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

NCT07183150 | Recruiting

• 1 other identifier: E20250853
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The lymph node metastasis rates in No.4sb-R, No.4sb-C and No.4d groups.

  Observation of lymph node metastasis in No.4sb-R, No.4sb-C and No.4d groups.

  400 cases enrolled within 3 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

400 patients with advanced gastric cancer，underwent radical laparoscopic distal gastrectomy. Observation of lymph node metastasis in different No.4sb subgroups.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Bin Ke, MD.

CONTACT

+86 022-23340123-1061; binke@tmu.edu.cn

Peng Ru Zhang, MD.

CONTACT

+86 022-23340123-1061; kebinchina@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 19, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): August 17, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-08

Locations

CN (1)