A Randomized, Open, Prospective Clinical Research Programs of Fluorouracil Implant (Sinofuan) to Improve Surgical Gallbladder Cancer and Bile Duct Cancer
Major Objective Through clinical practice, to explore if the application of Fluorouracil
implant could effectively delay the local tumor recurrence and improvement the postoperative
survival time in patients with gallbladder cancer and bile duct cancer.
1) If Fluorouracil implants application in clinical surgery could lead to the incidence of
complications increased in biliary-enteric anastomosis.
2）Assess drug safety according to drug-related clinical and / or laboratory adverse events.
3）Observe the postoperative complication rate of Fluorouracil implants. 4）Observe the
quality of life of patients used Fluorouracil implants.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
duration of survival after operation
China: Food and Drug Administration