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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
114
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
Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,
Tehran, Iran
Comparison of EUS-FNB sensitivity using two types of FNB needles
Comparison of EUS-FNB sensitivity using two types of FNB needles
Time frame: 6 months
Comparing per-pass sensitivity in two types of FNB needles
Comparing per-pass sensitivity in two types of FNB needles
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 6 months
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