A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer
A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer
The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.
To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.
Inclusion Criteria:
histologically proven primary gastric adenocarcinoma
T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location
No evidence of other distant metastasis
not stump carcinoma,(vi) aged 20-80 year old
performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
adequate organ functions defined as indicated below:
Exclusion Criteria: