This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants will receive DWJ1319, while the other will receive a placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
521
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul Natioanl University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Proportion of patient developing gallstone at 12 month after gastrectomy
Time frame: 12 months
Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy
Time frame: 3, 6 and 9 months
Time to gallstone formation
Time frame: 12 months
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...and 2 more locations