Endoscopic Ultrasound vs Percutaneous Route for Liver Biopsy

Not Applicable

Completed

• Conditions: Liver Biopsy
• Interventions: Diagnostic Test: biopsy

• Registration Number: NCT04003766
• Lead Sponsor: AdventHealth

Brief Summary

This study is to evaluate and directly compare the technical success, tissue quality, diagnostic efficacy and safety profile of Percutaneous and Endoscopic Ultrasound-guided Liver Biopsy.

Detailed Description

Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.1 Since it was first performed in 1883, percutaneous (PC) liver biopsy has become routine practice and is usually performed under the guidance of real-time imaging using transabdominal ultrasound (US) or computed tomography (CT).1,2 However, in recent times, liver biopsy has been increasingly performed via transgastric or transduodenal routes under endoscopic ultrasound (EUS) guidance. The perceived advantages of performing EUS-LB compared to PC-LB are the ability to simultaneously assess other organs such as common bile duct and pancreas, access to both left and right lobes of the liver and the routine use of conscious sedation during EUS procedures.3 Although single arm cohort studies and retrospective comparative studies assessing the technical success, tissue quality and safety of these different liver biopsy modalities exist, currently there are no randomized trials comparing PC and EUS-guided LB.4-7

Study Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-01
• Study Start: 2019-07-25
• Primary Completion: 2020-12-31
• Status Verified: 2022-02
• Study Completion: 2022-02-11
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. All patients referred for liver biopsy for any reason
2. Informed consent obtained from the patient
3. ≥ 18 years old
4. Able to undergo conscious sedation for EUS procedure

Exclusion Criteria

1. <18 years old
2. Unable to obtain informed consent from the patient
3. Medically unfit for sedation
4. Pregnant patients
5. Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging
6. Irreversible coagulopathy as determined by platelet count < 50,000 mm3 or International Normalized Ratio (INR) > 1.5
7. Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure
8. Hemophilia
9. Presence of an alternative etiology for elevated liver tests seen during liver biopsy, e.g. choledocholithiasis discovered during EUS examination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous Biopsy	biopsy	The subject would undergo the standard of care procedure for a percutaneous biopsy of the liver. All percutaneous biopsies will be performed after administration of local anesthetic. No pre-procedure antibiotics will be administered. Subcostal or subxyphoid area will be cleaned and draped in the standard manner. 2% lidocaine solution will be injected subcutaneously using a 25-gauge needle and then administered into the subcutaneous tissue up to the liver capsule. A 16-gauge biopsy needle is inserted into the liver parenchyma under US or CT-guidance, with the location of needle placement left to the discretion of the performing radiologist. One or two core biopsy samples will be obtained. All procured specimens will be placed in a single specimen container of 10% formalin for tissue processing. When biopsy samples have been obtained, the patient will be taken to the recovery area for post-procedure monitoring.
Endoscopic-guided Ultrasound Biopsy	biopsy	The subject would undergo the standard of care procedure for an endoscopic-guided biopsy of the liver. The left lobe of the liver is identified from the gastric lumen, EUS-guided fine needle biopsy (FNB) will be performed using a 19-gauge FNB needle, with the choice of needle type at the discretion of the performing endoscopist. Stylet will only be used to puncture the liver at the time of the first pass and then subsequently removed. No suction will be used. Fanning technique will not be used. A total of 10 to-and-fro needle movements will be performed during each pass. A total of two passes will be performed.All tissue specimens procured will be placed in a single specimen container of 10% formalin for tissue processing. When two passes are complete under EUS-guidance, the echoendoscope will be withdrawn from the patient and the patient will be taken to the recovery area for post-procedure monitoring.

Primary Outcome Measures

Name	Time	Method
Diagnostic adequacy of the tissue sample	24 hours	The primary outcome of the randomized trial is to compare between EUS-LB and PC-LB, the rate of procurement of diagnostically adequate specimens, defined as the presence of both maximum specimen length ≥ 25mm AND total no. of complete portal tracts ≥ 11.

Secondary Outcome Measures

Name	Time	Method
Pain scores	24 hours, 1 week, 30 days	Pain scores measured using the Visual Analog Scale (VAS) on a scale of 0 - 10 with 0 representing no pain and 10 representing the worst pain the subject has ever had; before and after biopsy has been performed.
Rate of adverse events	24 hours, 1 week, 30 days	The subject will be asked to report and medical records will be reviewed for any adveerse events related to the procedure.
Specimen length	24 hours	Maximum specimen length in millimeters after formalin fixation will be documented.
Portal tracts	24 hours	The total number of complete portal tracts for each biopsy specimen will be documented.
Rates of specimen adequacy	24 hours	Inadequate specimen - defined as biopsy specimens from which a definitive histological diagnosis cannot be rendered by the pathologist.
Cross over	1 week, 30 days	The rate of crossover to the other treatment arm will be documented
Procedure duration	24 hours	The total length of time for the procedure will be documented in minutes.
Procedural costs	30 days	The subject's account will be reviewed for total costs associated with the procedure.

Trial Locations

Locations (1)

Center for Interventional Endoscopy; 🇺🇸 Orlando, Florida, United States