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

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ClinicalTrials.gov Identifier: NCT04975620
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Mehdi Mohamadnejad, University of Tehran

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.


Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Device: Fine needle biopsy Not Applicable

Detailed Description:
Patients with solid mass lesions in the pancreas or extrahepatic biliary system will be randomly assigned to one of two types of FNB needle. Four passes of FNB will be acquired from the mass lesion in each patient. The primary aim is to compare sensitivity of two types of FNB needle to diagnose malignancy. Also, each pass of FNB needle will be assessed separately by two expert pathologists to determine per-pass sensitivity of two types of FNB needles.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The pathologists who assess the FNB specimens are blinded on the needle type
Primary Purpose: Diagnostic
Official Title: Comparison of Two Types of Biopsy Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) in Solid Pancreatobiliary Mass Lesions
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Franseen needle with three symmetric cutting edges
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
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

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




Primary Outcome Measures :
  1. Comparison of EUS-FNB sensitivity using two types of FNB needles [ Time Frame: 6 months ]
    Comparison of EUS-FNB sensitivity using two types of FNB needles


Secondary Outcome Measures :
  1. Comparing per-pass sensitivity in two types of FNB needles [ Time Frame: 6 months ]
    Comparing per-pass sensitivity in two types of FNB needles

  2. Comparing the adequacy of specimen for each pass in two types of FNB needles [ Time Frame: 6 months ]
    Comparing the adequacy of specimen for each pass in two types of FNB needles

  3. Comparing the rate of core tissue acquisition for each pass in two types of FNB needles [ Time Frame: 6 months ]
    Comparing the rate of core tissue acquisition for each pass in two types of FNB needles

  4. Comparing specimen cellularity for each pass in two types of FNB needles [ Time Frame: 6 months ]
    Comparing specimen cellularity for each pass in two types of FNB needles

  5. Comparing the score of blood content n for each pass in two types of FNB needles. [ Time Frame: 6 months ]
    Comparing the score of blood content n for each pass in two types of FNB needles. (The blood content is scored from 1 to 3 in which 1 represents minimal presence of blood in the specimen).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04975620


Contacts
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Contact: Mehdi Mohamadnejad, MD +982182415118 mehdi.nejad@gmail.com

Locations
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Iran, Islamic Republic of
Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave., Recruiting
Tehran, Iran, Islamic Republic of, 1411713135
Contact: Mehdi Mohamadnejad, MD    +982182415118      
Sponsors and Collaborators
University of Tehran
Publications of Results:
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Responsible Party: Mehdi Mohamadnejad, Associate professor of medicine, University of Tehran
ClinicalTrials.gov Identifier: NCT04975620    
Other Study ID Numbers: IR.TUMS.DDRI.REC.1400.008
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mehdi Mohamadnejad, University of Tehran:
Fine needle biopsy
Endoscopic ultrasonography
Diagnosis
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases