Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass
NCT ID: NCT01727921
Last Updated: 2016-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
219 participants
INTERVENTIONAL
2013-01-31
2015-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Endoscopic Ultrasound-guided Fine Needle Biopsy With 25-gauge Biopsy Needles for Solid Pancreatic Masses
NCT01795066
Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors
NCT03444051
Comparing the Diagnostic Efficacy of Different Suction Techniques for EUS-FNB of Pancreatic Solid Lesions
NCT04100941
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy in Solid Pancreatic Masses
NCT02936960
Needle-based Confocal Endomicroscopy Examination of Pancreatic Masse
NCT01734967
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
We used confidence intervals (CIs) with a prespecified non-inferiority margin of 10% for the non-inferiority analysis. We concluded non-inferiority of PC25 to PC22 if the lower limit of the 95% CI for the difference (PC25-PC22) was not lower than -10%. It was assumed that the diagnostic accuracy of one pass was 75% and that of three cumulative passes was estimated to be 98.4% in PC22. Based on these assumptions, the calculated sample size was 216 samples with power of 80% and significance level of 5%.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
22 gauge ProCore needle biopsy
EUS-guided pancreatic or peripancreatic mass biopsy with 22 gauge ProCore biopsy needle.
22 gauge ProCore needle biopsy
22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
25 gauge ProCore needle biopsy
EUS-guided pancreatic or peripancreatic mass biopsy with 25 gauge ProCore biopsy needle.
25 gauge ProCore needle biopsy
25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
22 gauge ProCore needle biopsy
22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
25 gauge ProCore needle biopsy
25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 years of age and older patients
* Patients who have pancreatic or peripancreatic mass in imaging studies
Exclusion Criteria
* Patients younger than 18 years old
* Bleeding tendency
* Cardiopulmonary dysfunction
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Samsung Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kwang Hyuck Lee
Assistant Professor of Medicine, Division of Gastroenterology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kwanghyuck Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Samsung Medical Center
Seoul, Seoul City, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-08-066-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.