Comparison of diagnostic performance of two needle types during EUS-guided FNA
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002495
- Lead Sponsor
- Samsung Changwon Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 56
The inclusion criteria is
(1) Between 19 and 99 years of age.
(2) Patients with solid pancreatic masses , which is diagnosed with USG, CT or magnetic resonance imaging (size= 1cm).
(3) Patients with solid peripancreatic lesion, which is greater than or equal to 1 cm diagnosed with USG, CT or magnetic resonance imaging
(4) The ability to provide informed consent
The exclusion criteria is
(1) Absolute contraindication for procedural sedation
(2) Coagulation disorder (prothrombin time-international normalized ratio > 1.5, activated partial
thromboplastin time < 50 seconds, platelet count < 50,000/mm3)
(3) History of acute pancreatitis in the preceding 4 weeks
(4) Evidence of systemic infection
(5) Pregnancy
(6) Refusal or inability to provide informed
consent
(7) The inability to undergo an endoscopic approach
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sample quality and diagnostic yield (evaluate as primary outcome by combining the following details: (1) Adequacy score (using largest yield sample)-Cytology (1-2), Histology (3-5) (2) sample quality on cytology, (3) Diagnosis on cytology, (4) Sample quality on histology, (5) Diagnosis on Histology, (6) IHC availability;Safety of EUS-needle
- Secondary Outcome Measures
Name Time Method Detection of KRAS mutations in EUS-FNA specimens from pancreatic masses