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First-in-human European experience with novel 22-G end-cutting fine-needle biopsy system: a prospective observational
Dominik Julian van de Loo1, Michael Tischendorf1, Feras Sanoubara1
1Department of Internal Medicine B, University Hospital Münster, Münster, Germany.
Background:
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.
