Clinical Trials Directory

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UnknownNCT05549856

Comparision of EUS-FNB Techniques for Diagnose of Solid Pancreatic Lesions

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Nanfang Hospital, Southern Medical University · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREWet suctionThe 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.
PROCEDUREDry suctionThe 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.

Timeline

Start date
2022-09-01
Primary completion
2023-12-01
Completion
2025-02-01
First posted
2022-09-22
Last updated
2022-09-23

Source: ClinicalTrials.gov record NCT05549856. Inclusion in this directory is not an endorsement.