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

University of Tehran

Status: Completed

Conditions: Pancreatic Neoplasms

Treatments: Device: Fine needle biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04975620

IR.TUMS.DDRI.REC.1400.008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

Franseen needle with three symmetric cutting edges

Experimental group

Description:

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.

Treatment:

Device: Fine needle biopsy

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

Experimental group

Description:

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.

Treatment:

Device: Fine needle biopsy