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

Completed

• Conditions: Portal Vein Thrombosis; Systemic Inflammatory Markers
• Interventions: Diagnostic Test: clinical laboratory tests, and imaging characteristics

• Registration Number: NCT05541562
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Study First Posted: 2022-09-15
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 478

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PVT group	clinical laboratory tests, and imaging characteristics	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. 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.
Non-PVT group	clinical laboratory tests, and imaging characteristics	(1) Patients with cirrhosis diagnosed in accordance with the 2019 Guidelines for the Diagnosis and Treatment of Cirrhosis;(2)Color ultrasound, CT, MRI, and other imaging studies confirmed the absence of portal vein thrombosis and the specific location of the thrombosis.

Primary Outcome Measures

Name	Time	Method
systemic inflammatory markers	9 years	systemic immune-inflammation index \[SII\], neutrophil-to-lymphocyte ratio \[NLR\], monocyte-to-lymphocyte ratio \[MLR\], and platelet-to-lymphocyte ratio (PLR)

Trial Locations

Locations (1)

the Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China