Duodenal AdenomaDuoP-ERNCT07781137
Analysis of Long-term Outcomes of Endoscopic Resection of Duodenal and Ampullary Mucosal and Submucosal Lesions
An observational study of Duodenal Adenoma and Duodenal Carcinoma, run by Western Sydney Local Health District at 1 site in Australia.
Trial summary
Mucosal and submucosal lesions of the duodenum represent a diverse group of pathologies, ranging from benign adenomas to lesions with significant malignant potential. Endoscopic resection has emerged as a minimally invasive approach; however, the success rates, recurrence patterns, and long-term outcomes remain poorly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Adenoma, Duodenal Carcinoma, Papillary Adenoma
- How many people
- 1,000 participants
- Where
- 1 siteAustralia
- Study dates
- 23 May 2025to Jan 2030
- 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: This study will be conducted at a tertiary referral centre specialising in endoscopic therapy in the duodenum and ampulla. Identifying patients: Participants will be sourced through the current electronic documentation system, utilising the following methods: Provation (endoscopic reporting software) key search for key terms related to: * Duodenal polyp(s) * Duodenal lesion * Duodenal SEL * Duodenal submucosal lesion * Duodenal EMR * Duodenal ESD * Papillectomy * Ampullectomy Electronic referral pathway for endoscopic retrograde cholangiopancreatogram (ERCP) at Westmead Hospital for indications showing: * Duodenal polyp(s) * Duodenal lesion * Duodenal EMR * Duodenal ESD * Papillectomy * Ampullectomy
Who may be able to join
- Age greater than 18
- Mucosal or submucosal lesion in the duodenum or ampulla with endoscopic resection performed at Westmead hospital Endoscopic resection occurred between January 2010 to March 2025
Who cannot join
- Age less than 18
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 Endoscopy, Westmead hospital, Western Sydney Local Health District
Sydney, New South Wales
Clarence Kerrison, MBChB, MBiomedSc, FRACP, +61413361347, clarence.kerrison@health.nsw.gov.au
About this study
Official title: Retrospective Analysis of Long-term Outcomes of Endoscopic Resection of Duodenal and Ampullary Mucosal and Submucosal Lesions
Mucosal and submucosal lesions of the duodenum represent a diverse group of pathologies, ranging from benign adenomas to lesions with significant malignant potential. Endoscopic resection has emerged as a minimally invasive approach; however, the success rates, recurrence patterns, and long-term outcomes remain poorly defined due to the heterogeneity of these lesions. This study aims to retrospectively evaluate the endoscopic management and long-term outcomes of patients who underwent endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla over a 15-year period. The investigators aim to assess key procedural outcomes, including complete resection rates, recurrence, complication rates, recurrence and morbidity and mortality of duodenal or ampullary malignancy. By analysing these factors, the investigators hope to better understand the role of endoscopic therapy in managing these challenging lesions and identify predictors of long-term success. This data will help guide future practice and optimize surveillance strategies for patients undergoing endoscopic resection in this complex anatomical region.
Primary Objective
Read more
- To evaluate the effectiveness of endoscopic resection of mucosal and submucosal lesions (MSML) in the duodenum and ampulla.
- To assess the safety profile of the procedure.
- To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy.
Secondary Objectives
- Diagnostic yield of endoscopic surveillance post endoscopic resection
- Requirements for surgery
- Conditions
- Duodenal Adenoma, Duodenal Carcinoma, Papillary Adenoma, Papillary Adenocarcinoma, Endoscopic Mucosal Resection
- Medical subject headings
- Duodenal Neoplasms, Adenoma, Adenocarcinoma, Papillary
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the recurrence rate of endoscopic resection of mucosal and submucosal lesions in the duodenum and papilla
Measured: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
To assess duodenal and ampulla endoscopic resection procedure adverse event rates
Measured: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy.
Measured: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
Secondary outcomes (1)
Requirements for surgery
Rate of surgery
Measured: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start23 May 2025
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal AdenomaStudies 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
- 1,000 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781137
- Sponsor's protocol ID
- 2025/PID00692 2025/ETH00587
- Acronym
- DuoP-ER
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and Data dictionary
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Long-term Outcomes of Endoscopic Resection of Duodenal and Ampullary Mucosal and Submucosal Lesions
- ClinicalTrials.gov ID
- NCT07781137
- Acronym / sponsor ID
- DuoP-ER / 2025/PID00692 2025/ETH00587
- Conditions
- Duodenal Adenoma, Duodenal Carcinoma, Papillary Adenoma, Papillary Adenocarcinoma, Endoscopic Mucosal Resection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 24 Aug 2026 (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.
Mucosal and submucosal lesions of the duodenum represent a diverse group of pathologies, ranging from benign adenomas to lesions with significant malignant potential. Endoscopic resection has emerged as a minimally invasive approach; however, the success rates, recurrence patterns, and long-term outcomes remain poorly defined due to the heterogeneity of these lesions. This study aims to retrospectively evaluate the endoscopic management and long-term outcomes of patients who underwent endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla over a 15-year period. The investigators aim to assess key procedural outcomes, including complete resection rates, recurrence, complication rates, recurrence and morbidity and mortality of duodenal or ampullary malignancy. By analysing these factors, the investigators hope to better understand the role of endoscopic therapy in managing these challenging lesions and identify predictors of long-term success. This data will help guide future practice and optimize surveillance strategies for patients undergoing endoscopic resection in this complex anatomical region.
Primary Objective
- To evaluate the effectiveness of endoscopic resection of mucosal and submucosal lesions (MSML) in the duodenum and ampulla.
- To assess the safety profile of the procedure.
- To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy.
Secondary Objectives
- Diagnostic yield of endoscopic surveillance post endoscopic resection
- Requirements for surgery
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted at a tertiary referral centre specialising in endoscopic therapy in the duodenum and ampulla. Identifying patients: Participants will be sourced through the current electronic documentation system, utilising the following methods: Provation (endoscopic reporting software) key search for key terms related to: * Duodenal polyp(s) * Duodenal lesion * Duodenal SEL * Duodenal submucosal lesion * Duodenal EMR * Duodenal ESD * Papillectomy * Ampullectomy Electronic referral pathway for endoscopic retrograde cholangiopancreatogram (ERCP) at Westmead Hospital for indications showing: * Duodenal polyp(s) * Duodenal lesion * Duodenal EMR * Duodenal ESD * Papillectomy * Ampullectomy
Key inclusion criteria (2 listed)
- Age greater than 18
- Mucosal or submucosal lesion in the duodenum or ampulla with endoscopic resection performed at Westmead hospital Endoscopic resection occurred between January 2010 to March 2025
Key exclusion criteria (1 listed)
- Age less than 18
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
To evaluate the recurrence rate of endoscopic resection of mucosal and submucosal lesions in the duodenum and papilla
Time frame: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
To assess duodenal and ampulla endoscopic resection procedure adverse event rates
Time frame: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy.
Time frame: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
1 secondary outcome
Requirements for surgery
Time frame: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
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 24 Aug 2026.
- Individual participant dataSharing planned: Yes. Study protocol and Data dictionary
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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.
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 Duodenal Adenoma and Duodenal Carcinoma, 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 2 inclusion and 1 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 24 Aug 2026. 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 Clarence Kerrison, MBChB, MBiomedSc, FRACP (+61413361347, clarence.kerrison@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the recurrence rate of endoscopic resection of mucosal and submucosal lesions in the duodenum and papilla (time frame: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)). 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 24 Aug 2026.