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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04975620
• Other study ID #: IR.TUMS.DDRI.REC.1400.008
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2023
• Source: University of Tehran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: June 30, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (3)

Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. EUS-guided fine needle biopsy of pancreatic masses can yield true histology. Gut. 2018 Dec;67(12):2081-2084. doi: 10.1136/gutjnl-2017-315154. Epub 2017 Oct 7. No abstract available — View Citation

Mohamadnejad M, Mullady D, Early DS, Collins B, Marshall C, Sams S, Yen R, Rizeq M, Romanas M, Nawaz S, Ulusarac O, Hollander T, Wilson RH, Simon VC, Kushnir V, Amateau SK, Brauer BC, Gaddam S, Azar RR, Komanduri S, Shah R, Das A, Edmundowicz S, Muthusamy — View Citation

Sadeghi A, Mohamadnejad M, Islami F, Keshtkar A, Biglari M, Malekzadeh R, Eloubeidi MA. Diagnostic yield of EUS-guided FNA for malignant biliary stricture: a systematic review and meta-analysis. Gastrointest Endosc. 2016 Feb;83(2):290-8.e1. doi: 10.1016/j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparing per-pass sensitivity in two types of FNB needles	Comparing per-pass sensitivity in two types of FNB needles	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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