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Nitrous oxide cryotherapy for treatment of esophageal squamous cell neoplasia: initial multicenter international experience with a novel portable cryoballoon ablation system (with video)

机译:用于治疗食管鳞状细胞瘤的二氮氧化物冷冻疗法:初始多中心与新型便携式冷冻消融系统的国际经验(带视频)

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Background and Aims Early esophageal squamous cell neoplasia (ESCN) can be successfully treated by EMR, endoscopic submucosal dissection (ESD), or radiofrequency ablation. A new portable, battery-powered cryotherapy system using nitrous oxide (cryoballoon focal ablation system [CbFAS]) has been used for Barrett’s esophagus. It consists of a small hand-held device containing liquid nitrous oxide, which converts to gas within a low-pressure–compliant through-the-scope balloon and freezes targeted mucosa in contact with the balloon. This study evaluated the feasibility of endoscopic eradication of early ESCN with the CbFAS. Methods Patients with early ESCN (defined as low-grade intraepithelial neoplasia [LGIN], high-grade intraepithelial neoplasia [HGIN], or early T1 squamous mucosal cancer) were treated with the CbFAS. After chromoendoscopy, all Lugol’s unstained lesions (USLs) were targeted with 8, 10, or 12 seconds of ice per site, and treatment was repeated until biopsy samples demonstrated eradication of ESCN. Postprocedure adverse events were recorded. Results Ten patients (4 men; median age, 69.5 years) with LGIN (n=2), HGIN (n=7), or esophageal squamous cell carcinoma (ESCC; n=1, after EMR) in 24 USLs were treated. The median maximum diameter of the largest USL was 1.5 cm (interquartile range, 1-2 cm), and median total length of all neoplastic USLs was 2 cm (range, 1-10 cm). Patients with focal disease received a median of 2 cryoablations, whereas 4 patients with large and/or multifocal circumferential neoplasia had 6 to 12 ablations per procedure. The median procedure time was 34 minutes (range, 18-57 minutes). Treatment was completed in all patients. No major adverse events occurred. Four patients developed mild self-limited chest pain requiring narcotic analgesics immediately after the procedure. Two patients who received circumferential ablation developed a stricture responding to dilation, with no recurrence. Complete endoscopic and pathologic response was achieved in all patients at 3 months. One year follow-up biopsy specimens in 7 patients showed no USL or ESCN. All patients were disease free at last visit, with a median follow-up time of 10.7 months (interquartile range, 4-14 months). Conclusions We report the first application of nitrous cryoballoon ablation for curative treatment of early primary or recurrent ESCN. Our initial experience suggests that efficacy is high and the safety profile is reasonable. Prospective trials are needed to optimize cryogen dosimetry and assess safety and efficacy.
机译:背景和目的早期食管鳞状细胞瘤形成(ESCN)可以通过EMR,内窥镜粘膜粘膜释放(ESD)或射频消融成功处理。使用氮氧化亚氮的新的便携式电池供电的冷冻疗法系统(Cryoballoon焦点烧蚀系统[CBFAS])已被用于Barrett的食道。它由含有含有液氮氧化物的小手持装置组成,其转化为低压符合副的通孔球囊内的气体,并冻结靶向粘膜与球囊接触。本研究评估了内窥镜消除早期ESCN与CBFA的可行性。方法用CBFA处理患者早期ESCN的患者(定义为低级初始肿瘤瘤[填充],高级术前准肿瘤瘤[填充]或早期的T1鳞状粘膜癌)。在透视镜检查后,所有Lugol的未染色病变(USL)每位靶向8,10或12秒的冰,重复治疗直至活检样本表明消除ESCN。记录了后预设不良事件。结果10名患者(4人;中位数年龄,69.5岁),含有填料(n = 2),净食管鳞状细胞癌(ESCC; N = 1,EMR之后)的24 usls。最大USL的最大直径最大直径为1.5厘米(四分位数范围,1-2厘米),所有肿瘤USL的中位数为2厘米(范围,1-10厘米)。患有局灶性疾病的患者接受了2个低温的中位数,而4例大和/或多焦点圆周肿瘤的患者每种程序具有6至12次消融。中位程序时间为34分钟(范围,18-57分钟)。治疗在所有患者中完成。没有发生重大不良事件。四名患者在手术后立即开发了温和的自限胸部疼痛,需要麻醉镇痛药。接受圆周消融的两名患者产生了响应扩张的狭窄,没有复发。所有患者在3个月内完成了完整的内窥镜和病理反应。 7例患者的一年后续活检标本显示没有USL或ESCN。所有患者在最后一次访问时都是无病的,中间后续时间为10.7个月(四分位数,4-14个月)。结论我们报告了第一次应用亚硝脱离杀菌剂治疗早期原发性或复发性ESCN的治疗方法。我们的初步体验表明,功效高,安全型材是合理的。需要进行前瞻性试验以优化低温剂量剂量,评估安全性和疗效。

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