Comparison of Two Types of Biopsy Needles for EUS-FNB in Solid Pancreatobiliary Mass Lesions

NCT04975620 | Completed FDA Device

• 1 other identifier: IR.TUMS.DDRI.REC.1400.008
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

EUS-guided tissue acquisition is an established modality to diagnose malignancies of the pancreas and extrahepatic bile ducts. In the recent years fine needle biopsy (FNB) needles have largely replaced fine needle aspiration (FNA) for EUS-guided tissue acquisition. The Acquire FNB needle is a Franseen needle which has three symmetric cutting edges to obtain core tissue specimens. The Trident FNB needle has been recently introduced to the market for EUS-guided tissue acquisition. It has a multi-blade three-prong tip which one of the tips is longer than the other two. The aim of this study is to prospectively compare these two types of needle in term of diagnostic accuracy, and safety profile.

Conditions

Pancreatic Neoplasms

Keywords

Fine needle biopsy; Endoscopic ultrasonography; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Comparison of EUS-FNB sensitivity using two types of FNB needles

  Comparison of EUS-FNB sensitivity using two types of FNB needles

  6 months

Secondary Outcomes (5)

• Comparing per-pass sensitivity in two types of FNB needles

  6 months

• Comparing the adequacy of specimen for each pass in two types of FNB needles

  6 months

• Comparing the rate of core tissue acquisition for each pass in two types of FNB needles

  6 months

• Comparing specimen cellularity for each pass in two types of FNB needles

  6 months

• Comparing the score of blood content n for each pass in two types of FNB needles.

  6 months

Study Arms (2)

Franseen needle with three symmetric cutting edges

EXPERIMENTAL

These patients will undergo endoscopic ultrasound-guided fine needle biopsy using the Franseen needle (Acquire FNB needle; Boston Scientific): eight back and forth movements within the lesion will be performed with simultaneous minimal negative pressure provided by withdrawing the needle stylet slowly. Four passes of FNB will be made from each mass lesion and the specimens from each pass will be placed in different containers for cell block preparation and histologic evaluation.

Device: Fine needle biopsy

Multi-blade needle with three-prong tip with one tip longer than the other two

EXPERIMENTAL

These patients will undergo endoscopic ultrasound-guided fine needle biopsy using a multi-blade three-prong tip needle (Trident; Microtech): eight back and forth movements within the lesion will be performed with simultaneous minimal negative pressure provided by withdrawing the needle stylet slowly. Four passes of FNB will be made from each mass lesion and the specimens from each pass will be placed in different containers for cell block preparation and histologic evaluation.

Device: Fine needle biopsy

Interventions

Fine needle biopsy DEVICE

Taking biopsy from solid pancreatobiliary mass lesions with 8 back and forth movement of the needle within the lesion with slow withdrawal of the stylet

Franseen needle with three symmetric cutting edges; Multi-blade needle with three-prong tip with one tip longer than the other two

Eligibility Criteria

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

You may qualify if:

• Inpatients and outpatients 18 years of age or older with solid mass lesions in the pancreas or extrahepatic biliary system

You may not qualify if:

• Uncorrectable coagulopathy (INR \> 1.5)
• Uncorrectable thrombocytopenia (platelet \< 50,000)
• Decline to participate in the study and sign the informed consent form
• Cystic lesions.

Sponsors & Collaborators

• University of Tehran: lead

Study Sites (1)

Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,

Tehran, 1411713135, Iran

Location

Related Publications (4)

• Mohamadnejad M, Mullady D, Early DS, Collins B, Marshall C, Sams S, Yen R, Rizeq M, Romanas M, Nawaz S, Ulusarac O, Hollander T, Wilson RH, Simon VC, Kushnir V, Amateau SK, Brauer BC, Gaddam S, Azar RR, Komanduri S, Shah R, Das A, Edmundowicz S, Muthusamy VR, Rastogi A, Wani S. Increasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic Ultrasound-Guided Fine-Needle Aspiration. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1071-1078.e2. doi: 10.1016/j.cgh.2016.12.018. Epub 2016 Dec 23.

  PMID: 28025154 RESULT

• Sadeghi A, Mohamadnejad M, Islami F, Keshtkar A, Biglari M, Malekzadeh R, Eloubeidi MA. Diagnostic yield of EUS-guided FNA for malignant biliary stricture: a systematic review and meta-analysis. Gastrointest Endosc. 2016 Feb;83(2):290-8.e1. doi: 10.1016/j.gie.2015.09.024. Epub 2015 Sep 28.

  PMID: 26422979 RESULT

• 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 RESULT

• Mohamadnejad M, Mirzaie V, Sotoudeh M, Nikmanesh A, Hosseini R, Muthusamy R. Comparing per-pass performance of 2 types of needles for EUS-guided fine-needle biopsy sampling of pancreatobiliary masses in a randomized trial. Gastrointest Endosc. 2023 Sep;98(3):371-380. doi: 10.1016/j.gie.2023.04.2070. Epub 2023 Apr 23.

  PMID: 37098399 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Disease

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The pathologists who assess the FNB specimens are blinded on the needle type
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of medicine

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 23, 2021
• Study Start: August 1, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 30, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

IR (1)