Comparsion of WT and SNP Techniques of EUS-FNB in Pancreatic Solid Mass (WESP-PSM)

Study Overview
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Brief Summary
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The purpose of this study is to compare the diagnosis accuracy between of wet suction (WS) technique and standard negative pressure (SNP) technique in EUS-FNB by 22G EUS Procore fine needle biopsy（FNB）device for solid pancreatic lesions.

Detailed Description
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This is a multi-center, single-blind, randomized, controlled trial. two hundred and ninety six patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to two groups. For group A which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is WS-SNP-WS-SNP technique. For group B with 22G EUS Procore fine needle biopsy device, the pass sequence is SNP-WS-SNP-WS. All procedures will be performed by experienced echo-endoscopists, 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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A Multicenter Prospective Clinical Study of Wet-suction Technique and Standard Negative Pressure Technique in EUS-FNB for the Diagnosis of Pancreatic Solid Mass

Conditions
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Pancreatic Neoplasms, Diagnoses Disease

Intervention / Treatment
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* Procedure: wet suction
* Procedure: standard negative pressure suction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent Subjects over 18 years old Imaging examination (ultrasound, CT or MRI) diagnosed or suspected solid pancreatic mass more than 1cm Exclusion Criteria: Unable or refused to sign informed consent suspended anticoagulant/antiplatelet therapy Being pregnant or breastfeeding Cystic lesions of the pancreas coagulation disorders (PLT <50×103/ L, INR > 1.5) A history of mental illness other medical conditions that are not suitable for FNB puncture

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WET First group<br>COOK ECHO-HD 22-C EchoTip Procore needle biopsy in WS-SNP-WS-SNP sequence | Procedure: wet suction<br>* Before pucturing the lesion, the stylet was removed and the needle was pre-flushed with 1-2 mL of saline using a 10-mL syringe, the endoscopist then punctured the lesion and replaced the 10-mL syringe with a 10-mL pre-vacuum syringe<br>Procedure: standard negative pressure suction<br>* after puncturing the lesion, the endoscopist removed the stylet and attached a 10-mL pre-vacuum syringe for aspiration.<br>|
| Experimental: STANDARD first group<br>COOK ECHO-HD 22-C EchoTip Procore needle in SNP-WS-SNP-WS sequence | Procedure: wet suction<br>* Before pucturing the lesion, the stylet was removed and the needle was pre-flushed with 1-2 mL of saline using a 10-mL syringe, the endoscopist then punctured the lesion and replaced the 10-mL syringe with a 10-mL pre-vacuum syringe<br>Procedure: standard negative pressure suction<br>* after puncturing the lesion, the endoscopist removed the stylet and attached a 10-mL pre-vacuum syringe for aspiration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic sensitivity of WS technique and SNP technique by EUS-FNB | Sensitivity will be calculated as the probability of actually having pancreatic diasease and being diagnosed by WS technique during EUS-FNB | 6 month | 
| diagnostic specificity of WS technique and SNP technique by EUS-FNB | specificity will be calculated as the probability of actually not having the pancreatic disease and being diagnosed as being free of the disease by WS or SNP technique during EUS-FNB | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sample adequacy of WS technique and SNP technique by EUS-FNB | The tissue integrity assessments of specimens will be evaluated by score 0-3. Score 3, sufficient material for adequate histological interpretation; Score 2, samples allowing limited histological assessment; Score 1,samples not providing histological information. | 6 month | 
| Cell density of WS technique and SNP technique by EUS-FNB | The Cell density assessments of specimens will be evaluated by score A-C. Score A：Satisfactory, more than 4 clusters of cells, each cluster more than 10 cells. Score B：Sufficient, approximately 2-4 clusters, each with more than 10 cells Score C: ：Unsatisfactory, less than 2 clusters or no cells on slide | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic ultrasound, endoscopic ultrasound guided FNB