Skip to content

Diagnostic study of FibroScan 630 special spleen hardness tester predicting significant portal hypertension

Diagnostic study of FibroScan 630 special spleen hardness tester predicting significant portal hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070270
Enrollment
Unknown
Registered
2023-04-07
Start date
2022-03-08
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis

Interventions

Gold Standard:The normal range of hepatic vein pressure gradient (HVPG) is 3 ~ 5mmHg. HVPG > 5mmHg can be defined as portal hypertension, and >= 10mmHg is clinically significant portal hypertension, w
Index test:FibroScan 630 special spleen hardness measuring instrument.

Sponsors

Beijing You'an Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age and sex are not limited; 2. The clinical diagnosis of liver cirrhosis is unlimited; 3. It is planned to conduct HVPG detection or TIPS operation; 4. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Hemorrhagic heart failure or severe valvular insufficiency; 2. Systemic infection or inflammation that is difficult to control; 3. Child Pugh score > 13 or end-stage liver disease score > 18; 4. Severe pulmonary hypertension; 5. Severe renal insufficiency; 6. Rapid progression of liver failure; 7. Diffuse malignant tumor of liver; 8. Combined with other system malignancies.

Design outcomes

Primary

MeasureTime frame
Spleen hardness measurement value;

Secondary

MeasureTime frame
Hepatic vein pressure gradient, HVPG;Liver stiffness measurement, LSM;Esophageal and gastric varices bleeding, EGVB;Ascites;Hepatic encephalopathy;Liver function;Subject operating characteristic curve (ROC);Sensitivity;Specificity;Positive predictive value;Negative predictive value;

Countries

China

Contacts

Public ContactZhang Jing

Beijing You'an Hospital, Capital Medical University

drzhangjing@163.com+86 13391859683

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026