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内镜黏膜下剥离术与胃切除术治疗早期肿瘤性病变的前瞻性对比研究,包括患者观点。

Prospective comparative study of endoscopic submucosal dissection and gastrectomy for early neoplastic lesions including patients' perspectives.

机构信息

Gastroenterology Department, Instituto Português de Oncologia do Porto, Porto, Portugal.

CINTESIS - Center for Health Technology and Services Research, Faculty of Medicine, University of Porto, Porto, Portugal.

出版信息

Endoscopy. 2019 Jan;51(1):30-39. doi: 10.1055/a-0628-6601. Epub 2018 Jul 3.

Abstract

BACKGROUND

There are no prospective studies comparing endoscopic submucosal dissection (ESD) and gastrectomy, especially evaluating patient-reported outcomes. Our aim was to compare the safety and impact on quality of life (QoL) of ESD and gastrectomy in patients with early gastric neoplasia.

METHODS

This prospective study included consecutive patients presenting with early gastric neoplasia in a tertiary center from January 2015 to August 2016. Data collection included curative resection, adverse events (AEs), and patient-reported outcomes (questionnaires: EORTC QLQ-C30, EORTC STO-22, EQ-5D-5 L, and Assessment of Survivor Concerns) before and after interventions (after 1 month, 3 - 6 months, and 1 year).

RESULTS

254 patients with early lesions were included: 153 managed by ESD and 101 by gastrectomy, the former being significantly older and with less advanced lesions. Mean procedural time and length of stay were significantly higher in the surgery group (164 vs 72 minutes and 16.3 vs 3.5 days;  < 0.001). Complete resection was higher in the surgical group (99 % vs 90 %;  = 0.02); ESD was curative in 79 % of patients. Severe AEs and surgical re-intervention were significantly more frequent in the gastrectomy group (21.8 % vs. 7.8 % and 11 % vs 1 %, respectively). Endoscopic treatment was associated with a positive impact on global health-related QoL at 1 year (net difference + 9.9;  = 0.006), role function and symptom scales (fatigue, pain, appetite, eating restrictions, dysphagia, and body image). Concerns about recurrence did not differ between the groups.

CONCLUSIONS

In patients with early gastric neoplasia, ESD is safer and is associated with a positive impact on health-related QoL when compared with gastrectomy, without increasing fear of recurrence and new lesions.

摘要

背景

目前尚无比较内镜黏膜下剥离术(ESD)和胃切除术的前瞻性研究,尤其是评估患者报告结局的研究。我们的目的是比较 ESD 和胃切除术治疗早期胃癌的安全性和对生活质量(QoL)的影响。

方法

本前瞻性研究纳入了 2015 年 1 月至 2016 年 8 月在一家三级中心就诊的早期胃癌患者。数据采集包括根治性切除、不良事件(AE)和患者报告结局(问卷:EORTC QLQ-C30、EORTC STO-22、EQ-5D-5L 和生存者关注评估),干预前后(术后 1 个月、3-6 个月和 1 年)进行评估。

结果

共纳入 254 例早期病变患者,其中 153 例接受 ESD 治疗,101 例接受胃切除术治疗,前者年龄更大,病变程度较轻。手术组的手术时间和住院时间明显更长(164 比 72 分钟和 16.3 比 3.5 天;<0.001)。手术组的完全切除率更高(99%比 90%;=0.02);ESD 治疗的患者中有 79%达到了根治性切除。胃切除术组的严重 AE 和再次手术干预更为常见(21.8%比 7.8%和 11%比 1%;分别)。内镜治疗在 1 年时对整体健康相关 QoL 具有积极影响(净差异+9.9;=0.006),还可改善角色功能和症状量表(疲劳、疼痛、食欲、饮食限制、吞咽困难和身体形象)。两组患者对复发的担忧无差异。

结论

在早期胃癌患者中,与胃切除术相比,ESD 更安全,并对健康相关 QoL 产生积极影响,同时不会增加对复发和新发病变的担忧。

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