Ludovico Alfarone, Roberto De Sire, Boris Rosenbaum, Ali Aidibi, Christophe Cellier, Cesare Hassan, Alessandro Repici, Gabriel Rahmi, Roberta Maselli
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This study evaluated a novel through-the-scope traction device (TRACMOTION, Fujifilm, Japan), which offers consistent and adjustable traction, in a pilot multicenter randomized ex vivo trial.</p><p><strong>Patients and methods: </strong>The study included six endoscopists with limited ESD experience performing ESD on ex vivo porcine stomach models. Participants were randomized into two groups: those using TRACMOTION-assisted ESD (TM-ESD) and those performing conventional ESD (C-ESD). Each trainee completed six procedures, split equally between both groups. The primary outcome was resection speed, whereas secondary outcomes included en bloc, R0 resection rates, perforation rates, and rates of speedy procedures (>20 mm²/min).</p><p><strong>Results: </strong>The TM-ESD group achieved a higher median resection speed of 20.75 mm²/min (95% confidence interval [CI] 14.56-29.25) in comparison to 15.10 mm²/min (95% CI 12.8-16.6) in the C-ESD group ( <i>P</i> =0.02). Perforation rates were significantly lower in the TM-ESD group (11.1% (95% CI 0.01-0.34) vs. 61.1% (95% CI 0.35-0.82; <i>P</i> =0.0002). No significant differences were observed in en bloc or R0 resection rates between the groups.</p><p><strong>Conclusions: </strong>TRACMOTION significantly improves the efficiency of ESD, reducing procedure time and complication rates. This traction device could potentially facilitate broader adoption of ESD in clinical practice. However, further research in human trials is necessary to validate these findings.</p>","PeriodicalId":11671,"journal":{"name":"Endoscopy International Open","volume":"13 ","pages":"a25765837"},"PeriodicalIF":2.3000,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12223946/pdf/","citationCount":"0","resultStr":"{\"title\":\"Ex vivo evaluation of a novel through-the-scope traction device for endoscopic submucosal dissection.\",\"authors\":\"Ludovico Alfarone, Roberto De Sire, Boris Rosenbaum, Ali Aidibi, Christophe Cellier, Cesare Hassan, Alessandro Repici, Gabriel Rahmi, Roberta Maselli\",\"doi\":\"10.1055/a-2576-5837\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and study aims: </strong>Endoscopic submucosal dissection (ESD) is a technique used for resection of large neoplastic lesions, providing great oncological outcomes. However, ESD is technically challenging with a long learning curve, high complication rates, and extended procedure times. To address these limitations, various traction-assisted methods have been developed. This study evaluated a novel through-the-scope traction device (TRACMOTION, Fujifilm, Japan), which offers consistent and adjustable traction, in a pilot multicenter randomized ex vivo trial.</p><p><strong>Patients and methods: </strong>The study included six endoscopists with limited ESD experience performing ESD on ex vivo porcine stomach models. Participants were randomized into two groups: those using TRACMOTION-assisted ESD (TM-ESD) and those performing conventional ESD (C-ESD). Each trainee completed six procedures, split equally between both groups. The primary outcome was resection speed, whereas secondary outcomes included en bloc, R0 resection rates, perforation rates, and rates of speedy procedures (>20 mm²/min).</p><p><strong>Results: </strong>The TM-ESD group achieved a higher median resection speed of 20.75 mm²/min (95% confidence interval [CI] 14.56-29.25) in comparison to 15.10 mm²/min (95% CI 12.8-16.6) in the C-ESD group ( <i>P</i> =0.02). Perforation rates were significantly lower in the TM-ESD group (11.1% (95% CI 0.01-0.34) vs. 61.1% (95% CI 0.35-0.82; <i>P</i> =0.0002). No significant differences were observed in en bloc or R0 resection rates between the groups.</p><p><strong>Conclusions: </strong>TRACMOTION significantly improves the efficiency of ESD, reducing procedure time and complication rates. This traction device could potentially facilitate broader adoption of ESD in clinical practice. 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引用次数: 0
摘要
背景与研究目的:内镜下粘膜下剥离术(ESD)是一种用于切除大型肿瘤病变的技术,具有良好的肿瘤学效果。然而,ESD在技术上具有挑战性,学习曲线长,并发症发生率高,操作时间长。为了解决这些局限性,各种牵引辅助方法被开发出来。本研究在一项多中心随机离体试验中评估了一种新型的全范围牵引装置(TRACMOTION,富士胶片公司,日本),该装置提供一致和可调节的牵引。患者和方法:该研究包括6名具有有限ESD经验的内窥镜医师对离体猪胃模型进行ESD。参与者被随机分为两组:tracmotion辅助ESD (TM-ESD)组和常规ESD (C-ESD)组。每个受训者完成六个程序,在两组中平均分配。主要结果是切除速度,而次要结果包括整体、R0切除率、穿孔率和快速手术率(bbb20 mm²/min)。结果:TM-ESD组的中位切除速度为20.75 mm²/min(95%可信区间[CI] 14.56-29.25),而C-ESD组的中位切除速度为15.10 mm²/min (95% CI 12.8-16.6) (P =0.02)。TM-ESD组的穿孔率明显较低(11.1% (95% CI 0.01-0.34) vs. 61.1% (95% CI 0.35-0.82;P = 0.0002)。两组间的整体或R0切除率无显著差异。结论:TRACMOTION可显著提高ESD的效率,减少手术时间和并发症发生率。这种牵引装置可能会促进ESD在临床实践中的广泛采用。然而,需要进一步的人体试验研究来验证这些发现。
Ex vivo evaluation of a novel through-the-scope traction device for endoscopic submucosal dissection.
Background and study aims: Endoscopic submucosal dissection (ESD) is a technique used for resection of large neoplastic lesions, providing great oncological outcomes. However, ESD is technically challenging with a long learning curve, high complication rates, and extended procedure times. To address these limitations, various traction-assisted methods have been developed. This study evaluated a novel through-the-scope traction device (TRACMOTION, Fujifilm, Japan), which offers consistent and adjustable traction, in a pilot multicenter randomized ex vivo trial.
Patients and methods: The study included six endoscopists with limited ESD experience performing ESD on ex vivo porcine stomach models. Participants were randomized into two groups: those using TRACMOTION-assisted ESD (TM-ESD) and those performing conventional ESD (C-ESD). Each trainee completed six procedures, split equally between both groups. The primary outcome was resection speed, whereas secondary outcomes included en bloc, R0 resection rates, perforation rates, and rates of speedy procedures (>20 mm²/min).
Results: The TM-ESD group achieved a higher median resection speed of 20.75 mm²/min (95% confidence interval [CI] 14.56-29.25) in comparison to 15.10 mm²/min (95% CI 12.8-16.6) in the C-ESD group ( P =0.02). Perforation rates were significantly lower in the TM-ESD group (11.1% (95% CI 0.01-0.34) vs. 61.1% (95% CI 0.35-0.82; P =0.0002). No significant differences were observed in en bloc or R0 resection rates between the groups.
Conclusions: TRACMOTION significantly improves the efficiency of ESD, reducing procedure time and complication rates. This traction device could potentially facilitate broader adoption of ESD in clinical practice. However, further research in human trials is necessary to validate these findings.