Liver CirrhosisNCT05208736
A Model Based on Computed Tomography Imaging Parameters to Predict Poor Survival in Patients With Liver Cirrhosis
An observational study of Liver Cirrhosis, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2021to 15 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- patients with liver cancer and other malignant tumors.
- Patients accompanied by severe respiratory and circulatory diseases.
- Patients had a history of previous transplantation.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shannxi, 710061
Fulian Zhao, 15109509175, zfl2002yc@163.com
Yingli He, 18991232863, heyingli2000@163.com
- Recruiting
First Affiliated Hospital, Xi'an Jiaotong University
Xi'an, Shannxi, 710061
Fulian Zhao, 15109509175, zfl2002yc@163.com
Yingli He, 18991232863, heyingli2000@163.com
About this study
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.
Read the detailed description
Cirrosis, which is always manifesting as ascites, hepatic encephalopathy, upper gastrointestinal bleeding, severe jaundice and coagulopathy, deteriorates rapidly with a high mortality. Early identification and accurate predicted model may be the key to make duly clinical decision and improve prognosis.
When hepatic disorders accur, cirrhosis is often accompanied by varying degrees of malnutrition, which is accurately reflexed by the cross-sectioned areas of the muscles at the third lumbar vertebra level normalized by the square of the height （L3-SMI）. In addition, previous studies have shown that lower density of adiposity and altered liver volume were often associated with adverse clinical events.
These changes in body composition can be accurately assessed and measured by using CT scans. However, there is no ideas whether these imaging patameters are reliable indicators to predict the mortality of cirrhosis. In this study, we aimed to evaluate the difference of serial changes of L3-SMI, the density of adiposity and liver volume between 5-year survival and non-survival group and develop a new prognostic model based on these CT imaging data. This study highlighted the clinical significance of serial changes of CT imaging data in predicting the long-term outcome of patients with cirrhosis for the first time.
- Conditions
- Liver Cirrhosis
- Keywords
- Predict Model Computed Tomography Liver Cirrhosis Survival
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of subjects with cirrhosis
Overall survival of patients with liver cirrhosis will be summarized and compared with control subject within 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Mar 2021
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208736
- Sponsor's protocol ID
- XJTU1AF2019LSL-026
- Status last verified
- Apr 2022
- First submitted
- 17 Jan 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model Based on Computed Tomography Imaging Parameters to Predict Poor Survival in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT05208736
- Acronym / sponsor ID
- XJTU1AF2019LSL-026
- Conditions
- Liver Cirrhosis
- Keywords
- Predict Model Computed Tomography Liver Cirrhosis Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cirrosis, which is always manifesting as ascites, hepatic encephalopathy, upper gastrointestinal bleeding, severe jaundice and coagulopathy, deteriorates rapidly with a high mortality. Early identification and accurate predicted model may be the key to make duly clinical decision and improve prognosis.
When hepatic disorders accur, cirrhosis is often accompanied by varying degrees of malnutrition, which is accurately reflexed by the cross-sectioned areas of the muscles at the third lumbar vertebra level normalized by the square of the height （L3-SMI）. In addition, previous studies have shown that lower density of adiposity and altered liver volume were often associated with adverse clinical events.
These changes in body composition can be accurately assessed and measured by using CT scans. However, there is no ideas whether these imaging patameters are reliable indicators to predict the mortality of cirrhosis. In this study, we aimed to evaluate the difference of serial changes of L3-SMI, the density of adiposity and liver volume between 5-year survival and non-survival group and develop a new prognostic model based on these CT imaging data. This study highlighted the clinical significance of serial changes of CT imaging data in predicting the long-term outcome of patients with cirrhosis for the first time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- patients with liver cancer and other malignant tumors.
- Patients accompanied by severe respiratory and circulatory diseases.
- Patients had a history of previous transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival of subjects with cirrhosis
Time frame: 5 years
Overall survival of patients with liver cirrhosis will be summarized and compared with control subject within 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fulian Zhao (15109509175, zfl2002yc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival of subjects with cirrhosis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.