Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass
Primary Purpose
Pancreatic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
22 gauge ProCore needle biopsy
25 gauge ProCore needle biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Neoplasms focused on measuring ProCore FNA biopsy
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
22 gauge ProCore needle biopsy
25 gauge ProCore needle biopsy
Arm Description
EUS-guided pancreatic or peripancreatic mass biopsy with 22 gauge ProCore biopsy needle.
EUS-guided pancreatic or peripancreatic mass biopsy with 25 gauge ProCore biopsy needle.
Outcomes
Primary Outcome Measures
Diagnostic accuracy
Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis
Secondary Outcome Measures
Technical success
Technical success means the gain of tissue or cells through EUS-guided FNA.
Full Information
NCT ID
NCT01727921
First Posted
October 21, 2012
Last Updated
April 27, 2016
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01727921
Brief Title
Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass
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 Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
Keywords
ProCore FNA biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
219 (Actual)
8. Arms, Groups, and Interventions
Arm Title
22 gauge ProCore needle biopsy
Arm Type
Active Comparator
Arm Description
EUS-guided pancreatic or peripancreatic mass biopsy with 22 gauge ProCore biopsy needle.
Arm Title
25 gauge ProCore needle biopsy
Arm Type
Active Comparator
Arm Description
EUS-guided pancreatic or peripancreatic mass biopsy with 25 gauge ProCore biopsy needle.
Intervention Type
Device
Intervention Name(s)
22 gauge ProCore needle biopsy
Intervention Description
22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
Intervention Type
Device
Intervention Name(s)
25 gauge ProCore needle biopsy
Intervention Description
25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis
Time Frame
October. 2014
Secondary Outcome Measure Information:
Title
Technical success
Description
Technical success means the gain of tissue or cells through EUS-guided FNA.
Time Frame
October. 2014
Other Pre-specified Outcome Measures:
Title
Complications
Description
Investigate the occurrence of complications such bleeding and perforation. Not only complications, but the size and location of lesion, puncture routes will be assessed.
Time Frame
November. 2014
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwanghyuck Lee, MD
Organizational Affiliation
Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul City
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass
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