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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05804331
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Western Sydney Local Health District
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael Bourke
Principal Investigator Affiliation WSLHD
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cancer of Stomach, Oesophageal Cancer, Gastric Cancer, Gastric Adenocarcinoma, GI Cancer, GIST, Neuroendocrine Tumors, Gastric Neoplasm, Esophageal Neoplasms
Additional Details

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

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Westmead Hospital, Sydney, New South Wales, Australia

Status

Recruiting

Address

Westmead Hospital

Sydney, New South Wales, 2145

Site Contact

Kathleen Goodrick

[email protected]

02 8890 5555

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