Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pancreas Neoplasms

Intervention / Treatment
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* Device: Using 22G FNB, the first pass is SP
* Device: Using 22G FNB, the first pass is MWST
* Device: Using 20G FNB, the first pass is SP
* Device: Using 20G FNB, the first pass is MWST


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 22G+SP<br>Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST. | Device: Using 22G FNB, the first pass is SP<br>* Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.<br>|
| Other: Arm 22G+MWST<br>Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP. | Device: Using 22G FNB, the first pass is MWST<br>* Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.<br>|
| Other: Arm 20G+SP<br>Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST. | Device: Using 20G FNB, the first pass is SP<br>* Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.<br>|
| Other: Arm 20G+MWST<br>Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP. | Device: Using 20G FNB, the first pass is MWST<br>* Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.technique-slow pull.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic yields | The investigators' primary outcome measure is to compare the diagnostic yields of 22G FNB and 20G FNB to the solid pancreatic lesions. | up to 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the tissue integrity | The investigators' secondary outcome measure is to assess the tissue size under a light microscope to compare the tissue obtained by 22G FNB and 20G FNB with Slow-pull or modified wet suction technique. | up to 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS-FNB, slow pull, modified wet suction technique