中国内镜下聚焦冷冻球囊消融治疗食管鳞癌的前瞻性研究。
Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China.
机构信息
Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Gastroenterology & Hepatology, Amsterdam University Medical Center, Amsterdam, the Netherlands; Department of Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands.
出版信息
Gastrointest Endosc. 2019 Aug;90(2):204-212. doi: 10.1016/j.gie.2019.03.017. Epub 2019 Mar 25.
BACKGROUND AND AIMS
Esophageal squamous cell neoplasia (ESCN) has a significant risk for progression to cancer. Current treatment options, endoscopic mucosal resection (EMR) or submucosal dissection (ESD), have their limitations. The cryoballoon focal ablation system (CbFAS) is a novel endoscopic ablation therapy device. We aimed to assess the safety, tolerability, and efficacy of CbFAS for eradication of ESCN.
METHODS
In this single-center prospective trial in China, patients with 1 flat unstained lesion (USL) on Lugol chromoendoscopy that contained moderate- or high-grade intraepithelial neoplasia (MGIN or HGIN, respectively) were enrolled. CbFAS was performed using side-by-side applications of 10 seconds, treatment was repeated at 3-month intervals until a complete response (CR) was established. The response at 12 months was the primary trial endpoint. Safety phone calls were performed at 2, 7, and 30 days after the initial CbFAS.
RESULTS
We enrolled 80 patients (59 MGIN, 21 HGIN) with a median USL length of 3 cm (interquartile range [IQR], 3-4). Seventy-nine received treatment, with a median of 5 side-by-side applications (IQR, 4-7) per patient over a median of 8 minutes (IQR, 5-10). After a single treatment, 70 of 78 patients (90%) exhibited CR, and 1 was lost to follow-up. The other 8 with persisting USLs were retreated, and all achieved CR after this second treatment. At 12 months after the initial CbFAS, 76 of 78 patients (97%) exhibited CR and 2 (3%) had recurrent MGIN. No strictures or serious adverse events occurred. Four patients developed self-limiting mucosal lacerations on balloon inflation. The postprocedure median pain score was 1 of 10 (IQR, 0-2) at day 2 and 0 (0-0) at days 7 and 30.
CONCLUSIONS
The results suggest that the CbFAS is safe, well tolerated, and effective in inducing endoscopic and histologic remission in patients with ESCN of limited size. (Clinical trial registration number: NCT02605759.).
背景与目的
食管鳞状细胞肿瘤（ESCN）有进展为癌症的重大风险。目前的治疗选择，内镜黏膜切除术（EMR）或黏膜下剥离术（ESD），都有其局限性。冷冻球囊聚焦消融系统（CbFAS）是一种新型的内镜消融治疗设备。我们旨在评估 CbFAS 对 ESCN 根除的安全性、耐受性和疗效。
方法
在中国的这项单中心前瞻性试验中，纳入了在卢戈氏碘染色内镜下有 1 个平坦无染色病变（USL）的患者，该病变包含中度或高度上皮内瘤变（MGIN 或 HGIN）。使用并排应用 10 秒的方法进行 CbFAS，每隔 3 个月重复治疗，直到建立完全缓解（CR）。12 个月时的反应是主要试验终点。在初始 CbFAS 后 2、7 和 30 天进行安全电话随访。
结果
我们纳入了 80 名患者（59 名 MGIN，21 名 HGIN），中位 USL 长度为 3cm（四分位距[IQR]，3-4）。79 名患者接受了治疗，每名患者中位接受了 5 次并排应用（IQR，4-7），中位治疗时间为 8 分钟（IQR，5-10）。单次治疗后，78 名患者中的 70 名（90%）表现出 CR，1 名失访。另外 8 名 USL 持续存在的患者进行了二次治疗，所有患者在第二次治疗后均获得了 CR。在初始 CbFAS 后 12 个月时，78 名患者中的 76 名（97%）表现出 CR，2 名（3%）出现复发性 MGIN。没有发生狭窄或严重不良事件。4 名患者在球囊充气时出现自限性黏膜撕裂。术后中位疼痛评分在第 2 天为 1/10（IQR，0-2），在第 7 天和第 30 天为 0（0-0）。
结论
结果表明，CbFAS 是一种安全、耐受良好且有效的治疗方法，可诱导 ESCN 患者内镜和组织学缓解，且病变大小有限。（临床试验注册号：NCT02605759.）
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