Chronic Liver DiseasesNCT07753577
Clinical Trial to Evaluate the Effectiveness of Liver Shear Wave Quantization Detector Spleen Stiffness Value in the Diagnosis of Esophageal Varices
An observational study of Chronic Liver Diseases and Spleen Stiffness, run by Beijing Friendship Hospital.
Trial summary
Esophageal variceal bleeding is one of the serious and life-threatening complications of chronic liver disease (CLD). Studies have shown that the prevalence of esophageal varices (EV) in patients with liver cirrhosis is about 50%-60%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Diseases, Spleen Stiffness, Esophageal Varices
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 30 Oct 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with chronic liver disease who met the protocol inclusion and exclusion criteria
Who may be able to join
- Age over 18 years old, male or female;
- patients with clinically diagnosed chronic liver disease, including hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, fatty liver disease, autoimmune liver disease, and alcoholic liver disease *;
- Liver stiffness measurement (LSM) ≥10kPa during screening or within one month before screening [4];
- able to communicate well with the investigators, understand and comply with the requirements of the study;
- Informed consent was signed voluntarily.
Who cannot join
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 U/L;
- complicated with jaundice (serum total bilirubin ≥50 μmol/L);
- complicated with important organ diseases (except liver) or serious systemic diseases (such as malignant tumors and HIV);
- after liver transplantation or TIPS;
- after splenectomy, splenic embolization or other portasystemic shunts;
- patients with moderate-to-large amount of ascites;
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- unstable condition in the acute stage of esophageal variceal bleeding;
- combined with liver malignant tumors;
- patients with non-cirrhotic portal hypertension, Budd-Chiari syndrome and other hepatic vascular diseases; Acute or chronic portal vein thrombosis;
- unhealed wounds or scars in the left abdomen were not suitable for ultrasound examination;
- pregnant women;
- Other conditions judged by the investigators as not suitable for participating in the study.
About this study
Esophageal variceal bleeding is one of the serious and life-threatening complications of chronic liver disease (CLD). Studies have shown that the prevalence of esophageal varices (EV) in patients with liver cirrhosis is about 50%-60%. The annual incidence of variceal bleeding in these patients is about 5%-15%, and the rebleeding rate can reach 30%-40% within 6 weeks after the first bleeding. The 6-week mortality related to variceal bleeding is as high as 10%-20%, which seriously threatens the life safety of patients with liver disease. Clinically, esophagogastroduodenoscopy (EGD) is the gold standard for the diagnosis and grading of esophageal varices. However, EGD is an invasive examination, which has certain application limitations such as related complications and high cost, which limits the promotion and application of this technology.
Therefore, there is an urgent need for an accurate, convenient and non-invasive method for esophageal varices. To address this clinical pain point, Baveno VII guidelines state that spleen stiffness measurement (SSM) based on vibration-controlled transient elastography (TE) can be used as a noninvasive marker to predict esophageal varices (EV). Several studies have shown that SSM measured by TE has good diagnostic performance in relation to the occurrence and severity of esophageal varices. A study involving 191 patients with liver disease showed that spleen stiffness was significantly higher in patients with varices than in those without varices (63.69 vs 47.78 kPa, P<0.0001), and the AUC of SSM for the diagnosis of EV was 0.74. In another study involving 260 patients with chronic liver disease, the AUC of SSM was 0.728 (95% CI: 0.665-0.791) for EV and 0.780 (95% CI: 0.714-0.846) for high-risk varix (HRV). The above results indicate that SSM has good clinical value in the prediction of EV.
Pro9000X, a liver function shear wave quantization detector based on vibration control TE, has been developed by Wuxi Hisiel Medical Technology Co., LTD. The device integrates ultrasound image positioning and TE function, aiming to achieve rapid, quantitative and non-invasive detection of liver stiffness measurement (LSM) and SSM. The results of EGD examination were used as the gold standard to evaluate the diagnostic performance of the spleen stiffness value detected by Pro9000X in patients with chronic liver disease, and the main evaluation indicators were the sensitivity and specificity of EV diagnosis. Secondary evaluation included AUROC, optimal cut-off value and diagnostic value of high-risk EV.
- Conditions
- Chronic Liver Diseases, Spleen Stiffness, Esophageal Varices, Diagnostic Performance Study
- Medical subject headings
- Esophageal and Gastric Varices
What is being measured
The primary outcome is the main question the study is designed to answer.
The results of esophagogastric duodenoscopy (EGD) were used as the gold standard to evaluate the diagnostic performance of spleen stiffness value detected by liver function shear wave quantization detector Pro9000X for esophageal varices (EV) in patients
Measured: day 1: Screening period visit（Sign the informed consent form, meet the inclusion and exclusion criteria, et al） day 2-day 30: Trial visit during the period of experimentation (EGD and Pro9000X Spleen Hardness Examination) day 31: Pre-group visitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- 246 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Hong You, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753577
- Sponsor's protocol ID
- 2026-P1-MD-011
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Effectiveness of Liver Shear Wave Quantization Detector Spleen Stiffness Value in the Diagnosis of Esophageal Varices
- ClinicalTrials.gov ID
- NCT07753577
- Acronym / sponsor ID
- 2026-P1-MD-011
- Conditions
- Chronic Liver Diseases, Spleen Stiffness, Esophageal Varices, Diagnostic Performance Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 7 Aug 2026 (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.
Esophageal variceal bleeding is one of the serious and life-threatening complications of chronic liver disease (CLD). Studies have shown that the prevalence of esophageal varices (EV) in patients with liver cirrhosis is about 50%-60%. The annual incidence of variceal bleeding in these patients is about 5%-15%, and the rebleeding rate can reach 30%-40% within 6 weeks after the first bleeding. The 6-week mortality related to variceal bleeding is as high as 10%-20%, which seriously threatens the life safety of patients with liver disease. Clinically, esophagogastroduodenoscopy (EGD) is the gold standard for the diagnosis and grading of esophageal varices. However, EGD is an invasive examination, which has certain application limitations such as related complications and high cost, which limits the promotion and application of this technology.
Therefore, there is an urgent need for an accurate, convenient and non-invasive method for esophageal varices. To address this clinical pain point, Baveno VII guidelines state that spleen stiffness measurement (SSM) based on vibration-controlled transient elastography (TE) can be used as a noninvasive marker to predict esophageal varices (EV). Several studies have shown that SSM measured by TE has good diagnostic performance in relation to the occurrence and severity of esophageal varices. A study involving 191 patients with liver disease showed that spleen stiffness was significantly higher in patients with varices than in those without varices (63.69 vs 47.78 kPa, P<0.0001), and the AUC of SSM for the diagnosis of EV was 0.74. In another study involving 260 patients with chronic liver disease, the AUC of SSM was 0.728 (95% CI: 0.665-0.791) for EV and 0.780 (95% CI: 0.714-0.846) for high-risk varix (HRV). The above results indicate that SSM has good clinical value in the prediction of EV.
Pro9000X, a liver function shear wave quantization detector based on vibration control TE, has been developed by Wuxi Hisiel Medical Technology Co., LTD. The device integrates ultrasound image positioning and TE function, aiming to achieve rapid, quantitative and non-invasive detection of liver stiffness measurement (LSM) and SSM. The results of EGD examination were used as the gold standard to evaluate the diagnostic performance of the spleen stiffness value detected by Pro9000X in patients with chronic liver disease, and the main evaluation indicators were the sensitivity and specificity of EV diagnosis. Secondary evaluation included AUROC, optimal cut-off value and diagnostic value of high-risk EV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver disease who met the protocol inclusion and exclusion criteria
Key inclusion criteria (5 listed)
- Age over 18 years old, male or female;
- patients with clinically diagnosed chronic liver disease, including hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, fatty liver disease, autoimmune liver disease, and alcoholic liver disease *;
- Liver stiffness measurement (LSM) ≥10kPa during screening or within one month before screening [4];
- able to communicate well with the investigators, understand and comply with the requirements of the study;
- Informed consent was signed voluntarily.
Key exclusion criteria (12 listed)
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 U/L;
- complicated with jaundice (serum total bilirubin ≥50 μmol/L);
- complicated with important organ diseases (except liver) or serious systemic diseases (such as malignant tumors and HIV);
- after liver transplantation or TIPS;
- after splenectomy, splenic embolization or other portasystemic shunts;
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
The results of esophagogastric duodenoscopy (EGD) were used as the gold standard to evaluate the diagnostic performance of spleen stiffness value detected by liver function shear wave quantization detector Pro9000X for esophageal varices (EV) in patients
Time frame: day 1: Screening period visit（Sign the informed consent form, meet the inclusion and exclusion criteria, et al） day 2-day 30: Trial visit during the period of experimentation (EGD and Pro9000X Spleen Hardness Examination) day 31: Pre-group visitation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Diseases and Spleen Stiffness, run by Beijing Friendship Hospital.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The results of esophagogastric duodenoscopy (EGD) were used as the gold standard to evaluate the diagnostic performance of spleen stiffness value detected by liver function shear wave quantization detector Pro9000X for esophageal varices (EV) in patients (time frame: day 1: Screening period visit（Sign the informed consent form, meet the inclusion and exclusion criteria, et al） day 2-day 30: Trial visit during the period of experimentation (EGD and Pro9000X Spleen Hardness Examination) day 31: Pre-group visitation). 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 7 Aug 2026.