Cancer of StomachANZ UGINCT05804331
The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
An observational study of Cancer of Stomach and Oesophageal Cancer, run by Western Sydney Local Health District at 1 site in Australia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Stomach, Oesophageal Cancer, Gastric Cancer
- How many people
- 500 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Mar 2023to 14 Sep 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to tertiary centre for endoscopic resection of gastrointestinal neoplasm
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Westmead Hospital
Sydney, New South Wales, 2145
Clarence Kerrison, clarence.kerrison@health.nsw.gov.au
About this 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
Read the detailed description
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
- Conditions
- Cancer of Stomach, Oesophageal Cancer, Gastric Cancer, Gastric Adenocarcinoma, GI Cancer, GIST
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Gastrointestinal Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with Gastrointestinal neoplasm | Pt referred for resection of gastrointestinal neoplasm. Observational data collected from endoscopic submucosal dissection (ESD), submucosal-tunnelling endoscopic resection (STER) or endoscopic full-thickness resection (EFTR) of gastrointestinal neoplasm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection
Determined based on clear margins in histology review
Measured: 2 weeks
Safety: intra and post procedural; bleeding; perforation; anaesthetic
Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome
Measured: 30 day
Long term outcomes: recurrent and residual disease
Determined at subsequent procedures
Measured: 3 years
Secondary outcomes (5)
Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives
Determined after follow up procedure to confirm no recurrence
Measured: 6 months
Need for more than one endoscopic therapy
Determined after follow up procedures
Measured: 3 years
Need for surgery
Determined after follow up procedures, histological review
Measured: 2 months
Post ESD, EFTR, STER defect features
Determined after complete resection
Measured: 1 day
Patient interviews/questionnaires
Determined after follow up procedures
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start14 Mar 2023
- Primary completion14 Mar 2028 (estimated)
- Study completion14 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of StomachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Michael Bourke, Western Sydney Local Health District
- Investigators
- Michael Bourke, Principal investigator, WSLHD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804331
- Sponsor's protocol ID
- 2022/PID02709
- Acronym
- ANZ UGI
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
- ClinicalTrials.gov ID
- NCT05804331
- Acronym / sponsor ID
- ANZ UGI / 2022/PID02709
- Conditions
- Cancer of Stomach, Oesophageal Cancer, Gastric Cancer, Gastric Adenocarcinoma, GI Cancer, GIST
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 14 Mar 2028 (estimated)
- Study completion
- 14 Sep 2028 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Gastrointestinal neoplasm | – | –Pt referred for resection of gastrointestinal neoplasm. Observational data collected from endoscopic submucosal dissection (ESD), submucosal-tunnelling endoscopic resection (STER) or endoscopic full-thickness resection (EFTR) of gastrointestinal neoplasm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to tertiary centre for endoscopic resection of gastrointestinal neoplasm
Key inclusion criteria (5 listed)
- UGI neoplastic lesions > 10mm
- Aged 18 years or older
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection
Time frame: 2 weeks
Determined based on clear margins in histology review
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
Long term outcomes: recurrent and residual disease
Time frame: 3 years
Determined at subsequent procedures
5 secondary outcomes
Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives
Time frame: 6 months
Need for more than one endoscopic therapy
Time frame: 3 years
Need for surgery
Time frame: 2 months
Post ESD, EFTR, STER defect features
Time frame: 1 day
Patient interviews/questionnaires
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Bourke principal investigator
WSLHD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Stomach and Oesophageal Cancer, run by Western Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Bourke (02 8890 5555, michael@citywestgastro.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.