Clinical trial NCT04085055: Fine Needle Biopsy of Solid Pancreatic Mass Lesions
Official title: Randomized Trial Comparing Fine Needle Biopsy Needles and Different Techniques for Endoscopic-guided Fine Needle Biopsy of Solid Pancreatic Mass Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Neoplasms
Keywords: pancreatic mass, pancreatic solid mass, pancreatic lesion
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. All patients referred for EUS-guided tissue acquisition of suspected or confirmed solid pancreatic mass lesions visualized on any radiological imaging
2. Able and willing to provide written or verbal consent
3. ≥ 18 years old
4. Able to undergo conscious sedation for EUS procedure

Exclusion Criteria:

1. \<18 years old
2. Unable to obtain informed consent from the patient
3. Medically unfit for sedation
4. Pregnant patients
5. No pancreatic mass lesions visualized on EUS
6. Irreversible coagulopathy as determined by platelet count \< 50,000/microL or International Normalized Ratio (INR) \> 1.5
7. Unable to stop anti-platelet agents prior to the procedure

Primary outcomes:
measure: Degree of cellularity in biopsy sample
timeFrame: 3 days
Secondary outcomes:
measure: Diagnostic adequacy of the biopsy sample
timeFrame: 1 day
measure: Specimen bloodiness in biopsy sample
timeFrame: 1 day
measure: Presence of crush artefact in biopsy sample
timeFrame: 1 day
measure: Technical failure
timeFrame: 1 day
measure: Adverse events
timeFrame: 7 days, 30 days, and 6 months
measure: Diagnostic operating characteristics
timeFrame: 6 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
Study officials:
affiliation: AdventHealth
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Varadarajulu S, Fraig M, Schmulewitz N, Roberts S, Wildi S, Hawes RH, Hoffman BJ, Wallace MB. Comparison of EUS-guided 19-gauge Trucut needle biopsy with EUS-guided fine-needle aspiration. Endoscopy. 2004 May;36(5):397-401. doi: 10.1055/s-2004-814316.
citation: Bang JY, Hawes R, Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy. 2016 Apr;48(4):339-49. doi: 10.1055/s-0034-1393354. Epub 2015 Nov 12.
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citation: Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2018 Jun;87(6):1432-1438. doi: 10.1016/j.gie.2017.11.036. Epub 2018 Jan 3.
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citation: Young Bang J, Krall K, Jhala N, Singh C, Tejani M, Arnoletti JP, Navaneethan U, Hawes R, Varadarajulu S. Comparing Needles and Methods of Endoscopic Ultrasound-Guided Fine-Needle Biopsy to Optimize Specimen Quality and Diagnostic Accuracy for Patients With Pancreatic Masses in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Apr;19(4):825-835.e7. doi: 10.1016/j.cgh.2020.06.042. Epub 2020 Jul 8.