NCT03910790

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

March 25, 2019

Last Update Submit

July 15, 2020

Conditions

Liver Biopsy

Keywords

livery biopsyfine needle biopsy19-gauge needle

Outcome Measures

Primary Outcomes (1)

  • Diagnostic adequacy

    Determine the diagnostic adequacy of the liver biopsy specimen by obtaining a histological specimen using a smaller (19 G) caliber needle. Diagnostic adequacy is defined as a sample that provides definitive pathological diagnosis (yes, no).

    At time of procedure

Secondary Outcomes (8)

  • Technique

    At time of procedure

  • Suction

    At time of procedure

  • Number of passes

    At time of procedure

  • Needle Dysfunction

    At time of procedure

  • Technical failure

    At time of procedure

  • +3 more secondary outcomes

Study Arms (1)

19 Gauge needle liver biopsy

EXPERIMENTAL

Obtaining liver tissue with a 19 gauge core needle

Device: 19 gauge needle liver biopsy

Interventions

19 gauge needle liver biopsyDEVICE

Obtaining liver tissue with a 19 gauge core 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 19 gauge core needle for liver biopsy.

19 Gauge needle liver biopsy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Age ≥ 19 years
  • Willing to provide informed consent verbal or written.

You may not qualify if:

  • Age \<19 years
  • Unable to safely undergo EUS for any reason
  • Coagulopathy (INR \>1.6, Thrombocytopenia with platelet count \<50,000/ml) for subjects on anti-coagulation therapy.
  • Unwilling or cognitively unable to provide informed consent verbal or written.
  • Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Interventional Endoscopy - Florida Hospital

Orlando, Florida, 32803, United States

Location

Related Publications (17)

  • 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.

    PMID: 19243014BACKGROUND

  • Kalambokis 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: 17561303BACKGROUND

  • Mathew 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: 17897349BACKGROUND

  • Gleeson 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: 19081532BACKGROUND

  • 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.

    PMID: 19231495BACKGROUND

  • 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.

    PMID: 22248599BACKGROUND

  • Nakai 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.

    PMID: 22396285BACKGROUND

  • 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.

    PMID: 26171433BACKGROUND

  • Maharaj B, Maharaj RJ, Leary WP, Cooppan RM, Naran AD, Pirie D, Pudifin DJ. Sampling variability and its influence on the diagnostic yield of percutaneous needle biopsy of the liver. Lancet. 1986 Mar 8;1(8480):523-5. doi: 10.1016/s0140-6736(86)90883-4.

    PMID: 2869260BACKGROUND

  • Mohan BP, Shakhatreh M, Garg R, Ponnada S, Adler DG. Efficacy and safety of EUS-guided liver biopsy: a systematic review and meta-analysis. Gastrointest Endosc. 2019 Feb;89(2):238-246.e3. doi: 10.1016/j.gie.2018.10.018. Epub 2018 Oct 31.

    PMID: 30389469BACKGROUND

  • 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.

    PMID: 23916397BACKGROUND

  • 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.

    PMID: 26278654BACKGROUND

  • Nieto J, Khaleel H, Challita Y, Jimenez M, Baron TH, Walters L, Hathaway K, Patel K, Lankarani A, Herman M, Holloman D, Saab S. EUS-guided fine-needle core liver biopsy sampling using a novel 19-gauge needle with modified 1-pass, 1 actuation wet suction technique. Gastrointest Endosc. 2018 Feb;87(2):469-475. doi: 10.1016/j.gie.2017.05.013. Epub 2017 May 24.

    PMID: 28551024BACKGROUND

  • Shah ND, Sasatomi E, Baron TH. Endoscopic Ultrasound-guided Parenchymal Liver Biopsy: Single Center Experience of a New Dedicated Core Needle. Clin Gastroenterol Hepatol. 2017 May;15(5):784-786. doi: 10.1016/j.cgh.2017.01.011. Epub 2017 Jan 23. No abstract available.

    PMID: 28126424BACKGROUND

  • Lee WJ, Uradomo LT, Zhang Y, Twaddell W, Darwin P. Comparison of the Diagnostic Yield of EUS Needles for Liver Biopsy: Ex Vivo Study. Diagn Ther Endosc. 2017;2017:1497831. doi: 10.1155/2017/1497831. Epub 2017 Sep 13.

    PMID: 29056843BACKGROUND

  • Schulman AR, Thompson CC, Odze R, Chan WW, Ryou M. Optimizing EUS-guided liver biopsy sampling: comprehensive assessment of needle types and tissue acquisition techniques. Gastrointest Endosc. 2017 Feb;85(2):419-426. doi: 10.1016/j.gie.2016.07.065. Epub 2016 Aug 13.

    PMID: 27530070BACKGROUND

  • Rombaoa C CA. Mo1351 The safety and feasibileity of endoscopic ultrasound-guided parenchymal liver biopsy at a large community hospital. Gastrointestinal endoscopy; 87(6): AB458.

    BACKGROUND

Study Officials

  • Muhammad Hasan, MD

    Florida Hospital (AdventHealth Orlando)

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: This research will be carried out in a non-randomized, prospective trial pattern.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

April 10, 2019

Study Start

March 20, 2019

Primary Completion

November 22, 2019

Study Completion

November 22, 2019

Last Updated

July 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual patient data.

Locations

US(1)