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Comparison of between techniques for EUS-guided tissue acquisitio

Not Applicable
Completed
Conditions
Neoplasms
Registration Number
KCT0004678
Lead Sponsor
Hallym University Medical Center-Dongtan
Brief Summary

The median quality score of the histological samples was significantly higher in the torque and fanning group than in the standard group (P <0.001). Furthermore, the torque technique provided improved sensitivity of 93.38% and accuracy of 94.30%. The standard technique provided diagnostic sensitivity of 68.84% and accuracy of 72.96%, while the fanning technique showed sensitivity of 91.85% and accuracy of 93.04%.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
155
Inclusion Criteria

1. Consecutive patients who will be referred to each medical center for EUS-FNB to evaluate pancreatic solid masses
2. Age of 19 or more years old
3. Able to voluntarily agree to participate and to sign informed consent
4. Willingness to participate and sign the informed consent agreement.

Exclusion Criteria

1) if the mass had only a cystic component without a solid component suspected with malignant transformation
2) if the coagulation parameters were abnormal (international normalized ratio >1.5 or platelet count <50,000 cells/cmm
3) postponing the antithrombotic therapy was impossible
4) if the patient had cardiopulmonary instability
5) pregnancy

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
the proportion of achievement of true diagnosis without ROSE on the first pass
Secondary Outcome Measures
NameTimeMethod
the procurement rate of optimal histologic cores (possible for IHC stain);Diagnostic yield: sensitivity, specificity, positive predict value, negative predict value;Rate of technical failure;Procedure/Device related major adverse events
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