Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device for Solid Pancreatic Lesions: a Prospective Multi-center, Randomized, and Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,224
- Locations
- 1
- Primary Endpoint
- The diagnostic yields
Study Overview
Brief Summary
The purpose of this study is to compare the diagnosis accuracy of 22G EUS Procore fine needle biopsy （FNB）device and 20G EUS Procore fine needle biopsy device for solid pancreatic lesions.
Detailed Description
This is a single-blind, randomized, controlled trial. One thousand two hundred and twenty four patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to 4 arms. For arm A1 which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is slow pull(SP)-modified wet suction technique(MWST)-slow pull(SP)-modified wet suction technique(MWST). For arm A2 with 22G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. For arm B1 with 20G EUS Procore fine needle biopsy device, the pass sequence is SP-MWST-SP-MWST. For arm B2 with 20G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. All procedures will be performed by experienced echoendoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >18 years old,<85 years old;
- •Gender: Male or Female;
- •Presence solid occupying pancreatic lesions (the diameter>1cm);
- •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;
- •Took anticoagulants such as aspirin, warfarin in the latest week;
- •Acute pancreatitis in the past two weeks;
- •Cardiopulmonary dysfunction;
- •Cannot sign the informed consent
Arms & Interventions
Arm 22G+SP
Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Intervention: Using 22G FNB, the first pass is SP (Device)
Arm 22G+MWST
Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
Intervention: Using 22G FNB, the first pass is MWST (Device)
Arm 20G+SP
Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Intervention: Using 20G FNB, the first pass is SP (Device)
Arm 20G+MWST
Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
Intervention: Using 20G FNB, the first pass is MWST (Device)
Outcomes
Primary Outcomes
The diagnostic yields
Time Frame: up to 15 months
The investigators' primary outcome measure is to compare the diagnostic yields of 22G FNB and 20G FNB to the solid pancreatic lesions.
Secondary Outcomes
- the tissue integrity(up to 15 months)
Investigators
Bin Cheng
professor
Huazhong University of Science and Technology