Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

Completed

• Conditions: Liver Cirrhosis; Venous Thrombosis; Varicose Veins; Hemorrhage; Portal Vein

• Registration Number: NCT02335580
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-12
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

1. A diagnosis of liver cirrhosis.
2. Patients should be diagnosed with high-risk varices endoscopically, or a prior history of variceal bleeding, or an episode of acute variceal bleeding.
3. Patients agreed to undergo endoscopy to evaluate the presence and severity of varices.
4. 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

1. Non-cirrhotic patients.
2. Malignancy.
3. Contrast-enhanced CT scans were neither feasible nor available.
4. Severe cardiopulmonary diseases.
5. Severe infectious diseases.
6. Pregnant or breastfeeding.
7. Allergic to contrast agents.
8. Poor adherence.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	6-24 months
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.
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.

Trial Locations

Locations (1)

Department of Gastroenterology, General Hospital of Shenyang Military Area; 🇨🇳 Shenyang, Liaoning, China