EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement

Cirrhosis Clinical Trial

Official title:

Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Gradient Measurement Compared to the Transjugular Approach: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118308
• Other study ID #: 2021.7601
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2021
• Est. completion date: December 4, 2023

Study information

• Verified date: December 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Amine Benmassaoud, MD
• Phone: 514-843-1421
• Email: amine.benmassaoud[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: December 4, 2023
• Est. primary completion date: November 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Cirrhosis
• Hypertension, Portal
• Liver Diseases
• Portal Hypertension

Intervention

Procedure:
• Transjugular hepatic venous pressure gradient measurement with liver biopsy
This procedure will be performed by an experienced interventional radiologist who will be supported by a radiology technician and nurse. Transjugular hepatic venous pressure gradient measurement will be performed using standard procedure. Following this, a transjugular liver biopsy will be obtained using an 18-gauge transjugular liver biopsy needle.
• Endoscopic ultrasound portal pressure gradient measurement with liver biopsy
A linear echoendoscope is inserted with the patient under conscious sedation. Using a through the scope 25-gauge needle connected to a digital manometer, portal and hepatic veins will be punctured under EUS guidance from a trans-gastric/hepatic approach. Following this, EUS-Liver biopsy is then performed immediately following EUS-PPG using a 19-gauge fine needle biopsy (FNB).

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the proportion of adequate Liver Biopsy specimens with reliable portal pressure gradient obtained by TJ or EUS	Liver Biopsy (LB) specimens are defined as a biopsy of at least 25mm in length following formalin fixation and at least 11 complete portal tracts. The Portal pressure gradient (PPG) measurement is defined as two PPG values with less than 2mmHg difference.	2 weeks
Secondary	Technical success	Compare the proportion of HVPG and LB obtained by TJ or EUS approach	1 day
Secondary	Liver biopsy-related outcomes	Number of adequate liver biopsies obtained, total aggregate length (defined as the sum of the lengths of all specimens following fixation), number of complete portal tracts per specimen, and total number of passes needed.	2 weeks
Secondary	PPG-related outcomes	Number of PPG obtained, number of reliable PPG obtained	1 day
Secondary	Adverse events	Proportion of adverse events in the TJ and EUS arms following the procedure, at day 7, and day 30.	30 days
Secondary	Satisfaction with sedation	Compare the score obtained on the sedation satisfaction surveys as completed by the participant and the physician within the 2 arms	1 day