A Randomized, Open, Prospective Clinical Research of Fluorouracil Implant to Improve Surgical Gallbladder Cancer and Bile Duct Cancer
|ClinicalTrials.gov Identifier: NCT01317069|
Recruitment Status : Unknown
Verified March 2011 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was: Recruiting
First Posted : March 17, 2011
Last Update Posted : March 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gallbladder Cancer Bile Duct Cancer||Drug: Fluorouracil implant||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open, Prospective Clinical Research Programs of Fluorouracil Implant (Sinofuan) to Improve Surgical Gallbladder Cancer and Bile Duct Cancer|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||April 2013|
|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
- duration of survival after operation [ Time Frame: 3 years ]
- disease free survival [ Time Frame: 1 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317069
|Contact: Yongjie Zhang, MD||86-021-81875271|
|Contact: Wenlong Yu, MD||86-021-81875272|
|Eastern Hepatobiliary Surgery Hospital||Recruiting|
|Shanghai, Shanghai, China, 200000|
|Contact: Yongjie Zhang, MD 86-021-81875271|
|Contact: Wenlong Yu, MD 86-021-81875272|
|Principal Investigator: Yongjie Zhang, MD|