Assessing EUS and Percutaneous Untargeted Liver Biopsy Quality

NCT07701031 | Completed

• 1 other identifier: MSLB2
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-center study evaluates and compares the tissue sample quality and patient comfort of different liver biopsy methods. While traditional percutaneous liver biopsy passes a needle through the abdominal wall into the liver, endoscopic ultrasound-guided liver biopsy (EUS-LB) offers an internal alternative performed via the stomach under sedation. However, the optimal EUS needle size and tip design remain unclear. Therefore, this trial directly compares the diagnostic tissue yield and patient-reported pain across four contemporary EUS needle strategies and the traditional percutaneous approach. The study utilizes a sequential-period cluster-randomized design, enrolling consecutive adult patients who require a clinically indicated, untargeted liver biopsy over five predefined, sequential eight-week periods. Each eight-week block serves as a cluster, during which all enrolled patients receive the specific biopsy needle assigned to that period. The trial begins with the standard percutaneous 18G TruCut needle cluster. To minimize bias, the sequence of the subsequent four EUS-guided needle clusters-consisting of 19G FNA, 19G FNB, 22G FNA, and 22G FNB needles-is determined beforehand using a computer-generated random sequence. All procedures are performed by the same clinical team using highly standardized techniques to compare total specimen length, complete portal tracts, and procedure-associated pain across all groups.

Conditions

Liver Cirrhosis; Liver Disease Chronic; Liver Transplant

Keywords

Endoscopic ultrasound; EUS; Liver biopsy

Outcome Measures

Primary Outcomes (2)

• Biopsy specimen length

  From enrollment within one week

• Number of complete portal tracts

  From enrollment within one week

Secondary Outcomes (3)

• Overall adequacy

  7 days (until pathologic examination finished)

• Adverse events

  72 hours

• Number of complete portal tracts ≥ 11

  7 days (until pathologic examination finished)

Study Arms (5)

Percutaneous Liver Biopsy 18G Trucut

Diagnostic Test: PC-LB 18G Trucut

EUS-LB 19G FNA

Diagnostic Test: EUS Liver biopsy 19G FNA

EUS-LB 19G FNB

Diagnostic Test: EUS LB 19G FNB

EUS-LB 22G FNA

Diagnostic Test: EUS LB 22G FNA

EUS-LB 22G FNB

Diagnostic Test: EUS LB 22G FNB

Interventions

EUS Liver biopsy 19G FNA DIAGNOSTIC_TEST

Liver biopsy performed with 19G FNA

EUS-LB 19G FNA

EUS LB 19G FNB DIAGNOSTIC_TEST

Liver biopsy performed with 19G FNB

EUS-LB 19G FNB

EUS LB 22G FNB DIAGNOSTIC_TEST

Liver biopsy performed with 22G FNB

EUS-LB 22G FNB

EUS LB 22G FNA DIAGNOSTIC_TEST

Liver biopsy performed with 22G FNA

EUS-LB 22G FNA

PC-LB 18G Trucut DIAGNOSTIC_TEST

Percutaneous Liver biopsy 18G Trucut

Percutaneous Liver Biopsy 18G Trucut

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive adult patients undergoing clinically indicated untargeted liver biopsy during the study period at our tertiary liver center.

You may qualify if:

• clinical indication for non-targeted liver biopsy
• written informed consent

You may not qualify if:

• ascites
• severe coagulopathy (INR \>2.0 or platelet count \<50 × 10³/µl)
• contraindications to endoscopy or sedation
• anatomical conditions precluding safe liver biopsy
• pregnancy

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Muenster

Münster, 48149, Germany

Location

Related Publications (10)

• Hajifathalian K, Westerveld D, Kaplan A, Dawod E, Herr A, Ianelli M, Saggese A, Kumar S, Fortune BE, Sharaiha RZ. Simultaneous EUS-guided portosystemic pressure measurement and liver biopsy sampling correlate with clinically meaningful outcomes. Gastrointest Endosc. 2022 Apr;95(4):703-710. doi: 10.1016/j.gie.2021.11.037. Epub 2021 Dec 7.

  PMID: 34890694 BACKGROUND

• 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: 33766911 BACKGROUND

• Diehl DL, Sangwan V, Johal AS, Khara HS, Confer B. Comparing a 19-gauge fine-needle biopsy needle with a 22-gauge fine-needle biopsy needle for EUS-guided liver biopsy sampling: a prospective randomized study. Gastrointest Endosc. 2024 Jun;99(6):931-937. doi: 10.1016/j.gie.2023.12.022. Epub 2023 Dec 21.

  PMID: 38141686 BACKGROUND

• 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: 31342474 BACKGROUND

• Mok SRS, Diehl DL, Johal AS, Khara HS, Confer BD, Mudireddy PR, Kovach AH, Diehl MM, Kirchner HL, Chen ZE. Endoscopic ultrasound-guided biopsy in chronic liver disease: a randomized comparison of 19-G FNA and 22-G FNB needles. Endosc Int Open. 2019 Jan;7(1):E62-E71. doi: 10.1055/a-0655-7462. Epub 2019 Jan 4.

  PMID: 30648141 BACKGROUND

• 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: 34918578 BACKGROUND

• 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: 36204798 BACKGROUND

• 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: 37693114 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.

  PMID: 19243014 BACKGROUND

• Neuberger J, Patel J, Caldwell H, Davies S, Hebditch V, Hollywood C, Hubscher S, Karkhanis S, Lester W, Roslund N, West R, Wyatt JI, Heydtmann M. Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology. Gut. 2020 Aug;69(8):1382-1403. doi: 10.1136/gutjnl-2020-321299. Epub 2020 May 28.

  PMID: 32467090 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of hepatology

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: January 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 15, 2024
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)