A Practical Nomogram Based on Systemic Inflammatory Markers for Predicting Portal Vein Thrombosis in Patients With Liver Cirrhosis

Portal Vein Thrombosis Clinical Trial

Official title:

A Practical Nomogram Based on Systemic Inflammatory Markers for Predicting Portal Vein Thrombosis in Patients With Liver Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05541562
• Other study ID #: QYFYW2LL26362
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: January 1, 2021

Study information

• Verified date: September 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Immunothrombosis has recently been used to describe the responses/mechanisms in thrombosis. Systemic inflammatory markers are prognostic markers for a variety of thrombotic conditions; however, their potential value in predicting portal vein thrombosis (PVT) is unknown. This study aimed to establish an easy-to-use nomogram based on systemic inflammatory markers to predict portal vein thrombosis (PVT) in patients with liver cirrhosis.

Description:

This retrospective study included 478 patients with cirrhosis between January 2013 and January 2021. Reputed systemic inflammatory markers (systemic immune-inflammation index [SII], neutrophil-to-lymphocyte ratio [NLR], monocyte-to-lymphocyte ratio [MLR], and platelet-to-lymphocyte ratio (PLR)) were measured, and the clinical data were recorded. The independent risk factors for PVT were determined using univariate analyses and multivariate logistic regression analyses, and a nomogram to predict the occurrence of PVT was established. The concordance index, receiver operating characteristic curves, and calibration plots were used to evaluate the performance of the model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 81 Years

Eligibility

Inclusion Criteria:The diagnosis of LC was based on clinical, laboratory, and radiological analyses, and/or liver biopsies. PVT was diagnosed according to the consensus for management of PVT in LC (2020, Shanghai) [1]. The inclusion criteria were as follows: (I) age =18 years, (II) Doppler ultrasound was the first-choice imaging modality; however, enhanced computed tomography or magnetic resonance imaging could also be used for confirmation at the time of admission to our hospital, and (III) patients with PVT on imaging examination but with insufficient evidence for the diagnosis of cirrhosis, hepatic vein pressure gradient measurement, and liver biopsy. -

Exclusion Criteria:Patients with primary or secondary hepatic malignant tumors, other malignant tumors, hematologic diseases, Budd-Chiari syndrome, non-cirrhotic PVT, inflammatory diseases, and other severe diseases were excluded.

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Related Conditions & MeSH terms

• Liver Cirrhosis
• Portal Vein Thrombosis
• Systemic Inflammatory Markers
• Thrombosis
• Venous Thrombosis

Intervention

Diagnostic Test:
• clinical laboratory tests, and imaging characteristics
Data included the demographic status, etiology of the liver disease, clinical laboratory tests, and imaging characteristics. Clinical laboratory tests included D-dimer, activated partial thromboplastin time (APTT), prothrombin time (PT), antithrombin III, international normalized ratio (INR), thrombin time (TT), albumin (Alb), serum creatinine, hemoglobin, platelet count, white blood cell count, neutrophil count, lymphocyte count, monocyte count, model for end-stage liver disease (MELD) score, and Child-Pugh score. Imaging characteristics included splenic vein diameter, splenic vein velocity, portal vein diameter, and portal vein velocity.

Locations

Country	Name	City	State
China	the Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systemic inflammatory markers	systemic immune-inflammation index [SII], neutrophil-to-lymphocyte ratio [NLR], monocyte-to-lymphocyte ratio [MLR], and platelet-to-lymphocyte ratio (PLR)	9 years