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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lymph Node Metastases, Gastric Cancer, Exanimation

Intervention / Treatment
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* Procedure: lymph node sorting for pathological examination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fine sorting lymph node group<br> | Procedure: lymph node sorting for pathological examination<br>* In this study, intervention methods include two kinds of lymph node sorting for pathological examination in gastric cancer samples after curative surgery. One is the fine sorting lymph nodes, representing the lymph nodes should be sorted one by one from the tissues around the stomach, celiac axis, and the main brunches of celiac axis. The other is the group sorting lymph nodes, representing the lymph nodes should be simply sorted in the soft tissues around the stomach, celiac axis, and the main brunches of celiac axis.<br>|
| No Intervention: Regional sorting lymph node group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migration of pN stage in gastric cancer patients | 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. | 60 months |