Gastric submucosal tumors
Conditions
Interventions
Trial group:Implement FASTER system-assisted EFTR
Control group:Implement standard EFTR
Sponsors
Zhongshan Hospital affiliated to Fudan University; Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age >= 18 and <= 80 years; (2) Normal body temperature prior to surgery; (3) Preoperative assessments (including gastroscopy, endoscopic ultrasound, CT, and MRI) confirm suitability for EFTR; (4) Preoperative evaluation indicates a submucosal tumor originating from the gastric muscularis propria, with a maximum diameter <5 cm; (5) Absence of other organic diseases of the stomach and colorectum; (6) Single lesion to be resected in one EFTR procedure; (7) The patient and family members are capable of understanding the study protocol, willing to participate in the study, and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: (1) Age 80 years; (2) Immunocompromised individuals, or those who undergoing treatment with immunosuppressive agents; (3) Patients with concurrent organic diseases of the stomach and colorectum; (4) Patients with a history of gastric surgery that may affect postoperative outcomes; (5) Pregnant or lactating women; (6) Patients with conditions such as severe emphysema, interstitial pneumonia, or ischemic heart disease who cannot tolerate anesthesia and surgery; (7) Patients with contraindications to EFTR; (8) Patients or family members are unable to understand the conditions and objectives of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure time; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Resection time;Closure time;Incidence of postoperative delayed perforation;Incidence of postoperative delayed bleeding;Incidence of postoperative infection;Incidence of postoperative electrocoagulation syndrome;Incidence of postoperative gas-related complications; | — |
Countries
China
Contacts
Public ContactZhong Yunshi
Zhongshan Hospital affiliated to Fudan University; Shanghai Xuhui Central Hospital
Outcome results
None listed