International journal of surgery (London, England) · 2025
Three-dimensionally printed navigational template technology for lung biopsy: a noninferiority, randomized trial.
СтатьяРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Huang Shenghao, Chen Bin, E Haoran, Sun Weiyan, Xu Long, Guo Zihan, Shen Xinchen, Zhang Lei, Deng Jiajun, She Yunlang, Zhao Deping, Chen Chang
Аннотация
BACKGROUND: Percutaneous transthoracic needle biopsy (PTNB) guided by computed tomography (CT) greatly depends on the operators' skill for accuracy. This study aimed to evaluate whether three-dimensionally (3D)-printed navigational templates for PTNB achieve diagnostic yield comparable to conventional CT guidance.
MATERIALS AND METHODS: Conducted from 1 November 2020 to 27 July 2023, this noninferiority randomized clinical trial included 159 patients with peripheral lung masses (≥30 mm). The analyses were performed using intention-to-treat (ITT) and per-protocol approaches.
RESULTS: A total of 150 patients were enrolled, with 144 analyzed in ITT analysis (72 per group). Diagnostic yields were 91.7% in the template-guided group and 94.4% in the CT-guided group, confirming noninferiority (difference, -2.8%; 95% CI, -11.1%-5.5%). There was no significant difference in biopsy deviation between the two groups (9.6 [4.6] mm vs 10.1 [3.4] mm; P = 0.505). The template-guided group exhibited shorter procedural duration (10.2 vs. 12.8 minutes; P < 0.001) and reduced radiation exposure (dose-length product: 233.4 vs. 320.1 mGy × cm; P < 0.001). Complication rates, including pneumothorax and hemorrhage, did not significantly differ between groups.
CONCLUSIONS: 3D-printed navigational templates for lung biopsy demonstrated noninferior diagnostic efficacy compared to CT guidance, significantly reducing procedure duration and radiation exposure. This technology enhances biopsy efficiency, benefiting operators with limited experience.
MATERIALS AND METHODS: Conducted from 1 November 2020 to 27 July 2023, this noninferiority randomized clinical trial included 159 patients with peripheral lung masses (≥30 mm). The analyses were performed using intention-to-treat (ITT) and per-protocol approaches.
RESULTS: A total of 150 patients were enrolled, with 144 analyzed in ITT analysis (72 per group). Diagnostic yields were 91.7% in the template-guided group and 94.4% in the CT-guided group, confirming noninferiority (difference, -2.8%; 95% CI, -11.1%-5.5%). There was no significant difference in biopsy deviation between the two groups (9.6 [4.6] mm vs 10.1 [3.4] mm; P = 0.505). The template-guided group exhibited shorter procedural duration (10.2 vs. 12.8 minutes; P < 0.001) and reduced radiation exposure (dose-length product: 233.4 vs. 320.1 mGy × cm; P < 0.001). Complication rates, including pneumothorax and hemorrhage, did not significantly differ between groups.
CONCLUSIONS: 3D-printed navigational templates for lung biopsy demonstrated noninferior diagnostic efficacy compared to CT guidance, significantly reducing procedure duration and radiation exposure. This technology enhances biopsy efficiency, benefiting operators with limited experience.