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Completed

NCT Number: NCT02335580

Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

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.

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Key information

Conditions

Liver Cirrhosis Cardiovascular Diseases Digestive System Diseases Embolism and Thrombosis Fibrosis Hemorrhage Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Vein Thrombosis Varicose Veins Vascular Diseases Venous Thrombosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, General Hospital of Shenyang Military Area

Shenyang, Liaoning, 110840, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Somatostatin and its analogs

Drug

Somatostatin and/or octreotide will be intravenously infused.

Endoscopic sclerotherapy, endoscopic variceal ligation, endoscopic tissue glue injection

Procedure

Endoscopic sclerotherapy, endoscopic variceal ligation, and/or endoscopic tissue glue injection will be performed based on the endoscopists' choice.

Primary outcomes

  1. Overall survival

    Time frame: 6-24 months

  2. First bleeding

    Time frame: 0-24 months

    As for the patients without any prior history of bleeding but with high-risk varices, the first bleeding was observed.

  3. Recurrent bleeding

    Time frame: 0-24 months

    As for the patients with a prior history of bleeding, the recurrent bleeding was observed.

  4. Treatment failure rate of acute variceal bleeding

    Time frame: 5 days

    As for the patients with acute variceal bleeding, the 5-day treatment failure of acute bleeding was observed.

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2015
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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