The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study (ANZ UGI)

Western Sydney Local Health District

Status: Enrolling

Conditions: Oesophageal Cancer; GI Cancer; Gastric Cancer; Gastric Neoplasm; Neuroendocrine Tumors; Cancer of Stomach; Esophageal Neoplasms; GIST; Gastric Adenocarcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT05804331

2022/PID02709

Details and patient eligibility

About

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

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Patient with Gastrointestinal neoplasm

Description:

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