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 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT04164095
Eligibility Criteria:
Inclusion Criteria:
1. 18 years old \< age \< 75 years old;
2. primary gastric lesions were diagnosed as gastric adenocarcinoma by biopsy;
3. the preoperative clinical stage was T1N0M0 according to ajcc-7thtnm;
4. it is predicted that R0 can be obtained by pylorogastric gastrectomy and D1 + lymph node dissection;
5. preoperative ECoG physical state score 0 / 1;
6. preoperative ASA score I-III;
7. informed consent of patients.
Exclusion Criteria:
1. pregnant or lactating women; suffering from serious mental illness;
2. the history of upper abdominal surgery (except laparoscopic cholecystectomy);
3. history of gastric surgery (including ESD / EMR for gastric cancer);
4. preoperative imaging examination showed regional enlarged lymph nodes;
5. having other malignant diseases within 5 years;
6. patients with gastric cancer who have received new adjuvant therapy or recommended new adjuvant therapy;
7. there was a history of unstable angina or myocardial infarction within 6 months;
8. have a history of cerebral infarction or cerebral hemorrhage within 6 months;
9. there was a history of continuous systemic corticosteroid therapy within 1 month;
10. simultaneous surgical treatment of other diseases is needed;
11. gastric cancer with complications (hemorrhage, perforation, obstruction) requires emergency surgery;
12. FEV1 of pulmonary function examination was less than 50% of the predicted value.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04164095
Study Brief:
Protocol Section:
NCT04164095