Clinical trial NCT03910790: Liver Biopsy Using a 19 Gauge Fine Needle Biopsy Needle
Official title: Endoscopic Ultrasound Guided Liver Biopsy Using a 19-gauge Fine Needle Biopsy Needle
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Liver Biopsy
Keywords: livery biopsy
fine needle biopsy
19-gauge needle
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This research will be carried out in a non-randomized, prospective trial pattern.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Diagnostic adequacy
timeFrame: At time of procedure
Secondary outcomes:
measure: Technique
timeFrame: At time of procedure
measure: Suction
timeFrame: At time of procedure
measure: Number of passes
timeFrame: At time of procedure
measure: Needle Dysfunction
timeFrame: At time of procedure
measure: Technical failure
timeFrame: At time of procedure
measure: Complications/Bleeding
timeFrame: At time of procedure; 3 days post-procedure; & 30 days post procedure
measure: Complications/Pain
timeFrame: At time of procedure; 3 days post-procedure; & 30 days post procedure
measure: Complications/Infection
timeFrame: At time of procedure; 3 days post-procedure; & 30 days post procedure
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Center for Interventional Endoscopy - Florida Hospital
state: Florida
Study officials:
affiliation: Florida Hospital (AdventHealth Orlando)
name: Muhammad Hasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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