Submucosal tumour of the stomach
Conditions
Interventions
Conventional SMIS Surgery Group:Conventional SMIS surgery (using standard multi-instrument mode)
All In One Electrosurgical Loop Knife SMIS Group:SMIS surgery using All In One single-use electrosurgical loop knife
Sponsors
The First Medical Centre of the PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and < 80 years, without restriction on gender. 2. Gastric gastrointestinal stromal tumour <= 1.5 cm. 3. Meeting surgical indications for SMIS. 4. Normal preoperative coagulation function, complete blood count, and biochemical parameters. 5. Absence of surgical contraindications. 6. Patient and family members understand the study protocol, voluntarily participate in this research, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participation in other clinical studies within the four weeks preceding enrolment in this study 2. Pregnant or lactating women, or female patients planning pregnancy during the study period 3. Subjects with poor physical condition due to severe cardiovascular disease, or other serious respiratory, haematological, hepatic, renal, or gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis) 4. Any of the following abnormal laboratory findings at screening: (1) AST or ALT > 2 times the upper limit of normal (ULN) (2) Total bilirubin > 2 times ULN (3) Creatinine > 2 times ULN 5. Electrocardiogram (ECG) abnormalities including: severe arrhythmia, multifocal ventricular premature contractions (PVCs), second-degree or higher atrioventricular block 6. History of upper gastrointestinal resection 7. Any other reason deemed by the investigator to render the subject unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| En bloc resection rate;R0 resection rate;Total operative time;Core resection time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative hospital stay duration; | — |
Countries
China
Contacts
Public ContactLinghu Enqiang
The First Medical Centre of the PLA General Hospital
Outcome results
None listed