTR, STER defect features

    Time frame: 1 day

    Determined after complete resection

  5. Patient interviews/questionnaires

    Time frame: 3 years

    Determined after follow up procedures

Study contacts

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

Michael Bourke

CONTACT

[email protected]

02 8890 5555

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Acronym: ANZ UGI

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 7, 2023
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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