Clinical trial · Interventional
Endoscopic Ultrasound Guided Liver Biopsy
Endoscopic Ultrasound Guided Liver Biopsy Using a 22 Gauge Fine Needle Biopsy Needle.
NCT03307811CI-TRIAL-00037014completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Cancer | — | UNRESOLVED | — |
| Hepatic Carcinoma | — | UNRESOLVED | — |
| Hepatic Neoplasm | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 22 gauge needle liver biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 22 gauge needle liver biopsy
- description
- EUS-LB will be performed using a 22 g FNB needle. Specimens obtained from each pass will be placed in a separate biopsy jar. If the third pass does not result in sufficient diagnostic material, a 19 G will be used. A maximum of 3 passes will be made using the alternate needle. The total number of passes with the 22 G needle and the 19 G needle is 6. Data will be collected about the procedure and the performance of the needles for each procedure.
- interventionNames
- Other: 22 gauge needle liver biopsy
Primary outcomes (1)
- measure
- Diagnostic adequacy of the liver biopsy specimen
- timeFrame
- Sample obtained during EUS-guided liver biopsy.
- description
- Determine the diagnostic adequacy of the liver biopsy specimen by obtaining a histological specimen using a smaller (22 G) caliber needle. Diagnostic adequacy is defined as a sample that provides definitive pathological diagnosis (yes, no).
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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)
References
Publications (9)
- BACKGROUNDRockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD; American Association for the Study of Liver Diseases. Liver biopsy. Hepatology. 2009 Mar;49(3):1017-44. doi: 10.1002/hep.22742. No abstract available. PMID 19243014
- BACKGROUNDKalambokis G, Manousou P, Vibhakorn S, Marelli L, Cholongitas E, Senzolo M, Patch D, Burroughs AK. Transjugular liver biopsy--indications, adequacy, quality of specimens, and complications--a systematic review. J Hepatol. 2007 Aug;47(2):284-94. doi: 10.1016/j.jhep.2007.05.001. Epub 2007 May 24. PMID 17561303
- BACKGROUNDMathew A. EUS-guided routine liver biopsy in selected patients. Am J Gastroenterol. 2007 Oct;102(10):2354-5. doi: 10.1111/j.1572-0241.2007.01353_7.x. No abstract available. PMID 17897349
- BACKGROUNDGleeson FC, Clayton AC, Zhang L, Clain JE, Gores GJ, Rajan E, Smyrk TC, Topazian MD, Wang KK, Wiersema MJ, Levy MJ. Adequacy of endoscopic ultrasound core needle biopsy specimen of nonmalignant hepatic parenchymal disease. Clin Gastroenterol Hepatol. 2008 Dec;6(12):1437-40. doi: 10.1016/j.cgh.2008.07.015. Epub 2008 Jul 26. PMID 19081532
- BACKGROUNDDewitt J, McGreevy K, Cummings O, Sherman S, Leblanc JK, McHenry L, Al-Haddad M, Chalasani N. Initial experience with EUS-guided Tru-cut biopsy of benign liver disease. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):535-42. doi: 10.1016/j.gie.2008.09.056. PMID 19231495
- BACKGROUNDStavropoulos SN, Im GY, Jlayer Z, Harris MD, Pitea TC, Turi GK, Malet PF, Friedel DM, Grendell JH. High yield of same-session EUS-guided liver biopsy by 19-gauge FNA needle in patients undergoing EUS to exclude biliary obstruction. Gastrointest Endosc. 2012 Feb;75(2):310-8. doi: 10.1016/j.gie.2011.09.043. PMID 22248599
- BACKGROUNDNakai Y, Samarasena JB, Iwashita T, Park DH, Lee JG, Hu KQ, Chang KJ. Autoimmune hepatitis diagnosed by endoscopic ultrasound-guided liver biopsy using a new 19-gauge histology needle. Endoscopy. 2012;44 Suppl 2 UCTN:E67-8. doi: 10.1055/s-0031-1291567. Epub 2012 Mar 6. No abstract available.