Clinical Endoscopy

The Korean Society of Gastrointestinal Endoscopy (대한소화기내시경학회)
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First-in-human European experience with novel 22-G end-cutting fine-needle biopsy system: a prospective observational pilot study

  • Received : 2025.10.08
  • Accepted : 2025.11.06
  • Published : 2026.05.30
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Abstract

Background/Aims: Endoscopic ultrasound (EUS)-guided biopsy remains a cornerstone for diagnosing and staging gastrointestinal diseases. Various systems are available, with needle designs for fine-needle aspiration and fine-needle biopsy (FNB) and gauges from 25-G to 19-G. We aimed to report the first European human experience with a novel 22-G end-cutting FNB system (EchoTip ClearCore; Cook Medical). Methods: This prospective observational study was conducted at our tertiary endoscopy center between November and December 2024. All patients undergoing EUS-guided puncture with the 22-G EchoTip ClearCore needle were included. User and patient experience were assessed using questionnaires. Clinical data were obtained from electronic hospital records. Results: Ten patients underwent 15 EUS-guided biopsies. The median patient age was 57 (range, 18-77) years, and 60% were male. Indications included liver biopsy for elevated liver enzymes or post-transplantation assessment (67%), evaluation of pancreatic lesions (20%), and sampling of pathological lymph nodes (13%). The technical success rate was 100%. Specimen quality was sufficient for diagnosis in 93% of cases. Operators rated the needle highly for EUS visibility (8.8/10), maneuverability and stability (7.9/10), and ease of tissue penetration (8.3/10). Overall patient satisfaction was high (5/5); no complications occurred. Conclusions: The 22-G EchoTip ClearCore needle is safe and effective, demonstrating excellent technical and clinical outcomes.

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References

  1. Kovacevic B, Vilmann P. EUS tissue acquisition: from A to B. Endosc Ultrasound 2020;9:225–231. https://doi.org/10.4103/eus.eus_21_20
  2. Facciorusso A, Del Prete V, Buccino VR, et al. Diagnostic yield of Franseen and Fork-Tip biopsy needles for endoscopic ultrasound-guided tissue acquisition: a meta-analysis. Endosc Int Open 2019;7:E1221–E1230. https://doi.org/10.1055/a-0982-2997
  3. Gkolfakis P, Crinò SF, Tziatzios G, et al. Comparative diagnostic performance of end-cutting fine-needle biopsy needles for EUS tissue sampling of solid pancreatic masses: a network meta-analysis. Gastrointest Endosc 2022;95:1067–1077. https://doi.org/10.1016/j.gie.2022.01.019
  4. Neilson LJ, Sharp L, Patterson JM, et al. The Newcastle ENDOPREM™: a validated patient reported experience measure for gastrointestinal endoscopy. BMJ Open Gastroenterol 2021;8:e000653. https://doi.org/10.1136/bmjgast-2021-000653
  5. Bang JY, Hawes R, Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy 2016;48:339–349.
  6. Facciorusso A, Wani S, Triantafyllou K, et al. Comparative accuracy of needle sizes and designs for EUS tissue sampling of solid pancreatic masses: a network meta-analysis. Gastrointest Endosc 2019;90:893–903. https://doi.org/10.1016/j.gie.2019.07.009
  7. Pouw RE, Barret M, Biermann K, et al. Endoscopic tissue sampling-part 1: upper gastrointestinal and hepatopancreatobiliary tracts. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2021;53:1174–1188. https://doi.org/10.1055/a-1611-5091
  8. Laleman W, Mertens J, Vanderschueren E, et al. Advances in endohepatology. Am J Gastroenterol 2023;118:1756–1767. https://doi.org/10.14309/ajg.0000000000002482
  9. Neuberger J, Patel J, Caldwell H, et al. Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology. Gut 2020;69:1382-1403. https://doi.org/10.1136/gutjnl-2020-321299