NIPH Clinical Trials Search

Prospective feasibility study of HYBRIDknifeflex-assisted gastric ESD using Gas-free Immersion and Flow-Assisted Coagulation

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Gastric adenoma and early gastric cancer indicated for endoscopic submucosal dissection (ESD)
Date of first enrollment	2026/06/22
Target sample size	50
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	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. The study prospectively evaluates the feasibility, safety, and procedural efficiency of this strategy.

Outcome(s)

Primary Outcome	Dissection speed (mm2min)
Secondary Outcome	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

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	100years-old
Gender	Male and Female
Include 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.
Exclude 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.