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Introduction <p>Accurate tissue acquisition (TA) of solid pancreatic lesions is essential for guiding treatment with endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) being the preferred method. Among FNB designs, the three-pronged Franseen-tip needle demonstrates strong diagnostic performance, though direct head-to-head comparisons with other FNB designs remain limited.</p> Methodology <p>This meta-analysis was conducted in accordance with PRISMA guidelines (PROSPERO: CRD420251123856). Eligible studies enrolled patients with solid pancreatic lesions who underwent EUS-guided FNB, directly compared the Franseen-tip with other FNB needles. Six databases were systematically searched through July 2025, and study selection, data extraction, and risk of bias assessment (QUADAS-2 tool) were performed independently by two reviewers. Pooled estimates were generated using random-effects and bivariate hierarchical models.</p> Results <p>Sixteen studies (2,010 Franseen vs. 2,811 comparator) were included. Bivariate analysis showed that sensitivity and specificity of the Franseen needle were comparable to newer-generation comparator needles (sensitivity 91.3% vs. 94.0%; specificity 99.99% vs. 99.15%), whereas older-generation needles demonstrated lower sensitivity (80.8%) and inferior discriminatory performance (Negative Likelihood Ratio [LR⁻] 0.19 vs. 0.09). Diagnostic accuracy was higher with the Franseen needle (RR 1.07, 95% CI 1.01–1.14; <i>I</i><sup>2</sup> = 69%). Sample adequacy was similar overall (RR 1.04, 95% CI 0.95–1.14) but superior to older-generation needles (RR 1.19, 95% CI 1.02–1.41) and in lesions &gt; 30&#xa0;mm (RR 1.14, 95% CI 1.02–1.28, <i>I</i><sup>2</sup> = 81.2%). The Franseen needle achieved nominally strong diagnostic performance (DOR 116.6), although small-study effects were observed. Primary procedural outcomes were comparable between Franseen and comparator needles, including technical success (RR 1.00, 95% CI 0.98–1.02) and histological core procurement (RR 1.04, 95% CI 0.92–1.17). The Franseen needle had fewer low-cellularity samples (RR 0.56, 95% CI 0.45–0.69) and lower specimen bloodiness (RR 0.48, 95% CI 0.25–0.90) but a slightly higher overall adverse event rate (RR 1.29, 95% CI 1.06–1.57).</p> Conclusion <p>The Franseen needle provides superior diagnostic accuracy and sample adequacy compared to older-generation FNB needles with comparable performance to newer-generation designs. It reduces low-cellularity samples and specimen bloodiness, although adverse events are slightly increased, with other primary procedural outcomes remaining comparable.</p> Trial Registration <p>PROSPERO (Registration No. CRD420251123856).</p>

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Endoscopic Ultrasound-Guided Franseen Fine-Needle Biopsy for Solid Pancreatic Lesions: A Systematic Review and Meta-Analysis

  • 期刊论文

  • 发表日期：

    2026年5月19日

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  • Adnan Bhat,
  • Muhammad Arham,
  • Zahra Ali,
  • Saniya Ishtiaq,
  • Muhammad Abdul Rehman,
  • Adil Ahmed,
  • Anchit Chauhan,
  • Haseeb Khan Tareen,
  • Kinza Bakht,
  • Faseeh Haider,
  • Allah Dad,
  • Lindsey Creech,
  • Aleksey Novikov,
  • Peter V. Draganov

摘要

Introduction

Accurate tissue acquisition (TA) of solid pancreatic lesions is essential for guiding treatment with endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) being the preferred method. Among FNB designs, the three-pronged Franseen-tip needle demonstrates strong diagnostic performance, though direct head-to-head comparisons with other FNB designs remain limited.

Methodology

This meta-analysis was conducted in accordance with PRISMA guidelines (PROSPERO: CRD420251123856). Eligible studies enrolled patients with solid pancreatic lesions who underwent EUS-guided FNB, directly compared the Franseen-tip with other FNB needles. Six databases were systematically searched through July 2025, and study selection, data extraction, and risk of bias assessment (QUADAS-2 tool) were performed independently by two reviewers. Pooled estimates were generated using random-effects and bivariate hierarchical models.

Results

Sixteen studies (2,010 Franseen vs. 2,811 comparator) were included. Bivariate analysis showed that sensitivity and specificity of the Franseen needle were comparable to newer-generation comparator needles (sensitivity 91.3% vs. 94.0%; specificity 99.99% vs. 99.15%), whereas older-generation needles demonstrated lower sensitivity (80.8%) and inferior discriminatory performance (Negative Likelihood Ratio [LR⁻] 0.19 vs. 0.09). Diagnostic accuracy was higher with the Franseen needle (RR 1.07, 95% CI 1.01–1.14; I2 = 69%). Sample adequacy was similar overall (RR 1.04, 95% CI 0.95–1.14) but superior to older-generation needles (RR 1.19, 95% CI 1.02–1.41) and in lesions > 30 mm (RR 1.14, 95% CI 1.02–1.28, I2 = 81.2%). The Franseen needle achieved nominally strong diagnostic performance (DOR 116.6), although small-study effects were observed. Primary procedural outcomes were comparable between Franseen and comparator needles, including technical success (RR 1.00, 95% CI 0.98–1.02) and histological core procurement (RR 1.04, 95% CI 0.92–1.17). The Franseen needle had fewer low-cellularity samples (RR 0.56, 95% CI 0.45–0.69) and lower specimen bloodiness (RR 0.48, 95% CI 0.25–0.90) but a slightly higher overall adverse event rate (RR 1.29, 95% CI 1.06–1.57).

Conclusion

The Franseen needle provides superior diagnostic accuracy and sample adequacy compared to older-generation FNB needles with comparable performance to newer-generation designs. It reduces low-cellularity samples and specimen bloodiness, although adverse events are slightly increased, with other primary procedural outcomes remaining comparable.

Trial Registration

PROSPERO (Registration No. CRD420251123856).