The Possible Range of No.4sb Lymph Node Dissection of Locally Advanced Distal Gastric Cancer

NCT ID: NCT07183150

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2027-12-30

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.

Conditions

Gastric Cancer (GC); No.4sb

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The reasonable range of No.4sb lymph node dissection

The No.4sb lymph node divided into the lymph nodes on the root of left gastric omentum vessels (No.4sb-R) and the lymph nodes on the greater curvature side (No.4sb-C). Observation of lymph node metastasis rates in two groups.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bin Ke, MD.

Role: CONTACT

binke@tmu.edu.cn

+86 022-23340123-1061

Peng Ru Zhang, MD.

Role: CONTACT

kebinchina@163.com

+86 022-23340123-1061

Facility Contacts

Bin Ke, MD.

Role: primary

binke@tmu.edu.cn

+86 13622036809

Other Identifiers

E20250853

Identifier Type: -

Identifier Source: org_study_id