Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

Sponsor

General Hospital of Shenyang Military Region (Other)

Overall Status

Recruiting

CT.gov ID

NCT02335580

Collaborator

(none)

400

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis Portal Vein Venous Thrombosis Varicose Veins Hemorrhage	Drug: Somatostatin and its analogs Procedure: Endoscopic sclerotherapy, endoscopic variceal ligation, endoscopic tissue glue injection

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.