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

T

Tianjin Medical University

Status

Unknown

Conditions

Lymph Node Metastases
Gastric Cancer
Exanimation

Treatments

Procedure: lymph node sorting for pathological examination

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

276 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

276 participants in 2 patient groups

Fine sorting lymph node group
Experimental group
Treatment:
Procedure: lymph node sorting for pathological examination
Regional sorting lymph node group
No Intervention group

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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