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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02306707




Registration number
NCT02306707
Ethics application status
Date submitted
1/12/2014
Date registered
3/12/2014
Date last updated
5/07/2019

Titles & IDs
Public title
Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Stomach
Scientific title
Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Stomach.
Secondary ID [1] 0 0
HREC2014/5/4.1 (3970)
Universal Trial Number (UTN)
Trial acronym
OERS
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 Stomach 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 - Perform cost-utility analyses comparing different treatment approaches for stomach lesions
Timepoint [1] 0 0
14 days

Eligibility
Key inclusion criteria
- Stomach 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Lesion less than 10mm

- Stomach 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
A patient referred to have a lesion in the stomach removed. The aims of this study are to
collect information on the technique of endoscopic removal of such lesions. By collecting
information on a large number of patients undergoing this procedure the investigators can
determine the best ways of diagnosing and removing these lesions safely and effectively.
Trial website
https://clinicaltrials.gov/show/NCT02306707
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
Rebecca Sonson, BN
Address 0 0
Country 0 0
Phone 0 0
98455555
Fax 0 0
Email 0 0
Rebecca.Sonson@health.nsw.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02306707