The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study

Gastric Cancer Clinical Trial

— ANZ UGI  

Official title:

The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804331
• Other study ID #: 2022/PID02709
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cancer of Stomach
• Esophageal Neoplasms
• Gastric Adenocarcinoma
• Gastric Cancer
• Gastric Neoplasm
• GI Cancer
• GIST
• Neoplasms
• Neuroendocrine Tumors
• Oesophageal Cancer
• Stomach Neoplasms

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