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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kwang Hyuck Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01727921
First received: October 21, 2012
Last updated: April 27, 2016
Last verified: April 2016
  Purpose

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.)


Condition Intervention
Pancreatic Neoplasms
Device: 22 gauge ProCore needle biopsy
Device: 25 gauge ProCore needle biopsy

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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Diagnostic accuracy [ Time Frame: October. 2014 ] [ Designated as safety issue: No ]
    Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis


Secondary Outcome Measures:
  • Technical success [ Time Frame: October. 2014 ] [ Designated as safety issue: No ]
    Technical success means the gain of tissue or cells through EUS-guided FNA.


Other Outcome Measures:
  • Complications [ Time Frame: November. 2014 ] [ Designated as safety issue: Yes ]
    Investigate the occurrence of complications such bleeding and perforation. Not only complications, but the size and location of lesion, puncture routes will be assessed.


Enrollment: 219
Study Start Date: January 2013
Study Completion Date: November 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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%.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01727921

Locations
Korea, Republic of
Samsung Medical Center
Seoul City, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kwanghyuck Lee, MD Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center
  More Information

Responsible Party: Kwang Hyuck Lee, Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01727921     History of Changes
Other Study ID Numbers: 2012-08-066-001 
Study First Received: October 21, 2012
Last Updated: April 27, 2016
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
ProCore FNA biopsy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 30, 2016