The aim of this study is to show better postoperative quality of life including lower incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with middle-third early gastric cancer
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 Hospital Medical Research Collaborating Center. Each group 128 patients, total 256 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
256
Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification.
Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification.
Kyungpook National University Hospital
Daegu, Jung-gu, South Korea
National Cacner Center
Goyang-si, South Korea
Department of Surgery, Seoul National University BUNDANG Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
Incidence of Dumping syndrome, assessed by Sigstad score (≥7)
Time frame: 1 years postoperatively
Relapse-free survival
Time frame: 3 years postoperatively
Overall survival
Time frame: 3 years postoperatively
Operative morbidity
Time frame: 30 days for early morbidity
Operative mortality
Time frame: mortality for 90 days
Body weight change
Time frame: check at every visit up to 3 years postoperatively
Fat volume change on abdominal CT scan
Time frame: check at every 1 year up to 3 years postoperatively
Change of Hemoglobin
Time frame: check at every visit up to 3 years postoperatively
Change of Protein
Time frame: check at every visit up to 3 years postoperatively
Change of Albumin
Time frame: check at every visit up to 3 years postoperatively
QOL measurement (EORTC C30/STO22) (composite)
Time frame: 6 month, 1 year, 2 year, 3 year postoperatively
Incidence of gallbladder stone
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Yonsei University Severance Hospital
Seoul, South Korea
Time frame: check at every 6 months up to 3 years postoperatively
Gross and microscopic changes measured by gastroscopy (composite)
Time frame: 1 year, 2 year, 3 year postoperatively