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| Name | Class |
|---|---|
| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
| Shenzhen People's Hospital | OTHER |
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Studies have shown that the wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. However, studies on wet suction on the diagnostic accuracy of EUS-FNB is small and the conclusions are controversial. Besides, the optional numeber of passes for EUS-FNB has not been determined.
The investigators aimed to design a large multicenter randomized trial to compare the diagnostic accuracy and the optimal number of passes required for EUS-FNB in solid pancreatic lesions using 22G Franseen under wet aspiration versus standard aspiration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry suction group | Experimental | 22G Franseen needle biopsy with dry suction technique(The puncture needle be filled with air) |
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| Wet suction group | Active Comparator | 22G Franseen needle biopsy with wet suction(The puncture needle be filled with saline before sugry) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wet suction | Procedure | The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). Before puncturing the lesion, flush the needle with 5ml saline, then use a 10 ml syringe in order to replacing the column of air with fluid. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique. |
| Measure | Description | Time Frame |
|---|---|---|
| diagnostic accuracy | compare the rate of diagnostic accuracy of EUS- FNB using the two different suction techniques (dry suction and wet suction) in patients with solid pancreatic lesions. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Samples tissue integrity | The tissue integrity on histological analysis was graded into 3 levels: Grade A, existing core tissue (defined as an architecturally intact piece of tissue with a long axis measuring at least 550 μm), which can clearlycharacterize the lesion, and is sufficient for diagnosis; Grade B, existing core fragments, which does not meet the criteria for architecturally intact histology, but can still yield a diagnosis based on cell morphology;and Grade C, no lesion tissue found, and a diagnosis cannot be made based on the sample. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Yue, Doctor | Contact | +86 15975537291 | liyue_1989919@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Yue, Doctor | Nanfang Hospital, Southern Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40019152 | Derived | Xu S, Guo J, Qin M, Meng Y, Xie F, Qiao W, Hu H, Peng P, Rownoak J, Heng S, Ung F, Ye Y, Wang J, Li W, Zou Y, Zou L, Huang S, Liu S, Wang J, Yao J, Li Y. Dry Suction Versus Wet Suction of Endoscopic Ultrasound-Guided Fine-Needle Biopsy for Diagnosis of Solid Pancreatic Lesions: A Multicenter Randomized Controlled Noninferiority Trial. Am J Gastroenterol. 2025 Nov 1;120(11):2529-2537. doi: 10.14309/ajg.0000000000003389. Epub 2025 Feb 27. | |
| 38093381 |
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| Dry suction | Procedure | The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). The stylet is removed and a 10 ml air-filled pre-vacuum syringe is attached. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique. |
|
| 12 months |
| Samples cellularity | The cellularity of the cytological specimens was graded into 3 levels as follows : Grade A, more than 4 clusters, with a minimum of 10 cells in each cluster; Grade B, approximately 2-4 clusters, with a minimum of 10 cells in each cluster; and Grade C, fewer than 2 clusters or no cellular smear. | 12 months |
| the diagnostic in relation to the number of needle passes | the diagnostic accuracy of each needle | 12 months |
| Time (minutes) of the procedures with dry suction and wet suction | Time of the procedure is defined by the time from flushing the needle with saline solution to the removal of the needle after the last pass. | 12 months |
| Percentage of procedure related adverse events [Safety] | Intra-procedural and post-procedural adverse events in the 2 arms will be evaluated | 24 months |
| Derived |
| Xu S, Wang J, Guo J, Xie F, Qiao W, Meng Y, Peng P, Hu H, Huang Y, Liu S, Qin M, Yao J, Li Y. Dry suction versus wet suction technique of endoscopic ultrasound-guided fine-needle biopsy for diagnosis of solid pancreatic lesions: study protocol of a multicenter randomized controlled non-inferiority trial. Trials. 2023 Dec 13;24(1):805. doi: 10.1186/s13063-023-07842-8. |