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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/NCT05804331




Registration number
NCT05804331
Ethics application status
Date submitted
12/03/2023
Date registered
7/04/2023
Date last updated
7/04/2023

Titles & IDs
Public title
The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
Scientific title
The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
Secondary ID [1] 0 0
2022/PID02709
Universal Trial Number (UTN)
Trial acronym
ANZ UGI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer of Stomach 0 0
Oesophageal Cancer 0 0
Gastric Cancer 0 0
Gastric Adenocarcinoma 0 0
GI Cancer 0 0
GIST 0 0
Neuroendocrine Tumors 0 0
Gastric Neoplasm 0 0
Esophageal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patient with Gastrointestinal neoplasm - Pt referred for resection of gastrointestinal neoplasm. Observational data collected from endoscopic submucosal dissection (ESD), submucosal-tunnelling endoscopic resection (STER) or endoscopic full-thickness resection (EFTR) of gastrointestinal neoplasm
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection
Timepoint [1] 0 0
2 weeks
Primary outcome [2] 0 0
Safety: intra and post procedural; bleeding; perforation; anaesthetic
Timepoint [2] 0 0
30 day
Primary outcome [3] 0 0
Long term outcomes: recurrent and residual disease
Timepoint [3] 0 0
3 years
Secondary outcome [1] 0 0
Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Need for more than one endoscopic therapy
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Need for surgery
Timepoint [3] 0 0
2 months
Secondary outcome [4] 0 0
Post ESD, EFTR, STER defect features
Timepoint [4] 0 0
1 day
Secondary outcome [5] 0 0
Patient interviews/questionnaires
Timepoint [5] 0 0
3 years

Eligibility
Key inclusion criteria
- UGI neoplastic lesions > 10mm

- Lesions for ESD limited to the mucosal and/or submucosal layer OR

- Lesions for EFTR limited to the muscularis propria layer OR

- Lesions for STER limited to the submucosal and/or muscularis propria layer

- 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
- Age less than 18

- Unable to give informed consent

- Pregnant or lactating patients

- Patients with bleeding diathesis or who cannot discontinue ADP blockers (e.g.
clopidogrel, prasugrel) or antithrombotics (e.g. warfarin, dabigatran)
periprocedurally

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
14/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/09/2028
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic
Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for
upper gastrointestinal neoplastic lesions
Trial website
https://clinicaltrials.gov/ct2/show/NCT05804331
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke
Address 0 0
WSLHD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathleen Goodrick
Address 0 0
Country 0 0
Phone 0 0
02 8890 5555
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/NCT05804331