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

April 27, 2016 updated by: Kwang Hyuck Lee, Samsung Medical Center

Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study

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.)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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%.

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: October. 2014
Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis
October. 2014

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: October. 2014
Technical success means the gain of tissue or cells through EUS-guided FNA.
October. 2014

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
November. 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Kwanghyuck Lee, MD, Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

October 21, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (Estimate)

November 16, 2012

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-08-066-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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