19G FNB Needle vs 22G FNB Needle for EUS-Guided Liver Biopsy

NCT06643520 | Completed

• 1 other identifier: EUS-LB
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

EUS-guided liver biopsy (EUS-LB) is increasingly used to diagnose patients with liver disease, especially in anxious patients who need sedation. There is an ongoing debate about the optimal needle size for EUS-LB. Some clinicians prefer a thinner 22-gauge biopsy needle because they presume it to be safer, and some studies show that their performance is the same as a thicker 19-gauge needle. However, some other studies show that the adequacy and diagnostic accuracy of a 19-gauge needle is better, and the rates of adverse events are the same. In this study, we aimed to compare the adequacy and diagnostic accuracy of samples obtained by the same endoscopist from the same liver lobe during the same session.

Conditions

Endoscopic Ultrasonography; Liver Biopsy

Outcome Measures

Primary Outcomes (1)

• Sample adequacy

  The sample must have at least 11 complete portal tracts and the length of the longest specimen should be at least 15mm

  1 month

Secondary Outcomes (1)

• Adverse events

  1 week

Study Arms (2)

19-gauge FNB needle

ACTIVE COMPARATOR

Biopsy samples obtained by a 19-gauge FNB needles for EUS-LB

Device: 19-gauge

22-gauge FNB needle

EXPERIMENTAL

Biopsy samples obtained by a 22-gauge FNB needles for EUS-LB

Device: 22-gauge

Interventions

19-gauge DEVICE

All procedures will be performed under monitored endoscopist- directed anesthesia. Patients will be placed in a semi-prone position and oxygen at a rate of 3 L/min will be administered routinely All procedures will be performed by the same endoscopist, who performed \> 500 diagnostic and interventional EUS procedures annually. A standard linear echoendoscope (EG34-J10U, Pentax Medi- cal, Hoya Corp, Japan) will be used. The patients are going to be followed up until the Modified Aldrete Score \> 9 after the procedure, and then they will be discharged. All biopsies will be performed with a standard 19 gauge FNA needle (Trident, Micro-Tech (Nanjing) Co., Ltd, Nan) with wet suction technique. Biopsy needles will be used without stylets and primed with diluted heparin (1:1 ratio) to obtain samples by wet-suction technique to prevent clot formation. All the biopsies will be performed from the left lobe of the liver as one pass and five actuations.

19-gauge FNB needle

22-gauge DEVICE

All procedures will be performed under monitored endoscopist- directed anesthesia. Patients will be placed in a semi-prone position and oxygen at a rate of 3 L/min will be administered routinely. All procedures will be performed by the same endoscopist, who performed \> 500 diagnostic and interventional EUS procedures annually. A standard linear echoendoscope (EG34-J10U, Pentax Medi- cal, Hoya Corp, Japan) will be used. The patients are going to be followed up until the Modified Aldrete Score \> 9 after the procedure, and then they will be discharged. All biopsies will be performed with a standard 22 gauge FNA needle (Trident, Micro-Tech (Nanjing) Co., Ltd, Nan) with wet suction technique. Biopsy needles will be used without stylets and primed with diluted heparin (1:1 ratio) to obtain samples by wet-suction technique to prevent clot formation. All the biopsies will be performed from the left lobe of the liver as one pass and five actuations.

22-gauge FNB needle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with unexplained elevation of liver enzymes and suspected hepatic paranchymal disease

You may not qualify if:

• Patients who had malignancy
• Patients who have decompensated cirrhosis
• Presence of ascites
• Patients with coagulopathy (platelets \< 50.000 μ/ mL and INR \> 1.5)
• The use of anticoagulant agents
• Pregnancy
• Unable to provide written informed consent

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University

Düzce, Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (3)

• Shah RM, Schmidt J, John E, Rastegari S, Acharya P, Kedia P. Superior Specimen and Diagnostic Accuracy with Endoscopic Ultrasound-Guided Liver Biopsies Using 19-Gauge versus 22-Gauge Core Needles. Clin Endosc. 2021 Sep;54(5):739-744. doi: 10.5946/ce.2020.212. Epub 2020 Nov 13.

  PMID: 33189102 BACKGROUND

• Dalal A, Kamat N, Patil G, Vadgaonkar A, Parekh S, Vora S, Maydeo A. Comparison of diagnostic outcomes, safety, and cost of Franseen-tip 19G versus 22G needles for endoscopic ultrasound-guided liver biopsies. Endosc Int Open. 2024 Feb 28;12(2):E291-E296. doi: 10.1055/a-2226-1337. eCollection 2024 Feb.

  PMID: 38420158 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof. of GI

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 16, 2024
• Study Start: July 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)