A Single Center Randomized Prospective Study on the Criteria for Lymph Node Sorting for Pathological Examination After Curative Surgery for Gastric Cancer

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country276 target enrollmentApril 1, 2018

ConditionsLymph Node Metastases Gastric Cancer Exanimation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lymph Node Metastases
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 276
Locations: 1
Primary Endpoint: Migration of pN stage in gastric cancer patients
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is intending to provide the optimal procedures of lymph node sorting for pathological examination after curative surgery for gastric cancer, which can discriminate the differences of the status of lymph node metastasis, pTNM classification and prognostic outcome of gastric cancer patients.

Registry

clinicaltrials.gov

Start Date

April 1, 2018

End Date

December 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Physical conditions compliance with the requirements for curative gastrectomy
•Consent to undergo the D2 lymphadenectomy
•Comply with the protocol during the whole study period
•No neoadjuvant therapy administration
•Sign informed consent and permission of withdraw in the whole study period
•Consent to provide the tissue specimens after surgery for this study
•Pathological examination confirmation the adenocarcinoma of stomach before surgery
•Estimation the overall survival after surgery no less than 6 months
•No anesthesia or operation contraindication disease
•cTanyNanyM0 stage demonstration by CT and endoscopic ultrasonography examinations

Exclusion Criteria

•Women during pregnant stage and breast-feed stage
•Women of childbearing age without any contraceptive measures
•Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
•Immunosuppressive therapists for organ transplantation
•Seriously uncontrolled recurrent infection
•other malignant tumors
•No abilities of self-knowledge or mental disorders
•Participating in other clinical trials
•Siewert I and II esophagogastric junction tumors
•Serious internal diseases obstruction surgery

Outcomes

Primary Outcomes

Migration of pN stage in gastric cancer patients

Time Frame: 60 months

According to the overall survival of all included patients, we will evaluate the optimal lymph node sorting method to obtain the accurately pathological stage of lymph node metastatic counts (pN stage) for prediction the prognosis of patients after curative surgery for gastric cancer.