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

NCT05804331 | Recruiting

• 1 other identifier: 2022/PID02709
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

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

  Determined based on clear margins in histology review

  2 weeks

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

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

  30 day

• Long term outcomes: recurrent and residual disease

  Determined at subsequent procedures

  3 years

Secondary Outcomes (5)

• Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives

  6 months

• Need for more than one endoscopic therapy

  3 years

• Need for surgery

  2 months

• Post ESD, EFTR, STER defect features

  1 day

• Patient interviews/questionnaires

  3 years

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to tertiary centre for endoscopic resection of gastrointestinal neoplasm

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Study Sites (1)

Westmead Hospital

Sydney, New South Wales, 2145, Australia

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms; Gastrointestinal Neoplasms; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Study Officials

• Michael Bourke

  WSLHD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Bourke

CONTACT

02 8890 5555; michael@citywestgastro.com.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: April 7, 2023
• Study Start: March 14, 2023
• Primary Completion (Estimated): March 14, 2028
• Study Completion (Estimated): September 14, 2028
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

AU (1)