Endoscopic Ultrasonography, Liver Biopsy
Conditions
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.
Interventions
DEVICE19-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.
DEVICE22-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.
Sponsors
Duzce University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed