A Model Based on Computed Tomography Imaging Parameters to Predict Poor Survival in Patients With Liver Cirrhosis

NCT05208736 | Unknown

• 1 other identifier: XJTU1AF2019LSL-026
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

Cirrhosis, as the end stage of most chronic liver diseases, is an important clinical landmark portending high risk of death. Early identification and accurate prognostic scores is critical issue to improve survival rate. Loss of muscle mass and other body features, which can be determined from CT, have been associated with mortality in cirrhosis or hepatic carcinoma. In this study, we sought to investigate serial changes of CT imaging parameters, such as the skeletal muscle index (SMI), liver volume, adiposity density and so forth, to develop a new prognostic model for long-term motality in patients with liver cirrhosis. The final predictive model was developed under the Cox regression framework with MELD, Child-Pugh score, baseline and serial changes of CT imaging parameters. The discrimination of the new risk score was assessed by the overall C index.

Conditions

Liver Cirrhosis

Keywords

Predict Model Computed Tomography Liver Cirrhosis Survival

Outcome Measures

Primary Outcomes (1)

• Overall survival of subjects with cirrhosis

  Overall survival of patients with liver cirrhosis will be summarized and compared with control subject within 5 years.

  5 years

Study Arms (2)

5-year nonsurvival or transplantation

Patients who died or underwent liver transplantation within 5 years since admission.

5-year transplantation-free survival

Patients who survival without liver transplantation at 5 years since admission.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All the patients were diagnosed with liver cirrhosis who met with the inclusion criteria and exclusion criteria. Two cohorts of subjects were enrolled in several liver centers. In the modeling cohort, subjects were identified retrospectively from patients with liver ciirhosis, referred from January 1, 2012 to December 31, 2020. In the validation cohort, subjects were enrolled from external liver centers. In addition, healthy volunteers who had normal liver function and normal BMI were recruited and acted as controls.

You may qualify if:

• Age 18-75 years
• The diagnosis of liver cirrhosis based on imaging, laboratory and/or histological patameters from a board-certified hepatologist.
• Patients who underwent at least two abdominal CT examinations, and the interval between the first and the second check was more than one year.
• CT examination included the cross-sectional areas of muscle at L3 level.
• Basic patient data included age, gender, weight, height, biochemical examination, complications and 5-year survival.
• Biochemical examinations were available within 7 days before or after CT scan.

You may not qualify if:

• patients with liver cancer and other malignant tumors.
• Patients accompanied by severe respiratory and circulatory diseases.
• Patients had a history of previous transplantation.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (2)

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, Shannxi, 710061, China

RECRUITING

First Affiliated Hospital, Xi'an Jiaotong University

Xi'an, Shannxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fulian Zhao

CONTACT

15109509175; zfl2002yc@163.com

Yingli He

CONTACT

18991232863; heyingli2000@163.com

Study Design

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

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 26, 2022
• Study Start: March 1, 2021
• Primary Completion: December 15, 2022
• Study Completion: March 15, 2023
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)