Exanimation, Gastric Cancer, Lymph Node Metastases
Conditions
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.
Interventions
PROCEDURElymph node sorting for pathological examination
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.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed