Comparison of EUS-Guided Liver Biopsy With Percutaneous Liver Biopsy

• ClinicalTrials.gov Identifier: NCT02947516
• Recruitment Status: Unknown
• First Posted: October 28, 2016
• Last Update Posted: October 28, 2016
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): Marvin Ryou, Brigham and Women's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibrosis	Procedure: Endoscopic ultrasound-guided liver biopsy; Procedure: Percutaneous liver biopsy	Not Applicable

Detailed Description:

Currently, liver biopsy is the gold standard for determining the index of liver fibrosis in a patient with chronic liver disease, and whether the patient has progressed to cirrhosis. These biopsies are predominantly performed percutaneously. However, there are several complications related to liver biopsy, the most common of which are pain and bleeding.

There has been significant movement over the past several years to assess the utility of alternative techniques and approaches for the evaluation of liver disease. Endoscopic ultrasound (EUS) is a well-established technique for diagnostic and therapeutic evaluation of gastrointestinal and pancreaticobiliary disorders. EUS-guided liver biopsy (EUS-LB) has shown to be technically simple, safe, and provides adequate diagnostic yield for evaluation of liver disease in both children and adults. There are several advantages to EUS-LB. First, it would theoretically be less painful than the percutaneous approach, as it does not require skin puncture and also offers the comfort of sedation and analgesia. It also eliminates the need for breath hold. Furthermore, it is an image-guided approach which allows visualization and avoidance of blood vessels even 1 mm in size. Additionally, it provides an access area to a much wider segment of liver parenchyma as the entire left lobe, and the majority of the right lobe can be evaluated for possible needle puncture sites from the stomach and duodenal bulb, respectively. In addition to obtaining tissue, EUS-LB also offers the benefit of evaluating the biliary tree, gallbladder, pancreas, lymph nodes, and vascular anatomy for a more comprehensive evaluation in the same setting. Finally, in patients ultimately found to have biopsy-proven cirrhosis, it simultaneously provides the necessary variceal screening which would otherwise require an additional procedure.

The aim of this study is to prospectively perform EUS-guided liver biopsies in patients who are otherwise candidates for percutaneous biopsy. We 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 transjugular liver biopsies.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Pain Scores Between Endoscopic Ultrasound (EUS)-Guided Liver Biopsy and Percutaneous Liver Biopsy
• Study Start Date: January 2017
• Estimated Primary Completion Date: June 2018
• Estimated Study Completion Date: December 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Percutaneous liver biopsy; 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; Participants will undergo percutaneous liver biopsy per standard protocol.
Experimental: EUS-guided liver biopsy; 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; Participants will undergo endoscopic ultrasound per standard technique, with liver biopsy performed at that time.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Pain Scores on the Universal Pain Assessment Tool (UPAT) [ Time Frame: 48 hours ]

Secondary Outcome Measures :

1. Pain Medication Requirements [ Time Frame: 48 hours ]
   Use of any analgesics/narcotics
2. Histologic Yield [ Time Frame: 1 week ]
   Number of portal triads on histology

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Marvin Ryou, MD; 617-732-6389; mryou@partners.org

Contact: Allison R Schulman, MD; 617-732-6389; arschulman@partners.org

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

• Principal Investigator: Marvin Ryou, MD; Brigham and Women's Hospital

More Information

Publications of Results:

Bedossa P, Dargère D, Paradis V. Sampling variability of liver fibrosis in chronic hepatitis C. Hepatology. 2003 Dec;38(6):1449-57.

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.

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. Review.

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.

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.

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

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.

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.

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.

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. Review.

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.

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-Muñoz 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.

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.

• Responsible Party: Marvin Ryou, Principal Investigator, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02947516
• Other Study ID Numbers: 20162017
• First Posted: October 28, 2016
• Last Update Posted: October 28, 2016
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Marvin Ryou, Brigham and Women's Hospital:

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

Additional relevant MeSH terms:

Fibrosis; Pathologic Processes; Liver Extracts; Hematinics