The Possible Range of No.12a Lymph Node Dissection of Locally Advanced Gastric Cancer

Recruiting

• Conditions: Gastric Cancer; No.12a Lymph Node Dissection

• Registration Number: NCT06033482
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

The main purpose of this study is to evaluate the reasonable range of No.12a lymph node dissection of locally advanced gastric cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-05
• Last Update Submitted: 2023-09-05
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The lymph node metastasis rates in No.12aa and No.12av groups.	100 cases enrolled within 1 year	Observation of lymph node metastasis in different No.12a subgroups12 years

Trial Locations

Locations (1)

Department of Gastric cancer, Tianjin Medical University Cancer Institute & Hospital,; 🇨🇳 Tianjin, None Selected, China