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

Duzce University

Status and phase: Enrolling; Phase 4

Conditions: Liver Biopsy; Endoscopic Ultrasonography

Treatments: Device: 19-gauge; Device: 22-gauge

Study type: Interventional

Funder types: Other

Identifiers

NCT06643520

EUS-LB

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 2 patient groups

19-gauge FNB needle

Active Comparator group

Description:

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

Treatment:

Device: 19-gauge

22-gauge FNB needle

Experimental group

Description:

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

Treatment:

Device: 22-gauge

Sponsor of this trial

Lead Sponsor

Duzce University