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| Name | Class |
|---|---|
| Shandong Provincial Hospital | OTHER_GOV |
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Portal hypertension is a common complication of chronic liver diseases and is responsible for most clinical consequences of cirrhosis. measurement of the hepatic venous pressure gradient(HVPG) is the gold standard for evaluating the presence and severity of portal hypertension, this technique is considered invasive and is not routinely performed in all centers. Wisteria floribunda agglutinin-positive human Mac-2 binding protein (WFA+-M2BP) is a secreted N-glycoprotein, which has been reported as a novel marker in assessing liver fibrosis.However, the correlation of WFA+-M2BP with HVPG is unclear.The aim of this study was to explore the relationship between WFA+-M2BP and HVPG.
Portal hypertension is a common complication of chronic liver diseases and is responsible for most clinical consequences of cirrhosis. Accurate assessment of portal hypertension is essential for strategy of treatment and judgement of prognosis. Although measurement of the hepatic venous pressure gradient(HVPG) is the gold standard for evaluating the presence and severity of portal hypertension, this technique is considered invasive and is not routinely performed in all centers. Therefore, it is urgent to explore a noninvasive assessment of portal hypertension.
Wisteria floribunda agglutinin-positive human Mac-2 binding protein (WFA+-M2BP) is a secreted N-glycoprotein, which has been reported as a novel marker in assessing liver fibrosis. Recently, a retrospective study investigated the role of WFA+-M2BP in assessing the degree of liver cirrhosis and predicting mortality. However, the correlation of WFA+-M2BP with HVPG is unclear. And the role of WFA+-M2BP in predicting the clinical outcome of liver fibrosis patients is needed to be further evaluated.
The aim of this study was to explore the relationship between WFA+-M2BP and HVPG, as well as its predictive ability of complication rate, including large varices, bleed status, and ascites, and liver disease-related mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HVPG group | When HVPG > 12 mmHg, patients would be treated with carvedilol at an initial dose of 6.25 mg once-daily that was adjusted over 5-7 days to the maximum tolerated dose, keeping heart rate >55 beats per minute, or up to 12.5 mg/day. After about 8 weeks, the patients treated with carvedilol will received the second HVPG monitoring wether achieved a decrease in HVPG below 12 mm Hg or>20% from baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug | an initial dose of 6.25 mg once-daily that was adjusted over 5-7 days to the maximum tolerated dose, keeping heart rate >55 beats per minute, or up to 12.5 mg/day |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of portal pressure (PP) | portal pressure (PP) will be estimated from the hepatic venous pressure gradient(HVPG) | 3 months |
| serum WFA+-M2BP levels | serum WFA+-M2BP levels | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of death or liver transplantation | number of death or liver transplantation | up to 1 year |
| complications of cirrhosis | large varices, bleed status and ascites |
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Inclusion Criteria:
Exclusion Criteria:
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From June 2017 to March 2018, patients with cirrhosis admitted to either of the two participating hospitals were consecutively enrolled.
Hospitals: Shanghai Changzheng hospital and Shandong Provincial Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-Fen Xie, MD | Contact | 86-21-81885341 | coss2008@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| Wei-Fen Xie, MD | Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai | Principal Investigator |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| 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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serum
| up to 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 |