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

Not Applicable

• Conditions: Pancreatic Neoplasms; Diagnoses Disease
• Interventions: Procedure: wet suction; Procedure: standard negative pressure suction

• Registration Number: NCT04605042
• Lead Sponsor: Ruijin Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-27
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-27
• Study Start: 2020-12-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

1. informed consent
2. Subjects over 18 years old
3. Imaging examination (ultrasound, CT or MRI) diagnosed or suspected solid pancreatic mass more than 1cm

Exclusion Criteria

1. Unable or refused to sign informed consent
2. suspended anticoagulant/antiplatelet therapy
3. Being pregnant or breastfeeding
4. Cystic lesions of the pancreas
5. coagulation disorders (PLT <50×103/ L, INR > 1.5)
6. A history of mental illness
7. other medical conditions that are not suitable for FNB puncture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
STANDARD first group	standard negative pressure suction	COOK ECHO-HD 22-C EchoTip Procore needle in SNP-WS-SNP-WS sequence
STANDARD first group	wet suction	COOK ECHO-HD 22-C EchoTip Procore needle in SNP-WS-SNP-WS sequence
WET First group	standard negative pressure suction	COOK ECHO-HD 22-C EchoTip Procore needle biopsy in WS-SNP-WS-SNP sequence
WET First group	wet suction	COOK ECHO-HD 22-C EchoTip Procore needle biopsy in WS-SNP-WS-SNP sequence

Primary Outcome Measures

Name	Time	Method
diagnostic sensitivity of WS technique and SNP technique by EUS-FNB	6 month	Sensitivity will be calculated as the probability of actually having pancreatic diasease and being diagnosed by WS technique during EUS-FNB
diagnostic specificity of WS technique and SNP technique by EUS-FNB	6 month	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

Secondary Outcome Measures

Name	Time	Method
Sample adequacy of WS technique and SNP technique by EUS-FNB	6 month	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.
Cell density of WS technique and SNP technique by EUS-FNB	6 month	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