Introduction Adequate tissue sampling for pathologic evaluation is one of the main challenges of endoscopic ultrasound (EUS) procedures. Novel needles for EUS fine needle biopsies (FNB) may improve tissue sampling. The distinctive tip geometry of the SharkCore needle (Medtronic, Dublin, Ireland) with six distal cutting edges has been designed to obtain consistent specimens without altering the tissue architecture. Our aim was to evaluate the diagnostic yield and safety of the Sharkcore needle for EUS-FNB.
Method We reviewed prospectively collected data from patients undergoing EUS-FNB using a 22-gauge(G) SharkCore needle from two high volume tertiary centres in London. Demographics and clinical data, lesion characteristics, EUS technical aspects and histology results were collected for each patient.
Based on histology reports, samples were classified as: diagnostic, suspicious or non-diagnostic. The proportion of diagnostic cases (regardless of being benign or malignant) was used to calculate the diagnostic yield. For all benign and suspicious/non-diagnostic cases, results of other diagnostic examinations and/or at least 4 months’ clinical follow-up were used to confirm the nature of the lesion.
Results In total 89 lesions were sampled using the SharkCore needles in 87 patients (Mean age 65 years; M/F: 47/40): 62 (69.7%) were pancreatic lesions, 10 (11.2%) lymph nodes, 8 (9%) submucosal lesions, and 9 (10.1%) other lesions. The average size of the lesions was 30.1 mm (range 8–110). A median of 2 passes were performed per lesion, ranging from 1 to 7. Six FNBs were performed from the oesophagus, 42 from the stomach, 23 from the bulb and 18 from the second portion of the duodenum.
The overall histological diagnostic yield was 87.6% (78/89); 51 cases (65.4%) had a definitive diagnosis of malignancy, while 27 (34.6%) were benign. Considering lesion location, the histological yield was 87.1% (54/62) for pancreas, 100% (10/10) for lymph nodes, 75% (6/8) for submucosal lesions and 88.9% (8/9) for all other lesions. When only solid mass pancreatic lesions were considered, the diagnostic yield increased to 91.4% (32/35). No significant difference was found between the histological yields of malignancy (86.4%) compared to benign disease (90%).
No major complications were recorded; one patient experienced acute post-procedural abdominal pain and in one patient a minor bleeding was observed after the FNB, both resolved conservatively and patients were discharged within 6 hours from the procedure.
Conclusion The 22G SharkCore needle for FNB, with a minimum number of required passes and excellent safety profile, achieved high histological diagnostic yield, in particular (>90%) for solid pancreatic mass lesions and lymph nodes.
Disclosure of Interest None Declared
- Fine Needle Biopsy
- Shark Core Needle