Clinical trial NCT04975620: Comparison of Two Types of Biopsy Needles for EUS-FNB in Solid Pancreatobiliary Mass Lesions
Official title: Comparison of Two Types of Biopsy Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) in Solid Pancreatobiliary Mass Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Keywords: Fine needle biopsy
Endoscopic ultrasonography
Diagnosis
Lead sponsor: University of Tehran
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of EUS-FNB sensitivity using two types of FNB needles
timeFrame: 6 months
Secondary outcomes:
measure: Comparing per-pass sensitivity in two types of FNB needles
timeFrame: 6 months
measure: Comparing the adequacy of specimen for each pass in two types of FNB needles
timeFrame: 6 months
measure: Comparing the rate of core tissue acquisition for each pass in two types of FNB needles
timeFrame: 6 months
measure: Comparing specimen cellularity for each pass in two types of FNB needles
timeFrame: 6 months
measure: Comparing the score of blood content n for each pass in two types of FNB needles.
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,
Study officials:
References:
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 VR, Rastogi A, Wani S. Increasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic Ultrasound-Guided Fine-Needle Aspiration. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1071-1078.e2. doi: 10.1016/j.cgh.2016.12.018. Epub 2016 Dec 23.
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.gie.2015.09.024. Epub 2015 Sep 28.
citation: 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.