Endoscopic Ultrasound Guided Liver Biopsy
Status: | Completed |
---|---|
Conditions: | Liver Cancer, Liver Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 19 - Any |
Updated: | 2/13/2019 |
Start Date: | August 1, 2017 |
End Date: | October 1, 2018 |
Endoscopic Ultrasound Guided Liver Biopsy Using a 22 Gauge Fine Needle Biopsy Needle.
This is a prospective study to determine the optimal technique for obtaining liver tissue
with a smaller caliber (22 gauge) 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 22 g
Fine Needle Biopsy needle for liver biopsy.
with a smaller caliber (22 gauge) 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 22 g
Fine Needle Biopsy needle for liver biopsy.
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. Other ways of performing liver biopsy are
transjugular fluoroscopy guided approach when percutaneous route is deemed not safe because
of coagulopathy or ascites. 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. It
can be performed in an outpatient setting and offers the comfort of sedation and analgesia.
Endoscopic Ultrasound (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. 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 endoscopic retrograde
cholangiopancreatography (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 G. The smaller size of the needle is expected to decrease the complications rate
(mainly pain and bleeding) even further. Many studies using a 19 G Tru-cut biopsy or Fine
Needle Aspiration (FNA) needle to acquire liver tissue have obtained specimens adequate for
histologic diagnosis but there has been a wide range of specimen adequacy (19-100%). The 19 G
Tru-cut biopsy needle has been associated with several technical difficulties that could
reflect negatively on tissue adequacy.
While it is easy and straight forward to biopsy the left lobe of the liver with any EUS
needle. The 19 G needle is a large bore needle for EUS use and it is sometimes difficult to
attain an adequate position for biopsy specially in duodenum where scope is torqued and this
is the only area of access to right lobe.
In this study the investigators will use a 22 G needle. Smaller caliber of the needle would
not only make it technically easier to access right lobe of the liver through the duodenum,
it is also expected to decrease the risks further due to smaller size. Also, the 22 G EUS-FNB
needle has three cutting points at the cutting edge of the needle that provide stability at
puncture while the high quality, fully formed heels are designed to maximize tissue capture
and minimize fragmentation, that would result in attaining a good histological specimen, a
main stay for liver biopsy.
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. Other ways of performing liver biopsy are
transjugular fluoroscopy guided approach when percutaneous route is deemed not safe because
of coagulopathy or ascites. 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. It
can be performed in an outpatient setting and offers the comfort of sedation and analgesia.
Endoscopic Ultrasound (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. 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 endoscopic retrograde
cholangiopancreatography (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 G. The smaller size of the needle is expected to decrease the complications rate
(mainly pain and bleeding) even further. Many studies using a 19 G Tru-cut biopsy or Fine
Needle Aspiration (FNA) needle to acquire liver tissue have obtained specimens adequate for
histologic diagnosis but there has been a wide range of specimen adequacy (19-100%). The 19 G
Tru-cut biopsy needle has been associated with several technical difficulties that could
reflect negatively on tissue adequacy.
While it is easy and straight forward to biopsy the left lobe of the liver with any EUS
needle. The 19 G needle is a large bore needle for EUS use and it is sometimes difficult to
attain an adequate position for biopsy specially in duodenum where scope is torqued and this
is the only area of access to right lobe.
In this study the investigators will use a 22 G needle. Smaller caliber of the needle would
not only make it technically easier to access right lobe of the liver through the duodenum,
it is also expected to decrease the risks further due to smaller size. Also, the 22 G EUS-FNB
needle has three cutting points at the cutting edge of the needle that provide stability at
puncture while the high quality, fully formed heels are designed to maximize tissue capture
and minimize fragmentation, that would result in attaining a good histological specimen, a
main stay for liver biopsy.
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)
We found this trial at
1
site
601 East Rollins Street
Orlando, Florida 32803
Orlando, Florida 32803
Phone: 407-303-2750
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