Biopsy, Fine-Needle, Biopsy, Fine-Needle/Methods, Endosonography
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Compare Adequacy of Diagnoses in Passes With and Without a Stylet | At 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
| Measure | Time frame | Description |
|---|---|---|
| Degree of Cellularity | At the time of EUS-FNA procedure (Day 1) | Percentage of area of slide that contains cells of the representative lesion |
| Adequacy of Specimen | At the time of EUS-FNA procedure (Day 1) | — |
| Contamination | At the time of EUS-FNA procedure (Day 1) | Percentage of area of slide that represents GI contamination |
| Amount of Blood | At 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
| Arm | Count |
|---|---|
| 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 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Cystic lesion | 5 |
| Overall Study | Cytology slides not available for review | 4 |
| Overall Study | Inadequate number of passes | 2 |
| Overall Study | Medically unstable | 1 |
| Overall Study | No solid lesion and FNA not indicated | 25 |
Baseline characteristics
| Characteristic | With Stylet & Without Stylet |
|---|---|
| Age, Continuous | 65.5 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 type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| With Stylet | Compare Adequacy of Diagnoses in Passes With and Without a Stylet | Atypical | 21 passes |
| With Stylet | Compare Adequacy of Diagnoses in Passes With and Without a Stylet | Malignant | 94 passes |
| With Stylet | Compare Adequacy of Diagnoses in Passes With and Without a Stylet | Suspicious | 23 passes |
| With Stylet | Compare Adequacy of Diagnoses in Passes With and Without a Stylet | Inadequate for reporting | 57 passes |
| With Stylet | Compare Adequacy of Diagnoses in Passes With and Without a Stylet | Benign or negative for malignancy | 80 passes |
| Without Stylet | Compare Adequacy of Diagnoses in Passes With and Without a Stylet | Inadequate for reporting | 64 passes |
| Without Stylet | Compare Adequacy of Diagnoses in Passes With and Without a Stylet | Benign or negative for malignancy | 68 passes |
| Without Stylet | Compare Adequacy of Diagnoses in Passes With and Without a Stylet | Atypical | 18 passes |
| Without Stylet | Compare Adequacy of Diagnoses in Passes With and Without a Stylet | Suspicious | 15 passes |
| Without Stylet | Compare Adequacy of Diagnoses in Passes With and Without a Stylet | Malignant | 110 passes |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| With Stylet | Adequacy of Specimen | Inadequate | 87 passes |
| With Stylet | Adequacy of Specimen | Adequate | 188 passes |
| Without Stylet | Adequacy of Specimen | Inadequate | 78 passes |
| Without Stylet | Adequacy of Specimen | Adequate | 197 passes |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| With Stylet | Amount of Blood | Minimal | 126 passes |
| With Stylet | Amount of Blood | Moderate | 82 passes |
| With Stylet | Amount of Blood | Significant | 67 passes |
| Without Stylet | Amount of Blood | Minimal | 120 passes |
| Without Stylet | Amount of Blood | Moderate | 86 passes |
| Without Stylet | Amount of Blood | Significant | 69 passes |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| With Stylet | Contamination | No contaminations seen | 212 passes |
| With Stylet | Contamination | Contamination present in <25% of the slide | 52 passes |
| With Stylet | Contamination | Contamination present in 25%-50% of the slide | 7 passes |
| With Stylet | Contamination | Contamination present in >50% of the slide | 4 passes |
| Without Stylet | Contamination | Contamination present in >50% of the slide | 3 passes |
| Without Stylet | Contamination | No contaminations seen | 220 passes |
| Without Stylet | Contamination | Contamination present in 25%-50% of the slide | 5 passes |
| Without Stylet | Contamination | Contamination present in <25% of the slide | 47 passes |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| With Stylet | Degree of Cellularity | No representative cells present | 66 passes |
| With Stylet | Degree of Cellularity | Representative cells present in <25% | 58 passes |
| With Stylet | Degree of Cellularity | Representative cells present in <25-50% slide | 97 passes |
| With Stylet | Degree of Cellularity | Representative cells present in >50% of the slide | 54 passes |
| Without Stylet | Degree of Cellularity | Representative cells present in >50% of the slide | 58 passes |
| Without Stylet | Degree of Cellularity | No representative cells present | 72 passes |
| Without Stylet | Degree of Cellularity | Representative cells present in <25-50% slide | 99 passes |
| Without Stylet | Degree of Cellularity | Representative cells present in <25% | 46 passes |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| With Stylet | Degree of Cellularity | Fair (<100 cells/slide) | 127 passes |
| With Stylet | Degree of Cellularity | Good (100-1000 cells/slide) | 70 passes |
| With Stylet | Degree of Cellularity | Excellent (>1000 cells/slide) | 78 passes |
| Without Stylet | Degree of Cellularity | Fair (<100 cells/slide) | 120 passes |
| Without Stylet | Degree of Cellularity | Good (100-1000 cells/slide) | 82 passes |
| Without Stylet | Degree of Cellularity | Excellent (>1000 cells/slide) | 73 passes |