Clinical Trial: A Randomized, Open, Prospective Clinical Research of Fluorouracil Implant to Improve Surgical Gallbladder Cancer and Bile Duct Cancer

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized, Open, Prospective Clinical Research Programs of Fluorouracil Implant (Sinofuan) to Improve Surgical Gallbladder Cancer and Bile Duct Cancer

Brief Summary: 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.

Detailed Summary:

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.

Secondary objective

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.

Sponsor: Simcere Pharmaceutical Co., Ltd

Current Primary Outcome: duration of survival after operation [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: disease free survival [ Time Frame: 1 years ]

Original Secondary Outcome: Same as current

Information By: Simcere Pharmaceutical Co., Ltd

Dates:
Date Received: March 15, 2011
Date Started: June 2010
Date Completion: April 2013
Last Updated: March 15, 2011
Last Verified: March 2011