Cancer of Stomach, Esophageal Neoplasms, Gastric Adenocarcinoma, Gastric Cancer, Gastric Neoplasm, GI Cancer, GIST, Neuroendocrine Tumors, Oesophageal Cancer
Conditions
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
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
Interventions
None listed
Sponsors
Western Sydney Local Health District
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection | 2 weeks | Determined based on clear margins in histology review |
| Safety: intra and post procedural; bleeding; perforation; anaesthetic | 30 day | Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome |
| Long term outcomes: recurrent and residual disease | 3 years | Determined at subsequent procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post ESD, EFTR, STER defect features | 1 day | Determined after complete resection |
| Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives | 6 months | Determined after follow up procedure to confirm no recurrence |
| Patient interviews/questionnaires | 3 years | Determined after follow up procedures |
| Need for more than one endoscopic therapy | 3 years | Determined after follow up procedures |
| Need for surgery | 2 months | Determined after follow up procedures, histological review |
Countries
Australia
Contacts
Primary ContactMichael Bourke
Outcome results
None listed