Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer

Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study

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.

Inclusion Criteria:

• Male or female at least 19 years of age
• Patient who undergoes gastrectomy (total, distal or proximal gastrectomy)
• D1+ or D2 lymph node dissection
• Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
• Written informed consent

Exclusion Criteria:

• Patients with cholangitis, cholecystitis, non-functional gall bladder, or biliary obstruction
• Presence of gallstones on ultrasonography and/or CT
• History of previous cholecystectomy
• Patients undergoing pylorus-preserving gastrectomy
• Pregnant or lactating women and fertile women who is not using proper contraceptive method
• Patients with history of drug or alcohol abuse within 5 years ago