Comparison of diagnostic performance of two needle types during EUS-guided FNA

Comparison of diagnostic performance of two needle types during EUS-guided FNA and clinical impact of KRAS mutations in patients with peripancreatic tumor

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002495

Enrollment

Registered

2017-10-13

Start date

2017-07-12

Completion date

Unknown

Last updated

2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Computer-generated randomization assignments will be placed in sealed envelopes and opened by the nurse during the procedure when patients met criteria for study in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Detection of KRAS mutations in EUS-FNA specimens from pancreatic masses	—

Countries

Korea, Republic of

Contacts

Public ContactKwang Min Kim

Samsung Changwon Medical Center

argonkim@gmail.com+82-55-233-5025

Outcome results