EUS-guided Response Assessment to NSBB

Официальное название

Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension

Обзор

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• EUS-guided response assessment to NSBB in the treatment of CSPH. [Срок оценки: Three months]

Вторичные конечные точки (6)

• Correlation of EUS-PPG with HVPG [Срок оценки: Three months]
• Correlation of FHVP with HVP. [Срок оценки: Three months]
• Correlation of PVP with WHVP. [Срок оценки: Three months]
• CSPH assessed via EUS-guided pressure measurement. [Срок оценки: Three months]
• Correlation of sequential EUS-PPG and HVPG with non-invasive assessment tools before/after treatment with NSBB. [Срок оценки: Three months]
• Safety of repeated EUS-PPG [Срок оценки: 14 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Бельгия · 1 центр

• University Hospital Leuven — Leuven

Идентификаторы

NCT: NCT06513195 · s67433

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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