Experimental: Laparoscopic proximal gastrectomy Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Active Comparator: Laparoscopic total gastrectomy Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Participating Surgeons Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated. Patients Registration It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms. After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Bundang Hospital Medical Research Collaborating Center. Each group 69 patients, total 138 subjects will be enrolled. Randomization The registration randomization should be done with 1:1 ratio for each researcher. Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table. Procedure Operations are performed according to the allocated group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Dong-A University Hospital
Busan, South Korea
Dankook University Hospital
Cheonan, South Korea
Keimyung University Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Eulji University Hospital, Deajon
Daejeon, South Korea
Chonnam National University Hospital
Hwasun, South Korea
National Cancer Center
Ilsan, South Korea
Pusan National University Hospital
Pusan, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
...and 6 more locations
Change of Hemoglobin
from blood sample
Time frame: up to 2 years postoperatively
Vitamin B12 cumulative supplement quantity
from blood sample
Time frame: up to 2 years postoperatively
Operative morbidity
Complications occuring after operation
Time frame: 30 days for early morbidity
Operative mortality
Mortality after operation
Time frame: mortality for 90 days
QOL measurement
EORTC C30/STO22
Time frame: 6 month, 1 year, 2 year, postoperatively
Reflux esophagitis
assessed by Visick score and endoscopic grading according to LA classification
Time frame: check at every 12 months up to 2 years postoperatively
Relapse-free survival
Relapse-free survival
Time frame: 2 years postoperatively
Overall survival
Overall survival
Time frame: 2 years postoperatively
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