Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
To collect prospective observational data on patients undergoing ESD, EFTR or STER for UGI neoplastic lesions
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives | Determined after follow up procedure to confirm no recurrence | 6 months |
| Need for more than one endoscopic therapy |
Not provided
Inclusion Criteria:
UGI neoplastic lesions > 10mm
Aged 18 years or older
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients referred to tertiary centre for endoscopic resection of gastrointestinal neoplasm
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Bourke | Contact | 02 8890 5555 | michael@citywestgastro.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Michael Bourke | WSLHD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Hospital | Recruiting | Sydney | New South Wales | 2145 | Australia |
Not provided
Not provided
Not provided
Not provided
Determined after follow up procedures
| 3 years |
| Need for surgery | Determined after follow up procedures, histological review | 2 months |
| Post ESD, EFTR, STER defect features | Determined after complete resection | 1 day |
| Patient interviews/questionnaires | Determined after follow up procedures | 3 years |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided