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

May 21, 2020 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Randomized Controlled Study Comparing Endoscopic Ultrasonography Guided Fine Needle Aspiration Using Free Stylet 22g and 25 g Needles in Solid Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

1. Objectives

PRIMARY To compare diagnostic yield 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.

SECONDARY

To investigate:

  1. specimen adequacy,
  2. number of FNA passes,
  3. ease of puncture,
  4. failure of the FNA needle and
  5. complications

3. Methods

3.1. Design: prospective randomized trial.

3.2. Inclusion: Consecutive patients referred for EUS-FNA of a solid lesion will be considered for inclusion.

3.3. Exclusion: 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, or inability or refusal to sign the informed consent.

3.4. Endoscopic procedures: Informed consent will be obtained before each procedure by one of the researchers. Patients will not receive economic compensation or reimbursement of their expenses for coming to the exploration, since it is a procedure previously indicated. Then, potential candidates will be randomized to 22 G or 25 G FNA using a computer generated random sequence. There will be block randomization for a) pancreatic masses, 2) lymph nodes, or 3) all other lesions.

All examinations will be performed by two experienced endosonographers with a lineal echoendoscope (AS and SP). EUS procedures will be carried out with the patient, in left lateral position under conscious sedation using midazolam (2.5-5 mg) plus meperidine (50-100 mg) and droperidol (2.5-5 mg). Before performing the EUS-FNA biopsy, a complete examination of the pancreas, liver as well as other vicinity organs will be performed.

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. Ease of puncture will be scored qualitatively as poor (scored 1), good (scored 2) or excellent (scored 3).[14] FNA failure will be also reported. All procedures will be digitally videotaped. The examinations will be reviewed by a endosonographer blinded to the type of needle used and visibility of the needle will be scored (score 1 "poor", score 2 "good", score 3 "excellent").[14] After the procedure, patients will be monitored in the recovery room at least 60 minutes before discharge. Immediate complications will be assessed and recorded by nurses and/or physicians during and after the procedure while the patient was recovering from sedation.

3.5. Cytological analysis: All passes will be read by one experienced cytopathologist on-site utilizing microscopic evaluation of air-dried slides stained with Diff-Quik (International Reagents Co., Ltd., Kobe, Japan). The cytopathologist will be blinded to the type of needle used. The final cytological diagnosis was made using a standard Papanicolaou stain. For each lesion, the cytologist assessed sample adequacy: cellularity (score 1 "poor", score 2 "good", score 3 "excellent"),[14] and bloodiness (score 1 "minimal", score 2 "moderate", score 3 "significant")[21] and the presence or absence of malignancy ("positive"/"negative"/"suspicious"/ inconclusive).

3.6. Follow up Lesions will be considered malignant in the following cases: positive cytological diagnosis, positive histological diagnosis and clinical or radiological progression in the next 6 months. In case of negative results in the cytological diagnosis absence of clinical worsening and radiologic progression at least in the following 6 months after FNA will be required.

3.7. Data collection Clinical data will be prospectively collected and saved in a database including: demographic information (age and gender), size and location of the target lesion (pancreas, lymph node, liver, adrenal gland, others) and technical and procedure variables: FNA path (esophagus, stomach, duodenum), number of needle passes, needle visibility, ease to puncture, needle failure, cellularity, bloodiness, cytological diagnosis, final diagnosis, immediate complications.

4. Statistical analysis Results for continuous variables will be expressed as means and standard deviations. Categorical variables will be expressed as frequencies and percentages. 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. Data were analyzed with the Statistical Package for Social Sciences v. 15.0 (SPSS Inc., Chicago, IL, USA). The diagnostic yield of 15 G and 22 G needle will be evaluated by four criteria: sensitivity, specificity, positive predictive value and negative predictive value.

Sample size An expected rate of diagnostic yield from EUS guided FNA by using 22G needle of 85% 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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X3J4
        • Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Boston Scientific
  • Cook Medical
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:
  • Boston Scientific
  • Cook Medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Specimen adequacy, number of FNA passes, ease of puncture, failure of the FNA needle and complications
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2011

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

February 27, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Actual)

May 22, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE 11.150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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