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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Device: Fine needle biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Franseen needle with three symmetric cutting edges<br>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<br>* 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<br>|
| Experimental: Multi-blade needle with three-prong tip with one tip longer than the other two<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing per-pass sensitivity in two types of FNB needles | 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 | 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 | 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 | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fine needle biopsy, Endoscopic ultrasonography, Diagnosis