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| Name | Class |
|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai Public Health Clinical Center | OTHER_GOV |
| ShuGuang Hospital | OTHER |
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The purpose of this study is to determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its effect on long-term rebleeding rate and mortality.
The treatment of cirrhotic patients with PVT (portal vein thrombosis) is clearly recommended in guideline now. Several published studies has confirm the effect and safety of anticoagulation therapy in cirrhotic patients with PVT.The present studies are most observation studies with small sample size and low quality. The investigators need more high-quality research such as randomized controlled trials. This is a Zelen-designed multicenter randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then the investigator will make sure wether their are fond of the group and make decision by themselves. The recanalization rate and complications will be analyzed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control. | Other | No anticoagulation,just routine follow up. |
|
| Anticoagulation | Experimental | Nadroparin Calcium and Warfarin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nadroparin Calcium and Warfarin | Drug | Patients will take warfarin started at a dose of 2.5mg/d and with titration of dose to maintain a target INR of 2-3, and during the of perioperative period of Endoscopic treatment changing to use Nadroparin Calcium 4100IU/d,subcutaneous. |
| Measure | Description | Time Frame |
|---|---|---|
| Recanalization rate of PVT | Patients will receive Doppler ultrasound and CT before enrolled and followed up by Doppler ultrasound every 3 months ,by CT every 6 months after enrolled,untill the end of the study. | through study completion,an average of 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rebleeding rate | The investigators observe the variceal rebleeding events during the study | through study completion,an average of 18 months |
| Incidence rate of complications | The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyao Chen, Professor | Contact | 86-13601767310 | chen.shiyao@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shiyao Chen, Professor | Shanghai Zhongshan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017762 | Nadroparin |
| D014859 | Warfarin |
| D018608 | Ultrasonography, Doppler |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
| OTHER |
| Shanghai Pudong New Area Gongli Hospital | OTHER |
| Eastern Hepatobiliary Surgery Hospital | OTHER |
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| Doppler ultrasound and CT | Device | all patient will take Doppler ultrasound examination every 3 months ;Abdominal CT will be done every 6 months。 |
|
| through study completion,an average of 18 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |