Endoscopic Ultrasound vs Percutaneous Route for Liver Biopsy

NCT ID: NCT04003766

Last Updated: 2022-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-25
• Study Completion Date: 2022-02-11

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

Conditions

Liver Biopsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Percutaneous 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.

Group Type: ACTIVE_COMPARATOR

biopsy

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

biopsy

Intervention Type: 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.

Interventions

biopsy

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AdventHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Hasan, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

Center for Interventional Endoscopy

Orlando, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11172192 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19243014 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30846147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26301407 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29091001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28972801 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30389469 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

1438608

Identifier Type: -

Identifier Source: org_study_id