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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05804331
Other study ID # 2022/PID02709
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 14, 2023
Est. completion date September 14, 2028

Study information

Verified date March 2023
Source Western Sydney Local Health District
Contact Kathleen Goodrick
Phone 02 8890 5555
Email kathleen.goodrick@health.nsw.gov.au
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Description:

To collect prospective observational data on patients undergoing ESD, EFTR or STER for UGI neoplastic lesions - Lesion characteristics including histology - Procedural outcomes - Safety Outcomes - Efficacy outcomes


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date September 14, 2028
Est. primary completion date March 14, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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


Locations

Country Name City State
Australia Westmead Hospital Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Western Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection Determined based on clear margins in histology review 2 weeks
Primary Safety: intra and post procedural; bleeding; perforation; anaesthetic Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome 30 day
Primary Long term outcomes: recurrent and residual disease Determined at subsequent procedures 3 years
Secondary Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives Determined after follow up procedure to confirm no recurrence 6 months
Secondary Need for more than one endoscopic therapy Determined after follow up procedures 3 years
Secondary Need for surgery Determined after follow up procedures, histological review 2 months
Secondary Post ESD, EFTR, STER defect features Determined after complete resection 1 day
Secondary Patient interviews/questionnaires Determined after follow up procedures 3 years
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