The prospective multicenter observational study of tissue acquisition by endoscopic ultrasound-guided fine-needle aspiration using the 25-gauge Franseen needle
Not Applicable
- Conditions
- esions with Indication for EUS-FNA
- Registration Number
- JPRN-UMIN000029612
- Lead Sponsor
- Hokkaido University Hospital
- Brief Summary
The patients were 57 males and 43 females with a median age of 70 years. The technical success rate was 100 %. The tissue acquisition rate at the first pass was 95.0 % and the acquisition rate of an adequate specimen for histological assessment was 82.0 %. The sensitivity, specificity, PPV, NPV and diagnostic accuracy were 87.0 %, 100 %, 100 %, 40.0 % and 88.0 %, respectively. The adverse event rate was 1.0 %, the detail of which was 1 moderate pancreatic fistula.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Cystic lesion (2) PT-INR =or >1.5 (3) Platelate count < 50000/m3 (4) ASA =or >3 (5) ECOG-PS=4 (6) Pregnancy (7) Unsuitable for inclusion at the discretion of the physician.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The tissue acquisition rate in the initial puncture
- Secondary Outcome Measures
Name Time Method (1) Quality of a tissue sample (2) Diagnostic accuracy Diagnostic accuracy, sensitivity, specificity, PPV, NPV in (3) pathological and (4) cytological malignancy or benignancy (5) Success rate of puncture (6) Adverse event rate in EUS-FNA