The Criteria for Lymph Node Sorting for Pathological Examination in Gastric Cancer

Not Applicable

• Conditions: Gastric Cancer; Exanimation; Lymph Node Metastases
• Interventions: Procedure: lymph node sorting for pathological examination

• Registration Number: NCT03478449
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-27
• Study Start: 2018-04-01
• Status Verified: 2020-11
• Primary Completion: 2020-11-02
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-13
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• 1. Physical conditions compliance with the requirements for curative gastrectomy
• 2. Consent to undergo the D2 lymphadenectomy
• 3. Comply with the protocol during the whole study period
• 4. No neoadjuvant therapy administration
• 5. Sign informed consent and permission of withdraw in the whole study period
• 6. Consent to provide the tissue specimens after surgery for this study
• 7. Pathological examination confirmation the adenocarcinoma of stomach before surgery
• 8. Estimation the overall survival after surgery no less than 6 months
• 9. No anesthesia or operation contraindication disease
• 10. cTanyNanyM0 stage demonstration by CT and endoscopic ultrasonography examinations
• 11. Negative cytological detection in operation
• 12. No seriously concomitance's diseases
• 13. Karnofsky Performance Scores (KPS) more than 60

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fine sorting lymph node group	lymph node sorting for pathological examination	-

Primary Outcome Measures

Name	Time	Method
Migration of pN stage in gastric cancer patients	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.

Trial Locations

Locations (1)

Cancer Hospital of Tianjin Medical University; 🇨🇳 Tianjin, China