Prospective Comparison of a Novel 22-gauge Core Biopsy Needle With Reverse Bevel Design to a Standard Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) Needle for Diagnosis of Solid Pancreatic Mass Lesions
Phase: NA
Conditions: Solid Pancreatic Mass Lesions, Malignant Neoplasm of Pancreas
Sponsor: M.D. Anderson Cancer Center

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DETAILED PROTOCOL  
 
Title:  
Prospective comparison of a novel 22-gauge core biopsy needle with reverse bevel design to a 
standard endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) needle for diagnosis of 
solid pancreatic mass lesions   
 
Principal Investigators:  
Brian R. Weston, MD, William A. Ross, MD. 
 
Co-Investigators:  
Manoop S. Bhutani, MD, Jeffrey H. Lee, MD, John Stewart, MD, Gregg Staerkel, MD, Wei Qiao, MS, 
Lianchun Xiao, MS. 
 
Location:  
The University of Texas MD Anderson Cancer Center  
 
 
 
 
 
 
 
 
 

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1. 
Objectives 
The ability to obtain an adequate specimen during endoscopic ultrasound (EUS) guided fine needle 
aspiration (FNA) is dependent on a variety of factors. New needle technology has been developed 
which potentially improves diagnostic yield and reduces the number of needle passes required. The 
latest ultrasound needle,  has a reverse bevel design with the potential to obtain a core specimen in a 
22-gauge size needle that may provide a better cytologic specimen than the most commonly used 
straight hollow-core standard (22-gauge and 25-gauge) FNA needles. A histologic specimen may 
also be provided which is not otherwise possible to obtain using current FNA needles of this size. 
 
Primary Aim:  
 To compare the performance of a novel 22-gauge core biopsy needle with reverse bevel 
design to straight hollow-core standard EUS guided FNA needles for cytologic diagnosis of 
solid pancreatic lesions. 
 
Secondary Aims:  
 To evaluate the performance of a novel 22-gauge core biopsy needle with reverse bevel 
design to obtain an adequate specimen for histologic diagnosis  
 To identify potential pancreatic lesions that are best suited for sampling with this needle 
 
2.  
Background  
Endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) is an effective technique to 
diagnose a variety of different lesions within or adjacent to the gastrointestinal tract including the 
pancreas.[1-3]  A cytologic specimen is provided with the most commonly used straight hollow-core 
22-gauge or 25-gauge standard EUS guided FNA needle and an immediate diagnosis can be made 
in the majority of cases.  The procedure is relatively safe and minimally invasive compared to 

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alternative methods.[4, 5]  The ability to obtain adequate sampling with minimal number of passes 
and trauma to surrounding tissue is desirable. 
 
The ability to obtain an adequate specimen has been shown to be dependent on a variety of factors 
i.e.: nature of lesion (i.e. pathology, tumor differentiation, presence of inflammation/necrosis, size, 
location), type and size of needle, number of passes taken, experience of endoscopist and 
cytopathologist, as well as the presence of immediate on-site cytologic evaluation, etc.[6-12]   
 
Standard EUS guided FNA needles used in clinical practice today are straight hollow core needles 
with a forward bevel design. The most commonly used size is either a 22- or 25-gauge needle; both 
have comparable results and may for the most part be used interchangeably.[7, 9, 12]  In our 
practice, the number of passes needed to obtain adequate cytologic sampling of solid pancreatic 
lesions in an estimated 90% of cases is approximately four with immediate on-site cytologic 
evaluation.  
 
Some lesions are difficult to adequately sample by EUS guided FNA, particularly in the pancreas. 
Additional passes may be required before a diagnosis is made and in some instances (<5%) cytologic 
findings alone may be insufficient. Larger cytologic yield or tissue histology for additional tests may be 
needed. Dedicated large core 19-gauge EUS needles or Tru-cut biopsy needles are currently 
available which have ability to obtain a larger cytological or pathological specimen when needed. 
However these larger needles have limitations and the potential for increased risks of complications 
which restricts their use.[13-18]  A major limitation of the larger 19-gauge needle devices is the 
technical difficulty of performing FNA with these less flexible needles when the tip of the endoscope is 
sharply deflected or in a tortuous position; this is a frequent problem for lesions located in the 
pancreatic head, the most common site of pancreatic adenocarcinoma. Smaller lesions (ie. less than 

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2cm) are also less suited to sampling with larger needles. Cytologic analysis will in most cases allow 
for immediate assessment to determine adequate sampling for diagnosis during EUS. Histologic 
tissue analysis does not lend itself to immediate assessment. However tissue specimens may allow 
for more detailed analysis versus cytologic specimens. On-site cytology for immediate assessment in 
not universally available and is resource intensive but may prevent patients from undergoing repeat 
procedures for nondiagnostic exams and unnecessary additional passes.    
 
A new EUS needle is commercially available – EchoTip® Procore™ High Definition Ultrasound 
Biopsy Needle from Cook Medical. This needle is a single use, disposable needle available in 22-
gauge size which was approved for use by the FDA on February 14, 2011. The novel reverse bevel 
design allows collection of a core sample which may be submitted for cytologic and histologic 
analysis unlike standard FNA needles which provide a cytologic specimen only.  Procore™ acts by 
shearing material from the target lesion during retrograde movement of the needle. A core trap at the 
tip of the needle receives the tissue sample while the reverse bevel enables collection of the core 
sample.  The tip of the needle has the same ultrasound visibility as current needles. The mechanism 
to use the needle is similar to current practice with only minor adjustments of technique which are 
standardized as per manufacturer recommendation. The needle may increase sampling yields and 
improve both accuracy and collection of core biopsies. The potential ability to take fewer needle 
passes may improve efficiency and safety of the procedure. The capacity to obtain a core specimen 
may provide tissue for additional histologic evaluation such as immunohistochemical and genetic 
biomarker studies.   
 
 

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3.  
Patient Eligibility  
3.1  
Inclusion Criteria:  
3.1.1 Patient age 18 years and older.  
3.1.2 All patients referred for EUS FNA of endoscopically accessible solid pancreatic 
lesions 
 
3.2  
Exclusion Criteria:  
3.2.1 Unable to obtain informed consent.  
3.2.2 Unable to tolerate the procedure.  
3.2.3 Women with known pregnancy at time 
3.2.4 Patient age less than 18 years of age 
3.2.5 Bleeding diathesis  
3.2.6 Cystic pancreatic lesions 
3.2.7 Lesion not accessible by EUS guided FNA 
 
4.  
Subject Enrollment: 
4.2.1 All consecutive patients referred for EUS FNA of solid pancreatic lesions  
 
Procedures for Obtaining Consent:  
Written consent to participate in the study will be obtained by the principal investigator or co-
investigators prior to the procedure. This consent will be in addition to the standard procedure 
consent for esophagogastroduodenoscopy with EUS FNA.  
 
 
 

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Source of Subjects and Recruitment Methods:  
Subjects for this study will be recruited from those patients referred for diagnostic EUS FNA of solid 
pancreatic lesions by a physician responsible for their care (i.e. gastroenterologists, oncologists, 
general internists, and surgeons) to the principal investigator or co-investigator / collaborators as per 
standard practice. 
 
5.  
Study Procedures  
Data to be Collected, Study Visits and Parameters Measured.  
Demographic data:  
Demographic related data will be collected from the subject, medical records and the referring 
physician. This includes age, gender, co-morbid illnesses, type of cancer, tumor location, presence of 
metastases, method of diagnosis, therapy to date, laboratory results, relevant imaging studies and 
reports.  
Procedural data: 
Procedural related data will also be recorded from procedure report such as lesion location, lesion 
size, echogenic features of lesion, number of FNA passes performed, site of FNA (i.e. transduodenal 
or transgastric), type and sequence of needle used, use of stylet, use of suction, cytologic and 
histologic diagnosis. 
Immediate outcomes: 
Immediate outcomes to be assessed are adequacy of specimen obtained for cytologic and histologic 
diagnosis. Adequacy of the specimen will be determined by review of cellular/tissue material obtained 
by a cytologist/pathologist for each needle pass that is taken. See appendix E & F for representative 
analysis. Any procedure-related complications related to the FNA will be recorded. 
 
 

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Medications:  
Subjects will not receive or be exposed to any additional medications as a result of participation in 
this study. Subjects will receive sedation for endoscopic procedures as this is standard practice and 
as would be administered regardless of participation in the study. Patient will have an intravenous line 
placed for administration of sedation prior to the procedure as is standard practice. Anesthesia will 
sedate and monitor all patients referred for EUS FNA procedures in accordance with our endoscopy 
unit practice. The duration of the procedure and length of sedation period is not expected to be any 
longer than would otherwise be required.  The patient will sign a separate consent for sedation.  
 
Devices (see device package inserts):  
The 22-gauge core biopsy needle with reverse bevel design (EchoTip® Procore™) will be compared 
prospectively to the standard straight hollow-core 22-gauge or 25-gauge FNA needle already used in 
our clinical practice for the diagnosis of solid pancreatic lesions.  The needles to be used in this study 
are FDA-approved, commercially available and currently in use at MDACC.  
 
EUS FNA 22/25-gauge Needle 
EUS FNA 22-gauge Needle 
Straight Hollow-Core Needle 
Reverse Bevel Design 
Collect only Cells 
Collect Cells and Tissue 
 
 
Interventions:  
Patients who are referred for EUS guided FNA and who consent to participate will have their 
examination performed using two different needles. As part of the study two passes will be performed 
with the standard 22-gauge or 25-gauge straight hollow core needle and two passes will be 

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performed using the 22-gauge EchoTip® Procore™ needle. All passes will be taken from a single 
lesion and from the same endoscopic location. All passes will be numbered. Both passes taken with 
the standard needle will be sent for immediate cytologic evaluation as is standard. One of the 22-
gauge EchoTip® Procore™ passes will be sent for immediate cytologic evaluation and one pass will 
be sent for histology.  Additional non-study passes will be obtained if necessary (after immediate 
cytologic evaluation of the three initial passes) using needle of endoscopist’s choice. If adequate 
sampling is believed to have been obtained in fewer than 4 total passes as confirmed by immediate 
cytologic assessment then no additional passes need be performed at the discretion of the 
endoscopist and analysis will be performed with existing data. All other elements of the exam will be 
otherwise unchanged. The endoscopist performing the procedure will alternate the sequence of EUS 
needles used in any given patient.  In addition we will alternate which Procore™ pass is sent for 
histology and cytology.  The primary intervention will be which needle is used and in which sequence. 
The reason for alternating sequence is to eliminate any confounding variable associated with 
sequence such as increased bloody aspirate or possible variability in cytologic yield related to 
increased number of passes.  The study does not involve an increased or excessive number of 
passes or other additional interventions beyond what would be current standard practice. This 
procedure will be explained to subjects at time of consent. 
Cytopathologic Evaluation:  
The specimens are to be assessed independently by members of the MDACC cytology/pathology 
department who will be blinded to the needle sequence and type of needle used. For the purposes of 
the study cytopathologic results will be recorded from the slides of each of the numbered individual 
passes taken. Reports for immediate assessment purposes will be based on the 3 passes sent to 
cytology and any additional passes required outside the study including the cellblock made from wash 
of all needle passes. The cytological specimen quality will be graded on cellularity and other features 

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comparable to the assessment in our earlier study by Lee et al. (10) (see Appendix E & F). The single 
Procore™ sample sent to histology will be processed like any other endoscopic biopsy specimen 
(immediate assessment not possible as with cytology due to processing requirements) and the final 
pathology report will be used for comparison purposes to the cytological specimen results.  
 
Study Duration:  
The expected duration of the study is approximately 2 years from the commencement of subject 
enrollment. Subject enrollment is expected to be up to one year. All subjects will be followed until 
surgery, death, or at least six months until last subject enrolled.  
6.  
Biostatistical Analysis  
 
Study design 
The primary objective of the study is to assess if the 22-gauge EchoTip® Procore™ needle has a 
better diagnostic performance compared to standard 22-gauge and 25-gauge  straight hollow core 
needles (both 22-gauge  and 25-gauge  needles are used interchangeably). The primary endpoint is 
whether or not the needle pass result provides diagnostic material (yes vs. no). For each patient, both 
needles will be used to sample the same lesion. Two needle passes will be performed with each 
needle type. The average number of needle passes needed to obtain a diagnostic specimen of solid 
lesions in the pancreas is four using the standard 22-gauge  or 25-gauge  straight hollow core needle 
in our practice (although the number of passes can be variable in any given lesion for a variety of 
reasons). All needle passes will be numbered and evaluated individually.  For the two passes taken 
from the straight hollow-core standard needle, the specimens are to be assessed by cytology for 
immediate review. For the two passes taken with the EchoTip® Procore™ needle, one pass will be 
submitted to cytology for immediate review and one pass for pathology (immediate review not 

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possible). Any additional passes will not be included in the study. The need for additional passes will 
be determined based on the three passes (two straight hollow-core standard FNA needle and one 
EchoTip® Procore™ needle) sent for immediate cytologic assessment during the procedure as is 
routine at our center. Immediate assessment is not possible for the one pass submitted for histologic 
analysis with the EchoTip® Procore™. Each needle pass submitted for review will be rated 
individually by the cytologist/pathologist (see appendix E & F for cytopathology rating sheet as 
applicable).  A final analysis will be performed on the diagnostic results from each needle pass.  For 
the purpose of the study, if the passes are adequate to be diagnostic, the result will be considered 
“yes”. If the passes are inadequate, the result will be considered “no”.  Equal number of biopsies will 
be taken for each needle sequence. 
 
Power and Sample Size:  
The two standard straight hollow-core FNA passes are assumed to be diagnostic in 65% of patients. 
The two Procore™ needle passes are assumed to be diagnostic in 85% of patients. Assuming a 
discordant proportion of 30%, a sample size of 60 patients will be needed to achieve 80% at a 5% 
significance level. 
For the comparison, McNemar’s test will be used for the sample size justification. Our null and 
alternative hypotheses are: 
H0: Pa - Pb =0 vs. Ha: Pa - Pb ≠ 0 
Where Pa and Pb are the diagnostic proportions for the 22-gauge EchoTip® Procore™ needle and 
standard 22-gauge or 25-gauge straight hollow core needle respectively.  
Table 1 displays in the scenario the sample sizes needed to achieve about 80% power with a two-
sided significance level of 0.05 for different scenarios with different assumptions for proportion 
discordant. 

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Sample size 
Difference  in 
positive 
proportions 
Proportion 
Discordant 
power 
60 
0.2 
0.3 
0.8 
 
In this study, we assume that the 22-gauge EchoTip® Procore™ needle will have a higher diagnostic 
yield (85%) than a standard straight hollow-core FNA needle after two passes (65%). A sample size 
of 60 patients will achieve about 80% power at a 5% significance level using a two-sided 
inequivalence test of correlated proportions when it is assumed that there is 20% difference regarding 
biopsy result (positive vs. negative) and the discordant proportion is 30%. 
Statistical Analysis:  
Data analysis will be performed using SAS as appropriate.  Intent-to-treat data will be used for primary 
analysis.  Demographic and disease characteristics of the patients at registration will be summarized 
using descriptive statistics such as mean, standard deviation (SD), median and range. Biopsy result 
(diagnostic proportion) from each needle type will be presented with 95% confidence intervals. 
McNemar test will be used to compare diagnostic ability (yes vs. no) between the two pass information 
obtained from the standard straight hollow-core needle (22-gauge or 25-gauge) and the one pass 
information obtained from the 22-gauge EchoTip® Procore™ needle. In addition, McNemar test will be 
used to compare diagnostic ability (yes vs. no) between either of the two pass information obtained 
from the standard straight hollow-core needle (22-gauge or 25-gauge) and the one pass information 
obtained from the 22-gauge EchoTip® Procore™ needle. 
Demographics and Other Characteristics:  

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Summary statistics for patients’ demographics and other characteristics will be presented 
descriptively.  
 
Primary Endpoint:  
Comparison of a diagnostic cytopathology specimen provided from FNA of a solid pancreatic lesion 
using the two different needles as determined by a cytologists who will be blinded to needle type and 
sequence.  
 
Secondary Endpoint: 
Assessment of adequate specimen for histologic diagnosis with Procore™ needle of a solid 
pancreatic lesion. Comparison of cytological diagnosis from both needle types with histological 
assessment of Procore™ needle specimen. 
 
7.  
Risks and Discomforts  
There is not expected to be any increased risk with use of either needle above and beyond what is 
standard for the procedure.  Both needles used in the study are already FDA approved, commercially 
available and used in clinical practice, including here at MD Anderson.  Both needles are similar in 
size.  There is no increased number of passes performed as part of this study.  In addition it would 
not be possible to determine any specific procedure related complication to use of one needle verses 
the other in the setting of this study.  We will keep track of the overall frequency of adverse events 
that are standard to the procedure. 
 
There will not be any additional laboratory studies, radiologic studies, interventions or exposure to 
medications or radiation. There will be no additional cost to the patient for use of a second needle. 
Specimens will be sent for cytological and histological evaluation as is standard. 

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There is an inherent risk of accidental disclosure of confidential information when gathering research 
data from a protected source, such as medical records. To minimize the risk to subjects, access to 
data will be restricted to study personnel only and all study personnel agree to and have signed the 
HSD Confidentiality Agreement. All data will be coded with a unique study code and the master list 
linking the subjects to the study code will be kept in a separate, secured location. The master list will 
be kept long enough to complete data analysis, at which time the link will be destroyed. Creation of 
this link is necessary in the event re-evaluation or clarification of data is required. The master list will 
be electronically stored on secure University of Texas servers with restricted and traceable user 
authorizations, accessible only to study personnel and further restricted via password protection. 
  
8.  
Potential Benefits  
Patients enrolled in this study will receive the standard of care. There will be no direct individual 
benefit.  
 
9.  
Monitoring and Quality Assurance  
Independent Monitoring of Source Data:  
The specimens are to be assessed independently by members of MDACC cytology/pathology 
department who will be blinded to the needle sequence and type of needle used. The results data will 
be monitored for completeness periodically by the principal investigator.  The protocol will be 
monitored by the MDACC Data and Safety Monitoring Board (DSMB).  
 
 
 

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Adverse Event Reporting:  
We will follow the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0/U.S., 
Department of Health and Human Services.   Adverse events will be reported to the Human Research 
Committee as follows. Serious adverse events including death, life-threatening experience, an event 
requiring hospitalization, an event requiring an intervention will be reported within 24 hours, followed 
by a full written report within 1 week. Mild to moderate adverse events that are unexpected and may 
be related to the study will be reported in writing within 2 weeks to the Human Research Committee. 
Mild to moderate adverse events that are unexpected but not related to the study will be reported to 
the Human Research Committee in the periodic review. Expected adverse events that are not serious 
will be reported to the Human Research Committee in the periodic review. A written periodic review 
will be submitted to the Human Research Committee for continuing review annually.  
 
 Instructions are given to each patient post procedure to call if having any problem (i.e. pain, bleeding, 
fever, or other problems) prior to discharge from endoscopy unit per standard protocol.  All adverse 
events (including but not limited to aspiration, adverse reaction sedation, bleeding, perforation, 
pancreatitis, infection, missed lesion) will be reviewed by the principal investigator.   
 
External Support:  
No external funding is forthcoming.  
 
 

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10.  
References:  
1. 
Baron, T.H., J.S. Mallery, W.K. Hirota, et al., The role of endoscopy in the evaluation and 
treatment of patients with pancreaticobiliary malignancy. Gastrointest Endosc, 2003. 58(5): 
p. 643-9. 
2. 
Gan, S.I., E. Rajan, D.G. Adler, et al., Role of EUS. Gastrointest Endosc, 2007. 66(3): p. 
425-34. 
3. 
Shah, J.N., N.A. Ahmad, M.C. Beilstein, et al., Clinical impact of endoscopic 
ultrasonography on the management of malignancies. Clin Gastroenterol Hepatol, 2004. 
2(12): p. 1069-73. 
4. 
Adler, D.G., B.C. Jacobson, R.E. Davila, et al., ASGE guideline: complications of EUS. 
Gastrointest Endosc, 2005. 61(1): p. 8-12. 
5. 
Wang, K.X., Q.W. Ben, Z.D. Jin, et al., Assessment of morbidity and mortality associated 
with EUS-guided FNA: a systematic review. Gastrointest Endosc. 73(2): p. 283-90. 
6. 
Eloubeidi, M.A., D. Jhala, D.C. Chhieng, et al., Yield of endoscopic ultrasound-guided fine-
needle aspiration biopsy in patients with suspected pancreatic carcinoma. Cancer, 2003. 
99(5): p. 285-92. 
7. 
Lee, J.H., J. Stewart, W.A. Ross, et al., Blinded prospective comparison of the performance 
of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration 
of the pancreas and peri-pancreatic lesions. Dig Dis Sci, 2009. 54(10): p. 2274-81. 
8. 
Nguyen, Y.P., J.T. Maple, Q. Zhang, et al., Reliability of gross visual assessment of 
specimen adequacy during EUS-guided FNA of pancreatic masses. Gastrointest Endosc, 
2009. 69(7): p. 1264-70. 
9. 
Sakamoto, H., M. Kitano, T. Komaki, et al., Prospective comparative study of the EUS 
guided 25-gauge FNA needle with the 19-gauge Trucut needle and 22-gauge FNA needle 
in patients with solid pancreatic masses. J Gastroenterol Hepatol, 2009. 24(3): p. 384-90. 

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10. Savides, T.J., M. Donohue, G. Hunt, et al., EUS-guided FNA diagnostic yield of malignancy 
in solid pancreatic masses: a benchmark for quality performance measurement. 
Gastrointest Endosc, 2007. 66(2): p. 277-82. 
11. Tadic, M., M. Kujundzic, T. Stoos-Veic, et al., Role of repeated endoscopic ultrasound-
guided fine needle aspiration in small solid pancreatic masses with previous indeterminate 
and negative cytological findings. Dig Dis, 2008. 26(4): p. 377-82. 
12. Yusuf, T.E., S. Ho, D.A. Pavey, et al., Retrospective analysis of the utility of endoscopic 
ultrasound-guided fine-needle aspiration (EUS-FNA) in pancreatic masses, using a 22-
gauge or 25-gauge needle system: a multicenter experience. Endoscopy, 2009. 41(5): p. 
445-8. 
13. Aithal, G.P., G.K. Anagnostopoulos, W. Tam, et al., EUS-guided tissue sampling: 
comparison of "dual sampling" (Trucut biopsy plus FNA) with "sequential sampling" (Trucut 
biopsy and then FNA as required). Endoscopy, 2007. 39(8): p. 725-30. 
14. Gines, A., M.J. Wiersema, J.E. Clain, et al., Prospective study of a Trucut needle for 
performing EUS-guided biopsy with EUS-guided FNA rescue. Gastrointest Endosc, 2005. 
62(4): p. 597-601. 
15. Jenssen, C. and C.F. Dietrich, Endoscopic ultrasound-guided fine-needle aspiration biopsy 
and trucut biopsy in gastroenterology - An overview. Best Pract Res Clin Gastroenterol, 
2009. 23(5): p. 743-59. 
16. Levy, M.J., Endoscopic ultrasound-guided trucut biopsy of the pancreas: prospects and 
problems. Pancreatology, 2007. 7(2-3): p. 163-6. 
17. Levy, M.J., R.P. Reddy, M.J. Wiersema, et al., EUS-guided trucut biopsy in establishing 
autoimmune pancreatitis as the cause of obstructive jaundice. Gastrointest Endosc, 2005. 
61(3): p. 467-72. 

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18. Shah, S.M., A. Ribeiro, J. Levi, et al., EUS-guided fine needle aspiration with and without 
trucut biopsy of pancreatic masses. JOP, 2008. 9(4): p. 422-30. 
 
 
 

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Appendix E 
 
Cytopathology Rating 
Criteria 
Scale 
Rating 
Clot 
0 
No Significant Obscuring Blood 
1+ 
= < 25% of tumor obscured by blood/blood clot 
2+ 
= < 25%  to < 75% of tumor obscured by blood/blood clot 
3+ 
= < 75% or more of tumor obscured by blood/blood clot 
Cellularity 
1+ 
Minimal 
2+ 
Mild 
3+ 
Moderate 
4+ 
Abundant 
Diagnostic 
Yes 
  
No 
  
 
 
 
 
 
 
 
 
 

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Appendix F. 
 
 
Histology Rating 
Criteria 
Scale 
Rating 
Diagnostic 
Yes 
  
No