Gastric Cancer
Conditions
Brief summary
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.
Interventions
DRUGDWJ1319
DRUGPlacebo
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patient developing gallstone at 12 month after gastrectomy | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy | 3, 6 and 9 months |
| Time to gallstone formation | 12 months |
Countries
South Korea
Outcome results
None listed