Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 219
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy
Study Overview
Brief Summary
Background:
EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with pancreatic mass with high specificity, specificity and accuracy. However FNA with small needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore needles were frequently used. However there was no comparative study of the efficacy and accuracy between 22 and 25 gauge ProCore needle yet.
Aim:
To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not inferior to 22 gauge ProCore needle.)
Detailed Description
Patient and methods:
Patients who have pancreatic or peripancreatic mass in imaging studies which need pathologic confirm. These patients were randomly assigned to 22 gauge or 25 gauge group.
Procedure:
They underwent EUS-guided FNA, 3 times with 10 times of to-and pro movement each.
The number of patients required:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who agree to participate in research
- •18 years of age and older patients
- •Patients who have pancreatic or peripancreatic mass in imaging studies
Exclusion Criteria
- •Contraindication to endoscopy
- •Patients younger than 18 years old
- •Bleeding tendency
- •Cardiopulmonary dysfunction
Arms & Interventions
22 gauge ProCore needle biopsy
EUS-guided pancreatic or peripancreatic mass biopsy with 22 gauge ProCore biopsy needle.
Intervention: 22 gauge ProCore needle biopsy (Device)
25 gauge ProCore needle biopsy
EUS-guided pancreatic or peripancreatic mass biopsy with 25 gauge ProCore biopsy needle.
Intervention: 25 gauge ProCore needle biopsy (Device)
Outcomes
Primary Outcomes
Diagnostic accuracy
Time Frame: October. 2014
Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis
Secondary Outcomes
- Technical success(October. 2014)
Investigators
Kwang Hyuck Lee
Assistant Professor of Medicine, Division of Gastroenterology
Samsung Medical Center