EUS-guided Response Assessment to NSBB

NCT06513195 | Recruiting

• 1 other identifier: s67433
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

portal hypertension; EUS-PPG; HVPG; cirrhosis; non-selective beta blockers

Outcome Measures

Primary Outcomes (1)

• EUS-guided response assessment to NSBB in the treatment of CSPH.

  To assess if a positive response to non-selective beta-blockers (NSBB) treatment, as determined by a reduction of 10% or more in the hepatic venous pressure gradient (HVPG) and/or a decrease to values less than 12 mmHg, can be similarly observed using endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement.

  Three months

Secondary Outcomes (6)

• Correlation of EUS-PPG with HVPG

  Three months

• Correlation of FHVP with HVP.

  Three months

• Correlation of PVP with WHVP.

  Three months

• CSPH assessed via EUS-guided pressure measurement.

  Three months

• Correlation of sequential EUS-PPG and HVPG with non-invasive assessment tools before/after treatment with NSBB.

  Three months

Study Arms (1)

EUS-PPG before and after NSBB

EXPERIMENTAL

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

Procedure: endoscopic ultrasound-guided portal pressure measurement

Interventions

endoscopic ultrasound-guided portal pressure measurement 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.

Also known as: EUS-PPG

EUS-PPG before and after NSBB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Schalk van der Merwe, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Vanderschueren, MD

CONTACT

0032 16 345918; emma.vanderschueren@uzleuven.be

Petra Windmolders

CONTACT

003216 347581; petra.windmolders@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 22, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 26, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)