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2019-09-09
2020-06-25
2020-12
130
NCT04085055
AdventHealth
AdventHealth
INTERVENTIONAL
Fine Needle Biopsy of Solid Pancreatic Mass Lesions
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.
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 ȯine 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-09-09 | N/A | 2020-08-03 |
2019-09-09 | N/A | 2020-08-05 |
2019-09-11 | N/A | 2020-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Single Group
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: 22 Gauge FNB Needle - ProCore The 22 Gauge FNB Needle - ProCore will be used to biopsy solid pancreatic mass lesions. | DIAGNOSTIC_TEST: Solid pancreatic mass lesion biopsy
|
| ACTIVE_COMPARATOR: 22 Gauge FNB Needle - Acquire The 22 Gauge FNB Needle - Acquire will be used to biopsy solid pancreatic mass lesions. | DIAGNOSTIC_TEST: Solid pancreatic mass lesion biopsy
|
| ACTIVE_COMPARATOR: 22 Gauge FNB Needle - SharkCore The 22 Gauge FNB Needle - SharkCore will be used to biopsy solid pancreatic mass lesions. | DIAGNOSTIC_TEST: Solid pancreatic mass lesion biopsy
|
| ACTIVE_COMPARATOR: 22 Gauge FNB needle - EZ Shot 3 Plus 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
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Shyam Varadarajulu, MD Phone Number: 407.303.2750 Email: shyam.varadarajulu.md@adventhealth.com |
Study Contact Backup Name: Robin Barron-Nelson Phone Number: 321.946.2747 Email: robin.barron@flhosp.org |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
