Adenoma, VillousUGI-EMRNCT02305290
Upper GI Outcomes Following EMR
An observational study of Adenoma, Villous, run by Professor Michael Bourke at 1 site in Australia.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoma, Villous
- What is being tested?
- Endoscopic Mucosal Resection
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2014to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 who have Upper Gastrointestinal Tract adenomas which are amendable to Endoscopic Mucosal Resection
Who may be able to join
- UGIT lesion > 10mm
- Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
- Aged 18 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Endoscopic Resection in the Upper Gastrointestinal Tract
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)
Read the detailed description
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.
- Conditions
- Adenoma, Villous
- Being tested
- Endoscopic Mucosal Resection
- Medical subject headings
- Adenoma, Villous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Mucosal ResectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Mucosal Resection | Patients who are referred for Endoscopic Mucosal Resection of Upper Gastrointestinal Lesions will be included in this cohort. Receives: Procedure: Endoscopic Mucosal Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed procedural data
Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
Measured: 14 days
Secondary outcomes (1)
Analysis of the costs of this procedure compared to previous treatments
Perform cost-utility analyses comparing different treatment approaches for UGIT lesions
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2023
- Study completionSep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenoma, VillousStudies 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Michael Bourke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Michael Bourke, Western Sydney Local Health District
- Investigators
- Michael J Bourke, MBBS, Principal investigator, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305290
- Sponsor's protocol ID
- HREC2014/7/4.6 (4033)
- Acronym
- UGI-EMR
- Status last verified
- Mar 2025
- First submitted
- 30 Jul 2014
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Gupta S, Mandarino FV, Lam B, Gauci J, Kerrison C, McLeod D, Lee E, Burgess N, Bourke MJ. Long-Term Outcomes of Endoscopic Submucosal Dissection for Esophageal Squamous High-Grade Dysplasia and Early Squamous Cell Carcinoma in the West: Absolute vs Outside Criteria. Clin Gastroenterol Hepatol. 2026 May 12:S1542-3565(26)00354-X. doi: 10.1016/j.cgh.2026.04.030. Online ahead of print.
PubMed 42128037
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
- Outcomes of Endoscopic Resection in the Upper Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT02305290
- Acronym / sponsor ID
- UGI-EMR / HREC2014/7/4.6 (4033)
- Conditions
- Adenoma, Villous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Professor Michael BourkeUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Sep 2023 (actual)
- First posted
- 2 Dec 2014 (estimated)
- 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.
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)
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Mucosal Resection | – | Procedure: Endoscopic Mucosal ResectionPatients who are referred for Endoscopic Mucosal Resection of Upper Gastrointestinal Lesions will be included in this cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have Upper Gastrointestinal Tract adenomas which are amendable to Endoscopic Mucosal Resection
Key inclusion criteria (3 listed)
- UGIT lesion > 10mm
- Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
- Aged 18 years or older
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Mucosal Resection | Procedure or surgery | Endoscopic Mucosal Resection |
Primary outcome
Observed procedural data
Time frame: 14 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
1 secondary outcome
Analysis of the costs of this procedure compared to previous treatments
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Derived from this study: PubMed 42128037Gupta S, Mandarino FV, Lam B, Gauci J, Kerrison C, McLeod D, Lee E, Burgess N, Bourke MJ. Long-Term Outcomes of Endoscopic Submucosal Dissection for Esophageal Squamous High-Grade Dysplasia and Early Squamous Cell Carcinoma in the West: Absolute vs Outside Criteria. Clin Gastroenterol Hepatol. 2026 May 12:S1542-3565(26)00354-X. doi: 10.1016/j.cgh.2026.04.030. Online ahead of print.
Related trials for Adenoma, Villous
RecruitingObservational study
Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla
Adenoma, Villous
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. This study is not recruiting at the moment.
Michael J Bourke, MBBS principal investigator
Western Sydney Local Health District
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 Adenoma, Villous, run by Professor Michael Bourke 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 3 inclusion and 3 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed procedural data (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305290, which also lists 1 linked publication.
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.