Fine Needle Biopsy of Solid Pancreatic Mass Lesions

Study Overview
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Brief Summary
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This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic sucess and safety profile of four different Fine Needle Biopsy needles.

Detailed Description
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Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is currently the standard method for sampling solid pancreatic masses, with reported sensitivity for malignant cytology of 85-95%, specificity of 95-98% and diagnostic accuracy of 78-95%. Diagnostic failure of EUS-FNA can be due to inadequate targeting, inexperience of the endoscopist/pathologist, or necrotic or fibrotic tumors in which viable cells are difficult to obtain. The cellularity and architectural representation of the sample can also be determined by the needle used and its specific features. Recently, new needles known as fine needle biopsy (FNB) needles have become available that are specially designed to promote the collection of core tissue by unique designs of their needle tips. The advantages of FNB over FNA needles are that (a) the quality of tissue procured is superior: FNA needles yield cytology whereas FNB needles yield histology (b) molecular marker analysis can be performed more reliably on histology samples than cytology aspirates and (c) as histological tissue is greater in quantity than cytological aspirates, a quicker diagnosis with fewer passes can be established by histology than cytology. Four different types of FNB needles are currently available - reverse-bevel tip (EchoTip ProCore HD Ultrasound Biopsy Needle, Cook Medical, Bloomington, IN), Menghini-tip (EZ shot, Olympus America, Center Valley, PA), Franseen tip (Acquire, Boston Scientific Corporation, Natick, MA) and fork-tip (SharkCore, Medtronic Corporation/Covidien, Newton, MA) needles, each with unique tip designs to facilitate procurement of histological core tissue. Although we have previously compared in randomized trials the diagnostic yield of Franseen and fork-tip FNB needles and have shown the two needles to be equivalent, there are currently no randomized trials directly comparing all four FNB needle types. EUS-guided tissue acquisition can also be performed using different techniques, including the use of suction, no use of suction and the stylet retraction technique. There are currently no studies comparing these different tissue acquisition techniques using the different FNB needles and no study has demonstrated the best technique for FNB.

Official Title
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Randomized Trial Comparing Fine Needle Biopsy Needles and Different Techniques for Endoscopic-guided Fine Needle Biopsy of Solid Pancreatic Mass Lesions

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Diagnostic Test: Solid pancreatic mass lesion biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients referred for EUS-guided tissue acquisition of suspected or confirmed solid pancreatic mass lesions visualized on any radiological imaging Able and willing to provide written or verbal consent ≥ 18 years old Able to undergo conscious sedation for EUS procedure Exclusion Criteria: <18 years old Unable to obtain informed consent from the patient Medically unfit for sedation Pregnant patients No pancreatic mass lesions visualized on EUS Irreversible coagulopathy as determined by platelet count < 50,000/microL or International Normalized Ratio (INR) > 1.5 Unable to stop anti-platelet agents prior to the procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a randomized trial comparing four types of FNB needles and three sampling techniques. Patients will be randomized to one of the four different FNB needles. All patients will then undergo FNB using the specified needle and all three sampling techniques (one pass per technique using the assigned needle).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 22 Gauge FNB Needle - ProCore<br>The 22 Gauge FNB Needle - ProCore will be used to biopsy solid pancreatic mass lesions. | Diagnostic Test: Solid pancreatic mass lesion biopsy<br>* The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.<br>* Other names: biopsy, fine needle biopsy, fine needle aspiration;|
| Active Comparator: 22 Gauge FNB Needle - Acquire<br>The 22 Gauge FNB Needle - Acquire will be used to biopsy solid pancreatic mass lesions. | Diagnostic Test: Solid pancreatic mass lesion biopsy<br>* The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.<br>* Other names: biopsy, fine needle biopsy, fine needle aspiration;|
| Active Comparator: 22 Gauge FNB Needle - SharkCore<br>The 22 Gauge FNB Needle - SharkCore will be used to biopsy solid pancreatic mass lesions. | Diagnostic Test: Solid pancreatic mass lesion biopsy<br>* The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.<br>* Other names: biopsy, fine needle biopsy, fine needle aspiration;|
| Active Comparator: 22 Gauge FNB needle - EZ Shot 3 Plus<br>The 22 Gauge FNB Needle - EZ Shot 3 Plus will be used to biopsy solid pancreatic mass lesions. | Diagnostic Test: Solid pancreatic mass lesion biopsy<br>* The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.<br>* Other names: biopsy, fine needle biopsy, fine needle aspiration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of cellularity in biopsy sample | Compare the degree of cellularity of the obtained tissue in the biopsy sample between the four FNB needles in patients undergoing EUS-guided sampling of pancreatic masses using the three different sampling techniques. Cellularity is defined as the proportion of core tissue to total specimen area. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic adequacy of the biopsy sample | Documentation of the presence of adequate tissue material (pancreatic parenchyma and tumor if applicable) in the biopsy sample. | 1 day | 
| Specimen bloodiness in biopsy sample | Measured as the area of bloodiness in the biopsy sample, with calculation as a percentage in the microscopic field. | 1 day | 
| Presence of crush artefact in biopsy sample | Documenting the presence or absence of crush artefact in the biopsy sample. If present, it is measured as the area of artefact in biopsy sample, with calculation as a percentage in relation to the total sample area. | 1 day | 
| Technical failure | Measured as the inability to successfully perform the fine needle biopsy using the assigned needle, due to any needle dysfunction. | 1 day | 
| Adverse events | The subject will be asked to report and medical records will be reviewed for any adverse events related to the procedure or the underlying disease. | 7 days, 30 days, and 6 months | 
| Diagnostic operating characteristics | Compare the diagnostic operating characteristics of the biopsy sample and detection of neoplasia (defined as sensitivity, specificity, negative predictive value, positive predictive value and accuracy) between the four FNB needles in patients undergoing EUS-guided sampling of pancreatic masses using the three different sampling techniques | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic mass, pancreatic solid mass, pancreatic lesion