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

This study has been completed.
Sponsor:
Collaborators:
University of Medicine and Pharmacy Craiova
Allgemeines Krankenhaus Celle, Celle, Germany
Pathologic Institute, Wittinger Strasse, Celle, Germany
Sana Hospital Lübeck GmbH, Lübeck, Germany
Hospital Grosshansdorf, Grosshandorf, Germany
University of Schleswig-Holstein
Information provided by (Responsible Party):
Peter Vilmann, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01016288
First received: November 18, 2009
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition
Mediastinal Tumours and Lymph Nodes
Celiac, Perigastric and Peri-pancreatic Lymph Nodes
Pancreatic Masses
Liver Masses
Adrenal Masses

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Multicenter Randomized Controlled Trial Comparing the Performance of 22 Gauge Versus 25 Gauge EUS-FNA Needles

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Pathology samples obtained through EUS-FNA biopsy processed by paraffin embedding.


Enrollment: 135
Study Start Date: November 2009
Study Completion Date: December 2012
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.).

Criteria

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
  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: NCT01016288

Locations
Denmark
Endoscopy Z-806, Gentofte, Department of Surgical Gastroenterology, Gentofte and Herlev Hospitals
Copenhagen, Denmark
Department of Pathology, Herlev University Hospital, Hellerup
Copenhagen, Denmark
Germany
Klinik für Gastroenterologie/GI-Onkologie, Allgemeines Krankenhaus Celle
Celle, Germany
Department of Medicine, GI Division, Allgemeines Krankenhaus MD
Celle, Germany
Pathologic Institute, Wittinger Strasse
Celle, Germany
Cytological Laboratory, Hospital Grosshansdorf - Center for Pneumology and Thoracic Surgery
Großhansdorf, Germany
Department of Pathology, Medical University Schleswig-Holstein
Luebeck, Germany
Department of Internal Medicine, Sana Hospital Lübeck GmbHg, MD
Lübeck, Germany
Romania
Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy
Craiova, Romania
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
University of Medicine and Pharmacy Craiova
Allgemeines Krankenhaus Celle, Celle, Germany
Pathologic Institute, Wittinger Strasse, Celle, Germany
Sana Hospital Lübeck GmbH, Lübeck, Germany
Hospital Grosshansdorf, Grosshandorf, Germany
University of Schleswig-Holstein
Investigators
Study Director: Peter Vilmann, Professor Gentofte Hospital, Copenhagen University, Denmark
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Vilmann, Professor, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01016288     History of Changes
Other Study ID Numbers: EUS-FNA-DK-PV-2009
Study First Received: November 18, 2009
Last Updated: April 7, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University Hospital, Gentofte, Copenhagen:
EUS-FNA
22 Gauge Needle
25 Gauge Needle

Additional relevant MeSH terms:
Mediastinal Neoplasms
Marfan Syndrome
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 21, 2014