EUS-guided Response Assessment to NSBB

NCT ID: NCT06513195

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2026-07-31

Brief Summary

The goal of this clinical trial is to learn if endoscopic ultrasound (EUS)-guided portal pressure measurement can determine the treatment response to non-selective beta-blockers (NSBB) in patients with cirrhosis and clinically significant portal hypertension (CSPH). Participants will undergo EUS-guided portal pressure measurement before start of Carvedilol en after three months of treatment. EUS-guided measurements will be paired with transjugular hepatic venous pressure gradient (HVPG) measurement as well as non-invasive tests for assessment of portal hypertension.

Conditions

Portal Hypertension Related to Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

EUS-PPG before and after NSBB

Patients will undergo EUS-PPG and HVPG before and after NSBB treatment and will thus serve as their own control.

Group Type: EXPERIMENTAL

endoscopic ultrasound-guided portal pressure measurement

Intervention Type: PROCEDURE

The portal pressure gradient will be determined by endoscopic ultrasound-guided pressure measurement in the hepatic vein and the portal vein. The gradient will be calculated by substracting the hepatic vein pressure from the portal vein pressure.

Interventions

endoscopic ultrasound-guided portal pressure measurement

The portal pressure gradient will be determined by endoscopic ultrasound-guided pressure measurement in the hepatic vein and the portal vein. The gradient will be calculated by substracting the hepatic vein pressure from the portal vein pressure.

Intervention Type: PROCEDURE

Other Intervention Names

EUS-PPG

Eligibility Criteria

Inclusion Criteria

• Patients with a clinical and/or pathological diagnosis of compensated cirrhosis.
• Patients with suspicion of CSPH and thus indication for NSBB treatment.
• Patients not yet on NSBB therapy.
• Patients willing and able to undergo repeated HVPG and EUS-guided pressure measurements as per protocol.

Exclusion Criteria

General criteria

• Patient is <18 or >80 years of age
• Patient is pregnant, breast-feeding or planning to become pregnant during the course of the study
• Patient is unwilling or unable to sign the informed consent
• Patients in whom general anesthesia or endoscopic procedures are contraindicated Medical criteria
• Patients with cirrhosis and HCC Portopulmonary hypertension Portal or splanchnic venous thrombosis Prior TIPS Prior liver transplantation
• Non-cirrhotic portal hypertension or pre-sinusoidal liver disease
• Cholestatic liver disease with total bilirubin >3 mg/dl
• Previous total or partial splenectomy
• Known infection that is not controlled by medical intervention
• Patients with contraindications for non-selective beta-blocker therapy, including but not limited to the following baseline vital signs:

Systolic BP <100 mmHg HR <50 bpm

• Patients with reduced life expectancy described by an ASA score of 4 or 5
• INR >1.7 or platelet count <50.000 per mm3
• eGFR <50 ml/min/1.73m2 (CKD-EPI formula) Anatomical criteria
• Anatomical abnormalities that prevent access via EUS-guided puncture to the hepatic vein or intrahepatic portion of the portal vein, including anatomy that predisposes to difficult to reach puncture sites or an inadequate needle angle.
• Visualization of ascites interposing the puncture tract on EUS
• Diagnosis of portal vein thrombosis during EUS
• Evidence of active gastrointestinal bleeding during EUS

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Schalk van der Merwe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

University Hospital Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Emma Vanderschueren, MD

Role: CONTACT

emma.vanderschueren@uzleuven.be

0032 16 345918

Petra Windmolders

Role: CONTACT

petra.windmolders@uzleuven.be

003216 347581

Facility Contacts

Emma Vanderschueren, MD

Role: primary

emma.vanderschueren@uzleuven.be

000-000-0000 ext. 003216349518

Other Identifiers

s67433

Identifier Type: -

Identifier Source: org_study_id