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| Name | Class |
|---|---|
| Eastern Hepatobiliary Surgery Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorouracil implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorouracil implant | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| duration of survival after operation | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival | 1 years |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongjie Zhang, MD | Contact | 86-021-81875271 | ||
| Wenlong Yu, MD | Contact | 86-021-81875272 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Hepatobiliary Surgery Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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|
| ID | Term |
|---|---|
| D005706 | Gallbladder Neoplasms |
| D001650 | Bile Duct Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
| D001649 | Bile Duct Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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