NCT07183150RecruitingNot Applicable
A Single Center, Prospective Study on the Possible Range of No.4sb Lymph Node Dissection of Locally Advanced Distal Gastric Cancer
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country400 target enrollmentStarted: August 18, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- The lymph node metastasis rates in No.4sb-R, No.4sb-C and No.4d groups.
Study Overview
Brief Summary
The main purpose of this study is to evaluate the reasonable range of No.4sb lymph node dissection of locally advanced distal gastric cancer.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 and ≤ 75 years of age; Preoperative gastric cancer patients with pathologically confirmed; Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16); Willing and able to comply with the program during the study period; Physical condition and organ function allows to tolerable abdominal surgery; Written informed consent provided; Under radical laparoscopic distal subtotal gastrectomy With more than a 6-month life expectancy; No other serious concomitant diseases; Sufficient organ functions; No previous history of chemotherapy or radiotherapy; Clinical stage: T2-4aNxM0; Karnofsky performance status (KPS)>60; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1.
Exclusion Criteria
- •Pregnancy or breast feeding; Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency; Organ transplantation patients need immunosuppressive therapy; Severe recurrent infections were not controlled or with other serious concomitant diseases; Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years; Psychiatric disease which require treatment; Have the history of organ transplantation; Within 6 months before study starts and in the process of this study, patients participate in other clinical researches.
Outcomes
Primary Outcomes
The lymph node metastasis rates in No.4sb-R, No.4sb-C and No.4d groups.
Time Frame: 400 cases enrolled within 3 years
Observation of lymph node metastasis in No.4sb-R, No.4sb-C and No.4d groups.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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