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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01727921

Enrollment

219

Registered

2012-11-16

Start date

2013-01-31

Completion date

2015-11-30

Last updated

2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Keywords

ProCore FNA biopsy

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%.

Interventions

DEVICE22 gauge ProCore needle biopsy

22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle

DEVICE25 gauge ProCore needle biopsy

25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy	October. 2014	Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis

Secondary

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

Other

Measure	Time frame	Description
Complications	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026