Defining how much No.4sb lymph node to remove for advanced distal stomach cancer
A Single Center, Prospective Study on the Possible Range of No.4sb Lymph Node Dissection of Locally Advanced Distal Gastric Cancer
This project will try to find the best range of No.4sb lymph node removal during surgery for people with locally advanced distal stomach cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT07183150 on ClinicalTrials.gov |
What this trial studies
This observational study at Tianjin Medical University Cancer Hospital follows adults with clinically T2-4a distal gastric cancer who undergo radical laparoscopic distal subtotal gastrectomy (D2, R0). Surgeons will record the precise anatomical extent of No.4sb lymph node dissection, operative details, and perioperative complications. Pathology will report nodal involvement and yield, and investigators will correlate dissection range with patterns of metastasis, surgical morbidity, and early oncologic outcomes. The goal is to identify a reasonable dissection boundary that balances thorough cancer removal with operative safety.
Who should consider this trial
Good fit: Adults 18–75 years old with pathologically confirmed locally advanced distal gastric cancer (clinical T2-4aNxM0) planned for radical laparoscopic distal subtotal gastrectomy (D2, R0), with good performance status (KPS >60 or ECOG 0–1) and no prior chemotherapy or radiotherapy are ideal candidates.
Not a fit: Patients with early-stage or metastatic disease, tumors in other stomach regions, poor performance status, significant uncontrolled comorbidities, prior chemo/radiation, or who are pregnant/breastfeeding are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could help surgeons remove the right amount of tissue to lower complication risk while keeping cancer control strong.
How similar studies have performed: While D2 lymphadenectomy is an established standard and retrospective reports have examined No.4sb metastasis patterns, prospective evidence specifically defining the optimal No.4sb dissection range is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical University Cancer Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Bin Ke, MD.
- Email: binke@tmu.edu.cn
- Phone: +86 022-23340123-1061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.