Liver CirrhosisNCT04640350
Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography
An observational study of Liver Cirrhosis and Gastroesophageal Varices, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Through the parameters of liver stiffness and spleen stiffness obtained by combi-elastography technique, summarize and analyze the warning index of esophagogastric variceal bleeding in patients with cirrhosis, so as to provide a new and valuable technique for clinical diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Gastroesophageal Varices, Variceal Hemorrhage
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2020to 31 May 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver cirrhosis and the gastroscopy is in line with the indications of portal hypertension.
Who may be able to join
- 18-80 years old, no gender limit;
- The clinical diagnosis is in line with patients with liver cirrhosis caused by chronic hepatitis B, and the gastroscopy is in line with the indications of portal hypertension;
- Gastroscopy needs to provide the degree of gastroesophageal varices;
- Sign the informed consent form.
Who cannot join
- Patients with cirrhosis and portal hypertension because of other causes or combined with other causes(such as viral hepatitis other than hepatitis B,Autoimmune liver disease, alcoholic liver disease, metabolism-related fatty liver disease, etc.)
- Patients with a history of spleen-related operations, such as splenectomy, splenic embolism;
- Patients undergoing portosystemic shunt or TIPS;
- Isolated esophageal venous tumor and its bleeding patients;
- History of upper gastrointestinal tumor or bleeding from gastric ulcer , etc;
- Those with serious diseases of other systems that cannot cooperate with elastography examination, such as heart failure, renal failure, mental illness, etc;
- Ascites before liver and spleen result unable to complete elasticity examination;
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Ping Liang, Doctor
About this study
Through the parameters of liver stiffness and spleen stiffness obtained by combi-elastography technique, summarize and analyze the warning index of esophagogastric variceal bleeding in patients with cirrhosis, so as to provide a new and valuable technique for clinical diagnosis.
Read the detailed description
Firstly,the combi-elastography technique developed by HITACHI uses the method of multi-index and multi-parameter to evaluate the liver stiffness and spleen stiffness comprehensively.
And then,this prospective study is designed to follow up patients with cirrhosis for a period of 12 months, summarize and analyze the warning index of bleeding in patients with cirrhosis,so as to provide a new and valuable technique for clinical diagnosis.
- Keywords
- Elasticity Imaging Techniques, Ultrasound
- Medical subject headings
- Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
F index
F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.
Measured: baseline
A index
A index is linked to the degree of hepatitis ,and it can be available by ultrasound elastography checking.
Measured: baseline
Spleen stiffness
Spleen stiffness can be available by ultrasound elastography checking.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start31 Dec 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640350
- Sponsor's protocol ID
- S2020-387-02
- Status last verified
- Jan 2021
- First submitted
- 10 Nov 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu X, Chen M, Zheng Y, Yang X, Zhang W, Zhang Y, Yin Z, Liao J, Tang Y, Yu J, Liang P, Meng F. A novel dual elastography-based model for screening high-risk varices in hepatitis B virus-related cirrhosis. Front Med (Lausanne). 2026 Feb 24;13:1707998. doi: 10.3389/fmed.2026.1707998. eCollection 2026.
PubMed 41816677
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography
- ClinicalTrials.gov ID
- NCT04640350
- Acronym / sponsor ID
- S2020-387-02
- Keywords
- Elasticity Imaging Techniques, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 23 Nov 2020 (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.
Through the parameters of liver stiffness and spleen stiffness obtained by combi-elastography technique, summarize and analyze the warning index of esophagogastric variceal bleeding in patients with cirrhosis, so as to provide a new and valuable technique for clinical diagnosis.
Detailed description
Firstly,the combi-elastography technique developed by HITACHI uses the method of multi-index and multi-parameter to evaluate the liver stiffness and spleen stiffness comprehensively.
And then,this prospective study is designed to follow up patients with cirrhosis for a period of 12 months, summarize and analyze the warning index of bleeding in patients with cirrhosis,so as to provide a new and valuable technique for clinical diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis and the gastroscopy is in line with the indications of portal hypertension.
Key inclusion criteria (4 listed)
- 18-80 years old, no gender limit;
- The clinical diagnosis is in line with patients with liver cirrhosis caused by chronic hepatitis B, and the gastroscopy is in line with the indications of portal hypertension;
- Gastroscopy needs to provide the degree of gastroesophageal varices;
- Sign the informed consent form.
Key exclusion criteria (8 listed)
- Patients with cirrhosis and portal hypertension because of other causes or combined with other causes(such as viral hepatitis other than hepatitis B,Autoimmune liver disease, alcoholic liver disease, metabolism-related fatty liver disease, etc.)
- Patients with a history of spleen-related operations, such as splenectomy, splenic embolism;
- Patients undergoing portosystemic shunt or TIPS;
- Isolated esophageal venous tumor and its bleeding patients;
- History of upper gastrointestinal tumor or bleeding from gastric ulcer , etc;
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
F index
Time frame: baseline
F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.
A index
Time frame: baseline
A index is linked to the degree of hepatitis ,and it can be available by ultrasound elastography checking.
Spleen stiffness
Time frame: baseline
Spleen stiffness can be available by ultrasound elastography checking.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Derived from this study: PubMed 41816677Hu X, Chen M, Zheng Y, Yang X, Zhang W, Zhang Y, Yin Z, Liao J, Tang Y, Yu J, Liang P, Meng F. A novel dual elastography-based model for screening high-risk varices in hepatitis B virus-related cirrhosis. Front Med (Lausanne). 2026 Feb 24;13:1707998. doi: 10.3389/fmed.2026.1707998. eCollection 2026.
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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.
Ping Liang, Doctor principal investigator
Chinese PLA General Hospital
1 site 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 and Gastroesophageal Varices, run by Chinese PLA General Hospital at 1 site 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 4 inclusion and 8 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 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jie Yu, Doctor (010-66937981, yu-jie301@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
F index (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04640350, which also lists 1 linked publication.
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 19 Jan 2021.