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

May 13, 2023 updated by: Mehdi Mohamadnejad, University of Tehran

Comparison of Two Types of Biopsy Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) in Solid Pancreatobiliary Mass Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1411713135
        • Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing per-pass sensitivity in two types of FNB needles
Time Frame: 6 months
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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tehran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

July 4, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 13, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.TUMS.DDRI.REC.1400.008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe