Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727921
• Other study ID #: 2012-08-066-001
• Status: Completed
• Phase: N/A
• First received: October 21, 2012
• Last updated: April 27, 2016
• Start date: January 2013
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.)

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: November 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Device:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul City

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	Investigate the occurrence of complications such bleeding and perforation. Not only complications, but the size and location of lesion, puncture routes will be assessed.	November. 2014	Yes
Primary	Diagnostic accuracy	Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis	October. 2014	No
Secondary	Technical success	Technical success means the gain of tissue or cells through EUS-guided FNA.	October. 2014	No