Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass
Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study
1 other identifier
interventional
219
1 country
1
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.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2012
CompletedFirst Posted
Study publicly available on registry
November 16, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedApril 28, 2016
April 1, 2016
1.9 years
October 21, 2012
April 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy
Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis
October. 2014
Secondary Outcomes (1)
Technical success
October. 2014
Other Outcomes (1)
Complications
November. 2014
Study Arms (2)
22 gauge ProCore needle biopsy
ACTIVE COMPARATOREUS-guided pancreatic or peripancreatic mass biopsy with 22 gauge ProCore biopsy needle.
25 gauge ProCore needle biopsy
ACTIVE COMPARATOREUS-guided pancreatic or peripancreatic mass biopsy with 25 gauge ProCore biopsy needle.
Interventions
22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
Eligibility Criteria
You may qualify if:
- Patients who agree to participate in research
- years of age and older patients
- Patients who have pancreatic or peripancreatic mass in imaging studies
You may not qualify if:
- Contraindication to endoscopy
- Patients younger than 18 years old
- Bleeding tendency
- Cardiopulmonary dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Seoul City, 135-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kwanghyuck Lee, MD
Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine, Division of Gastroenterology
Study Record Dates
First Submitted
October 21, 2012
First Posted
November 16, 2012
Study Start
January 1, 2013
Primary Completion
December 1, 2014
Study Completion
November 1, 2015
Last Updated
April 28, 2016
Record last verified: 2016-04