Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

Study Overview
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Brief Summary
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The prevalence of portal vein thrombosis (PVT) in patients with liver cirrhosis is 5-20%. Current evidence regarding the effect of portal vein thrombosis on the prognosis of cirrhotic patients remains under debate. Considering that PVT potentially elevates the portal pressure and thereby increase the risk of variceal bleeding, we focus on the patients with high-risk varices and variceal bleeding as the study population. Thus, the main goals are to analyze the effect of PVT on the incidence of first variceal bleeding in patients without any prior bleeding history but with high-risk varices, the incidence of recurrent variceal bleeding in patients with a history of variceal bleeding, and the treatment failure rate of variceal bleeding in patients with acute variceal bleeding. Certainly, the survival is also observed in all patients.

Official Title
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Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Cohort Study

Conditions
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Liver Cirrhosis, Portal Vein, Venous Thrombosis, Varicose Veins, Hemorrhage

Intervention / Treatment
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* Drug: Somatostatin and its analogs
* Procedure: Endoscopic sclerotherapy, endoscopic variceal ligation, endoscopic tissue glue injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of liver cirrhosis. Patients should be diagnosed with high-risk varices endoscopically, or a prior history of variceal bleeding, or an episode of acute variceal bleeding. Patients agreed to undergo endoscopy to evaluate the presence and severity of varices. Patients agreed to undergo contrast-enhanced CT scans to evaluate the portal vein patency. But if an abdominal contrast-enhanced CT scans was performed within 3 months after admission, it was not necessarily repeated. Exclusion Criteria: Non-cirrhotic patients. Malignancy. Contrast-enhanced CT scans were neither feasible nor available. Severe cardiopulmonary diseases. Severe infectious diseases. Pregnant or breastfeeding. Allergic to contrast agents. Poor adherence.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Somatostatin and its analogs|Somatostatin and/or octreotide will be intravenously infused.|
|Procedure: Endoscopic sclerotherapy, endoscopic variceal ligation, endoscopic tissue glue injection|Endoscopic sclerotherapy, endoscopic variceal ligation, and/or endoscopic tissue glue injection will be performed based on the endoscopists' choice.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 6-24 months | 
| First bleeding | As for the patients without any prior history of bleeding but with high-risk varices, the first bleeding was observed. | 0-24 months | 
| Recurrent bleeding | As for the patients with a prior history of bleeding, the recurrent bleeding was observed. | 0-24 months | 
| Treatment failure rate of acute variceal bleeding | As for the patients with acute variceal bleeding, the 5-day treatment failure of acute bleeding was observed. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prognosis