Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass
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|ClinicalTrials.gov Identifier: NCT01727921|
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : April 28, 2016
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.
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.)
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms||Device: 22 gauge ProCore needle biopsy Device: 25 gauge ProCore needle biopsy||Not Applicable|
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.
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%.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||219 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||November 2015|
Active Comparator: 22 gauge ProCore needle biopsy
EUS-guided pancreatic or peripancreatic mass biopsy with 22 gauge ProCore biopsy needle.
Device: 22 gauge ProCore needle biopsy
22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
Active Comparator: 25 gauge ProCore needle biopsy
EUS-guided pancreatic or peripancreatic mass biopsy with 25 gauge ProCore biopsy needle.
Device: 25 gauge ProCore needle biopsy
25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
- Diagnostic accuracy [ Time Frame: October. 2014 ]Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis
- Technical success [ Time Frame: October. 2014 ]Technical success means the gain of tissue or cells through EUS-guided FNA.
- Complications [ Time Frame: November. 2014 ]Investigate the occurrence of complications such bleeding and perforation. Not only complications, but the size and location of lesion, puncture routes will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727921
|Korea, Republic of|
|Samsung Medical Center|
|Seoul City, Korea, Republic of, 135-710|
|Principal Investigator:||Kwanghyuck Lee, MD||Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center|