Status:
NOT_YET_RECRUITING
22G-Adapt Needle Biopsy Versus Fine-needle Aspiration in Endoscopic Ultrasound-guided Sampling of Solid Lesions
Lead Sponsor:
Huazhong University of Science and Technology
Collaborating Sponsors:
Peking Union Medical College Hospital
Fudan University
Conditions:
Pancreatic Neoplasms
Mediastinal Neoplasms
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The investigators conduct a multicenter randomized controlled study to evaluate the diagnostic value and safety of 22G Adapt Aspiration puncture needle for histopathology of solid lesions.
Detailed Description
The study subjects are divided into two groups: the EUS-FNA(22G EchoTip Ultra needles) Group and EUS-FNB group(22 Adapt Aspiration).Take the malignant occupying lesion diagnosis accuracy as the resear...
Eligibility Criteria
Inclusion
- Over 18 years old and under 85 years old;
- Imaging examinations (MRI, CT, B-ultrasound) reveal the presence of solid masses (with a diameter \> 1 cm) within the regions accessible by endoscopic ultrasound in the pancreas, peripancreatic area, liver, adrenal gland, kidney, mediastinum, lung, and gastrointestinal submucosa. Biopsy is necessary for the diagnosis of these lesions;
- Must be able to receive examinations in the research center;
- Must be able to sign the informed consent.
Exclusion
- Hemoglobin ≤8.0 g/dL;
- Pregnant women;
- Coagulation disorders (PLT \<50,000/mm3,INR \> 1.5);
- Took anticoagulants such as aspirin, warfarin in the latest week;
- Acute pancreatitis in the past two weeks;
- inability to safely perform EUS-TA (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction); refusal or inability to provide an informed consent.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
656 Patients enrolled
Trial Details
Trial ID
NCT06563232
Start Date
September 1 2024
End Date
February 1 2026
Last Update
August 20 2024
Active Locations (1)
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1
Tongji Hospital, Tongji Medical College, HUST
Wuhan, Hubei, China, 430030