Comparison of EUS-Guided Liver Biopsy With Percutaneous Liver Biopsy

NCT02947516 | Withdrawn DMC

• 1 other identifier: 20162017
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

There are several ways to perform liver biopsies, including the percutaneous route (historical gold standard) and via endoscopic ultrasound (EUS) guidance. The primary aim of this study is to prospectively compare patients undergoing EUS-guided liver biopsies to patients undergoing percutaneous biopsy. The investigators hypothesize that (1) patients who are randomized to undergo EUS-guided liver biopsy will rate themselves as having less pain in the 48 hours following the procedure, and (2) will have comparable histologic yield to a 2:1 matched cohort of patients undergoing percutaneous liver biopsies.

Conditions

Fibrosis

Keywords

Endoscopic Ultrasound-Guided Fine Needle Aspiration; liver; biopsy; pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pain Scores on the Universal Pain Assessment Tool (UPAT)

  48 hours

Secondary Outcomes (2)

• Pain Medication Requirements

  48 hours

• Histologic Yield

  1 week

Study Arms (2)

Percutaneous liver biopsy

ACTIVE COMPARATOR

Participants will be referred for liver biopsy by their hepatologist/gastroenterologist. The intervention is that these participants will undergo a percutaneous liver biopsy per standard protocol.

Procedure: Percutaneous liver biopsy

EUS-guided liver biopsy

EXPERIMENTAL

Participants will be referred for liver biopsy by their hepatologist/gastroenterologist. The intervention is that these participants will undergo an endoscopic ultrasound procedure per standard protocol. The liver will be identified, and Color Doppler imaging prior to needle puncture will confirm lack of significant vascular structures within the needle path. Liver biopsies using up to 1-2 passes from the left hepatic lobe using a transgastric approach and up to 1-2 passes from the right hepatic lobe using a transduodenal bulb approach will be performed. The participant will be observed in the recovery unit for up to 60 minutes after the EUS-LB, and discharged if no pain or signs of complication.

Procedure: Endoscopic ultrasound-guided liver biopsy

Interventions

Endoscopic ultrasound-guided liver biopsy PROCEDURE

Participants will undergo endoscopic ultrasound per standard technique, with liver biopsy performed at that time.

EUS-guided liver biopsy

Percutaneous liver biopsy PROCEDURE

Participants will undergo percutaneous liver biopsy per standard protocol.

Percutaneous liver biopsy

Eligibility Criteria

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

You may qualify if:

• Age 18 years and older
• Eligibility for receiving conscious sedation or monitored anesthesia care
• Abnormal liver function tests with comprehensive previous evaluation (including serologic testing and cross-sectional imaging) leading to an appropriate decision to proceed with liver biopsy and/or portal pressure measurements.

You may not qualify if:

• Suspected or known malignant liver disease
• Severe thrombocytopenia (platelets \<50,000/microL)
• Severe coagulopathy (international normalized ratio \[INR\] \> 1.7 or other known coagulopathy)
• Use of antiplatelet agents within 7 days of the procedure
• Inability to provide informed consent
• Pregnancy or suspected pregnancy

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (13)

• Bedossa P, Dargere D, Paradis V. Sampling variability of liver fibrosis in chronic hepatitis C. Hepatology. 2003 Dec;38(6):1449-57. doi: 10.1016/j.hep.2003.09.022.

  PMID: 14647056 RESULT

• Eisenberg E, Konopniki M, Veitsman E, Kramskay R, Gaitini D, Baruch Y. Prevalence and characteristics of pain induced by percutaneous liver biopsy. Anesth Analg. 2003 May;96(5):1392-1396. doi: 10.1213/01.ANE.0000060453.74744.17.

  PMID: 12707140 RESULT

• Caldwell SH. Controlling pain in liver biopsy, or "we will probably need to repeat the biopsy in a year or two to assess the response". Am J Gastroenterol. 2001 May;96(5):1327-9. doi: 10.1111/j.1572-0241.2001.03847.x. No abstract available.

  PMID: 11374664 RESULT

• Piccinino F, Sagnelli E, Pasquale G, Giusti G. Complications following percutaneous liver biopsy. A multicentre retrospective study on 68,276 biopsies. J Hepatol. 1986;2(2):165-73. doi: 10.1016/s0168-8278(86)80075-7.

  PMID: 3958472 RESULT

• Huang JF, Hsieh MY, Dai CY, Hou NJ, Lee LP, Lin ZY, Chen SC, Wang LY, Hsieh MY, Chang WY, Yu ML, Chuang WL. The incidence and risks of liver biopsy in non-cirrhotic patients: An evaluation of 3806 biopsies. Gut. 2007 May;56(5):736-7. doi: 10.1136/gut.2006.115410. No abstract available.

  PMID: 17440193 RESULT

• Perrault J, McGill DB, Ott BJ, Taylor WF. Liver biopsy: complications in 1000 inpatients and outpatients. Gastroenterology. 1978 Jan;74(1):103-6.

  PMID: 618417 RESULT

• Firpi RJ, Soldevila-Pico C, Abdelmalek MF, Morelli G, Judah J, Nelson DR. Short recovery time after percutaneous liver biopsy: should we change our current practices? Clin Gastroenterol Hepatol. 2005 Sep;3(9):926-9. doi: 10.1016/s1542-3565(05)00294-6.

  PMID: 16234032 RESULT

• Stone MA, Mayberry JF. An audit of ultrasound guided liver biopsies: a need for evidence-based practice. Hepatogastroenterology. 1996 Mar-Apr;43(8):432-4.

  PMID: 8714240 RESULT

• Hollerbach S, Willert J, Topalidis T, Reiser M, Schmiegel W. Endoscopic ultrasound-guided fine-needle aspiration biopsy of liver lesions: histological and cytological assessment. Endoscopy. 2003 Sep;35(9):743-9. doi: 10.1055/s-2003-41593.

  PMID: 12929021 RESULT

• Fuccio L, Larghi A. Endoscopic ultrasound-guided fine needle aspiration: How to obtain a core biopsy? Endosc Ultrasound. 2014 Apr;3(2):71-81. doi: 10.4103/2303-9027.123011.

  PMID: 24955336 RESULT

• Stavropoulos SN, Im GY, Jlayer Z, Harris MD, Pitea TC, Turi GK, Malet PF, Friedel DM, Grendell JH. High yield of same-session EUS-guided liver biopsy by 19-gauge FNA needle in patients undergoing EUS to exclude biliary obstruction. Gastrointest Endosc. 2012 Feb;75(2):310-8. doi: 10.1016/j.gie.2011.09.043.

  PMID: 22248599 RESULT

• Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.

  PMID: 21420083 RESULT

• Johal AS, Khara HS, Maksimak MG, Diehl DL. Endoscopic ultrasound-guided liver biopsy in pediatric patients. Endosc Ultrasound. 2014 Jul;3(3):191-4. doi: 10.4103/2303-9027.138794.

  PMID: 25184126 RESULT

MeSH Terms

Conditions

Fibrosis; Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Marvin Ryou, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 28, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share