Long-term outcomes of endoscopic procedures for upper gastrointestinal cancers
The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
This study looks at how well certain endoscopic procedures work for treating larger upper gastrointestinal cancers and what the long-term results are for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western Sydney Local Health District Academic / other |
| Locations | 1 site (Sydney, New South Wales) |
| Trial ID | NCT05804331 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on patients undergoing Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR), or Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions. It will assess lesion characteristics, procedural outcomes, safety, and efficacy of these interventions. The study will focus on lesions larger than 10mm and will gather prospective data to evaluate long-term outcomes. The findings could provide valuable insights into the effectiveness of these endoscopic techniques in treating upper GI cancers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with upper gastrointestinal neoplastic lesions larger than 10mm.
Not a fit: Patients under 18, those unable to provide informed consent, or those with specific bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and outcomes for patients with upper gastrointestinal cancers.
How similar studies have performed: Other studies have shown promising results with similar endoscopic techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sydney, New South Wales
- Westmead Hospital — Sydney, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: Michael Bourke — Wslhd
- Study coordinator: Michael Bourke
- Email: michael@citywestgastro.com.au
- Phone: 02 8890 5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.