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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWestern Sydney Local Health District

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients referred to tertiary centre for endoscopic resection of gastrointestinal neoplasm

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: Patient with Gastrointestinal neoplasm

Trial outcomes

Primary outcomes

1

Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection

Determined based on clear margins in histology review

Time frame
2 weeks
2

Safety: intra and post procedural; bleeding; perforation; anaesthetic

Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome

Time frame
30 day
3

Long term outcomes: recurrent and residual disease

Determined at subsequent procedures

Time frame
3 years

Secondary outcomes

1

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

Time frame
6 months
2

Need for more than one endoscopic therapy

Determined after follow up procedures

Time frame
3 years
3

Need for surgery

Determined after follow up procedures, histological review

Time frame
2 months
4

Post ESD, EFTR, STER defect features

Determined after complete resection

Time frame
1 day

Other outcomes

Sponsors and contacts

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