Diagnostic Yield of 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions
Technical Feasibility and Diagnostic Yield of New 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions; Comparison With 22-gauge Procore Needle
1 other identifier
interventional
35
1 country
1
Brief Summary
This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore needle. The study design is prospective, randomized study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
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
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 28, 2016
CompletedFirst Posted
Study publicly available on registry
September 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedOctober 3, 2017
October 1, 2017
1.3 years
September 28, 2016
October 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
single diagnostic yield of the histologic core
up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
Secondary Outcomes (1)
total diagnostic yield of the histologic core
up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
Study Arms (2)
EUS-FNB with 20-gauge
EXPERIMENTALEUS-FNB with 20-gauge procore needle
EUS-FNB with 22-gauge
ACTIVE COMPARATOREUS-FNB with 22-gauge procore needle
Interventions
EUS-FNB with 20-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
EUS-FNB with 22-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
Eligibility Criteria
You may qualify if:
- Patients older than 20 years referred to our medical center for EUS-FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung Bae Yoonlead
- Seoul St. Mary's Hospitalcollaborator
Study Sites (1)
The Catholic University of Korea
Seoul, No State, 06591, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
In Seok Lee, MD
The Catholic University of Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 28, 2016
First Posted
September 30, 2016
Study Start
July 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
October 3, 2017
Record last verified: 2017-10