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氧化亚氮冷冻疗法治疗食管鳞状细胞肿瘤:新型便携式冷冻球囊消融系统的初步多中心国际经验(附视频)。

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

机构信息

Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.

Digestive and Liver Disease, Columbia University Medical Center, New York, New York, USA.

出版信息

Gastrointest Endosc. 2018 Feb;87(2):574-581. doi: 10.1016/j.gie.2017.07.013. Epub 2017 Jul 16.

DOI:10.1016/j.gie.2017.07.013
PMID:28720474
Abstract

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.

摘要

背景和目的

早期食管鳞状细胞肿瘤(ESCN)可通过内镜下黏膜切除术(EMR)、内镜黏膜下剥离术(ESD)或射频消融术成功治疗。一种新的便携式、电池供电的一氧化二氮(笑气)冷冻疗法系统(cryoballoon focal ablation system [CbFAS])已用于 Barrett 食管。它由一个包含液态一氧化二氮的小型手持式设备组成,该设备在低压顺应性经内镜球囊内转化为气体,并冷冻与球囊接触的靶向黏膜。本研究评估了使用 CbFAS 内镜根除早期 ESCN 的可行性。

方法

对早期 ESCN(定义为低级别上皮内瘤变[LGIN]、高级别上皮内瘤变[HGIN]或早期 T1 食管黏膜癌)患者进行 CbFAS 治疗。在染色内镜后,对所有 Lugol 无染色病变(USL)进行靶向治疗,每个病变部位给予 8、10 或 12 秒的冰,直到活检样本显示 ESCN 根除为止,重复治疗。记录术后不良事件。

结果

24 个 USL 中共有 10 名患者(4 名男性;中位年龄 69.5 岁)接受治疗,包括 2 名 LGIN、7 名 HGIN 或 1 名食管鳞状细胞癌(EMR 后)。最大 USL 的中位最大直径为 1.5cm(四分位间距,1-2cm),所有肿瘤性 USL 的中位总长度为 2cm(范围,1-10cm)。接受局灶性疾病治疗的患者接受了中位 2 次冷冻消融,而 4 名患有大或/多发环状肿瘤的患者在每次治疗中接受了 6 至 12 次消融。中位手术时间为 34 分钟(范围,18-57 分钟)。所有患者均完成治疗。无重大不良事件发生。4 名患者在手术后立即出现轻度自限性胸痛,需要使用麻醉性镇痛药。2 名接受环状消融的患者出现狭窄,对扩张有反应,无复发。所有患者在 3 个月时均获得完全内镜和病理缓解。7 名患者在 1 年的随访活检标本中未发现 USL 或 ESCN。末次随访时,所有患者均无疾病,中位随访时间为 10.7 个月(四分位间距,4-14 个月)。

结论

我们报告了首例使用笑气冷冻球囊消融治疗早期原发性或复发性 ESCN。我们的初步经验表明,疗效高,安全性合理。需要前瞻性试验来优化冷冻剂量,并评估安全性和疗效。

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