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

Not Applicable

Completed

• Conditions: Pancreatic Neoplasms
• Interventions: Device: 22 gauge ProCore needle biopsy; Device: 25 gauge ProCore needle biopsy

• Registration Number: NCT01727921
• Lead Sponsor: Samsung Medical Center

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%.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-10-21
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-16
• Study Start: 2013-01
• Primary Completion: 2014-12
• Study Completion: 2015-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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

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Exclusion Criteria

• Contraindication to endoscopy
• Patients younger than 18 years old
• Bleeding tendency
• Cardiopulmonary dysfunction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
22 gauge ProCore needle biopsy	22 gauge ProCore needle biopsy	EUS-guided pancreatic or peripancreatic mass biopsy with 22 gauge ProCore biopsy needle.
25 gauge ProCore needle biopsy	25 gauge ProCore needle biopsy	EUS-guided pancreatic or peripancreatic mass biopsy with 25 gauge ProCore biopsy needle.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	October. 2014	Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis

Secondary Outcome Measures

Name	Time	Method
Technical success	October. 2014	Technical success means the gain of tissue or cells through EUS-guided FNA.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul City, Korea, Republic of