Fine Needle Biopsy of Solid Pancreatic Mass Lesions

NCT04085055 | Unknown DMC FDA Device

• 1 other identifier: 1469116
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms

Keywords

pancreatic mass, pancreatic solid mass, pancreatic lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Diagnostic adequacy of the biopsy sample

  1 day

• Specimen bloodiness in biopsy sample

  1 day

• Presence of crush artefact in biopsy sample

  1 day

• Technical failure

  1 day

• Adverse events

  7 days, 30 days, and 6 months

Study Arms (4)

22 Gauge FNB Needle - ProCore

ACTIVE COMPARATOR

The 22 Gauge FNB Needle - ProCore will be used to biopsy solid pancreatic mass lesions.

Diagnostic Test: Solid pancreatic mass lesion biopsy

22 Gauge FNB Needle - Acquire

ACTIVE COMPARATOR

The 22 Gauge FNB Needle - Acquire will be used to biopsy solid pancreatic mass lesions.

Diagnostic Test: Solid pancreatic mass lesion biopsy

22 Gauge FNB Needle - SharkCore

ACTIVE COMPARATOR

The 22 Gauge FNB Needle - SharkCore will be used to biopsy solid pancreatic mass lesions.

Diagnostic Test: Solid pancreatic mass lesion biopsy

22 Gauge FNB needle - EZ Shot 3 Plus

ACTIVE COMPARATOR

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

Interventions

Solid pancreatic mass lesion biopsy DIAGNOSTIC_TEST

The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.

Also known as: biopsy, fine needle biopsy, fine needle aspiration

22 Gauge FNB Needle - Acquire; 22 Gauge FNB Needle - ProCore; 22 Gauge FNB Needle - SharkCore; 22 Gauge FNB needle - EZ Shot 3 Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

Related Publications (12)

• Ngamruengphong S, Li F, Zhou Y, Chak A, Cooper GS, Das A. EUS and survival in patients with pancreatic cancer: a population-based study. Gastrointest Endosc. 2010 Jul;72(1):78-83, 83.e1-2. doi: 10.1016/j.gie.2010.01.072.

  PMID: 20620274 BACKGROUND

• Othman MO, Wallace MB. The role of endoscopic ultrasonography in the diagnosis and management of pancreatic cancer. Gastroenterol Clin North Am. 2012 Mar;41(1):179-88. doi: 10.1016/j.gtc.2011.12.014. Epub 2012 Jan 16.

  PMID: 22341257 BACKGROUND

• Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.

  PMID: 22248600 BACKGROUND

• 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.

  PMID: 15100946 BACKGROUND

• 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.

  PMID: 26561917 BACKGROUND

• Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. EUS-guided fine needle biopsy of pancreatic masses can yield true histology. Gut. 2018 Dec;67(12):2081-2084. doi: 10.1136/gutjnl-2017-315154. Epub 2017 Oct 7. No abstract available.

  PMID: 28988195 BACKGROUND

• 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.

  PMID: 29305893 BACKGROUND

• Lee KY, Cho HD, Hwangbo Y, Yang JK, Han SJ, Choi HJ, Lee YN, Cha SW, Moon JH, Cho YD, Park SH, Lee TH. Efficacy of 3 fine-needle biopsy techniques for suspected pancreatic malignancies in the absence of an on-site cytopathologist. Gastrointest Endosc. 2019 Apr;89(4):825-831.e1. doi: 10.1016/j.gie.2018.10.042. Epub 2018 Nov 4.

  PMID: 30403966 BACKGROUND

• Saxena P, El Zein M, Stevens T, Abdelgelil A, Besharati S, Messallam A, Kumbhari V, Azola A, Brainard J, Shin EJ, Lennon AM, Canto MI, Singh VK, Khashab MA. Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial. Endoscopy. 2018 May;50(5):497-504. doi: 10.1055/s-0043-122381. Epub 2017 Dec 22.

  PMID: 29272906 BACKGROUND

• Nakai Y, Isayama H, Chang KJ, Yamamoto N, Hamada T, Uchino R, Mizuno S, Miyabayashi K, Yamamoto K, Kawakubo K, Kogure H, Sasaki T, Hirano K, Tanaka M, Tada M, Fukayama M, Koike K. Slow pull versus suction in endoscopic ultrasound-guided fine-needle aspiration of pancreatic solid masses. Dig Dis Sci. 2014 Jul;59(7):1578-85. doi: 10.1007/s10620-013-3019-9. Epub 2014 Jan 16.

  PMID: 24429514 BACKGROUND

• Chow, S.C.; Shao, J.; Wang, H. 2008. Sample Size Calculations in Clinical Research, 2nd Edition. Chapman & Hall/CRC. Boca Raton, FL. Pages 99-100.

  BACKGROUND

• 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.

  PMID: 32652307 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Shyam Varadarajulu, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shyam Varadarajulu, MD

CONTACT

407.303.2750; shyam.varadarajulu.md@adventhealth.com

Robin Barron-Nelson

CONTACT

321.946.2747; robin.barron@flhosp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The patients, pathologists assessing the biopsy specimens and the research staff responsible for follow-up will be blinded to the FNB needle type utilized. Data will also be blinded for statistical analysis.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: September 9, 2019
• Primary Completion: June 25, 2020
• Study Completion: December 1, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Locations

US (1)