Clinical trialNACompleted
Comparison of Two Types of Biopsy Needles for EUS-FNB in Solid Pancreatobiliary Mass Lesions
Comparison of Two Types of Biopsy Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) in Solid Pancreatobiliary Mass Lesions
- Outcome
- Finished, no results posted
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- 1 August 2021
- Expected end
- 30 June 2022
- Enrollment
- 114 participants
- Sites
- 1
- Primary outcomes
- Comparison of EUS-FNB sensitivity using two types of FNB needles
- Sponsor
- Other
- Results posted
- No
- Last update
- 16 May 2023
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Papers 4
- Builds on itComparing per-pass performance of 2 types of needles for EUS-guided fine-needle biopsy sampling of pancreatobiliary mas… DOI 10.1016/j.gie.2023.04.2070↗
- BackgroundEUS-guided fine needle biopsy of pancreatic masses can yield true histology. DOI 10.1136/gutjnl-2017-315154↗
- BackgroundIncreasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic … DOI 10.1016/j.cgh.2016.12.018↗
- BackgroundDiagnostic yield of EUS-guided FNA for malignant biliary stricture: a systematic review and meta-analysis. DOI 10.1016/j.gie.2015.09.024↗