Clinical trial NCT05118308: EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement
Official title: Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Gradient Measurement Compared to the Transjugular Approach: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Portal Hypertension
Chronic Liver Disease
Cirrhosis
Keywords: eus-portal pressure gradient
eus-liver biopsies
liver biopsy
portal pressure gradient
hepatic venous pressure gradient
transjugular-portal pressure gradient
Transjugular-Liver biopsies
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will directly compare the endoscopic ultrasound guided approach to obtain adequate liver biopsies and portal pressure gradient measurements to the current standard of care which uses the transjugular approach.

Detailed description: Current guidelines recommend that when a hepatic venous pressure gradient and a liver biopsy are needed, the liver biopsy should be done by the transjugular approach during the same session. A major limitation is that liver biopsies obtained by the transjugular approach meet quality criteria proposed by the American Association for the Study of Liver Diseases (at least 2-3cm with at least 11 complete portal tracts) in only 40% of cases.

Recent studies have shown that endoscopic ultrasound-guided liver biopsy (EUS-LB) can achieve a high rate of adequate liver biopsies using the same strict criteria described above. In addition, a novel endoscopic-ultrasound adapted manometer allows the safe and accurate measurement of portal pressure gradient (PPG) which correlates well with hepatic venous pressures (HVPG) obtained by the transjugular approach. Unfortunately to this day, no randomized controlled trials has compared the EUS-LB and PPG vs TJ-LB and HVPG directly.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Undergoing evaluation for chronic liver disease or portal hypertension
* Planned to undergo a liver biopsy and HVPG by their treating hepatologist for clinical purposes
* Signed informed consent

Exclusion Criteria:

* Uncorrectable coagulopathy (INR above 1.5)
* Uncorrectable thrombocytopenia (Platelets under 50,000)
* Anticoagulation or antiplatelet therapy that cannot be discontinued
* Surgically altered upper digestive anatomy
* Biliary obstruction
* Grade II ascites or more
* Intrahepatic portal vein thrombosis
* Previous liver transplantation
* Past hypersensitivity reaction to midazolam or ketamine
* History of psychotic disorder
* Pregnancy

Primary outcomes:
measure: Compare the proportion of adequate Liver Biopsy specimens with reliable portal pressure gradient obtained by TJ or EUS
timeFrame: 2 weeks
Secondary outcomes:
measure: Technical success
timeFrame: 1 day
measure: Liver biopsy-related outcomes
timeFrame: 2 weeks
measure: PPG-related outcomes
timeFrame: 1 day
measure: Adverse events
timeFrame: 30 days
measure: Satisfaction with sedation
timeFrame: 1 day
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References: