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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/NCT02305290




Registration number
NCT02305290
Ethics application status
Date submitted
30/07/2014
Date registered
2/12/2014
Date last updated
29/06/2023

Titles & IDs
Public title
Upper GI Outcomes Following EMR
Scientific title
Outcomes of Endoscopic Resection in the Upper Gastrointestinal Tract
Secondary ID [1] 0 0
HREC2014/7/4.6 (4033)
Universal Trial Number (UTN)
Trial acronym
UGI-EMR
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 Upper Gastrointestinal 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
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
- UGIT lesion > 10mm

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

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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

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

Ethics approval
Ethics application status

Summary
Brief 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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT02305290
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
kathleen.goodrick@health.nsw.gov.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02305290