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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 the study is to compare the effect of HVPG-guided individualized therapy and non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.
The study is a randomized controlled trial of Zelen-design. Patients randomly enter two treatment groups: 1) the HVPG group and 2) the non-HVPG group. Treatment allocation is by block randomization with an equal number for both groups. The results are concealed in opaque envelopes.After randomization, patients will have a second chance to decide if they want to stay in the current group.Patients can switch to another group according to their will. If they are in the HVPG group，they will receive HVPG measurement before treatment. If they are in the non-HVPG group, they start treatment without HVPG measurement and receive endoscopic treatment plus Carvedilol.The mortality rate and rebleeding rate will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HVPG group | Experimental | HVPG-guided therapy |
|
| non-HVPG group | Other | routine therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVPG-guided therapy | Procedure | Patients with an HVPG over 20mmHg will be suggested to receive transjugular intrahepatic portocaval shunt (TIPS) or surgical shunt operation. Patients with an HVPG between 16 and 20mmHg can choose either endoscopic treatment or TIPS according their willingness and indication. Patients with an HVPG below 16mmHg will be treated by endoscopy plus Carvedilol, until endoscopic treatment fails. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | The investigators observe the mortality events in both groups during the study | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rebleeding rate | The investigators observe the rebleeding events in both groups during the study | through study completion, an average of 1 year |
| Adverse Events | The investigators observe any severe adverse events caused by HVPG measurement, endoscopic procedures,use of Carvedilol, surgical operations or TIPS |
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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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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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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|
| routine therapy | Other | Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol. |
|
| Carvedilol | Drug | Patients in HVPG group with HVPG below 16mmHg and all patients in non-HVPG group will take Carvedilol 12.5mg/d if they have no contraindications. |
|
| through study completion, an average of 1 year |
| Total cost | The investigators calculate the total cost of treatment of each patient during the study | through study completion, an average of 1 year |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |