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

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

NCT ID: NCT05804331

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

Conditions: Official terms:
Neoplasms
Stomach Neoplasms
Neuroendocrine Tumors
Esophageal Neoplasms

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

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

Detailed 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

Criteria for eligibility:

Study pop:
Patients referred to tertiary centre for endoscopic resection of gastrointestinal neoplasm

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Westmead Hospital

Address:
City: Sydney
Zip: 2145
Country: Australia

Status: Recruiting

Contact:
Last name: Kathleen Goodrick
Email: kathleen.goodrick@health.nsw.gov.au

Start date: March 14, 2023

Completion date: September 14, 2028

Lead sponsor:
Agency: Western Sydney Local Health District
Agency class: Other

Source: Western Sydney Local Health District

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05804331