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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02306603




Registration number
NCT02306603
Ethics application status
Date submitted
1/12/2014
Date registered
3/12/2014
Date last updated
29/06/2023

Titles & IDs
Public title
Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla
Scientific title
Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla
Secondary ID [1] 0 0
HREC 2014/5/4.3 (3972)
Universal Trial Number (UTN)
Trial acronym
OERDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenoma, Villous 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic Mucosal Resection

Endoscopic Mucosal Resection - Patients who are referred for Endoscopic Mucosal Resection of Duodenal and Ampullary Lesions will be included in this cohort.


Treatment: Surgery: Endoscopic Mucosal Resection
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Analysis of the costs of this procedure compared to previous treatments
Timepoint [1] 0 0
14 days

Eligibility
Key inclusion criteria
* Duodenal and ampullary lesion > 10mm

- Lesion limited to the mucosal and/or submucosal layer (T1 lesion)

- Aged 18 years or older
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital Endoscopy Unit - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02306603
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Bourke, MBBS
Address 0 0
Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathleen Goodrick, BN
Address 0 0
Country 0 0
Phone 0 0
88905555
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02306603