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

Gastric Cancer Clinical Trial

Official title:

A Single Center, Prospective Study on the Possible Range of No.12a Lymph Node Dissection of Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033482
• Other study ID #: E20230548
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Bin Ke, MD
• Phone: +86 022-23340123-1061
• Email: binke[@]tmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Department of Gastric cancer, Tianjin Medical University Cancer Institute & Hospital,	Tianjin	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The lymph node metastasis rates in No.12aa and No.12av groups.	Observation of lymph node metastasis in different No.12a subgroups12 years	100 cases enrolled within 1 year