Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 19-gauge FNB needle | Active Comparator | Biopsy samples obtained by a 19-gauge FNB needles for EUS-LB |
|
| 22-gauge FNB needle | Experimental | Biopsy samples obtained by a 22-gauge FNB needles for EUS-LB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sample adequacy | The sample must have at least 11 complete portal tracts and the length of the longest specimen should be at least 15mm | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 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." | 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duzce University | Düzce | Düzce | 81620 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33189102 | Background | Shah RM, Schmidt J, John E, Rastegari S, Acharya P, Kedia P. Superior Specimen and Diagnostic Accuracy with Endoscopic Ultrasound-Guided Liver Biopsies Using 19-Gauge versus 22-Gauge Core Needles. Clin Endosc. 2021 Sep;54(5):739-744. doi: 10.5946/ce.2020.212. Epub 2020 Nov 13. | |
| 38420158 | Background | Dalal A, Kamat N, Patil G, Vadgaonkar A, Parekh S, Vora S, Maydeo A. Comparison of diagnostic outcomes, safety, and cost of Franseen-tip 19G versus 22G needles for endoscopic ultrasound-guided liver biopsies. Endosc Int Open. 2024 Feb 28;12(2):E291-E296. doi: 10.1055/a-2226-1337. eCollection 2024 Feb. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 38141686 | Background | Diehl DL, Sangwan V, Johal AS, Khara HS, Confer B. Comparing a 19-gauge fine-needle biopsy needle with a 22-gauge fine-needle biopsy needle for EUS-guided liver biopsy sampling: a prospective randomized study. Gastrointest Endosc. 2024 Jun;99(6):931-937. doi: 10.1016/j.gie.2023.12.022. Epub 2023 Dec 21. |