None listed
Conditions
Brief summary
Background: Endoscopic ultrasound fine needle aspiration (EUS FNA) allows cytologic and/or histologic diagnosis of lesions within or adjacent to the gastrointestinal tract (GIT). Several studies have shown this approach to be cost-effective and safe with complication rates less than 2%. EUS FNA also carries a high-diagnostic yield with accuracy ranging from approximately 80-95%. Currently there are multiple different needle types, including the recent development of fine needle biopsy (FNB) needles, which aim to increase the amount of tissue acquired. Studies comparing needles have mainly focused on diagnostic yield as well as complication rates. However any differences, if found, have frequently been non-significant. The quantity of diagnostic tissue obtained is becoming increasingly important in the work up of cancer patients, where personalised therapy is a goal. Treatment can now be influenced not only by histological subtype, but also based on the presence of molecular markers. In order to sub classify tumours further, adequate tissue samples are needed for both diagnosis and molecular testing. Therefore, when comparing different needle types or sizes, studies should also look at the amount of tissue obtained. The Echo Tip ProCore is a FNB device with a side-bevel designed to obtain histological cores of tissue. It is well-established, has been extensively studied and shown to be safe and highly accurate. The 19G EZ Shot 3 Plus needle is a newer needle that is also designed to obtain a histological core, with the addition of the flexibility one would expect from a smaller gauge needle. It has been approved by the Australian Register of Therapeutic Goods. Hypothesis: The 19G EZ shot 3 Plus needle will obtain equal diagnostic tissue quantity to the ProCore needle in solid pancreatic lesions. Aim: To compare the diagnostic accuracy and obtained tissue quantity of 19G EZ shot 3 Plus needle versus the ProCore needle in the investigation of solid pancreatic masses. Design: This is a non-inferior paired, prospective, single-centre study involving patients undergoing EUS evaluation of solid pancreatic masses. It will involve 66 patients who will each have a single pass using the EZ shot 3 Plus and ProCore needles (2 passes total).
Interventions
A Head to Head Comparative Pilot Trial of EUS Core Biopsy Needles: 19G ProCore vs 19G EZ Shot 3Plus.
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, in accordance with the attached form.
Consenting patients will
A Head to Head Comparative Pilot Trial of EUS Core Biopsy Needles: 19G ProCore vs 19G EZ Shot 3Plus. 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, in accordance with the attached form. Consenting patients will have the procedure under deep sedation (Propofol), administered by qualified anaesthetists, and will be performed at the Royal Adelaide Hospital. 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. 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. The total number of needle passes per participant is 1 pass using the 19G ProCore, and 1 pass using the 19G EZ Shot 3Plus (i.e. 2 passes in total). Intervention adherence will not be assessed.
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. Patients requiring endoscopic ultrasound and tissue sampling of solid lesions greater than 1cm diameter in the pancreas that are visualized and within the 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