Biopsy, Fine-NeedleNCT01316614
EUS-guided Fine Needle Aspiration (FNA) With and Without the Use of a Stylet
A study testing FNA with and without a stylet in people with Biopsy, Fine-Needle and Biopsy, Fine-Needle/Methods, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biopsy, Fine-Needle, Biopsy, Fine-Needle/Methods, Endosonography
- What is being tested?
- FNA with and without a stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Randomized Controlled Trial of Endoscopic Ultrasound Guided Fine Needle Aspiration of Solid Lesions With and Without a Stylet
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.
Read the 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.
- Being tested
- FNA with and without a stylet
- Keywords
- Fine-Needle Aspiration, Stylet, Solid Mass, Endoscopic Ultrasound (EUS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNA with and without a styletDevice
Also called Cook Medical EchoTip® Ultra Endoscopic Ultrasound Needles
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.
| Study group | Role | What they receive |
|---|---|---|
| With Stylet & Without Stylet | Experimental | 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. Each pass will be individually assessed by a skilled cytopathologist who is blinded to the technique used. We will compare the adequacy of both techniques to determine whether or not a stylet leads to a higher diagnostic accuracy rate in patients with solid lesions. Receives: Device: FNA with and without a stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of EUS-FNA procedure (Day 1)
Secondary outcomes (5)
Degree of Cellularity
Percentage of area of slide that contains cells of the representative lesion
Measured: At the time of EUS-FNA procedure (Day 1)
Degree of Cellularity
Number of cells per slide
Measured: At the time of EUS-FNA procedure (Day 1)
Adequacy of Specimen
Measured: At the time of EUS-FNA procedure (Day 1)
Contamination
Percentage of area of slide that represents GI contamination
Measured: At the time of EUS-FNA procedure (Day 1)
Amount of Blood
Measured: At the time of EUS-FNA procedure (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Biopsy, Fine-NeedleStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel K Mullady, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316614
- Sponsor's protocol ID
- 201105404
- Status last verified
- Nov 2014
- First submitted
- 14 Mar 2011
- Last updated
- 3 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. doi: 10.1016/s0016-5085(97)70164-1.
PubMed 9097990Harewood GC, Wiersema MJ. Endosonography-guided fine needle aspiration biopsy in the evaluation of pancreatic masses. Am J Gastroenterol. 2002 Jun;97(6):1386-91. doi: 10.1111/j.1572-0241.2002.05777.x.
PubMed 12094855Chhieng DC, Jhala D, Jhala N, Eltoum I, Chen VK, Vickers S, Heslin MJ, Wilcox CM, Eloubeidi MA. Endoscopic ultrasound-guided fine-needle aspiration biopsy: a study of 103 cases. Cancer. 2002 Aug 25;96(4):232-9. doi: 10.1002/cncr.10714.
PubMed 12209665Eloubeidi MA, Chen VK, Eltoum IA, Jhala D, Chhieng DC, Jhala N, Vickers SM, Wilcox CM. Endoscopic ultrasound-guided fine needle aspiration biopsy of patients with suspected pancreatic cancer: diagnostic accuracy and acute and 30-day complications. Am J Gastroenterol. 2003 Dec;98(12):2663-8. doi: 10.1111/j.1572-0241.2003.08666.x.
PubMed 14687813Savides TJ, Donohue M, Hunt G, Al-Haddad M, Aslanian H, Ben-Menachem T, Chen VK, Coyle W, Deutsch J, DeWitt J, Dhawan M, Eckardt A, Eloubeidi M, Esker A, Gordon SR, Gress F, Ikenberry S, Joyce AM, Klapman J, Lo S, Maluf-Filho F, Nickl N, Singh V, Wills J, Behling C. EUS-guided FNA diagnostic yield of malignancy in solid pancreatic masses: a benchmark for quality performance measurement. Gastrointest Endosc. 2007 Aug;66(2):277-82. doi: 10.1016/j.gie.2007.01.017.
PubMed 17643700Eloubeidi MA, Jhala D, Chhieng DC, Chen VK, Eltoum I, Vickers S, Mel Wilcox C, Jhala N. Yield of endoscopic ultrasound-guided fine-needle aspiration biopsy in patients with suspected pancreatic carcinoma. Cancer. 2003 Oct 25;99(5):285-92. doi: 10.1002/cncr.11643.
PubMed 14579295Vander Noot MR 3rd, Eloubeidi MA, Chen VK, Eltoum I, Jhala D, Jhala N, Syed S, Chhieng DC. Diagnosis of gastrointestinal tract lesions by endoscopic ultrasound-guided fine-needle aspiration biopsy. Cancer. 2004 Jun 25;102(3):157-63. doi: 10.1002/cncr.20360.
PubMed 15211474Mitsuhashi T, Ghafari S, Chang CY, Gu M. Endoscopic ultrasound-guided fine needle aspiration of the pancreas: cytomorphological evaluation with emphasis on adequacy assessment, diagnostic criteria and contamination from the gastrointestinal tract. Cytopathology. 2006 Feb;17(1):34-41. doi: 10.1111/j.1365-2303.2006.00277.x.
PubMed 16417563Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28.
PubMed 19640524LeBlanc JK, Ciaccia D, Al-Assi MT, McGrath K, Imperiale T, Tao LC, Vallery S, DeWitt J, Sherman S, Collins E. Optimal number of EUS-guided fine needle passes needed to obtain a correct diagnosis. Gastrointest Endosc. 2004 Apr;59(4):475-81. doi: 10.1016/s0016-5107(03)02863-3.
PubMed 15044881Cappelli C, Pirola I, Gandossi E, De Martino E, Agosti B, Castellano M. Fine-needle aspiration cytology of thyroid nodule: does the needle matter? South Med J. 2009 May;102(5):498-501. doi: 10.1097/SMJ.0b013e31819c7343.
PubMed 19373168Erickson RA, Sayage-Rabie L, Beissner RS. Factors predicting the number of EUS-guided fine-needle passes for diagnosis of pancreatic malignancies. Gastrointest Endosc. 2000 Feb;51(2):184-90. doi: 10.1016/s0016-5107(00)70416-0.
PubMed 10650262Gonen M. Sample size and power for McNemar's test with clustered data. Stat Med. 2004 Jul 30;23(14):2283-94. doi: 10.1002/sim.1768.
PubMed 15236431Obuchowski NA. On the comparison of correlated proportions for clustered data. Stat Med. 1998 Jul 15;17(13):1495-507. doi: 10.1002/(sici)1097-0258(19980715)17:133.0.co;2-i.
PubMed 9695194Nguyen YP, Maple JT, Zhang Q, Ylagan LR, Zhai J, Kohlmeier C, Jonnalagadda S, Early DS, Edmundowicz SA, Azar RR. Reliability of gross visual assessment of specimen adequacy during EUS-guided FNA of pancreatic masses. Gastrointest Endosc. 2009 Jun;69(7):1264-70. doi: 10.1016/j.gie.2008.08.030. Epub 2009 Feb 24.
PubMed 19243768
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Endoscopic Ultrasound Guided Fine Needle Aspiration of Solid Lesions With and Without a Stylet
- ClinicalTrials.gov ID
- NCT01316614
- Acronym / sponsor ID
- 201105404
- Keywords
- Fine-Needle Aspiration, Stylet, Solid Mass, Endoscopic Ultrasound (EUS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Posted 3 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| With Stylet & Without Stylet | Experimental | Device: FNA with and without a styletThere 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. Each pass will be individually assessed by a skilled cytopathologist who is blinded to the technique used. We will compare the adequacy of both techniques to determine whether or not a stylet leads to a higher diagnostic accuracy rate in patients with solid lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FNA with and without a styletAlso: Cook Medical EchoTip® Ultra Endoscopic Ultrasound NeedlesIf 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. | Device | With Stylet & Without Stylet |
Primary outcome
Compare Adequacy of Diagnoses in Passes With and Without a Stylet
Time frame: 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.
5 secondary outcomes
Degree of Cellularity
Time frame: At the time of EUS-FNA procedure (Day 1)
Degree of Cellularity
Time frame: At the time of EUS-FNA procedure (Day 1)
Adequacy of Specimen
Time frame: At the time of EUS-FNA procedure (Day 1)
Contamination
Time frame: At the time of EUS-FNA procedure (Day 1)
Amount of Blood
Time frame: At the time of EUS-FNA procedure (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9097990Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. doi: 10.1016/s0016-5085(97)70164-1.
- Background: PubMed 12094855Harewood GC, Wiersema MJ. Endosonography-guided fine needle aspiration biopsy in the evaluation of pancreatic masses. Am J Gastroenterol. 2002 Jun;97(6):1386-91. doi: 10.1111/j.1572-0241.2002.05777.x.
- Background: PubMed 12209665Chhieng DC, Jhala D, Jhala N, Eltoum I, Chen VK, Vickers S, Heslin MJ, Wilcox CM, Eloubeidi MA. Endoscopic ultrasound-guided fine-needle aspiration biopsy: a study of 103 cases. Cancer. 2002 Aug 25;96(4):232-9. doi: 10.1002/cncr.10714.
- Background: PubMed 14687813Eloubeidi MA, Chen VK, Eltoum IA, Jhala D, Chhieng DC, Jhala N, Vickers SM, Wilcox CM. Endoscopic ultrasound-guided fine needle aspiration biopsy of patients with suspected pancreatic cancer: diagnostic accuracy and acute and 30-day complications. Am J Gastroenterol. 2003 Dec;98(12):2663-8. doi: 10.1111/j.1572-0241.2003.08666.x.
- Background: PubMed 17643700Savides TJ, Donohue M, Hunt G, Al-Haddad M, Aslanian H, Ben-Menachem T, Chen VK, Coyle W, Deutsch J, DeWitt J, Dhawan M, Eckardt A, Eloubeidi M, Esker A, Gordon SR, Gress F, Ikenberry S, Joyce AM, Klapman J, Lo S, Maluf-Filho F, Nickl N, Singh V, Wills J, Behling C. EUS-guided FNA diagnostic yield of malignancy in solid pancreatic masses: a benchmark for quality performance measurement. Gastrointest Endosc. 2007 Aug;66(2):277-82. doi: 10.1016/j.gie.2007.01.017.
- Background: PubMed 14579295Eloubeidi MA, Jhala D, Chhieng DC, Chen VK, Eltoum I, Vickers S, Mel Wilcox C, Jhala N. Yield of endoscopic ultrasound-guided fine-needle aspiration biopsy in patients with suspected pancreatic carcinoma. Cancer. 2003 Oct 25;99(5):285-92. doi: 10.1002/cncr.11643.
- Background: PubMed 15211474Vander Noot MR 3rd, Eloubeidi MA, Chen VK, Eltoum I, Jhala D, Jhala N, Syed S, Chhieng DC. Diagnosis of gastrointestinal tract lesions by endoscopic ultrasound-guided fine-needle aspiration biopsy. Cancer. 2004 Jun 25;102(3):157-63. doi: 10.1002/cncr.20360.
- Background: PubMed 16417563Mitsuhashi T, Ghafari S, Chang CY, Gu M. Endoscopic ultrasound-guided fine needle aspiration of the pancreas: cytomorphological evaluation with emphasis on adequacy assessment, diagnostic criteria and contamination from the gastrointestinal tract. Cytopathology. 2006 Feb;17(1):34-41. doi: 10.1111/j.1365-2303.2006.00277.x.
- Background: PubMed 19640524Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28.
- Background: PubMed 15044881LeBlanc JK, Ciaccia D, Al-Assi MT, McGrath K, Imperiale T, Tao LC, Vallery S, DeWitt J, Sherman S, Collins E. Optimal number of EUS-guided fine needle passes needed to obtain a correct diagnosis. Gastrointest Endosc. 2004 Apr;59(4):475-81. doi: 10.1016/s0016-5107(03)02863-3.
- Background: PubMed 19373168Cappelli C, Pirola I, Gandossi E, De Martino E, Agosti B, Castellano M. Fine-needle aspiration cytology of thyroid nodule: does the needle matter? South Med J. 2009 May;102(5):498-501. doi: 10.1097/SMJ.0b013e31819c7343.
- Background: PubMed 10650262Erickson RA, Sayage-Rabie L, Beissner RS. Factors predicting the number of EUS-guided fine-needle passes for diagnosis of pancreatic malignancies. Gastrointest Endosc. 2000 Feb;51(2):184-90. doi: 10.1016/s0016-5107(00)70416-0.
Related trials for Biopsy, Fine-Needle
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
Breast Atypical Ductal Hyperplasia, Breast Ductal Carcinoma In Situ
Not yet recruitingObservational study
Bethesda Classification and Risk Stratification in Differentiated Thyroid Carcinoma
Differentiated Thyroid Carcinoma, Papillary Thyroid Carcinoma
Active, not recruiting
Feasibility and Identification of Breast Cancer Patients for Potential Avoidance of Surgery
Breast Cancer
Active, not recruitingObservational study
AI for Onsite Cytology Evaluation in Endoscopic Ultrasound
Gastrointestinal Neoplasm, Mass Lesion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel K Mullady, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FNA with and without a stylet in people with Biopsy, Fine-Needle and Biopsy, Fine-Needle/Methods, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Adequacy of Diagnoses in Passes With and Without a Stylet (time frame: At the time of EUS-FNA procedure (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316614, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.