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

Not Applicable

Completed

• Conditions: Pancreatic Neoplasms

• Registration Number: NCT04975620
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-23
• Study Start: 2021-08-01
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-13
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of EUS-FNB sensitivity using two types of FNB needles	6 months	Comparison of EUS-FNB sensitivity using two types of FNB needles

Secondary Outcome Measures

Name	Time	Method
Comparing the adequacy of specimen for each pass in two types of FNB needles	6 months	Comparing the adequacy of specimen for each pass in two types of FNB needles
Comparing per-pass sensitivity in two types of FNB needles	6 months	Comparing per-pass sensitivity 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 the rate of core tissue acquisition for each pass in two types of FNB needles
Comparing specimen cellularity for each pass in two types of FNB needles	6 months	Comparing specimen cellularity 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.	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).

Trial Locations

Locations (1)

Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,; 🇮🇷 Tehran, Iran, Islamic Republic of