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

Phase 4

Recruiting

• Conditions: Endoscopic Ultrasonography; Liver Biopsy

• Registration Number: NCT06643520
• Lead Sponsor: Duzce University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-13
• Last Update Submitted: 2024-10-13
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sample adequacy	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 Outcome Measures

Name	Time	Method
Adverse events	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."

Trial Locations

Locations (1)

Duzce University; 🇹🇷 Duzce, Turkey