Clinical trial NCT04605042: Comparsion of WT and SNP Techniques of EUS-FNB in Pancreatic Solid Mass (WESP-PSM)
Official title: A Multicenter Prospective Clinical Study of Wet-suction Technique and Standard Negative Pressure Technique in EUS-FNB for the Diagnosis of Pancreatic Solid Mass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Neoplasms
Diagnoses Disease
Keywords: endoscopic ultrasound
endoscopic ultrasound guided FNB
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Second Affiliated Hospital of Soochow University
First posted: 2020-10-27
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: diagnostic sensitivity of WS technique and SNP technique by EUS-FNB
timeFrame: 6 month
measure: diagnostic specificity of WS technique and SNP technique by EUS-FNB
timeFrame: 6 month
Secondary outcomes:
measure: Sample adequacy of WS technique and SNP technique by EUS-FNB
timeFrame: 6 month
measure: Cell density of WS technique and SNP technique by EUS-FNB
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Ruijin hospital Shanghai Jiaotong Universtity, school of medicine
name: DuoWu Zou, Ph.D,M.D
role: STUDY_CHAIR
References:
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