NCT06643520

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Duzce University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	19-gauge	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.
DEVICE	22-gauge	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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-03-01
• Completion: 2025-04-01
• First posted: 2024-10-16
• Last updated: 2025-12-05

Locations

1 site across 1 country: Turkey (Türkiye)