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

NCT ID: NCT06033482

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-12-31

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.

Conditions

Gastric Cancer; No.12a Lymph Node Dissection

Study Design

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

Interventions

The reasonable range of No.12a lymph node dissection

The lymph node overlying the proper hepatic artery is defined as No.12aa. The lymph node overlying the left side of the portal vein is defined as No.12av. Observation of lymph node metastasis rates in two groups.

Intervention Type: PROCEDURE

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: 75 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

Principal Investigators

Bin Ke, MD

Role: STUDY_DIRECTOR

Department of Gastric cancer, Tianjin Medical University Cancer Institute & Hospital

Peng Ru Zhang, MD

Role: STUDY_DIRECTOR

Department of Gastric cancer, Tianjin Medical University Cancer Institute & Hospital

Locations

Department of Gastric cancer, Tianjin Medical University Cancer Institute & Hospital,

Tianjin, None Selected, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bin Ke, MD

Role: CONTACT

binke@tmu.edu.cn

+86 022-23340123-1061

Facility Contacts

Bin Ke, md

Role: primary

binke@tmu.edu.cn

Other Identifiers

E20230548

Identifier Type: -

Identifier Source: org_study_id