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

Sponsor
The Affiliated Hospital of Qingdao University (Other)
Overall Status
Completed
CT.gov ID
NCT05541562
Collaborator
(none)
478
1
96
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: clinical laboratory tests, and imaging characteristics

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 Design

Study Type:
Observational
Actual Enrollment :
478 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
A Practical Nomogram Based on Systemic Inflammatory Markers for Predicting Portal Vein Thrombosis in Patients With Liver Cirrhosis
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
PVT group

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.

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.

Non-PVT group

(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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 81 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 the Affiliated Hospital of Qingdao University Qingdao Shandong China

Sponsors and Collaborators

  • The Affiliated Hospital of Qingdao University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Affiliated Hospital of Qingdao University
ClinicalTrials.gov Identifier:
NCT05541562
Other Study ID Numbers:
  • QYFYW2LL26362
First Posted:
Sep 15, 2022
Last Update Posted:
Sep 15, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Affiliated Hospital of Qingdao University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2022