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Clinical Trials/JPRN-UMIN000029612
JPRN-UMIN000029612
Completed
未知

The prospective multicenter observational study of tissue acquisition by endoscopic ultrasound-guided fine-needle aspiration using the 25-gauge Franseen needle - The prospective multicenter observational study of tissue acquisition by endoscopic ultrasound-guided fine-needle aspiration using the 25-gauge Franseen needle

Hokkaido University Hospital0 sites100 target enrollmentOctober 18, 2017

Overview

Phase
未知
Intervention
Not specified
Conditions
esions with Indication for EUS-FNA
Sponsor
Hokkaido University Hospital
Enrollment
100
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
who.int
Start Date
October 18, 2017
End Date
April 2, 2018
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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