Department of Radiology, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
Imaging Division, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
Int J Surg. 2015 Feb;14:1-6. doi: 10.1016/j.ijsu.2014.12.019. Epub 2015 Jan 2.
Our aim was to evaluate the development of microbubble-enhanced sentinel lymph node (SLN) localization with placement of an I-125 seed in breast cancer patients as a potential alternative for SLN localization with nanocolloid. The study is conducted and reported following the IDEAL recommendations for evaluation of a new technique at Stage 2a (Prospective Development Study).
Fourteen consecutive patients with 15 lesions underwent microbubble-enhanced SLN localization with placement of an I-125 seed after the standard SLN localization (nanocolloid). We placed an I-125 seed within or near the SLN following its identification using intradermally injected microbubbles. The SLN was excised guided by nanocolloid and the SLN containing the I-125 seed was searched for. All technical modifications are described and standardized outcomes measured.
Twelve (80%) microbubble procedures with I-125 seed placements were technically successful. In three cases no microbubble-enhancing lymph node could be detected. Intraoperatively, we found nine I-125 seeds within 0.5 cm of the nanocolloid confirmed SLN. One I-125 seed was found next to a non-SLN and two I-125 seeds were not near any lymph node. Overall, the procedure was successful in 60% (9 out of 15) of the cases.
Given the low success rate, we conclude that microbubble-enhanced SLN is not a viable alternative to the standard SLN procedure. Modifications to this technique did not improve its performance. Planned study (NTR3690 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3690) was stopped early due to this conclusion and results reported in order to provide a full and transparent record of the evolution of technique.
我们的目的是评估在乳腺癌患者中使用 I-125 种子进行微泡增强前哨淋巴结 (SLN) 定位的发展，作为 SLN 定位用纳米胶体的潜在替代方法。该研究是按照 IDEAL 建议对新技术进行评估的 2a 期（前瞻性发展研究）进行的。
14 例连续患者（15 个病灶）在标准 SLN 定位（纳米胶体）后进行微泡增强 SLN 定位和 I-125 种子放置。我们在使用皮内注射微泡识别 SLN 后，将 I-125 种子放置在 SLN 内或附近。根据纳米胶体引导切除 SLN，并寻找含有 I-125 种子的 SLN。描述了所有技术修改并测量了标准化结果。
12 例（80%）微泡 I-125 种子放置术技术成功。在三种情况下，无法检测到微泡增强的淋巴结。术中，我们在距离纳米胶体确认的 SLN 0.5cm 内发现了 9 个 I-125 种子。一个 I-125 种子位于非 SLN 旁边，两个 I-125 种子不在任何淋巴结附近。总体而言，该程序在 15 例中的 9 例（60%）中成功。
鉴于成功率低，我们得出结论，微泡增强 SLN 不是标准 SLN 程序的可行替代方法。该技术的修改并未提高其性能。由于这一结论，计划的研究（NTR3690 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3690）提前停止，并报告了结果，以提供技术演变的完整和透明记录。
