Clinical trial NCT02947516: Comparison of EUS-Guided Liver Biopsy With Percutaneous Liver Biopsy
Official title: Comparison of Pain Scores Between Endoscopic Ultrasound (EUS)-Guided Liver Biopsy and Percutaneous Liver Biopsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fibrosis
Keywords: Endoscopic Ultrasound-Guided Fine Needle Aspiration
liver
biopsy
pain
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Pain Scores on the Universal Pain Assessment Tool (UPAT)
timeFrame: 48 hours
Secondary outcomes:
measure: Pain Medication Requirements
timeFrame: 48 hours
measure: Histologic Yield
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Marvin Ryou, MD
role: PRINCIPAL_INVESTIGATOR
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