Adenoma, VillousOERDANCT02306603
Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla
An observational study of Adenoma, Villous, run by Professor Michael Bourke at 1 site in Australia.
Trial summary
This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- 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
- Oct 2014to Apr 2027
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have Duodenal and ampullary adenomas which are amendable to Endoscopic Mucosal Resection
Who may be able to join
- Duodenal and ampullary 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
- Duodenal or ampullary 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. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Westmead Hospital Endoscopy Unit
Sydney, New South Wales, 2145
Clarence Kerrison, MBBS, 88905555, clarence.kerrison@health.nsw.gov.au
Michael J Bourke, MBBS, westmeadendoscopyresearch@gmail.com
About this study
Official title: Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla
This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.
Read the detailed description
Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla 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 duodenum and ampulla.
- 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 Duodenal and Ampullary 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 duodenal and ampullary 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 posted3 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Prospective
- Enrolment
- 200 participants (estimated)
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
- NCT02306603
- Sponsor's protocol ID
- HREC 2014/5/4.3 (3972)
- Acronym
- OERDA
- Status last verified
- Mar 2025
- First submitted
- 1 Dec 2014
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gupta S, Craciun A, Wang H, Whitfield A, Gauci J, O'Sullivan T, Cronin O, Abu Arisha M, Klein A, Lee EYT, Burgess NG, Bourke MJ. Hybrid resection versus conventional resection for laterally spreading lesions of the papilla. Gastrointest Endosc. 2024 Mar;99(3):428-436. doi: 10.1016/j.gie.2023.10.034. Epub 2023 Oct 17.
PubMed 37858758Wang H, Sidhu M, Gupta S, Cronin O, O'Sullivan T, Whitfield A, Burgess NG, Bourke MJ. Cold snare EMR for the removal of large duodenal adenomas. Gastrointest Endosc. 2023 Jun;97(6):1100-1108. doi: 10.1016/j.gie.2023.01.040. Epub 2023 Jan 28.
PubMed 36720290Sidhu M, Fritzsche JA, Klein A, Shahidi N, Vosko S, van Hattem WA, Tate DJ, Bourke MJ. Outcomes of thermal ablation of the defect margin after duodenal endoscopic mucosal resection (with videos). Gastrointest Endosc. 2021 Jun;93(6):1373-1380. doi: 10.1016/j.gie.2020.11.024. Epub 2020 Dec 4.
PubMed 33285144Klein A, Qi Z, Bahin FF, Awadie H, Nayyar D, Ma M, Voermans RP, Williams SJ, Lee E, Bourke MJ. Outcomes after endoscopic resection of large laterally spreading lesions of the papilla and conventional ampullary adenomas are equivalent. Endoscopy. 2018 Oct;50(10):972-983. doi: 10.1055/a-0587-5228. Epub 2018 May 16.
PubMed 29768645
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 of Mucosal and Submucosal Lesions in the Duodenum and Ampulla
- ClinicalTrials.gov ID
- NCT02306603
- Acronym / sponsor ID
- OERDA / HREC 2014/5/4.3 (3972)
- Conditions
- Adenoma, Villous
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Professor Michael BourkeUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 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.
This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.
Detailed description
Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla 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 duodenum and ampulla.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Mucosal Resection | – | Procedure: Endoscopic Mucosal ResectionPatients who are referred for Endoscopic Mucosal Resection of Duodenal and Ampullary Lesions will be included in this cohort. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have Duodenal and ampullary adenomas which are amendable to Endoscopic Mucosal Resection
Key inclusion criteria (3 listed)
- Duodenal and ampullary 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
- Duodenal or ampullary 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: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
Time frame: 14 days
1 secondary outcome
Analysis of the costs of this procedure compared to previous treatments
Time frame: 14 days
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.
- Derived from this study: PubMed 37858758Gupta S, Craciun A, Wang H, Whitfield A, Gauci J, O'Sullivan T, Cronin O, Abu Arisha M, Klein A, Lee EYT, Burgess NG, Bourke MJ. Hybrid resection versus conventional resection for laterally spreading lesions of the papilla. Gastrointest Endosc. 2024 Mar;99(3):428-436. doi: 10.1016/j.gie.2023.10.034. Epub 2023 Oct 17.
- Derived from this study: PubMed 36720290Wang H, Sidhu M, Gupta S, Cronin O, O'Sullivan T, Whitfield A, Burgess NG, Bourke MJ. Cold snare EMR for the removal of large duodenal adenomas. Gastrointest Endosc. 2023 Jun;97(6):1100-1108. doi: 10.1016/j.gie.2023.01.040. Epub 2023 Jan 28.
- Derived from this study: PubMed 33285144Sidhu M, Fritzsche JA, Klein A, Shahidi N, Vosko S, van Hattem WA, Tate DJ, Bourke MJ. Outcomes of thermal ablation of the defect margin after duodenal endoscopic mucosal resection (with videos). Gastrointest Endosc. 2021 Jun;93(6):1373-1380. doi: 10.1016/j.gie.2020.11.024. Epub 2020 Dec 4.
- Derived from this study: PubMed 29768645Klein A, Qi Z, Bahin FF, Awadie H, Nayyar D, Ma M, Voermans RP, Williams SJ, Lee E, Bourke MJ. Outcomes after endoscopic resection of large laterally spreading lesions of the papilla and conventional ampullary adenomas are equivalent. Endoscopy. 2018 Oct;50(10):972-983. doi: 10.1055/a-0587-5228. Epub 2018 May 16.
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 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: 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, MBBS (88905555, michael@citywestgastro.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes (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 NCT02306603, which also lists 4 linked publications.
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.