Endoscopic Ultrasonography (EUS) Guided Fine Needle Aspiration Using Free Stylet 22g and 25 g Needles

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01543282
First received: December 15, 2011
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

This is a randomized controlled study comparing EUS-FNA with 22 gauge and 25 gauge needles in consecutive patients.

Summary

Background: three needle sizes for endoscopic ultrasonography guided fine needle aspiration (EUS-FNA) are currently available: 22 Gauge (G), 25 G and 19 G. However, well design studies comparing them regarding efficacy and feasibility are lacking.

Aims: to investigate diagnostic yield, specimen adequacy, feasibility and complications of the conventional 22 G compared with the 25 G needle.

Methods: patients ≥ 18 years, referred to EUS-FNA for a solid lesion will be considered for inclusion. Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis, significant coagulopathy (APT < 50% or platelets < 50000/mm3), use of warfarin or other anticoagulants, use of clopidogrel within 7 days of EUS, inability or refusal to sign the informed consent and pregnancy or suspected pregnancy will be excluded.

Participants will be randomized to 22 G needle and 25 G FNA. Chi-square test will be used to compare proportions. Continuous variables will be compared using Student´s t test. A two-tailed P values of less than 0.05 will be considered statistically significant. The diagnostic yield of 25 G and 22 G needle will be evaluated by four criteria: sensitivity, specificity, positive predictive value and negative predictive value. An expected rate of 85% diagnostic yield from EUS guided FNA by using 22G needle will be considered. By using a power of 80% and an α value of 0.05 would be necessary 120 patients per group to detect a 15% difference in the rate of diagnostic yield.


Condition Intervention
Solid Neoplasms
Device: Endosonography guided fine needle aspiration cytology ( Cook Medical, Boston Scientific)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Study Comparing Endoscopic Ultrasonography Guided Fine Needle Aspiration Using Free Stylet 22g and 25 g Needles in Solid Lesions

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Accuracy of stylet-free, solid lesion EUS-FNA using the 22 G FNA vs the 25 G FNA needle, in consecutive patients referred to EUS-FNA. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Specimen adequacy, number of FNA passes, ease of puncture, failure of the FNA needle and complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: December 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EUS 22 gauge needle
EUS 22 g needle is the most common needle used in clinical practice. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.
Device: Endosonography guided fine needle aspiration cytology ( Cook Medical, Boston Scientific)
Patients will be randomized either to receive EUS-FNA with a 22 g needle or 25 g needle. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.
Other Names:
  • Cook Medical
  • Boston Scientific
Experimental: EUS 25 gauge needle
25 gauge needle is usually used less frequently but nowadays is increasingly used and is as well a valid option. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.
Device: Endosonography guided fine needle aspiration cytology ( Cook Medical, Boston Scientific)
Patients will be randomized either to receive EUS-FNA with a 22 g needle or 25 g needle. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.
Other Names:
  • Cook Medical
  • Boston Scientific

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive patients referred for EUS-FNA of a solid lesion.

Exclusion Criteria:

  • Age < 18 years
  • Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis or other lesions in which a large amount of tissue will be required for diagnosis
  • Significant coagulopathy (INR > 1.5, platelets < 50000/mm3
  • Use of low molecular weight heparin, use of clopidogrel within 7 days of EUS)
  • Cystic lesions
  • Inability or refusal to sign the informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543282

Locations
Canada, Quebec
Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal)
Montreal, Quebec, Canada, H2X3J4
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Anand V Sahai, MD Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal) Montreal, Quebec, Canada
  More Information

Publications:

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01543282     History of Changes
Other Study ID Numbers: CE 11.150
Study First Received: December 15, 2011
Last Updated: February 25, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
endoscopic ultrasonography
fine needle aspiration cytology
22 gauge
25 gauge

ClinicalTrials.gov processed this record on October 22, 2014