NCT06231082

Brief Summary

This is a randomized comparative trial between percutaneous liver biopsy and EUS FNB guided liver biopsy in patients with parenchymal liver disease. Studies so far have been shown that EUS FNB guided liver biopsy is non inferior to percutaneous liver biopsy in terms of efficacy, provided several conditions are met (type of needle, wet suction, actuations). În terms of safety, it may be that EUS FNB have an advantage, as needle diameter is slightly smaller, needle is inserted under better visualisation especially in patients with large subcutaneous fat tissue and the possibility of examining the needle tract and plugging it with needle content if needed ("the blood patch technique"). However, although severe, the incidence of liver bleeding is low, so a comparative trial with the hypothesis that EUS FNB has fewer liver bleedings than percutaneous techniques would have a very large sample size. A recent study found out that abdominal pain at 2 hours after procedure is predictive for liver bleeding. So we have design a randomized prospective trial assuming that EUS FNB guided liver biopsy has significantly less abdominal pain at 2 hours after procedure when compared to percutaneous route, using abdominal pain at 2 hours as a surrogate marker for risk of liver bleeding.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

January 9, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

January 9, 2024

Last Update Submit

May 6, 2024

Conditions

Liver Disease Parenchymal

Outcome Measures

Primary Outcomes (1)

  • Post procedure pain at 2 hours after procedure

    Post procedure pain at 2 hours measured by Visual Analogue Scale (0 - 10)

    2 hours

Secondary Outcomes (9)

  • Post procedure pain at 24 hours after procedure

    24 hours

  • Proportion of post procedure liver bleeding

    7 days

  • Longest intact specimen

    2 hours

  • Aggregate specimen length

    2 hours

  • Total number of specimens

    2 hours

  • +4 more secondary outcomes

Study Arms (2)

Group one - percutaneous (P)

ACTIVE COMPARATOR

Percutaneous procedure will be performed under standard conditions, under transabdominal ultrasound guidance. After choosing the optimum needle trajectory, the skin site will be marked, standard skin sterilization with iodine and surgical draping of the site will be performed. Local anesthesia of the site with gradual lidocaine solution infiltration of the skin and underlying planes will be performed. Under ultrasound guidance, with collaboration of the patient for the respiratory movements, one or two passages with a 16G needle will be performed (BARD Max Core 16G, Becton Dickinson, USA). Specimens will be collected in formalin and send to pathology for processing.

Procedure: Group one - percutaneous (P)

Group two - EUS FNB (E)

ACTIVE COMPARATOR

EUS guided liver FNB will be performed under deep sedation with propofol under anesthesiology monitoring. A 19G gauge Franseen needle (Acquire 19G, Boston Scientific, USA) will be used with the "wet suction" technique. Before inserting into the operating channel, the stylet will be removed, and the needle will be primed with heparin (500UI/5ml). After liver puncture, the 20ml aspiration syringe will be attached. Three needle actuations will be performed, one or two passes in the left liver lobe. At the end of the 3rd actuation, the syringe aspiration will be stopped, the needle will be left in place in the liver parenchyma for 2 to 3 minutes. The liver needle path will be examined with Doppler ultrasound to look for possible bleeding. If present, about 25% of the needle content will be pushed in the liver path, as previously described - the "blood patch" technique

Procedure: Group two - EUS FNB (E)

Interventions

Group one - percutaneous (P)PROCEDURE

Percutaneous procedure will be performed under standard conditions, under transabdominal ultrasound guidance. After choosing the optimum needle trajectory, the skin site will be marked, standard skin sterilization with iodine and surgical draping of the site will be performed. Local anesthesia of the site with gradual lidocaine solution infiltration of the skin and underlying planes will be performed. Under ultrasound guidance, with collaboration of the patient for the respiratory movements, one or two passages with a 16G needle will be performed (BARD Max Core 16G, Becton Dickinson, USA). Specimens will be collected in formalin and send to pathology for processing.

Group one - percutaneous (P)
Group two - EUS FNB (E)PROCEDURE

EUS guided liver FNB will be performed under deep sedation with propofol under anesthesiology monitoring. A 19G gauge Franseen needle (Acquire 19G, Boston Scientific, USA) will be used with the "wet suction" technique. Before inserting into the operating channel, the stylet will be removed, and the needle will be primed with heparin (500UI/5ml). After liver puncture, the 20ml aspiration syringe will be attached. Three needle actuations will be performed, one or two passes in the left liver lobe. At the end of the 3rd actuation, the syringe aspiration will be stopped, the needle will be left in place in the liver parenchyma for 2 to 3 minutes. The liver needle path will be examined with Doppler ultrasound to look for possible bleeding. If present, about 25% of the needle content will be pushed in the liver path, as previously described - the "blood patch" technique.

Group two - EUS FNB (E)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diffuse parenchymal liver disease with indication for liver biopsy for diagnostic and/or staging purposes,
  • Eligibility for deep sedation with propofol
  • Age above 18 years old
  • Informed consent

You may not qualify if:

  • Coagulation disorders which cannot be corrected
  • Anticoagulant and/or antiagregant medication which cannot be stopped temporarily.
  • Contraindications for liver biopsy, to local lidocaine anesthesia and to deep propofol sedation
  • Absence of written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Prof. Dr. Agrippa Ionescu" Clinical and Emerency Hospital

Bucharest, 0112013, Romania

RECRUITING

Related Publications (18)

  • Facciorusso A, Crino SF, Ramai D, Fabbri C, Mangiavillano B, Lisotti A, Muscatiello N, Cotsoglou C, Fusaroli P. Diagnostic yield of endoscopic ultrasound-guided liver biopsy in comparison to percutaneous liver biopsy: a systematic review and meta-analysis. Expert Rev Gastroenterol Hepatol. 2022 Jan;16(1):51-57. doi: 10.1080/17474124.2022.2020645. Epub 2021 Dec 29.

    PMID: 34918578BACKGROUND

  • Zeng K, Jiang Z, Yang J, Chen K, Lu Q. Role of endoscopic ultrasound-guided liver biopsy: a meta-analysis. Scand J Gastroenterol. 2022 May;57(5):545-557. doi: 10.1080/00365521.2021.2025420. Epub 2022 Jan 20.

    PMID: 35049405BACKGROUND

  • Chandan S, Deliwala S, Khan SR, Mohan BP, Dhindsa BS, Bapaye J, Goyal H, Kassab LL, Kamal F, Sayles HR, Kochhar GS, Adler DG. EUS-guided versus percutaneous liver biopsy: A comprehensive review and meta-analysis of outcomes. Endosc Ultrasound. 2023 Mar-Apr;12(2):171-180. doi: 10.4103/EUS-D-21-00268.

    PMID: 36204798BACKGROUND

  • Laleman W, Vanderschueren E, Mehdi ZS, Wiest R, Cardenas A, Trebicka J. Endoscopic procedures in hepatology: Current trends and new developments. J Hepatol. 2024 Jan;80(1):124-139. doi: 10.1016/j.jhep.2023.08.032. Epub 2023 Sep 18.

    PMID: 37730125BACKGROUND

  • Thomaides-Brears HB, Alkhouri N, Allende D, Harisinghani M, Noureddin M, Reau NS, French M, Pantoja C, Mouchti S, Cryer DRH. Incidence of Complications from Percutaneous Biopsy in Chronic Liver Disease: A Systematic Review and Meta-Analysis. Dig Dis Sci. 2022 Jul;67(7):3366-3394. doi: 10.1007/s10620-021-07089-w. Epub 2021 Jun 15.

    PMID: 34129125BACKGROUND

  • Bissonnette J, Riescher-Tuczkiewicz A, Gigante E, Bourdin C, Boudaoud L, Soliman H, Durand F, Ronot M, Valla D, Vilgrain V, de Raucourt E, Rautou PE. Predicting bleeding after liver biopsy using comprehensive clinical and laboratory investigations: A prospective analysis of 302 procedures. J Thromb Haemost. 2022 Dec;20(12):2786-2796. doi: 10.1111/jth.15888. Epub 2022 Oct 5.

    PMID: 36128757BACKGROUND

  • Ching-Companioni RA, Diehl DL, Johal AS, Confer BD, Khara HS. 19 G aspiration needle versus 19 G core biopsy needle for endoscopic ultrasound-guided liver biopsy: a prospective randomized trial. Endoscopy. 2019 Nov;51(11):1059-1065. doi: 10.1055/a-0956-6922. Epub 2019 Jul 23.

    PMID: 31342474BACKGROUND

  • Nieto J, Dawod E, Deshmukh A, Penn E, Adler D, Saab S. EUS-guided fine-needle core liver biopsy with a modified one-pass, one-actuation wet suction technique comparing two types of EUS core needles. Endosc Int Open. 2020 Jul;8(7):E938-E943. doi: 10.1055/a-1165-1767. Epub 2020 Jun 16.

    PMID: 32617398BACKGROUND

  • Aggarwal SN, Magdaleno T, Klocksieben F, MacFarlan JE, Goonewardene S, Zator Z, Shah S, Shah HN. A prospective, head-to-head comparison of 2 EUS-guided liver biopsy needles in vivo. Gastrointest Endosc. 2021 May;93(5):1133-1138. doi: 10.1016/j.gie.2020.09.050. Epub 2020 Oct 9.

    PMID: 33045222BACKGROUND

  • Ching-Companioni RA, Johal AS, Confer BD, Forster E, Khara HS, Diehl DL. Single-pass 1-needle actuation versus single-pass 3-needle actuation technique for EUS-guided liver biopsy sampling: a randomized prospective trial (with video). Gastrointest Endosc. 2021 Sep;94(3):551-558. doi: 10.1016/j.gie.2021.03.023. Epub 2021 Mar 23.

    PMID: 33771557BACKGROUND

  • Bang JY, Ward TJ, Guirguis S, Krall K, Contreras F, Jhala N, Navaneethan U, Hawes RH, Varadarajulu S. Radiology-guided percutaneous approach is superior to EUS for performing liver biopsies. Gut. 2021 Dec;70(12):2224-2226. doi: 10.1136/gutjnl-2021-324495. Epub 2021 Mar 25. No abstract available.

    PMID: 33766911BACKGROUND

  • Hashimoto R, Lee DP, Samarasena JB, Chandan VS, Guo W, Lee JG, Chang KJ. Comparison of Two Specialized Histology Needles for Endoscopic Ultrasound (EUS)-Guided Liver Biopsy: A Pilot Study. Dig Dis Sci. 2021 May;66(5):1700-1706. doi: 10.1007/s10620-020-06391-3. Epub 2020 Jun 17.

    PMID: 32556821BACKGROUND

  • Ali AH, Nallapeta NS, Yousaf MN, Petroski GF, Sharma N, Rao DS, Yin F, Davis RM, Bhat A, Swi AIA, Al-Juboori A, Ibdah JA, Hammoud GM. EUS-guided versus percutaneous liver biopsy: A prospective randomized clinical trial. Endosc Ultrasound. 2023 May-Jun;12(3):334-341. doi: 10.1097/eus.0000000000000010. Epub 2023 Jul 25.

    PMID: 37693114BACKGROUND

  • Choi AY, Li X, Guo W, Chandan VS, Samarasena J, Lee JG, Chang KJ, Hu KQ. Performance of Endoscopic Ultrasound-Guided Versus Percutaneous Liver Biopsy in Diagnosing Stage 3-4 Fibrosis. Dig Dis Sci. 2023 Sep;68(9):3774-3780. doi: 10.1007/s10620-023-08019-8. Epub 2023 Aug 4.

    PMID: 37540389BACKGROUND

  • Rai P, Majeed A, Kumar P, Rajput M, Goel A, Rao RN. Endoscopic ultrasound-guided liver biopsy using a single-pass, slow-pull technique with a 19-G Franseen tip fine-needle biopsy needle: A prospective study. Indian J Gastroenterol. 2023 Jun;42(3):418-424. doi: 10.1007/s12664-023-01339-7. Epub 2023 Apr 25.

    PMID: 37097513BACKGROUND

  • Sundaram S, Shah B, Jagtap N, Angadi S, Jain AK, Afzalpurkar S, Giri S. Diagnostic efficacy of endoscopic ultrasound-guided liver biopsy for diffuse liver diseases and its predictors - a multicentric retrospective analysis. Clin Exp Hepatol. 2023 Sep;9(3):243-250. doi: 10.5114/ceh.2023.130618. Epub 2023 Aug 23.

    PMID: 37790688BACKGROUND

  • Sowa P, Kolb J, Samarasena J, Chang KJ. EUS-guided blood patch delivery during liver biopsy: nature's gel foam. VideoGIE. 2021 Jul 22;6(11):487-488. doi: 10.1016/j.vgie.2021.06.006. eCollection 2021 Nov.

    PMID: 34765837BACKGROUND

  • 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

Central Study Contacts

Mihai Ciocirlan

CONTACT

0040722322625ciocirlanm@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Gastroenterology

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 30, 2024

Study Start

May 6, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)