In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric cancer in advanced gastric cancer (stage IB/IIA/IIB ).
■ Background of Hypothesis A. JCOG (Japanese Clinical Oncology Group) 9501 Study : Addition of aorta lymph node dissection to D2 lymph node dissection does not increase survival rate. Wide range of operation is not always the best treatment. If invasion rate can be kept as minimal as possible while maintaining survival rate, it can lead to more secure operation while also reducing the frequency of complication after the surgery. 20 It may be advantageous for patients in terms of operation time, cost, and quality of life. B. COACT 1001 study A previous study which compared the feasibility of lymph node dissection in open surgery and lapraroscopic surgery for advanced gastric cancer. 11p, 12a lymph node (D2) resection rate: 79.2% and 88.8% respectively in all advance gastric cancer. 11p, 12a lymph node (D2) metastasis rate: 1.9% and 2.9% respectively. Subgroup analysis 11p, 12a lymph node resection in cStage IB/IIA: 74.5-80.0% and 86.7-96.1% respectively. : 0% metastasis rate for both. lymph node dissection in cStage IIB/IIIA: 81.1-82.3% and 87.5-89.2% respectively.: metastasis rates are 2.1% and 2.4-12.1% respectively. Application: 11p and 12a lymph nodes, which belong in D2 lymph nodes, need to be resected in advance gastric cancer in IIB stage or higher. However, in earlier stages of advance gastric cancer, the probability of metastasis is very low; therefore, resection of D1+ lymph nodes, excluding 11p and 12a, is enough.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,880
D2 includes Nos.1.3,4sb,4d,5,6,7,8a,9,11p,and 12a nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
D1+ includes Nos.1,3,4sb,4d,5,6,7,8a,and 9 nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy
overall survival
To test non-inferiority of survival of D1+ gastrectomy versus D2 gastrectomy for clinical stage I B \& II advanced gastric cancer
Time frame: 5 year
disease free survival
3 year disease free survival
Time frame: 3 year
Subgroup analysis of Laparoscopic surgery versus open surgery
Subgroup analysis of Laparoscopic surgery versus open surgery in terms of 3 year relapse free survival and 5 year overall survival
Time frame: 3 year , 5 year
Operating time
Operating time
Time frame: op day
Early postoperative complications
Early postoperative complications
Time frame: within 30 days
Long term postoperative complications
Long term postoperative complications
Time frame: after 30 days
Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
Time frame: baseline, 1 week, 1month, 6 month, 1 year, 3 year
Overall cost for the treatment
Overall cost for the treatment (from operative day to discharge day)
Time frame: operation day to discharge
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Finding biomarkers predicting lymph node metastasis and recurrence
Finding biomarkers predicting lymph node metastasis and recurrence for prediction of lymph node metastasis and recurrence
Time frame: 3 year