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EUS-guided Fine Needle Aspiration (FNA) With and Without the Use of a Stylet

Randomized Controlled Trial of Endoscopic Ultrasound Guided Fine Needle Aspiration of Solid Lesions With and Without a Stylet

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01316614
Enrollment
137
Registered
2011-03-16
Start date
2010-07-31
Completion date
2011-07-31
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biopsy, Fine-Needle, Biopsy, Fine-Needle/Methods, Endosonography

Keywords

Fine-Needle Aspiration, Stylet, Solid Mass, Endoscopic Ultrasound (EUS)

Brief summary

The purpose of this study is to determine that there is no difference in final diagnosis of FNA specimens without a stylet, compared to using a stylet, when examined by a skilled cytopathologist.

Detailed description

Endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) is a highly accurate method for cytologic diagnosis of malignancy and is routinely performed to diagnose and stage pancreatobiliary, esophageal, gastric, rectal malignancies and subepithelial gastrointestinal lesions. There are variations in EUS-FNA technique including the use of suction, the area of the lesion to target (center versus periphery), gauge of needle, and use of a stylet. The stylet is a metal wire which is included in the needle assembly. The use of a stylet is used purely for mechanical purposes, not for the protection or safety of the patients. It is thought that the stylet prevents the needle from becoming clogged with gastrointestinal epithelial cells or mucus. To our knowledge, comparing the diagnostic accuracy of EUS-FNA with a stylet to the accuracy without a stylet has not been studied. The optimal technique for EUS-FNA has not been established. The reported accuracy rate of EUS-FNA (which contains heterogeneous sampling techniques, including with and without a stylet) is 71-98% for pancreatic masses, 90% for lymph nodes, and 67-92% for submucosal gastrointestinal lesions. Typically, FNA is performed with or without a stylet using a 22 gauge or 25 gauge needle with similar diagnostic accuracy. When the target lesion is identified, the needle is advanced through the gastrointestinal wall into the lesion under ultrasound guidance. If a stylet is being used, it is removed at this point. A 10 cc syringe under suction is then placed on the end of the needle assembly and the needle is moved back and forth within the lesion to gather cells. The assembly is then removed and the needle contents are expelled onto slides and into preservative media. The stylet is then reinserted and the needle assembly is advanced through the scope for another pass. In the absence of on-site cytopathology, 7 passes with or without a stylet of a solid lesion and 5 passes of lymph nodes with or without a stylet are recommended to achieve high diagnostic accuracy. EUS-FNA is time consuming, mainly because the stylet needs to be carefully reinserted through the needle prior to each pass. Theoretically, the use of a stylet prevents clogging of the needle with gastrointestinal epithelial cells and mucus which can affect the adequacy of the specimen. However, there are no data to support this. As such there is a variation in practice patterns, with some endosonographers who routinely use a stylet and those that do not. Additionally, those who perform percutaneous FNA frequently do so using needles that do not have a stylet. A recent study suggests that the use of a stylet improves diagnostic accuracy in percutaneous FNA of thyroid lesions. To our knowledge, there have been no studies assessing the use of a stylet on tissue adequacy in EUS-guided FNA. If the practice of using a stylet during EUS-guided FNA is found to yield the same number of adequate tissue samples as those done without a stylet, then the use of a stylet would be an unnecessary. As stylet replacement is the most time consuming step in FNA, the time of the procedure could be shortened significantly if the stylet is not required. We propose a randomized controlled trial of EUS guided FNA with and without stylet which will help determine whether the use of a stylet is integral in obtaining adequate tissue aspirates in the diagnosis of solid lesions. To our knowledge, there have been no prospective, randomized studies addressing the effect of the presence or absence of a stylet on specimen adequacy during EUS-guided FNA.

Interventions

DEVICEFNA with and without a stylet

If the patient agrees to enrollment in the study, the initial stage of the EUS exam will be performed in the usual manner. If a solid lesion that requires FNA is identified, an envelope will be opened which contains a computer generated randomization sequence for all passes. These sequences will be generated by a web-based program at http://www.randomizer.org/form.htm. Passes will be made based on the randomization, either with or without a stylet. Six passes (three with a stylet and three without a stylet) will be performed on solid lesions and four passes (two with and two without a stylet) will be performed on lymph nodes. Additional passes will be made at the discretion of the endosonographer as clinically indicated but will not be included in the data.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients referred to the Washington University Interventional Endoscopy Division for EUS-guided FNA of a solid lesion (e.g. pancreatic mass, gastric wall mass, or lymphadenopathy)

Exclusion criteria

* Patients \<18 years of age * patients who cannot provide independent informed consent (i.e. patients with dementia or with a health care proxy) * pregnant women (as determined by pregnancy test given as part of standard of care) * prisoners

Design outcomes

Primary

MeasureTime frameDescription
Compare Adequacy of Diagnoses in Passes With and Without a StyletAt the time of EUS-FNA procedure (Day 1)The number of passes was determined by the lesion site and mirrored clinical practice (6 passes for pancreatic/other lesions and 4 passes for lymph nodes). The order of these passes was determined by a preprinted randomization sequence kept in an opaque sealed envelope that was opened by the research coordinator or EUS technologist after enrollment. Each participant had an equal number of passes with stylet and without stylet. There was no communication between the endosonographer and the cytopathologist regarding the adequacy of the specimen or diagnosis until all passes had been completed. The on-site evaluation of smears was performed to assess cellular adequacy and to assess the need for any additional passes. Additional passes were made at the discretion of the endosonographer as clinically indicated but were not included in the final analysis. The cytology slides were evaluated by 3 experienced cytopathologists who were all blinded to the stylet status of the passes.

Secondary

MeasureTime frameDescription
Degree of CellularityAt the time of EUS-FNA procedure (Day 1)Percentage of area of slide that contains cells of the representative lesion
Adequacy of SpecimenAt the time of EUS-FNA procedure (Day 1)
ContaminationAt the time of EUS-FNA procedure (Day 1)Percentage of area of slide that represents GI contamination
Amount of BloodAt the time of EUS-FNA procedure (Day 1)

Countries

United States

Participant flow

Recruitment details

The study opened to participant enrollment on 07/21/2010 and closed to participant enrollment on 02/07/2012.

Participants by arm

ArmCount
With Stylet & Without Stylet
There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
100
Total100

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyCystic lesion5
Overall StudyCytology slides not available for review4
Overall StudyInadequate number of passes2
Overall StudyMedically unstable1
Overall StudyNo solid lesion and FNA not indicated25

Baseline characteristics

CharacteristicWith Stylet & Without Stylet
Age, Continuous65.5 years
STANDARD_DEVIATION 10.9
Lesions that underwent EUS-FNA
Ampulla
1 participants
Lesions that underwent EUS-FNA
Biliary stricture
3 participants
Lesions that underwent EUS-FNA
Esophageal subepithelial lesion
2 participants
Lesions that underwent EUS-FNA
Gastric subepithelial lesion
6 participants
Lesions that underwent EUS-FNA
Hilar mass
1 participants
Lesions that underwent EUS-FNA
Left adrenal gland
1 participants
Lesions that underwent EUS-FNA
Liver
1 participants
Lesions that underwent EUS-FNA
Lymph nodes
25 participants
Lesions that underwent EUS-FNA
Mediastinal mass
2 participants
Lesions that underwent EUS-FNA
Pancreatic masses
58 participants
Needle gauge used
22-gauge
77 participants
Needle gauge used
25-gauge
23 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
13 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
87 Participants
Region of Enrollment
United States
100 participants
Sex: Female, Male
Female
46 Participants
Sex: Female, Male
Male
54 Participants
Size of lesions
All lesions
2.95 centimeters (cm)
STANDARD_DEVIATION 21.8
Size of lesions
All other lesions
3.35 centimeters (cm)
STANDARD_DEVIATION 4
Size of lesions
Lymph node
2.08 centimeters (cm)
STANDARD_DEVIATION 1.3
Size of lesions
Pancreas
3.18 centimeters (cm)
STANDARD_DEVIATION 1.53
Tissue echogenecity
Hypoechoic
86 participants
Tissue echogenecity
Mixed echogenicity
14 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 100
serious
Total, serious adverse events
0 / 100

Outcome results

Primary

Compare Adequacy of Diagnoses in Passes With and Without a Stylet

The number of passes was determined by the lesion site and mirrored clinical practice (6 passes for pancreatic/other lesions and 4 passes for lymph nodes). The order of these passes was determined by a preprinted randomization sequence kept in an opaque sealed envelope that was opened by the research coordinator or EUS technologist after enrollment. Each participant had an equal number of passes with stylet and without stylet. There was no communication between the endosonographer and the cytopathologist regarding the adequacy of the specimen or diagnosis until all passes had been completed. The on-site evaluation of smears was performed to assess cellular adequacy and to assess the need for any additional passes. Additional passes were made at the discretion of the endosonographer as clinically indicated but were not included in the final analysis. The cytology slides were evaluated by 3 experienced cytopathologists who were all blinded to the stylet status of the passes.

Time frame: At the time of EUS-FNA procedure (Day 1)

Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 overall passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.

ArmMeasureGroupValue (NUMBER)
With StyletCompare Adequacy of Diagnoses in Passes With and Without a StyletAtypical21 passes
With StyletCompare Adequacy of Diagnoses in Passes With and Without a StyletMalignant94 passes
With StyletCompare Adequacy of Diagnoses in Passes With and Without a StyletSuspicious23 passes
With StyletCompare Adequacy of Diagnoses in Passes With and Without a StyletInadequate for reporting57 passes
With StyletCompare Adequacy of Diagnoses in Passes With and Without a StyletBenign or negative for malignancy80 passes
Without StyletCompare Adequacy of Diagnoses in Passes With and Without a StyletInadequate for reporting64 passes
Without StyletCompare Adequacy of Diagnoses in Passes With and Without a StyletBenign or negative for malignancy68 passes
Without StyletCompare Adequacy of Diagnoses in Passes With and Without a StyletAtypical18 passes
Without StyletCompare Adequacy of Diagnoses in Passes With and Without a StyletSuspicious15 passes
Without StyletCompare Adequacy of Diagnoses in Passes With and Without a StyletMalignant110 passes
Secondary

Adequacy of Specimen

Time frame: At the time of EUS-FNA procedure (Day 1)

Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.

ArmMeasureGroupValue (NUMBER)
With StyletAdequacy of SpecimenInadequate87 passes
With StyletAdequacy of SpecimenAdequate188 passes
Without StyletAdequacy of SpecimenInadequate78 passes
Without StyletAdequacy of SpecimenAdequate197 passes
Secondary

Amount of Blood

Time frame: At the time of EUS-FNA procedure (Day 1)

Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.

ArmMeasureGroupValue (NUMBER)
With StyletAmount of BloodMinimal126 passes
With StyletAmount of BloodModerate82 passes
With StyletAmount of BloodSignificant67 passes
Without StyletAmount of BloodMinimal120 passes
Without StyletAmount of BloodModerate86 passes
Without StyletAmount of BloodSignificant69 passes
Secondary

Contamination

Percentage of area of slide that represents GI contamination

Time frame: At the time of EUS-FNA procedure (Day 1)

Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.

ArmMeasureGroupValue (NUMBER)
With StyletContaminationNo contaminations seen212 passes
With StyletContaminationContamination present in <25% of the slide52 passes
With StyletContaminationContamination present in 25%-50% of the slide7 passes
With StyletContaminationContamination present in >50% of the slide4 passes
Without StyletContaminationContamination present in >50% of the slide3 passes
Without StyletContaminationNo contaminations seen220 passes
Without StyletContaminationContamination present in 25%-50% of the slide5 passes
Without StyletContaminationContamination present in <25% of the slide47 passes
Secondary

Degree of Cellularity

Percentage of area of slide that contains cells of the representative lesion

Time frame: At the time of EUS-FNA procedure (Day 1)

Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.

ArmMeasureGroupValue (NUMBER)
With StyletDegree of CellularityNo representative cells present66 passes
With StyletDegree of CellularityRepresentative cells present in <25%58 passes
With StyletDegree of CellularityRepresentative cells present in <25-50% slide97 passes
With StyletDegree of CellularityRepresentative cells present in >50% of the slide54 passes
Without StyletDegree of CellularityRepresentative cells present in >50% of the slide58 passes
Without StyletDegree of CellularityNo representative cells present72 passes
Without StyletDegree of CellularityRepresentative cells present in <25-50% slide99 passes
Without StyletDegree of CellularityRepresentative cells present in <25%46 passes
Secondary

Degree of Cellularity

Number of cells per slide

Time frame: At the time of EUS-FNA procedure (Day 1)

Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.

ArmMeasureGroupValue (NUMBER)
With StyletDegree of CellularityFair (<100 cells/slide)127 passes
With StyletDegree of CellularityGood (100-1000 cells/slide)70 passes
With StyletDegree of CellularityExcellent (>1000 cells/slide)78 passes
Without StyletDegree of CellularityFair (<100 cells/slide)120 passes
Without StyletDegree of CellularityGood (100-1000 cells/slide)82 passes
Without StyletDegree of CellularityExcellent (>1000 cells/slide)73 passes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026