Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT07260461
Eligibility Criteria:
Inclusion Criteria:
1. Aged from 18 to 75 years old;
2. Histologically confirmed proximal gastric adenocarcinoma, CT1-2N0M0 stage;
3. The tumor was located in the proximal third of the stomach.
4. ECOG score of 0 or 1;
5. D1+ or D2 dissection according to guidelines (depending on tumor location and intraoperative evaluation).
6. ASA grade I to III;
7. The preoperative nutritional status of the patients was good without severe malnutrition.
8. Voluntarily sign informed consent.
Exclusion Criteria:
1. Concurrent with other active malignant tumors, or a history of other malignant tumors within 5 years (excluding basal cell carcinoma of the skin and carcinoma in situ of the cervix);
2. Severe cardiovascular diseases: such as NYHA class Ⅲ and above cardiac dysfunction, recent myocardial infarction (within 6 months), refractory hypertension or arrhythmia;
3. Severe respiratory diseases: severe impairment of lung function (FEV1%\<50%) or chronic respiratory failure;
4. Severe liver and kidney dysfunction: ALT/AST \> 3 times the upper limit of normal, or eGFR \< 30 mL/min/1.73m²;
5. patients complicated with other major chronic diseases, such as active tuberculosis, rheumatoid, systemic lupus erythematosus and other autoimmune diseases that affect surgical tolerance;
6. Tumor imaging suggested the presence of distant metastasis (M1) or regional lymph node involvement, and the tumor was unresectable.
7. Complicated with other upper gastrointestinal diseases, such as active gastric ulcer, pyloric obstruction, persistent bleeding, which seriously affect the operation;
8. Previous major gastric or upper abdominal surgery (such as subtotal gastrectomy, esophagogastric anastomosis, etc.) affecting the reconstruction method;
9. Received preoperative neoadjuvant chemoradiotherapy or targeted therapy (unless specifically permitted by the study design);
10. Pregnant or lactating women;
11. Patients with mental disorders, cognitive impairment, poor compliance, inability to understand the study content, or inability to cooperate with the follow-up;
12. Severe malnutrition before surgery: BMI \< 16 kg/m² or albumin \< 25 g/L;
13. Other individual conditions deemed unsuitable for enrollment by the investigator (e.g., poor willingness to cooperate, high risk of loss to follow-up, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
75 Years
Study:
NCT07260461
Study Brief:
Protocol Section:
NCT07260461