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索拉克石经会阴聚焦激光消融治疗前列腺癌的安全性和可行性以及多中心初步研究的短期生活质量分析

Safety and Feasibility of Soractelite Transperineal Focal Laser Ablation for Prostate Cancer and Short-term Quality of Life Analysis from a Multicenter Pilot Study.

作者信息

van Riel Luigi A M J G, van Kollenburg Rob A A, Vis André N, van Leeuwen Pim J, de Reijke Theo M, de Bruin Daniel M, Oddens Jorg R

机构信息

Urology, Amsterdam University Medical Centres: Amsterdam Universitair Medische Centra, Amsterdam, the Netherlands.

Netherlands Cancer Institute: Antoni van Leeuwenhoek Nederlands Kanker Instituut, Amsterdam, the Netherlands.

出版信息

Eur Urol Open Sci. 2022 Apr 2;39:48-54. doi: 10.1016/j.euros.2022.02.012. eCollection 2022 May.

Abstract

BACKGROUND

Soractelite™ transperineal focal laser ablation (TPLA) for the treatment of localized prostate cancer (PCa) using the Echolaser® system is a novel minimally invasive technique that has the potential to induce tissue ablation, while reducing treatment-related morbidity, when compared with robot-assisted radical prostatectomy (RARP) and radiotherapy.

OBJECTIVE

To determine the short-term safety and feasibility of single or multifiber TPLA, its functional outcomes, and quality of life (QoL).

DESIGN SETTING AND PARTICIPANTS

TPLA was performed in 12 patients, consecutively assigned to four treatment regimens, with localized PCa who were scheduled for RARP ("ablate and resect design"). The treatment regimens were as follows: (1) a single fiber at 3 W, (2) two fibers at 5 mm distance at 3 W, (3) two fibers at 10 mm distance at 3 W, and (4) a single fiber at 5 W. TPLA was scheduled 4 wk prior to RARP.

INTERVENTION

TPLA using the Echolaser® system under local anesthesia at the outpatient clinic.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Safety and feasibility were determined by the assessment of device-related peri- and postoperative adverse events (AEs), and length of hospital stay. Functional outcomes and QoL were measured using validated questionnaires. Feasibility of RARP was assessed by a questionnaire for the urologist.

RESULTS AND LIMITATIONS

Patients were dismissed after a median (interquartile range) hospital admission of 3.25 (1.25) h. No device-related AEs occurred. AEs that occurred were mostly related to lower urinary tract symptoms and were mild (grade 1-2). Most AEs resolved within 1 wk. A QoL analysis showed no significant differences for all treatment regimens. Functional outcomes remained unchanged, except for erectile function after 1 wk, which returned to baseline after 4 wk. TPLA treatment did not compromise RARP, based on the questionnaires.

CONCLUSIONS

TPLA for the treatment of PCa at the outpatient clinic appears to be safe and feasible with good short-term QoL and functional outcomes; oncological results are awaited.

PATIENT SUMMARY

Focal treatment of localized prostate cancer can safely be performed in a daycare setting using a new technique, based on laser ablation, without compromising quality of life.

摘要

背景

使用Echolaser®系统的Soractelite™经会阴聚焦激光消融术(TPLA)治疗局限性前列腺癌(PCa)是一种新型微创技术,与机器人辅助根治性前列腺切除术(RARP)和放射治疗相比,该技术有可能诱导组织消融,同时降低治疗相关的发病率。

目的

确定单纤维或多纤维TPLA的短期安全性和可行性、其功能结果及生活质量(QoL)。

设计、地点和参与者:对12例计划接受RARP的局限性PCa患者(“消融并切除设计”)连续进行TPLA治疗,这些患者被依次分配到四种治疗方案。治疗方案如下:(1)3W单纤维;(2)3W时两根纤维相距5mm;(3)3W时两根纤维相距10mm;(4)5W单纤维。TPLA安排在RARP前4周进行。

干预

在门诊局部麻醉下使用Echolaser®系统进行TPLA。

结果测量和统计分析

通过评估与设备相关的围手术期和术后不良事件(AE)以及住院时间来确定安全性和可行性。使用经过验证的问卷测量功能结果和QoL。通过泌尿外科医生问卷评估RARP的可行性。

结果和局限性

患者在中位(四分位间距)住院3.25(1.25)小时后出院。未发生与设备相关的AE。发生的AE大多与下尿路症状有关,且为轻度(1-2级)。大多数AE在1周内缓解。QoL分析显示所有治疗方案之间无显著差异。功能结果保持不变,但1周后的勃起功能除外,其在4周后恢复至基线。根据问卷,TPLA治疗未影响RARP。

结论

门诊使用TPLA治疗PCa似乎安全可行,短期QoL和功能结果良好;有待观察肿瘤学结果。

患者总结

基于激光消融的新技术可在日间护理环境中安全地对局限性前列腺癌进行局部治疗,且不影响生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab59/9068724/2fbf16f7f150/gr1.jpg

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