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

NCT05541562 | Completed

• 1 other identifier: QYFYW2LL26362
• Study Type: observational
• Target: 478
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Inflammatory Markers; Portal Vein Thrombosis

Keywords

Portal Vein Thrombosis; systemic inflammatory markers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

clinical laboratory tests, and imaging characteristics DIAGNOSTIC_TEST

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; PVT group

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This retrospective study included 478 patients with cirrhosis between January 2013 and January 2021 at the Affiliated Hospital of Qingdao University (China).There were 239 patients with portal vein thrombosis and 239 patients without portal vein thrombosis.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

MeSH Terms

Interventions

Clinical Laboratory Techniques

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: January 1, 2013
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)