使用锚定套环Tip-in与预切割技术进行内窥镜粘膜切除术治疗小型直肠神经内分泌肿瘤。

IF 2.2 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Korean Journal of Internal Medicine Pub Date : 2024-03-01 Epub Date: 2023-12-08 DOI:10.3904/kjim.2023.263
Seung Wook Hong, Dong-Hoon Yang, Yoo Jin Lee, Dong Hoon Baek, Jaeyoung Chun, Hyun Gun Kim, Sung Joo Kim, Seung-Mo Hong, Dae-Seong Myung
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引用次数: 0

摘要

背景/目的:小型直肠神经内分泌肿瘤(NET)可通过改良内镜粘膜切除术(EMR)进行治疗。然而,最佳的EMR方法仍有待确定。我们旨在评估Tip-in EMR与预切EMR(EMR-P)治疗直肠NET的非劣效性:这项前瞻性多中心随机对照试验招募了直径小于 10 毫米的直肠 NET 患者。患者按1:1的比例随机分配到EMR-P组和Tip-in EMR组。主要结果是两种方法的切缘阴性(R0)切除率,非劣效差为10%:对73名患者的75个NET病灶进行了评估,其中包括64个符合条件的病灶(EMR-P组和Tip-in EMR组各32个病灶)。在修改后的意向治疗分析中,EMR-P组和Tip-in EMR组的R0切除率分别为96.9%和90.6%,未显示出非劣效性(风险差异为-6.3[95%置信区间:-18.0至5.5])。EMR-P组的切除时间长于Tip-in EMR组(P < 0.001)。两组各有一例术中出血报告:结论:在治疗小型直肠NET方面,Tip-in EMR与EMR-P相比并无劣势。然而,两种技术的R0切除率都很高,足以应用于临床。
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Endoscopic mucosal resection using anchored snare Tip-in versus precut technique for small rectal neuroendocrine tumors.

Background/aims: Small rectal neuroendocrine tumors (NETs) can be treated with modified endoscopic mucosal resection (EMR). However, an optimal EMR method remains to be established. We aimed to assess the non-inferiority of Tip-in EMR versus precut EMR (EMR-P) for treating rectal NETs.

Methods: This prospective, multicenter, randomized controlled trial enrolled patients with rectal NETs of < 10 mm in diameter. The patients were randomly assigned to EMR-P and Tip-in EMR groups in a 1:1 ratio. Primary outcome was margin-negative (R0) resection rate between the two methods, with a noninferiority margin of 10%.

Results: Seventy-five NETs in 73 patients, including 64 eligible lesions (32 lesions in each, EMR-P and Tip-in EMR groups), were evaluated. In a modified intention-to-treat analysis, R0 resection rates of the EMR-P and Tip-in EMR groups were 96.9% and 90.6%, respectively, which did not demonstrate non-inferiority (risk difference, -6.3 [95% confidence interval: -18.0 to 5.5]). Resection time in the EMR-P group was longer than that in the Tip-in EMR group (p < 0.001). One case of intraprocedural bleeding was reported in each group.

Conclusion: We did not demonstrate the non-inferiority of Tip-in EMR compared to EMR-P for treating small rectal NETs. However, the R0 resection rates for both techniques were high enough for clinical application.

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来源期刊
Korean Journal of Internal Medicine
Korean Journal of Internal Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
5.10
自引率
4.20%
发文量
129
审稿时长
20 weeks
期刊介绍: The Korean Journal of Internal Medicine is an international medical journal published in English by the Korean Association of Internal Medicine. The Journal publishes peer-reviewed original articles, reviews, and editorials on all aspects of medicine, including clinical investigations and basic research. Both human and experimental animal studies are welcome, as are new findings on the epidemiology, pathogenesis, diagnosis, and treatment of diseases. Case reports will be published only in exceptional circumstances, when they illustrate a rare occurrence of clinical importance. Letters to the editor are encouraged for specific comments on published articles and general viewpoints.
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