A Randomized, Open, Prospective Clinical Research of Fluorouracil Implant to Improve Surgical Gallbladder Cancer and Bile Duct Cancer
NCT ID: NCT01317069
Last Updated: 2011-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2010-06-30
2013-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fluorouracil implant
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 70 years old, male or female, body condition score generally ECOG 0～2, expected survival ≥ 3 months.
* Subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators:
Blood: WBC count \> 3.0 × 109 / L, Platelet count\> 100 × 109 / L, Hb \> 8.0g/dl. Liver function：serum bilirubin less than 1.5 times the upper limit of normal; ALT and AST less than 3 times the upper limit of normal.
Renal function: creatinine less than 1.5 times the upper limit of normal.
* Participants have used other chemotherapy drugs, subject to the 30-day washout period before proceeding with the test.
* Patients had no anaphylactic reaction with oxaliplatin and fluorouracil in the past.
* Patients who can understand the circumstances of this study and signed informed consent.
Exclusion Criteria
* Pregnancy, breast-feeding patients；
* Primary brain tumors or central nervous system metastatic tumor is not controlled;
* Patients received chemotherapy, radiotherapy, biological therapy, other drugs or instrument therapy 30 days before enrollment.
* Patients with purulent and chronic infected wounds which delayed healing.
* Patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease;
* Patients has a history of mental illness and difficult to control;
* Patients who was considered inappropriate to participate in the trials by the researchers.
18 Years
70 Years
ALL
No
Sponsors
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Eastern Hepatobiliary Surgery Hospital
OTHER
Simcere Pharmaceutical Co., Ltd
OTHER
Responsible Party
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Eastern Hepatobiliary Surgery Hospital
Locations
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Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Yongjie Zhang, MD
Role: CONTACT
Wenlong Yu, MD
Role: CONTACT
Facility Contacts
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Yongjie Zhang, MD
Role: primary
Wenlong Yu, MD
Role: backup
Other Identifiers
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Sinofuan201101
Identifier Type: -
Identifier Source: org_study_id
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