A Randomized, Open, Prospective Clinical Research of Fluorouracil Implant to Improve Surgical Gallbladder Cancer and Bile Duct Cancer
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open, Prospective Clinical Research Programs of Fluorouracil Implant (Sinofuan) to Improve Surgical Gallbladder Cancer and Bile Duct Cancer|
- duration of survival after operation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- disease free survival [ Time Frame: 1 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Experimental: Fluorouracil implant||
Drug: Fluorouracil implant
Before the abdomen was closed, fluorouracil implant 1000mg was sprayed evenly on the surface of tumor resection area, and some of the drugs were put into mesenteric root based on the location
Other Name: Sinofuan
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317069
|Eastern Hepatobiliary Surgery Hospital|
|Shanghai, Shanghai, China, 200000|