Comparison of Two Types of Biopsy Needles for EUS-FNB in Solid Pancreatobiliary Mass Lesions
- Conditions
- Pancreatic Neoplasms
- Interventions
- Device: Fine needle biopsy
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- Inpatients and outpatients 18 years of age or older with solid mass lesions in the pancreas or extrahepatic biliary system
- 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
- Arm && Interventions
Group Intervention Description Franseen needle with three symmetric cutting edges Fine needle biopsy These patients will undergo endoscopic ultrasound-guided fine needle biopsy using the Franseen needle (Acquire FNB needle; Boston Scientific): eight back and forth movements within the lesion will be performed with simultaneous minimal negative pressure provided by withdrawing the needle stylet slowly. Four passes of FNB will be made from each mass lesion and the specimens from each pass will be placed in different containers for cell block preparation and histologic evaluation. Multi-blade needle with three-prong tip with one tip longer than the other two Fine needle biopsy These patients will undergo endoscopic ultrasound-guided fine needle biopsy using a multi-blade three-prong tip needle (Trident; Microtech): eight back and forth movements within the lesion will be performed with simultaneous minimal negative pressure provided by withdrawing the needle stylet slowly. Four passes of FNB will be made from each mass lesion and the specimens from each pass will be placed in different containers for cell block preparation and histologic evaluation.
- 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