Non-invasive tests to safely avoid screening endoscopy in patients with liver cirrhosis in Kuwait
| ISRCTN | ISRCTN17426305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17426305 |
| Sponsor | Adan Hospital |
| Funder | Adan Hospital |
- Submission date
- 15/07/2026
- Registration date
- 16/07/2026
- Last edited
- 16/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Cirrhosis (liver scarring) can cause enlarged veins in the food pipe, called varices, which may bleed. Doctors usually screen for these with a camera test (endoscopy), but many patients turn out to be at low risk and gain nothing from the test. This study looked at whether two simple, non-invasive measurements, a FibroScan (a painless scan of liver stiffness) and a routine blood platelet count, can safely identify which patients can avoid endoscopy. It focused on patients whose cirrhosis is linked to fatty liver disease, including those with obesity, in a Kuwaiti (Gulf Arab) population where these criteria had not been tested before.
Who can participate?
Adults aged 18 years and over with early-stage (compensated) cirrhosis who were undergoing routine liver assessment
What does the study involve?
Participants had the tests that are already part of their routine care: a FibroScan, a blood test for platelet count, and an upper endoscopy. The non-invasive measurements were compared against the endoscopy findings to see how reliably they identify patients with high-risk varices so that endoscopy could be safely avoided in the future. No extra procedures, medicines, or samples were added for the study.
What are the possible benefits and risks of participating?
Participants may not benefit directly. The findings may help doctors decide which patients with cirrhosis can safely avoid unnecessary endoscopy in the future. There were no additional risks beyond the routine tests participants were already having.
Where is the study run from?
Al Adan Hospital (Kuwait)
When is the study starting and how long is it expected to run for?
January 2022 to April 2026
Who is funding the study?
Al Adan Hospital (Kuwait)
Who is the main contact?
Dr Yaqoub Alshatti, dralshattiy@gmail.com
Contact information
Public, Scientific, Principal investigator
Gastroenterology Unit and Endoscopy Department, Al Adan Hospital, Ministry of Health, Ahmadi Health Region
Hadiya Area
61001
Kuwait
 ORCID ID |
0000-0003-1142-5314 |
|---|---|
| Phone | +965 (0)66635336 |
| alshatti1862@moh.gov.kw; dralshattiy@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | Baveno VII endoscopy-sparing criteria in MASLD-predominant compensated cirrhosis: a prospective validation from a Gulf Arab population (Kuwait) |
| Study acronym | BAVENO-KW |
| Study objectives | To prospectively evaluate whether the Baveno VII non-invasive criteria (liver stiffness measurement by transient elastography plus platelet count) can safely identify patients with compensated cirrhosis who may avoid screening endoscopy for high-risk oesophageal varices, with pre-specified analysis by MASLD and obesity status, and to externally assess the ANTICIPATE-NASH model for predicting clinically significant portal hypertension |
| Ethics approval(s) |
Approved 04/01/2022, Research Ethics Committee (Ministry of Health, Kuwait, 13001, Kuwait; +965 (0)90069869; hkhamis@moh.gov.kw), ref: MOH/REC/060720221394 |
| Health condition(s) or problem(s) studied | Compensated cirrhosis (compensated advanced chronic liver disease), predominantly due to metabolic dysfunction-associated steatotic liver disease (MASLD) |
| Methodology | Consecutive Kuwaiti adults with compensated cirrhosis underwent, within 3 months, vibration-controlled transient elastography (liver stiffness measurement and controlled attenuation parameter), a platelet count, and reference-standard upper gastrointestinal endoscopy performed by endoscopists blinded to elastography results. Baveno VI, Expanded Baveno VI, Baveno VII, and ANTICIPATE-NASH criteria were applied, with high-risk varices at endoscopy as the primary endpoint. Aetiology was classified per the 2023 multi-society MASLD nomenclature. Diagnostic performance (miss rate, negative predictive value, sensitivity, specificity) was calculated for the full cohort and by pre-specified subgroups (MASLD with obesity, MASLD without obesity, non-MASLD). Analyses used Wilson 95% confidence intervals, DeLong's method for ROC comparison, and multivariable logistic regression. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/04/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 380 |
| Total final enrolment | 380 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/01/2022 |
| Date of final enrolment | 30/04/2026 |
Locations
Countries of recruitment
- Kuwait
Study participating centre
Kuwait
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
16/07/2026: Study's existence confirmed by Adan Hospital.
