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Completed

NCT Number: NCT01727921

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

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.)

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Key information

Conditions

Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, Seoul City, 135-710, South Korea

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

22 gauge ProCore needle biopsy

Device

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

25 gauge ProCore needle biopsy

Device

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

Primary outcomes

  1. Diagnostic accuracy

    Time frame: October. 2014

    Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis

Secondary outcomes

  1. Technical success

    Time frame: October. 2014

    Technical success means the gain of tissue or cells through EUS-guided FNA.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Nov 16, 2012
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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