Endoscopic Ultrasound vs Percutaneous Route for Liver Biopsy

NCT04003766 | Completed DMC FDA Device

• 1 other identifier: 1438608
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Biopsy

Keywords

percutaneous biopsy; endoscopic guided biopsy; liver; hepatic conditions

Outcome Measures

Primary Outcomes (1)

• Diagnostic adequacy of the tissue sample

  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.

  24 hours

Secondary Outcomes (8)

• Specimen length

  24 hours

• Portal tracts

  24 hours

• Rates of specimen adequacy

  24 hours

• Cross over

  1 week, 30 days

• Procedure duration

  24 hours

Study Arms (2)

Percutaneous Biopsy

ACTIVE COMPARATOR

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.

Diagnostic Test: biopsy

Endoscopic-guided Ultrasound Biopsy

ACTIVE COMPARATOR

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.

Diagnostic Test: biopsy

Interventions

biopsy DIAGNOSTIC_TEST

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.

Endoscopic-guided Ultrasound Biopsy; Percutaneous Biopsy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Center for Interventional Endoscopy

Orlando, Florida, 32803, United States

Location

Related Publications (8)

• Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med. 2001 Feb 15;344(7):495-500. doi: 10.1056/NEJM200102153440706. No abstract available.

  PMID: 11172192 BACKGROUND

• Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD; American Association for the Study of Liver Diseases. Liver biopsy. Hepatology. 2009 Mar;49(3):1017-44. doi: 10.1002/hep.22742. No abstract available.

  PMID: 19243014 BACKGROUND

• Diehl DL. Endoscopic Ultrasound-guided Liver Biopsy. Gastrointest Endosc Clin N Am. 2019 Apr;29(2):173-186. doi: 10.1016/j.giec.2018.11.002. Epub 2019 Feb 2.

  PMID: 30846147 BACKGROUND

• Pineda JJ, Diehl DL, Miao CL, Johal AS, Khara HS, Bhanushali A, Chen EZ. EUS-guided liver biopsy provides diagnostic samples comparable with those via the percutaneous or transjugular route. Gastrointest Endosc. 2016 Feb;83(2):360-5. doi: 10.1016/j.gie.2015.08.025. Epub 2015 Aug 22.

  PMID: 26301407 BACKGROUND

• Tublin ME, Blair R, Martin J, Malik S, Ruppert K, Demetris A. Prospective Study of the Impact of Liver Biopsy Core Size on Specimen Adequacy and Procedural Complications. AJR Am J Roentgenol. 2018 Jan;210(1):183-188. doi: 10.2214/AJR.17.17792. Epub 2017 Nov 1.

  PMID: 29091001 BACKGROUND

• Hall TC, Deakin C, Atwal GS, Singh RK. Adequacy of percutaneous non-targeted liver biopsy under real-time ultrasound guidance when comparing the Biopince and Achieve biopsy needle. Br J Radiol. 2017 Dec;90(1080):20170397. doi: 10.1259/bjr.20170397. Epub 2017 Oct 3.

  PMID: 28972801 BACKGROUND

• Mohan BP, Shakhatreh M, Garg R, Ponnada S, Adler DG. Efficacy and safety of EUS-guided liver biopsy: a systematic review and meta-analysis. Gastrointest Endosc. 2019 Feb;89(2):238-246.e3. doi: 10.1016/j.gie.2018.10.018. Epub 2018 Oct 31.

  PMID: 30389469 BACKGROUND

• Wyatt J, Hubscher S, Bellamy C. Tissue pathways for liver biopsies for the investigation of medical disease and for focal lesions. London, UK: The Royal College of Pathologists; 2014.

  BACKGROUND

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Muhammad Hasan, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The pathologist will be blinded to the procedure received by the patient.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized trial comparing two methods for procuring liver biopsy: 1) EUS-guided and 2) percutaneous.

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: July 1, 2019
• Study Start: July 25, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 11, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)