BACKGROUND. Endoscopic ultrasound-guided tissue acquisition (EUS-TA) is essential for diagnosing solid pancreatic lesions (SPLs), especially pancreatic ductal adenocarcinoma (PDAC). Third-generation fine needle biopsy (FNB) needles have advanced diagnostic accuracy by obtaining larger, well-preserved histological samples. However, the lack of on-site pathology in many centers and the rising demand for molecular profiling in personalized cancer therapy, especially for PDAC, highlight the need for further innovation. This study evaluates the performance of a novel asymmetric three-pronged Franseen-type needle for diagnostic accuracy and comprehensive molecular profiling (CMP). METHODS. This retrospective study included 89 patients with SPLs requiring EUS-guided tissue sampling between October 2023 and September 2024. Procedures utilized a 22-gauge asymmetric three-pronged tip needle with fanning and stylet slow-pull techniques. Diagnostic accuracy, tissue adequacy, and molecular profiling success were assessed. Histological and molecular evaluations were conducted using formalin-fixed, paraffin-embedded samples processed for next-generation sequencing (NGS). Statistical analysis compared outcomes between groups based on the number of needle passes. RESULTS.The overall diagnostic accuracy was 92%, with histological confirmation in 88.6% of cases in the two-pass group and 94.4% in the three-pass group. Tissue adequacy was achieved in 100% of cases as per operator assessment. Subgroup analysis focusing on PDAC lesions, revealed that the specimen yield was significantly higher in the 3-passes group demonstrating superior success rates for both IHC and NGS analysis (94.9%, p=0.004; and 94.1%, p=0.009, respectively). Visual on-site evaluation (VOSE) optimized procedural efficiency, reducing reliance on cytopathology. CONCLUSIONS. The novel asymmetric three-pronged needle demonstrated excellent diagnostic accuracy and tissue adequacy, comparable to established third-generation designs. VOSE streamlined procedures while maintaining high diagnostic performance. Although two passes sufficed for diagnostic accuracy, three passes provided superior yield for molecular profiling. Further prospective, multicenter studies are necessary to establish optimal protocols for tissue acquisition in the era of personalized medicine.

Performance of a Novel Asymmetric Three-Prong Tip Needle in EUS-Guided Tissue Sampling of Pancreatic Lesions: Implications for Diagnosis and Molecular Profiling

BUSATTO, ALBERTO
2022/2023

Abstract

BACKGROUND. Endoscopic ultrasound-guided tissue acquisition (EUS-TA) is essential for diagnosing solid pancreatic lesions (SPLs), especially pancreatic ductal adenocarcinoma (PDAC). Third-generation fine needle biopsy (FNB) needles have advanced diagnostic accuracy by obtaining larger, well-preserved histological samples. However, the lack of on-site pathology in many centers and the rising demand for molecular profiling in personalized cancer therapy, especially for PDAC, highlight the need for further innovation. This study evaluates the performance of a novel asymmetric three-pronged Franseen-type needle for diagnostic accuracy and comprehensive molecular profiling (CMP). METHODS. This retrospective study included 89 patients with SPLs requiring EUS-guided tissue sampling between October 2023 and September 2024. Procedures utilized a 22-gauge asymmetric three-pronged tip needle with fanning and stylet slow-pull techniques. Diagnostic accuracy, tissue adequacy, and molecular profiling success were assessed. Histological and molecular evaluations were conducted using formalin-fixed, paraffin-embedded samples processed for next-generation sequencing (NGS). Statistical analysis compared outcomes between groups based on the number of needle passes. RESULTS.The overall diagnostic accuracy was 92%, with histological confirmation in 88.6% of cases in the two-pass group and 94.4% in the three-pass group. Tissue adequacy was achieved in 100% of cases as per operator assessment. Subgroup analysis focusing on PDAC lesions, revealed that the specimen yield was significantly higher in the 3-passes group demonstrating superior success rates for both IHC and NGS analysis (94.9%, p=0.004; and 94.1%, p=0.009, respectively). Visual on-site evaluation (VOSE) optimized procedural efficiency, reducing reliance on cytopathology. CONCLUSIONS. The novel asymmetric three-pronged needle demonstrated excellent diagnostic accuracy and tissue adequacy, comparable to established third-generation designs. VOSE streamlined procedures while maintaining high diagnostic performance. Although two passes sufficed for diagnostic accuracy, three passes provided superior yield for molecular profiling. Further prospective, multicenter studies are necessary to establish optimal protocols for tissue acquisition in the era of personalized medicine.
2022
Performance of a Novel Asymmetric Three-Prong Tip Needle in EUS-Guided Tissue Sampling of Pancreatic Lesions: Implications for Diagnosis and Molecular Profiling
EUS tissue sampling
FNB needles
Pancreatic lesions
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.12608/81463