None listed
Conditions
Brief summary
The primary purpose of this trial is to compare the efficacy of three types of core biopsy needles used for Endoscopic Ultrasound-Guided (EUS) fine needle biopsy. Who is it for? You may be eligible to enroll in this trial if you are aged 18 years old or older and require endoscopic ultrasound and tissue sampling of solid lesions in the pancreas, which are suitable for EUS fine needle aspiration. Study details All participants enrolled in this trial will have tissue sampling performed using three different biopsy devices: the ProCore, the Shark Core and Acquire devices. The order in which each device is used will be randomly allocated (by chance). Only a single pass (i.e. a single attempt at sampling) will be completed for each device. The tissue obtained using each device will be stored and analysed by cytologists and pathologists to determine the diagnosis and adequacy of samples obtained using each device. It is hoped that the findings from this trial will provide information on which of the three devices provides the most sufficient samples for analysis and diagnosis of pancreatic lesions.
Interventions
A Head to Head Comparative Pilot Trial of EUS Core Biopsy Needles: ProCore vs Shark Core and Acquire
All aspects of the study will be discussed with each subject during a phone interview or screening visit. An information sheet will be provided, and each subject will be given the opportunity to seek medical advice or to discuss the study with friends or family prior to involvement. Each volunteer will give written, informed consent, and the subjects will be free to withdraw from the study at any
A Head to Head Comparative Pilot Trial of EUS Core Biopsy Needles: ProCore vs Shark Core and Acquire All aspects of the study will be discussed with each subject during a phone interview or screening visit. An information sheet will be provided, and each subject will be given the opportunity to seek medical advice or to discuss the study with friends or family prior to involvement. Each volunteer will give written, informed consent, and the subjects will be free to withdraw from the study at any time. Consenting patients will have the procedure under deep sedation (Propofol), administered by qualified anaesthetists. After the lesion is evaluated by EUS, the endoscopist will perform the tissue sampling using all needles consecutively. The order of the needle passes will be pre-determined in a randomized fashion using a computerized program. Each patient will have a single pass using the Shark Core, Acquire and ProCore needles (3 passes total). All aspirated material will be placed in formalin (separate pots for each needle) to undergo direct histological processing (filtered through a microcassette, immersed in Ponceau S tinted neutral buffered formalin and processed as standard histological blocks). All patients will be observed in recovery for a minimum 2 hours following the procedure for any complications. Trained cytologists and pathologists (who are blinded to the needle type used) will assess the final processed samples from each group in order to determine the diagnosis. In order to objectively quantify the tissue acquired from each needle, the slides will be scanned using the NanoZoomer (Hamamatsu Phototonic, Japan) and high definition images stored electronically. Using the associated software (NDP.view2, Phototonic, Japan), the characteristics of the diagnostic tissue will be examined for the presence of tissue-core (defined as tissue showing preserved architectural integrity, in which the length of the core is at least twice of the nominal inner diameter of the used needle). The tissue-cores will then be objectively quantified by measuring the total core surface area, length and diameter. The quality of the specimen obtained was also assessed by measuring the surface area of diagnostic tissue in each core.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years old or older 2. Patients requiring endoscopic ultrasound and tissue sampling of solid lesions greater than 1cm in diameter in the pancreas, which are visualised and within reach of EUS FNA.
Exclusion criteria
1. Pregnant females 2. Uncorrectable coagulation disorder (INR greater than 1.5) 3. Those with medical co-morbidities that preclude them from sedation (as determined by anaesthetic team) 4. Actively on medications that increase the risk of bleeding from EUS guided tissue acquisition (NOAC, warfarin, combined aspirin and clopidogrel) 5. Those unable to give informed consent
Outcome results
None listed