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Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy remains an important method for helping to determine the etiology and stage of LD. Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well as the adequacy of specimens obtained in this fashion. Most studies involve a 19-g needle, therefore in this study we hope to compare the tissue yields of a 19-g fine needle biopsy (FNB) needle, in comparison to conventional 19-g fine needle aspiration (FNA) needle. We predict that 19-g FNA and 19-g FNB needle will demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly, we predict the safety to be equal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 19-gauge FNA needle | Active Comparator | A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle. |
|
| 19-gauge FNB needle | Active Comparator | A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 19-gauge FNA needle | Device | A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle. |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-processing Length of the Longest Piece (LLP) | Pre-processing Length of the longest piece (LLP) measured in centimeter | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-processing Length of the Longest Piece (LLP) | Post-processing Length of the longest piece (LLP) measured in centimeter | 3-5 days |
| Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Diehl, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19243014 | Background | Rockey 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. | |
| 16447288 | Background | Rockey DC, Bissell DM. Noninvasive measures of liver fibrosis. Hepatology. 2006 Feb;43(2 Suppl 1):S113-20. doi: 10.1002/hep.21046. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 19-gauge FNA Needle | A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle. 19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle. |
| FG001 | 19-gauge FNB Needle | A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle. 19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 19-gauge FNA Needle | A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle. 19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pre-processing Length of the Longest Piece (LLP) | Pre-processing Length of the longest piece (LLP) measured in centimeter | Posted | Mean | Standard Deviation | centimeter | up to 5 days |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 19-gauge FNA Needle | A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle. 19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
Research was completed at a high-volume center; therefore, our outcomes may not be fully applicable to small practices.
Learning curve to achieving best possible tissue samples with EUS-LB, which appears to be between 10 and 20 procedures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David L. Diehl, MD | Geisinger Medical Center | 570-214-2411 | dldiehl@geisinger.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2017 | Jul 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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Participants are assigned to one of two groups for the duration of the study.
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| 19-gauge FNB needle | Device | A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle. |
|
Pre-processing Length of the longest piece (LLP) subgroups:
< 2 cm > 2cm
| 3-5 days |
| Pre-processing Aggregate Specimen Length (ASL) | Pre-processing Aggregate specimen length (ASL) measured in centimeter | 3-5 days |
| Post-processing Aggregate Specimen Length (ASL) | Post-processing Aggregate specimen length (ASL) measured in centimeter | 3-5 days |
| Portal Triads Number (Mean) | Number of portal triads (PT) in the specimen. | 3-5 days |
| Portal Triads Quantity (Median) | Number of portal triads (PT) in the specimen. | 3-5 days |
| Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads | Portal triads groups, n (%) < 11 Portal triads > 11 Portal triads | 3-5 days |
| No. of Fragments > 9 mm, Mean (SD) | No. of fragments > 9 mm, mean (SD) Pre-processing Post-processing | 3-5 days |
| Specimen Quality for Histologic Diagnosis | Number of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle. | 3-5 days |
| Length of Longest Piece | Number Analyzed |
| 15690481 | Background | Ziol M, Handra-Luca A, Kettaneh A, Christidis C, Mal F, Kazemi F, de Ledinghen V, Marcellin P, Dhumeaux D, Trinchet JC, Beaugrand M. Noninvasive assessment of liver fibrosis by measurement of stiffness in patients with chronic hepatitis C. Hepatology. 2005 Jan;41(1):48-54. doi: 10.1002/hep.20506. |
| 3902951 | Background | Sherlock S, Dick R, Van Leeuwen DJ. Liver biopsy today. The Royal Free Hospital experience. J Hepatol. 1985;1(1):75-85. doi: 10.1016/s0168-8278(85)80070-2. |
| 12707140 | Background | Eisenberg E, Konopniki M, Veitsman E, Kramskay R, Gaitini D, Baruch Y. Prevalence and characteristics of pain induced by percutaneous liver biopsy. Anesth Analg. 2003 May;96(5):1392-1396. doi: 10.1213/01.ANE.0000060453.74744.17. |
| 16234032 | Background | Firpi RJ, Soldevila-Pico C, Abdelmalek MF, Morelli G, Judah J, Nelson DR. Short recovery time after percutaneous liver biopsy: should we change our current practices? Clin Gastroenterol Hepatol. 2005 Sep;3(9):926-9. doi: 10.1016/s1542-3565(05)00294-6. |
| 8714240 | Background | Stone MA, Mayberry JF. An audit of ultrasound guided liver biopsies: a need for evidence-based practice. Hepatogastroenterology. 1996 Mar-Apr;43(8):432-4. |
| 2101588 | Background | McGill DB, Rakela J, Zinsmeister AR, Ott BJ. A 21-year experience with major hemorrhage after percutaneous liver biopsy. Gastroenterology. 1990 Nov;99(5):1396-400. doi: 10.1016/0016-5085(90)91167-5. |
| 8416324 | Background | Janes CH, Lindor KD. Outcome of patients hospitalized for complications after outpatient liver biopsy. Ann Intern Med. 1993 Jan 15;118(2):96-8. doi: 10.7326/0003-4819-118-2-199301150-00003. |
| 17440193 | Background | Huang JF, Hsieh MY, Dai CY, Hou NJ, Lee LP, Lin ZY, Chen SC, Wang LY, Hsieh MY, Chang WY, Yu ML, Chuang WL. The incidence and risks of liver biopsy in non-cirrhotic patients: An evaluation of 3806 biopsies. Gut. 2007 May;56(5):736-7. doi: 10.1136/gut.2006.115410. No abstract available. |
| 11172192 | Background | Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med. 2001 Feb 15;344(7):495-500. doi: 10.1056/NEJM200102153440706. No abstract available. |
| 6629116 | Background | Bull HJ, Gilmore IT, Bradley RD, Marigold JH, Thompson RP. Experience with transjugular liver biopsy. Gut. 1983 Nov;24(11):1057-60. doi: 10.1136/gut.24.11.1057. |
| 8781934 | Background | Poniachik J, Bernstein DE, Reddy KR, Jeffers LJ, Coelho-Little ME, Civantos F, Schiff ER. The role of laparoscopy in the diagnosis of cirrhosis. Gastrointest Endosc. 1996 Jun;43(6):568-71. doi: 10.1016/s0016-5107(96)70192-x. |
| 17198072 | Background | Denzer U, Arnoldy A, Kanzler S, Galle PR, Dienes HP, Lohse AW. Prospective randomized comparison of minilaparoscopy and percutaneous liver biopsy: diagnosis of cirrhosis and complications. J Clin Gastroenterol. 2007 Jan;41(1):103-10. doi: 10.1097/01.mcg.0000225612.86846.82. |
| 26171433 | Background | Diehl DL, Johal AS, Khara HS, Stavropoulos SN, Al-Haddad M, Ramesh J, Varadarajulu S, Aslanian H, Gordon SR, Shieh FK, Pineda-Bonilla JJ, Dunkelberger T, Gondim DD, Chen EZ. Endoscopic ultrasound-guided liver biopsy: a multicenter experience. Endosc Int Open. 2015 Jun;3(3):E210-5. doi: 10.1055/s-0034-1391412. Epub 2015 Feb 27. |
| 14499774 | Background | DeWitt J, LeBlanc J, McHenry L, Ciaccia D, Imperiale T, Chappo J, Cramer H, McGreevy K, Chriswell M, Sherman S. Endoscopic ultrasound-guided fine needle aspiration cytology of solid liver lesions: a large single-center experience. Am J Gastroenterol. 2003 Sep;98(9):1976-81. doi: 10.1111/j.1572-0241.2003.07638.x. |
| 12024141 | Background | tenBerge J, Hoffman BJ, Hawes RH, Van Enckevort C, Giovannini M, Erickson RA, Catalano MF, Fogel R, Mallery S, Faigel DO, Ferrari AP, Waxman I, Palazzo L, Ben-Menachem T, Jowell PS, McGrath KM, Kowalski TE, Nguyen CC, Wassef WY, Yamao K, Chak A, Greenwald BD, Woodward TA, Vilmann P, Sabbagh L, Wallace MB. EUS-guided fine needle aspiration of the liver: indications, yield, and safety based on an international survey of 167 cases. Gastrointest Endosc. 2002 Jun;55(7):859-62. doi: 10.1067/mge.2002.124557. |
| 26278654 | Background | Sey MS, Al-Haddad M, Imperiale TF, McGreevy K, Lin J, DeWitt JM. EUS-guided liver biopsy for parenchymal disease: a comparison of diagnostic yield between two core biopsy needles. Gastrointest Endosc. 2016 Feb;83(2):347-52. doi: 10.1016/j.gie.2015.08.012. Epub 2015 Aug 13. |
| 19231495 | Background | Dewitt 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. |
| 23916397 | Background | Gor N, Salem SB, Jakate S, Patel R, Shah N, Patil A. Histological adequacy of EUS-guided liver biopsy when using a 19-gauge non-Tru-Cut FNA needle. Gastrointest Endosc. 2014 Jan;79(1):170-2. doi: 10.1016/j.gie.2013.06.031. Epub 2013 Jul 31. No abstract available. |
| 22248599 | Background | Stavropoulos 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. |
| 12873821 | Background | Colloredo G, Guido M, Sonzogni A, Leandro G. Impact of liver biopsy size on histological evaluation of chronic viral hepatitis: the smaller the sample, the milder the disease. J Hepatol. 2003 Aug;39(2):239-44. doi: 10.1016/s0168-8278(03)00191-0. |
| 9695993 | Background | Crawford AR, Lin XZ, Crawford JM. The normal adult human liver biopsy: a quantitative reference standard. Hepatology. 1998 Aug;28(2):323-31. doi: 10.1002/hep.510280206. |
| 11903883 | Background | Rocken C, Meier H, Klauck S, Wolff S, Malfertheiner P, Roessner A. Large-needle biopsy versus thin-needle biopsy in diagnostic pathology of liver diseases. Liver. 2001 Dec;21(6):391-7. doi: 10.1034/j.1600-0676.2001.210605.x. |
| 24355092 | Background | Bhatia V, Hijioka S, Hara K, Mizuno N, Imaoka H, Yamao K. Endoscopic ultrasound description of liver segmentation and anatomy. Dig Endosc. 2014 May;26(3):482-90. doi: 10.1111/den.12216. Epub 2013 Dec 19. |
| 23684089 | Background | ASGE Standards of Practice Committee; Early DS, Acosta RD, Chandrasekhara V, Chathadi KV, Decker GA, Evans JA, Fanelli RD, Fisher DA, Fonkalsrud L, Hwang JH, Jue TL, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf RN, Shergill AK, Cash BD. Adverse events associated with EUS and EUS with FNA. Gastrointest Endosc. 2013 Jun;77(6):839-43. doi: 10.1016/j.gie.2013.02.018. No abstract available. |
| 20189503 | Background | Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available. |
| BG001 | 19-gauge FNB Needle | A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle. 19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
|
| Secondary | Post-processing Length of the Longest Piece (LLP) | Post-processing Length of the longest piece (LLP) measured in centimeter | Posted | Mean | Standard Deviation | centimeter | 3-5 days |
|
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| Secondary | Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm | Pre-processing Length of the longest piece (LLP) subgroups: < 2 cm > 2cm | Posted | Count of Participants | Participants | 3-5 days |
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| Secondary | Pre-processing Aggregate Specimen Length (ASL) | Pre-processing Aggregate specimen length (ASL) measured in centimeter | Posted | Mean | Standard Deviation | centimeter | 3-5 days |
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| Secondary | Post-processing Aggregate Specimen Length (ASL) | Post-processing Aggregate specimen length (ASL) measured in centimeter | Posted | Mean | Standard Deviation | centimeter | 3-5 days |
|
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| Secondary | Portal Triads Number (Mean) | Number of portal triads (PT) in the specimen. | Posted | Mean | Standard Deviation | Portal Triads | 3-5 days |
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| Secondary | Portal Triads Quantity (Median) | Number of portal triads (PT) in the specimen. | Posted | Median | Full Range | Complete number of portal triads | 3-5 days |
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| Secondary | Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads | Portal triads groups, n (%) < 11 Portal triads > 11 Portal triads | Posted | Count of Participants | Participants | 3-5 days |
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| Secondary | No. of Fragments > 9 mm, Mean (SD) | No. of fragments > 9 mm, mean (SD) Pre-processing Post-processing | Posted | Mean | Standard Deviation | Number of Fragments | 3-5 days |
|
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| Secondary | Specimen Quality for Histologic Diagnosis | Number of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle. | Posted | Count of Participants | Participants | 3-5 days |
|
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| Secondary | Length of Longest Piece | Posted | Median | Full Range | mm | Number Analyzed |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 8 |
| 20 |
| EG001 | 19-gauge FNB Needle | A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle. 19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle. | 0 | 20 | 0 | 20 | 7 | 20 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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