Controlled Trial Comparing the Performance of 22 Gauge Versus 25 Gauge EUS-FNA Needles (FNA-22G-25G)

April 7, 2014 updated by: Peter Vilmann, University Hospital, Gentofte, Copenhagen

Multicenter Randomized Controlled Trial Comparing the Performance of 22 Gauge Versus 25 Gauge EUS-FNA Needles

The aim of the study is to compare the performance characteristics of EUS-FNA 22 Gauge needle and EUS FNA 25 Gauge needle in terms of cellularity and diagnostic yield for diagnosis of various pathologies, including lymph nodes, pancreatic, luminal and other lesions outlined by EUS.

Study Overview

Status

Completed

Conditions

Detailed Description

Tissue acquisition by Endoscopic ultrasound plays a central role in diagnosis of several pathologies; this is achieved by obtaining cytological material with fine needle aspiration (FNA) needles that are able to provide smears of malignant cells. Several needles are at present available including 19 Gauge, 22 Gauge and 25 Gauge needles. A 22 Gauge needle is at present the standard needle and most of the EUS-FNA results are based on FNA with this needle.

Twenty five Gauge needles presently available on the market are distinctly small, highly flexible and may be easier to penetrate hard pancreatic tumors. There even is anecdotal messages that this size of needle may be able to traverse relatively large vascular structures without major risk. However, there is very scant data on whether a 25 G needle is comparable to a standard 22 G needle in terms of specimen cellularity and quality. There is only one small randomized trial published as an abstract by Lee et al reporting no statistical significant difference in cellularity between the two groups of needle size as judged by 2 different cytologists. However, the conclusion is dubious because considerable bias may be present since both needles were used in the same lesion. There is therefore a need for a properly designed randomized study comparing different needle sizes.

This study is a prospective randomized multicenter study. Patients referred to one of the participating departments for an EUS examination will be included prospectively. Linear EUS examination will be done with a linear echoendoscope for lymph nodes, mediastinal, pancreatic and other intra-abdominal masses.

Tumor and lymph node characteristics will be carefully described: size (long axis), echogeneity (hypoechoic, hyperechoic, mixed), and echostructure (homogenous, in-homogenous, calcifications), shape (round, oval, triangular), border (regular, irregular).

EUS-guided cell sampling will be performed with a 22 G (Medi-Globe, Sonotip II) and 25 G (Medi-Globe, Sonotip II) needles under EUS and Colour-Doppler guidance.

Needle order will be selected randomly, one single needle pr. Lesion. Three passes will be performed with either of the needles after randomization, using 6 uniform to and fro movements on every pass with continuous 10cc suction for the reason of standardization. The material will be expelled on separate numbered glass slides. The cytopathologist will review the material after staining blinded to the needle size and will be using standardized criteria for evaluation of cellularity.

Doubtless, this multicenter randomized controlled trial comparison, as any other experimental method, needs with necessity a serious statistical evaluation, bringing the benefits of improving the reliability and credibility of the findings thus obtained. Accordingly, both exploratory data analysis and statistical inference will be performed. Technically, the expected number of lesions to be included in the study will be 220, 110 in each group. Block randomization (block size = 4) will be used to ensure exactly equal treatment numbers at certain equally spaced points in the sequence of patients assignments (Knuth shuffle algorithm for random permutations).

For diagnostic tests the sensitivity, specificity positive and negative predictive value and diagnostic accuracy will be calculated and calculated separately for EUS-FNA during 1st pass, 2nd pass and 3rd pass by comparing the results with the final diagnosis. All results will be expressed as mean, standard deviation (SD) and confidence interval. Testing hypotheses will be used afterwards. An a priori power analysis will be performed to determine the appropriate sample size in order to achieve adequate power for the statistical tests subsequently used. The data from both groups will be compared by standard comparison tests chi-square test or Fishers exact test where appropriate. The level of statistical significance is stated as 0.05.

Study Type

Observational

Enrollment (Actual)

135

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

  • Denmark
      • Copenhagen, Denmark
        • Department of Pathology, Herlev University Hospital, Hellerup
      • Copenhagen, Denmark
        • Endoscopy Z-806, Gentofte, Department of Surgical Gastroenterology, Gentofte and Herlev Hospitals
  • Germany
      • Celle, Germany
        • Department of Medicine, GI Division, Allgemeines Krankenhaus MD
      • Celle, Germany
        • Klinik für Gastroenterologie/GI-Onkologie, Allgemeines Krankenhaus Celle
      • Celle, Germany
        • Pathologic Institute, Wittinger Strasse
      • Großhansdorf, Germany
        • Cytological Laboratory, Hospital Grosshansdorf - Center for Pneumology and Thoracic Surgery
      • Luebeck, Germany
        • Department of Pathology, Medical University Schleswig-Holstein
      • Lübeck, Germany
        • Department of Internal Medicine, Sana Hospital Lübeck GmbHg, MD
  • Romania
      • Craiova, Romania
        • Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred to one of the participating departments for an EUS examination with EUS-FNA (mediastinal tumours and lymph nodes, celiac, perigastric and peri-pancreatic lymph nodes, pancreatic masses, liver masses, adrenal masses, etc.).

Description

Inclusion Criteria:

  • Patients referred for an EUS examination and EUS-FNA of a solid mass lesion adjacent to the upper GI tract
  • Well informed signed consent for EUS-guided FNA

Exclusion Criteria:

  • Severe coagulopathy
  • Uncorrectable severe platelet dysfunction
  • Presence of large intervening vessels on color or power Doppler
  • Failure to provide 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

Cohorts and Interventions

Group / Cohort
22 G Needle EUS-FNA
Patients referred for an EUS examination and EUS-FNA of a solid mass lesion adjacent to the upper GI tract using a 22 G needle
25 G Needle EUS-FNA
Patients referred for an EUS examination and EUS-FNA of a solid mass lesion adjacent to the upper GI tract using a 25 G needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Value of EUS-FNA 22 Gauge needle comparing with EUS-FNA 25 Gauge needle in terms of cellularity and diagnostic yield for diagnosis of various pathologies.
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

University Hospital Schleswig-Holstein
University of Medicine and Pharmacy Craiova
LungenClinic Grosshansdorf
Allgemeines Krankenhaus Celle, Celle, Germany
Pathologic Institute, Wittinger Strasse, Celle, Germany
Sana Hospital Lübeck GmbH, Lübeck, Germany

Investigators

  • Study Director: Peter Vilmann, Professor, Gentofte Hospital, Copenhagen University, Denmark

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

November 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 18, 2009

First Submitted That Met QC Criteria

November 18, 2009

First Posted (Estimate)

November 19, 2009

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUS-FNA-DK-PV-2009

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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