Gastric adenoma and early gastric cancer indicated for endoscopic submucosal dissection (ESD)
Conditions
Interventions
Gastric ESD will be performed using HYBRIDknifeflex under the Gas-free Immersion (GFI) system. Flow-Assisted Coagulation (FAC) will be used for prophylactic coagulation and hemostasis when appropriate
Sponsors
Suzuka General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 to 100 years. 2. Patients with gastric adenoma, early gastric cancer, or gastric epithelial neoplasms suspected of early gastric cancer. 3. Patients judged to be indicated for gastric ESD according to clinical practice and relevant guidelines. 4. Patients scheduled to undergo gastric ESD during hospitalization. 5. Patients who provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients for whom surgical treatment is considered more appropriate. 2. Patients with severe comorbidities precluding safe endoscopic treatment or sedation. 3. Patients with severe coagulation disorders or other conditions that make ESD unsafe. 4. Pregnant women or patients suspected of being pregnant. 5. Patients judged inappropriate for participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dissection speed (mm2min) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Procedure time 2. Resection time 3. Injection time 4. Hemostasis time 5. Number of intraoperative bleeding events 6. Total bleeding duration 7. Volume of injection solution 8. Number of hemostatic forceps uses 9. En bloc resection rate 10. R0 resection rate 11. Intraoperative perforation 12. Delayed bleeding 13. PECS 14. Aspiration pneumonia | — |
Countries
Japan
Contacts
Public ContactTatsuma Nomura
Suzuka General Hospital Department of Gastroenterology
Outcome results
None listed