Comparison of EUS-Guided Liver Biopsy With Percutaneous Liver Biopsy

Fibrosis Clinical Trial

Official title:

Comparison of Pain Scores Between Endoscopic Ultrasound (EUS)-Guided Liver Biopsy and Percutaneous Liver Biopsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02947516
• Other study ID #: 20162017
• Status: Withdrawn
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: April 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis

Intervention

Procedure:
• Endoscopic ultrasound-guided liver biopsy
Participants will undergo endoscopic ultrasound per standard technique, with liver biopsy performed at that time.
• Percutaneous liver biopsy
Participants will undergo percutaneous liver biopsy per standard protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

References & Publications (13)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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

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. — View Citation

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. 20 — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Pain Scores on the Universal Pain Assessment Tool (UPAT)		48 hours
Secondary	Pain Medication Requirements	Use of any analgesics/narcotics	48 hours
Secondary	Histologic Yield	Number of portal triads on histology	1 week