A study comparing three types of biopsy needles in patients with pancreatic lesions undergoing endoscopic ultrasound-guided tissue sampling

This is a prospective, multi-centre, randomised controlled trial involving adults with solid pancreatic lesions greater than 1 cm who require endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) as part of standard clinical care. The study does not introduce an experimental treatment or additional invasive procedure; the study-specific intervention is randomisation to one of three commercially available 22G FNB needle types used for the clinically indicated EUS-FNB procedure. Participants will be randomised in a 1:1:1 ratio to one of the following needle groups: 1. 22G SecureFlex dual-bevel Raptor-tip needle (Olympus) 2. 22G Trident 3-prong-tip needle (Micro-Tech Endoscopy) 3. 22G Franseen-tip needle (Acquire [Boston Scientific] or ClearCore [Cook Medical]) Pre-procedure: Participants will undergo the usual clinical assessment required before EUS-FNB, including confirmation of eligibility, review of relevant medical history, medications and bleeding risk, and assessment of available imaging and clinical information. Written informed consent for the study will be obtained before randomisation and the EUS-FNB procedure. During the procedure: EUS will be performed by an appropriately trained and credentialed gastroenterologist/endoscopist, with assistance from nursing staff and an anaesthetist or appropriately trained sedation practitioner as required according to local institutional practice. The pancreatic lesion will be assessed using standard EUS techniques. Doppler assessment will be used to identify and avoid intervening vascular structures. Contrast-enhanced EUS and/or elastography may be used at the discretion of the endoscopist where clinically appropriate. Following EUS assessment, the participant will undergo EUS-FNB using the needle type allocated through randomisation. Standard EUS-FNB techniques, including fanning and avoidance of vascular structures, will be used. The use of suction will be at the discretion of the endoscopist. Each needle pass will involve advancing the needle into the pancreatic lesion and performing at least 10 ‘back-and-forth’ needle movements before withdrawing the needle and collecting the tissue specimen. The first three needle passes form part of the same EUS-FNB procedure and are performed sequentially during the same procedure. They do not represent separate visits or separate procedures and are not required to target different pancreatic lesions. Each pass will be numbered sequentially (Pass 1, Pass 2 and Pass 3), with the endoscopist targeting the appropriate area of the pancreatic lesion based on EUS findings. Macroscopic on-site evaluation (MOSE) will be performed after each pass to assess the tissue obtained, including the presence and length of visible white core tissue. The core length from each pass will be recorded. A pass will be considered adequate when the measured core is greater than/equal to 11 mm. If adequate tissue cannot be obtained after three passes, additional passes may be performed, up to a maximum of five passes, where considered clinically necessary and safe to obtain a tissue diagnosis. The procedure will be performed as part of standard clinical care and will generally take the time required for a routine EUS-FNB procedure. The actual procedural time will be recorded for the study. Tissue specimens will undergo routine histopathological assessment by the participating site's designated pathologist, including assessment of quantity, quality, blood contamination and diagnostic findings. Post-procedure: Participants will receive routine post-EUS-FNB clinical care and monitoring and will be reviewed prior to discharge. A further assessment will occur approximately 24 hours after the procedure, followed by assessments at 30 days, 3 months and 6 months. These assessments will record clinical outcomes, procedure-related complications, diagnostic outcomes and whether any repeat tissue acquisition procedure was required. The pre-discharge and 24-hour assessments will be undertaken as part of the participant's clinical review where possible; the 30-day, 3-month and 6-month assessments may be performed during routine clinical review and/or by telephone or medical record review where appropriate. Each follow-up assessment is expected to take approximately 5–15 minutes, depending on the participant's clinical circumstances. If the initial EUS-FNB does not provide a definitive diagnosis, any repeat EUS-FNB or other diagnostic procedure will be undertaken only where clinically indicated and in accordance with the treating clinician's usual practice. Repeat procedures are not performed solely because of participation in the study. Where a repeat procedure occurs, relevant clinical and diagnostic outcomes will be recorded for the study. The intervention will be delivered once for each participant during the initial clinically indicated EUS-FNB procedure. The total study follow-up period is 6 months. Intervention adherence and fidelity: Adherence to the allocated intervention will be assessed through study records and procedure documentation. The allocated needle type, needle gauge, number of passes, core length, procedural time, use of suction and other protocol-required procedural assessments will be recorded. Deviations from the allocated needle type or other protocol requirements will be documented and reviewed by the study team. Participating sites will use standardised study data collection procedures, with data entered into the site's approved electronic data capture system and subject to central data review by the coordinating study team.