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Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02335580
Enrollment
475
Registered
2015-01-12
Start date
2014-12-31
Completion date
2022-12-31
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Prognosis

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.

Interventions

DRUGSomatostatin and its analogs

Somatostatin and/or octreotide will be intravenously infused.

PROCEDUREEndoscopic 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.

Sponsors

General Hospital of Shenyang Military Region
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall survival6-24 months
First bleeding0-24 monthsAs for the patients without any prior history of bleeding but with high-risk varices, the first bleeding was observed.
Recurrent bleeding0-24 monthsAs for the patients with a prior history of bleeding, the recurrent bleeding was observed.
Treatment failure rate of acute variceal bleeding5 daysAs for the patients with acute variceal bleeding, the 5-day treatment failure of acute bleeding was observed.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026