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

NCT06033482 | Unknown

• 1 other identifier: E20230548
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

The reasonable range of No.12a lymph node dissection PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients with advanced gastric cancer，underwent radical laparoscopic distal gastrectomy. Observation of lymph node metastasis in different No.12a subgroups.

You may qualify if:

• ≥ 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.

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)

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

Tianjin, None Selected, 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

Study Officials

• Bin Ke, MD

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

  STUDY DIRECTOR

• Peng Ru Zhang, MD

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

  STUDY DIRECTOR

Central Study Contacts

Bin Ke, MD

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: June 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)