The investigators conduct a prospective, multicenter, blinded, randomized controlled trial to compare the diagnostic value and safety of the 22G Adapt needle versus the 22G Franseen needle for histopathological evaluation of solid lesions.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* Over 18 years old and under 85 years old;
* Presence of a solid lesion greater than 1 cm in diameter, as identified by cross-sectional imaging (Magnetic Resonance Imaging, Computed Tomography or abdominal ultrasound), located in anatomical regions accessible via endoscopic ultrasound (EUS)-including but not limited to the pancreas, retroperitoneum, liver, mediastinum, or subepithelial layers of the gastrointestinal tract-where tissue acquisition is clinically indicated to establish a definitive histopathological diagnosis.;
* Must be able to receive examinations in the research center;
* Must be able to sign the informed consent.
Exclusion Criteria:
* Hemoglobin ≤8.0 g/dL;
* Pregnant women;
* Coagulation disorders(Platelet \<50,000/mm3, International Normalized Ratio \> 1.5);
* Took anticoagulants such as aspirin, warfarin in the latest week;
* Acute pancreatitis in the past two weeks;
* inability to safely perform Endoscopic Ultrasound-Guided Tissue Acquisition (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction); refusal or inability to provide an informed consent.
Primary outcome measure(s)
The histological diagnostic yields — up to 15 months The primary outcome measure of the study is to compare the histological diagnostic yield of EUS-guided fine-needle biopsy (EUS-FNB) using a 22G Franseen needle versus a 22G Adapt needle for both pancreatic and non-pancreatic solid lesions.
Trial sites (1)
Facility
City
Region
Status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
More Huazhong University of Science and Technology trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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