PeerJ · 2026
Diagnostic yield of Franseen biopsy needles in endoscopic ultrasound-guided tissue acquisition: a systematic review and meta-analysis.
СтатьяСистематический обзорМетаанализНазвание и аннотация: Перевод пока не подготовлен
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Gao Cheng, Lai Yongfei, Qu Xiang
Аннотация
BACKGROUND: Endoscopic ultrasound (EUS)-guided tissue acquisition is pivotal for diagnosing solid gastrointestinal and pancreaticobiliary lesions. The Franseen needle, featuring a three-pronged crown tip, promises improved core procurement and diagnostic accuracy. This study systematically compares the performance of Franseen versus standard needles across key procedural and diagnostic outcomes.
METHODS: PubMed, Embase, Scopus, Web of Science, and Cochrane CENTRAL were systematically searched for studies published up to April 2025, with an updated search conducted in July 2026, evaluating Franseen and comparator needles in adult patients. Outcomes included sample adequacy, diagnostic accuracy (sensitivity, specificity, the area under the receiver operating characteristic (ROC) curve (AUROC), histological core procurement, number of needle passes per patient, and adverse events. Random-effects meta-analyses were performed, and the data were reported as odds ratios (OR) or weighted mean differences (WMD) with 95% confidence intervals (CI). Heterogeneity was assessed using Cochran's Q and I 2 statistics.
RESULTS: Thirty studies (n≈12,000 observations) were included. Franseen needles were associated with significantly higher odds of sample adequacy than standard needles (OR 2.83; 95% CI [2.13-3.75]; I 2 = 17%). Diagnostic sensitivity and specificity were 0.92 (95% CI [0.87-0.95]) and 0.98 (95% CI [0.92-1.00]), respectively, with AUROC 0.99. Optimal histological cores were procured in 89% of patients (95% CI [81-94%]), with a five-fold higher likelihood than standard needles (OR 5.02; 95% CI [3.29-7.68]). Franseen needles reduced passes per patient by 0.36 on average (WMD -0.36; 95% CI [-0.61 to -0.10]). Adverse event rates did not differ significantly between Franseen and the standard needles (OR 1.13; 95% CI [0.58-2.19]).
CONCLUSION: Franseen needles improve sample adequacy and core procurement and may enhance diagnostic accuracy while maintaining safety; however, diagnostic accuracy estimates should be interpreted cautiously given evidence of small-study effects.
METHODS: PubMed, Embase, Scopus, Web of Science, and Cochrane CENTRAL were systematically searched for studies published up to April 2025, with an updated search conducted in July 2026, evaluating Franseen and comparator needles in adult patients. Outcomes included sample adequacy, diagnostic accuracy (sensitivity, specificity, the area under the receiver operating characteristic (ROC) curve (AUROC), histological core procurement, number of needle passes per patient, and adverse events. Random-effects meta-analyses were performed, and the data were reported as odds ratios (OR) or weighted mean differences (WMD) with 95% confidence intervals (CI). Heterogeneity was assessed using Cochran's Q and I 2 statistics.
RESULTS: Thirty studies (n≈12,000 observations) were included. Franseen needles were associated with significantly higher odds of sample adequacy than standard needles (OR 2.83; 95% CI [2.13-3.75]; I 2 = 17%). Diagnostic sensitivity and specificity were 0.92 (95% CI [0.87-0.95]) and 0.98 (95% CI [0.92-1.00]), respectively, with AUROC 0.99. Optimal histological cores were procured in 89% of patients (95% CI [81-94%]), with a five-fold higher likelihood than standard needles (OR 5.02; 95% CI [3.29-7.68]). Franseen needles reduced passes per patient by 0.36 on average (WMD -0.36; 95% CI [-0.61 to -0.10]). Adverse event rates did not differ significantly between Franseen and the standard needles (OR 1.13; 95% CI [0.58-2.19]).
CONCLUSION: Franseen needles improve sample adequacy and core procurement and may enhance diagnostic accuracy while maintaining safety; however, diagnostic accuracy estimates should be interpreted cautiously given evidence of small-study effects.