Liver Biopsy Using a 19 Gauge Fine Needle Biopsy Needle

July 15, 2020 updated by: AdventHealth

Endoscopic Ultrasound Guided Liver Biopsy Using a 19-gauge Fine Needle Biopsy Needle

A 19 gauge FNB needle, using same technique as with 22 gauge needle, to obtain liver histological specimen in regards to core length and the number of Complete Portal Triads.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Liver biopsy (LB) has historically been performed by percutaneous route without image guidance (blind biopsy). However, in the last several years there has been more reliance on image guidance ultrasound-guided (USG) or computed tomography (CT) to direct the needle into the liver with the hope of limiting complications 1. Other ways of performing liver biopsy are transjugular fluoroscopy guided approach when percutaneous route is deemed not safe because of coagulopathy or ascites 2. Surgical LB (either laparoscopic or open) is yet another way of obtaining liver tissue.

Endoscopic ultrasound guided liver biopsy (EUS-LB) is proposed as a newer method that may offer several potential advantages over existing techniques for attaining liver tissue 3-8. It can be performed in an outpatient setting and offers the comfort of sedation and analgesia. EUS-LB is a technically reproducible approach regardless of body habitus, because the needle only requires traversing the gastric or duodenal wall to reach hepatic parenchyma. It also offers the benefit of a comprehensive evaluation of the GI tract, including screening or surveying for esophageal varices. EUS provides high resolution images of left lobe of the liver and a good portion of the right lobe of the liver. This coupled with Doppler capability the biopsy needle can be safely directed into the liver for sampling under real time image guidance. Intervening structures such as pleura, bowel loops and gallbladder can be easily seen by EUS and thus avoided that further decreases the risk of adverse events. It has been recognized that sampling error can lead to diagnostic inaccuracy of a biopsy from a single site 9. As compared to USG or CT scan the EUS allows easy and safe biopsy of both left and right lobes of the liver during same setting, potentially addressing concerns about sampling error.

The cost of the endoscopic procedure is the main expense of EUS-LB. Thus, this approach is best used for patients requiring EUS for evaluation of elevated liver tests. If no obstructive lesion is identified by EUS that will require ERCP then it would cost-effective to perform EUS LB during the same setting without much additional time and risks. This approach can spare the patient the additional discomfort and expense of a second dedicated LB procedure by any of the other available techniques (percutaneous, transjugular etc.). In such setting the equipment costs for the EUS-LB will mainly include only the Fine Needle Biopsy (FNB) needle, which is similar in expense to the cost of needles for the transjugular or percutaneous approach.

The traditionally used transcutaneous LB needle is 16 gauge (G) while largest EUS biopsy needle is 19 gauge. The smaller size of the needle is expected to decrease the complications rate (mainly pain and bleeding) even further. Many studies using a 19 gauge Tru-cut biopsy or Fine Needle Aspiration (FNA) needle to acquire liver tissue have obtained specimens adequate for histologic diagnosis 3-7 but there has been a wide range of specimen adequacy (19-100%). Overall, there is limited data comparing the diagnostic yield of different FNA and FNB needles.

In a recently reported systematic review and meta-analysis 10, the insufficient specimen rate with 19 gauge FNA needle was 4% compared with 20% with 19 gauge core needles, with a p value of 0.03. FNA needle demonstrated a non-significant trend toward better diagnostic results (95.8% vs 92.7%, p=0.59) and a non-significant trend toward lower rates of adverse-events (0.9% vs 2.7%, p=0.28) when compared with the core biopsy needles. The 19-gauge FNA needle used was EchoTip (Wilson Cook Medical) in one study 6 and Expect (Boston Scientific) in rest two studies 8,11. The various types of core needles used were Quick-Core 12, Pro-Core 12, SharkCore 13,14, and the Acquire needle 15.

The 19 gauge FNA needle was used in 22 patients and yielded adequate tissue for histological analysis in 20 (91 %) of them 6. In the largest multi-center EUS-LB study of 110 patients 8 where a 19 gauge FNA needle was used for liver biopsy, bilobular liver biopsy was obtained in 68 patients (62%). Even though 108 (98 %) of 110 patients yielded specimens sufficient for definitive pathological diagnosis, there were five patients where the tissue yield was less than 6 complete portal triads (CPTs) with aggregate length less than 15 mm; the value used as a reference standard in recent studies 4-6. The rate of complications was very low (1/110) 0.9% in this study.

Two ex-vivo studies demonstrated the significantly superior histologic yield, with a greater number of CPT, obtained using the novel 19 gauge SharkCore FNB 16 and 22 gauge SharkCore FNB needles 16,17, compared with 18 gauge percutaneous needles and existing 19 gauge FNA and other core needles.

The study team prospectively aimed at evaluating the diagnostic adequacy and safety of EUS-LB using a 22 gauge FNB needle while using proper technique of tissue expression from the needle to prevent fragmentation of the specimen. Forty patients underwent EUS-LB. Adequate core tissue for histopathological evaluation was obtained in all 40 patients (100%) without the use of suction. The overall tissue yield per pass was a median core length (longest fragment per pass) of 5 mm (range 2mm-33mm) and median CPT of 17 (range 8-65). The most common minor complication was mild abdominal pain in 3 patients (17.6 %) at 24 hours. There were no major complications, and no immediate or delayed bleeding (presented at DDW 2018).

In this study the study team will use a 19 gauge FNB needle, using same technique as with 22 gauge needle, to obtain liver histological specimen in regards to core length and the number of CPT.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Center for Interventional Endoscopy - Florida Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All patients referred to Florida Hospital Endoscopy Unit for assessment of elevated liver tests with EUS and are found to have no obstructive lesion to explain elevation of liver tests and will not require ERCP.
  2. Age ≥ 19 years
  3. Willing to provide informed consent verbal or written.

Exclusion Criteria:

  1. Age <19 years
  2. Unable to safely undergo EUS for any reason
  3. Coagulopathy (INR >1.6, Thrombocytopenia with platelet count <50,000/ml) for subjects on anti-coagulation therapy.
  4. Unwilling or cognitively unable to provide informed consent verbal or written.
  5. Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 19 Gauge needle liver biopsy
Obtaining liver tissue with a 19 gauge core needle
Device: 19 gauge needle liver biopsy
Obtaining liver tissue with a 19 gauge core needle and whether a good core biopsy can be obtained without the use of suction and secondly to determine the diagnostic yield and safety of 19 gauge core needle for liver biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic adequacy
Time Frame: At time of procedure
Determine the diagnostic adequacy of the liver biopsy specimen by obtaining a histological specimen using a smaller (19 G) caliber needle. Diagnostic adequacy is defined as a sample that provides definitive pathological diagnosis (yes, no).
At time of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technique
Time Frame: At time of procedure
Refine and determine the optimal technique of EUS-LB determined by the diagnostic adequacy of the liver biopsy specimen
At time of procedure
Suction
Time Frame: At time of procedure
Sample was obtained using suction (yes/no).
At time of procedure
Number of passes
Time Frame: At time of procedure
Assessing the median number of passes required to obtain diagnostically adequate histological samples histological samples histological samples
At time of procedure
Needle Dysfunction
Time Frame: At time of procedure
Did needle dysfunction occur (yes/no)?
At time of procedure
Technical failure
Time Frame: At time of procedure
Was there a technical failure (yes/no)?
At time of procedure
Complications/Bleeding
Time Frame: At time of procedure; 3 days post-procedure; & 30 days post procedure
Assessing subjects for post-procedural complications via follow up phone calls. Bleeding (yes/no).
At time of procedure; 3 days post-procedure; & 30 days post procedure
Complications/Pain
Time Frame: At time of procedure; 3 days post-procedure; & 30 days post procedure
Assessing subjects for post-procedural complications via follow up phone calls. Pain (yes/no).
At time of procedure; 3 days post-procedure; & 30 days post procedure
Complications/Infection
Time Frame: At time of procedure; 3 days post-procedure; & 30 days post procedure
Assessing subjects for post-procedural complications via follow up phone calls. Infection (yes/no).
At time of procedure; 3 days post-procedure; & 30 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Muhammad Hasan, MD, Florida Hospital (AdventHealth Orlando)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Actual)

November 22, 2019

Study Completion (Actual)

November 22, 2019

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1354057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share individual patient data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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