Official Title: Dry Suction Technique Versus Wet Suction Technique of Endoscopic Ultrasound-Guided Fine-needle Biopsy for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial
Sponsor study identifier
interventional
200
0 countries
N/A
Study Start
September 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 18, 2022
Actual (reported)September 22, 2022
Actual (reported)December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Samples tissue integrity
12 months
Samples cellularity
12 months
the diagnostic in relation to the number of needle passes
12 months
Time (minutes) of the procedures with dry suction and wet suction
12 months
Percentage of procedure related adverse events [Safety]
24 months
22G Franseen needle biopsy with dry suction technique(The puncture needle be filled with air)
22G Franseen needle biopsy with wet suction(The puncture needle be filled with saline before sugry)
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.
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.
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.
Li Yue, Doctor
Nanfang Hospital, Southern Medical University
First Submitted
September 18, 2022
First Posted
September 22, 2022
Study Start
September 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2023
Estimated (date passed)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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 23, 2022
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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