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

NCT ID: NCT01016288

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-12-31

Brief Summary

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.

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medicine and Pharmacy Craiova

OTHER

Sponsor Role: collaborator

Allgemeines Krankenhaus Celle, Celle, Germany

UNKNOWN

Sponsor Role: collaborator

Pathologic Institute, Wittinger Strasse, Celle, Germany

UNKNOWN

Sponsor Role: collaborator

Sana Hospital Lübeck GmbH, Lübeck, Germany

UNKNOWN

Sponsor Role: collaborator

LungenClinic Grosshansdorf

OTHER

Sponsor Role: collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Peter Vilmann

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Vilmann, Professor

Role: STUDY_DIRECTOR

Gentofte Hospital, Copenhagen University, Denmark

Locations

Department of Pathology, Herlev University Hospital, Hellerup

Copenhagen, , Denmark

Endoscopy Z-806, Gentofte, Department of Surgical Gastroenterology, Gentofte and Herlev Hospitals

Copenhagen, , Denmark

Department of Medicine, GI Division, Allgemeines Krankenhaus MD

Celle, , Germany

Klinik für Gastroenterologie/GI-Onkologie, Allgemeines Krankenhaus Celle

Celle, , Germany

Pathologic Institute, Wittinger Strasse

Celle, , Germany

Cytological Laboratory, Hospital Grosshansdorf - Center for Pneumology and Thoracic Surgery

Großhansdorf, , Germany

Department of Internal Medicine, Sana Hospital Lübeck GmbHg, MD

Lübeck, , Germany

Department of Pathology, Medical University Schleswig-Holstein

Lübeck, , Germany

Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy

Craiova, , Romania

Countries

Denmark; Germany; Romania

References

Vilmann P, Puri R. The complete ''medical'' mediastinoscopy (EUS-FNA + EBUS-TBNA). Minerva Med. 2007 Aug;98(4):331-8.

Reference Type: BACKGROUND

PMID: 17921946 (View on PubMed)

Saftoiu A, Vilmann P, Guldhammer Skov B, Georgescu CV. Endoscopic ultrasound (EUS)-guided Trucut biopsy adds significant information to EUS-guided fine-needle aspiration in selected patients: a prospective study. Scand J Gastroenterol. 2007 Jan;42(1):117-25. doi: 10.1080/00365520600789800.

Reference Type: BACKGROUND

PMID: 17190771 (View on PubMed)

Vilmann P, Saftoiu A, Hollerbach S, Skov BG, Linnemann D, Popescu CF, Wellmann A, Gorunescu F, Clementsen P, Freund U, Flemming P, Hassan H, Gheonea DI, Streba L, Ioncica AM, Streba CT. Multicenter randomized controlled trial comparing the performance of 22 gauge versus 25 gauge EUS-FNA needles in solid masses. Scand J Gastroenterol. 2013 Jul;48(7):877-83. doi: 10.3109/00365521.2013.799222.

Reference Type: DERIVED

PMID: 23795663 (View on PubMed)

Other Identifiers

EUS-FNA-DK-PV-2009

Identifier Type: -

Identifier Source: org_study_id