Compensated cirrhosis (compensated advanced chronic liver disease), predominantly due to metabolic dysfunction-associated steatotic liver disease (MASLD) Digestive System
Conditions
Interventions
Consecutive Kuwaiti adults with compensated cirrhosis underwent, within 3 months, vibration-controlled transient elastography (liver stiffness measurement and controlled attenuation parameter), a plat
Sponsors
Adan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Kuwaiti nationality 3. Compensated cirrhosis (Child–Pugh A or B, no prior decompensation) 4. Liver stiffness measurement by vibration-controlled transient elastography within 3 months of index endoscopy 5. Concurrent platelet count within 3 months 6. Qualifying upper gastrointestinal endoscopy as reference standard 7. No prior non-selective beta-blocker therapy for portal hypertension prophylaxis 8. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Decompensated cirrhosis 2. Active hepatocellular carcinoma or other malignancy 3. Portal vein thrombosis >50% luminal occlusion 4. Prior transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt 5. Prior endoscopic variceal band ligation 6. Technically unreliable liver stiffness measurement (LSM) (interquartile range/median >30% with LSM >7.1 kPa) 7. Acute-on-chronic liver failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of high-risk oesophageal varices measured using detection of high-risk varices (F2/F3 oesophageal varices, or any varix with high-risk stigmata) at upper gastrointestinal endoscopy, compared against the Baveno VII rule-out criterion (LSM 150 × 10?/L); expressed as miss rate and negative predictive value; at enrolment (single timepoint; index endoscopy within 3 months of elastography) | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparative performance of Baveno VI, Expanded Baveno VI, and Baveno VII criteria measured using the proportion of endoscopies spared and miss rate for each at enrolment;ANTICIPATE-NASH performance for clinically significant portal hypertension measured using positive predictive value versus LSM =25 kPa alone, with Hosmer–Lemeshow calibration, at enrolment;Optimal LSM threshold by subgroup measured using area under the receiver operating characteristic curve (AUROC) and Youden cutoff by DeLong's method at enrolment | — |
Countries
Kuwait
Contacts
Public ContactYaqoub Alshatti
Outcome results
None listed