Endoscopic Ultrasound vs Percutaneous Route for Liver Biopsy

Liver Biopsy Clinical Trial

Official title:

Randomized Trial Comparing Endoscopic Ultrasound-guided Liver Biopsy vs. Percutaneous Liver Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003766
• Other study ID #: 1438608
• Status: Completed
• Phase: N/A
• Start date: July 25, 2019
• Est. completion date: February 11, 2022

Study information

• Verified date: February 2022
• Source: AdventHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 11, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Biopsy

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Center for Interventional Endoscopy	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med. 2001 Feb 15;344(7):495-500. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Specimen length	Maximum specimen length in millimeters after formalin fixation will be documented.	24 hours
Secondary	Portal tracts	The total number of complete portal tracts for each biopsy specimen will be documented.	24 hours
Secondary	Rates of specimen adequacy	Inadequate specimen - defined as biopsy specimens from which a definitive histological diagnosis cannot be rendered by the pathologist.	24 hours
Secondary	Cross over	The rate of crossover to the other treatment arm will be documented	1 week, 30 days
Secondary	Procedure duration	The total length of time for the procedure will be documented in minutes.	24 hours
Secondary	Rate of adverse events	The subject will be asked to report and medical records will be reviewed for any adveerse events related to the procedure.	24 hours, 1 week, 30 days
Secondary	Procedural costs	The subject's account will be reviewed for total costs associated with the procedure.	30 days
Secondary	Pain scores	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.	24 hours, 1 week, 30 days