Diagnoses Disease, Pancreatic Neoplasms
Conditions
Keywords
endoscopic ultrasound, endoscopic ultrasound guided FNB
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.
Interventions
PROCEDUREwet suction
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
PROCEDUREstandard negative pressure suction
after puncturing the lesion, the endoscopist removed the stylet and attached a 10-mL pre-vacuum syringe for aspiration.
Sponsors
Changhai Hospital
Second Affiliated Hospital of Soochow University
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactDuoWu Zou, Ph.D,M.D
Backup ContactChunhua Zhou, Ph.D,M.D
Outcome results
None listed