Liver Biopsy Clinical Trial
Official title:
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.
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.
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