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NCT Number: NCT06643520

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

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.

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Key information

Conditions

Endoscopic Ultrasonography Liver Biopsy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duzce University

Düzce, 81620, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Sample adequacy

    Time frame: 1 month

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

Secondary outcomes

  1. Adverse events

    Time frame: 1 week

    The rates of adverse events will be recorded. According to the American Society of Gastrointestinal Endoscopy lexicon, an adverse event is "… an event preventing the completion of the planned procedure and/or results in admission to the hospital, prolonga- tion of existing hospital stay, another procedure (needing sedation/anesthesia), or subsequent medical consultation."

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study title

Sample Adequacy and Diagnostic Accuracy of a 22 Gauge FNB Needle vs a 19G FNB Needle for EUS-guided Liver Biopsy: a Prospective Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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