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内镜黏膜下剥离术与食管切除术治疗 T1 期食管鳞癌的真实世界队列研究结果。

Outcomes of Endoscopic Submucosal Dissection vs Esophagectomy for T1 Esophageal Squamous Cell Carcinoma in a Real-World Cohort.

机构信息

Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China.

Department of Internal Medicine, Mount Sinai St. Luke's-West Hospital Center, New York, New York.

出版信息

Clin Gastroenterol Hepatol. 2019 Jan;17(1):73-81.e3. doi: 10.1016/j.cgh.2018.04.038. Epub 2018 Apr 25.

Abstract

BACKGROUND & AIMS: Esophagectomy is the standard treatment for early-stage esophageal squamous cell carcinoma (EESCC), but patients who undergo this procedure have high morbidity and mortality. Endoscopic submucosal dissection (ESD) is a less-invasive procedure for treatment of EESCC, but is considered risky because this tumor frequently metastasizes to the lymph nodes. We aimed to directly compare outcomes of patients with EESCC treated with ESD vs esophagectomy.

METHODS

We performed a retrospective cohort study of patients with T1a-m2/m3, or T1b EESCCs who underwent ESD (n = 322) or esophagectomy (n = 274) from October 1, 2011 through September 31, 2016 at Zhongshan Hospital in Shanghai, China. The primary outcome was all-cause mortality at the end of follow up (minimum of 6 months). Secondary outcomes included operation time, hospital stay, cost, perioperative mortalities/severe non-fatal adverse events, requirement for adjuvant therapies, and disease-specific mortality and cancer recurrence or metastasis at the end of the follow up period.

RESULTS

Patients who underwent ESD were older (mean 63.5 years vs 62.3 years for patients receiving esophagectomy; P = .006) and a greater proportion was male (80.1% vs 70.4%; P = .006) and had a T1a tumor (74.5% vs 27%; P = .001). A lower proportion of patients who underwent ESD had perioperative mortality (0.3% vs 1.5% of patients receiving esophagectomy; P = .186) and non-fatal severe adverse events (15.2% vs 27.7%; P = .001)-specifically lower proportions of esophageal fistula (0.3% of patients receiving ESD vs 16.4% for patients receiving esophagectomy; P = .001) and pulmonary complications (0.3% vs 3.6%; P = .004). After a median follow-up time of 21 months (range, 6-73 months), there were no significant differences between treatments in all-cause mortality (7.4% for ESD vs 10.9%; P = .209) or rate of cancer recurrence or metastasis (9.1% for ESD vs 8.9%; P = .948). Disease-specific mortality was lower among patients who received ESD (3.4%) vs patients who patients who received esophagectomy (7.4%) (P = .049). In Cox regression analysis, depth of tumor invasion was the only factor associated with all-cause mortality (T1a-m3 or deeper vs T1a-m2: hazard ration, 3.54; P = .04).

CONCLUSION

In a retrospective study of patients with T1am2/m3 or T1b EESCCs treated with ESD (n = 322) or esophagectomy (n = 274), we found lower proportions of patients receiving ESD to have perioperative adverse events or disease specific mortality after a median follow up time of 21 months. We found no difference in overall survival or cancer recurrence or metastasis in patients with T1a or T1b ESCCs treated with ESD vs esophagectomy.

摘要

背景与目的

食管切除术是早期食管鳞状细胞癌(EESCC)的标准治疗方法,但接受该手术的患者发病率和死亡率较高。内镜黏膜下剥离术(ESD)是治疗 EESCC 的一种侵袭性较小的方法,但由于这种肿瘤经常转移到淋巴结,因此被认为是有风险的。我们旨在直接比较接受 ESD 或食管切除术治疗的 EESCC 患者的结局。

方法

我们对 2011 年 10 月 1 日至 2016 年 9 月 31 日期间在中国上海中山医院接受 ESD(n=322)或食管切除术(n=274)治疗的 T1a-m2/m3 或 T1b EESCC 患者进行了回顾性队列研究。主要结局是随访结束时(至少 6 个月)的全因死亡率。次要结局包括手术时间、住院时间、费用、围手术期死亡率/严重非致命不良事件、辅助治疗的需求以及随访期末疾病特异性死亡率和癌症复发或转移。

结果

接受 ESD 的患者年龄较大(平均 63.5 岁 vs 接受食管切除术的患者 62.3 岁;P=0.006),且男性比例更高(80.1% vs 70.4%;P=0.006),肿瘤为 T1a 期(74.5% vs 27%;P=0.001)。接受 ESD 的患者围手术期死亡率(接受食管切除术的患者为 1.5%,接受 ESD 的患者为 0.3%;P=0.186)和非致命性严重不良事件(接受 ESD 的患者为 15.2%,接受食管切除术的患者为 27.7%;P=0.001)的比例较低,特别是食管瘘(接受 ESD 的患者为 0.3%,接受食管切除术的患者为 16.4%;P=0.001)和肺部并发症(接受 ESD 的患者为 0.3%,接受食管切除术的患者为 3.6%;P=0.004)的比例较低。中位随访时间为 21 个月(范围 6-73 个月)后,ESD 治疗与食管切除术治疗在全因死亡率(ESD 为 7.4%,食管切除术为 10.9%;P=0.209)或癌症复发或转移率(ESD 为 9.1%,食管切除术为 8.9%;P=0.948)方面无显著差异。接受 ESD 的患者疾病特异性死亡率较低(3.4% vs 7.4%;P=0.049)。在 Cox 回归分析中,肿瘤浸润深度是唯一与全因死亡率相关的因素(T1a-m3 或更深 vs T1a-m2:风险比,3.54;P=0.04)。

结论

在一项对接受 ESD(n=322)或食管切除术(n=274)治疗的 T1am2/m3 或 T1b EESCC 患者的回顾性研究中,我们发现接受 ESD 的患者在中位随访时间为 21 个月后,围手术期不良事件或疾病特异性死亡率的比例较低。我们发现 T1a 或 T1b ESCC 患者接受 ESD 与食管切除术治疗在总生存率或癌症复发或转移方面无差异。

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