Endoscopic Ultrasound-guided Fine Needle Biopsy With 25-gauge Biopsy Needles for Solid Pancreatic Masses

Study Overview
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Brief Summary
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For 12 months after approvement by the University of Yonsei institutional review board, of the 59 patients older than 20 years referred to our medical center for EUS-FNA or FNB, all consecutive pancreatic lesions were evaluated for inclusion in our prospective study. The inclusion criteria for this study were the following: diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies with need of histologic tissue confirmation by EUS-FNA or EUS-FNB. The exclusion criteria were the following: cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study. Patients undergoing anticoagulant or anti- platelet therapy for non-critical problems discontinued treatment at least 5 days before the endoscopic procedure. Written informed consent was obtained from all patients for the procedures performed and participation in the study, and the study protocol was approved by the University of Yonsei institutional review board. All patients were underwent the procedure under conscious sedation with propofol and midazolam according to the current guidelines.8 After procedure, the patients were monitored for at least six hours in order to immediately detect post-procedural complications and were followed for up to 7 days in order to detect late complications.

Conditions
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Solid Pancreatic Masses

Intervention / Treatment
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* Device: EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 20 years referred to our medical center for EUS-FNA or FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies Exclusion Criteria: cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS-FNB with 25-gauge<br> | Device: EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)<br> <br> * Other names: EUS-FNA with the use of Wilson-Cook procore 25-gauge needles (Echotip, Wilson-Cook, Winston Salem, NC, USA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accessing the rate for procurement of the histologic core | The tissue samples were immediately fixed in formalin. The histologic cassette was processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist (K.H.K) for the presence of a histologic core. If the histologic core was present, the specimen was graded as optimal or suboptimal. Optimal specimens were those in which the procured material enabled satisfactory assessment of histologic architecture that either did not change the original diagnosis or yielded additional findings. Suboptimal specimens were those in which the quality of the histologic core was unsatisfactory for assessment of histologic architecture. When required, immunohistochemical or special staining was performed for differentiation of morphologically challenging lesions.10 | up to 5 minuites after endoscopic ultrasound-guided fine needle biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation of 25-gauge biopsy needle | The tissue samples were immediately fixed in formalin. The histologic cassette was processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist (K.H.K) for the presence of a histologic core. If the histologic core was present, the specimen was graded as optimal or suboptimal. Optimal specimens were those in which the procured material enabled satisfactory assessment of histologic architecture that either did not change the original diagnosis or yielded additional findings. Suboptimal specimens were those in which the quality of the histologic core was unsatisfactory for assessment of histologic architecture. When required, immunohistochemical or special staining was performed for differentiation of morphologically challenging lesions.10 | up to 5 minuites after after endoscopic ultrasound-guided fine needle biopsy |