比较食管切除术与单纯替代术治疗腐蚀性食管狭窄的随机试验。
Randomized trial comparing esophageal resection versus substitution alone for corrosive esophageal strictures.
文献信息
| PMID | 42763383 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Nihar Ranjan Dash |
| 作者单位 | Department of Gastrointestinal Surgery and Liver Transplant, All India Institute of Medical Sciences, New Delhi, India. |
| 期刊 | Esophagus : official journal of the Japan Esophageal Society |
| SCI 分区 | Q1 |
| IF | 3.4 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
目的： 比较食管切除术与单纯替代术在经内镜扩张难以治愈的腐蚀性食管狭窄患者中的围手术期安全性和长期功能结局。
方法： 这项前瞻性、单中心、开放标签、平行组、非劣效性随机对照试验在印度一家三级转诊中心进行。纳入年龄14-60岁、对连续扩张无反应的腐蚀性食管狭窄患者。参与者按1:1比例随机分配至食管切除术组或单纯替代术组。主要结局是30天内术后肺部并发症（PPC）的发生率。次要结局包括手术参数、术后并发症、死亡率以及使用胃肠道生活质量指数（GIQLI）评估的健康相关生活质量（HRQOL）。
结果： 2012年9月至2023年12月期间，143例患者被随机分组（切除术组，n=69；单纯替代术组，n=74），并全部纳入分析。PPC在切除术组的发生率为11.6%，在单纯替代术组为8.1%（绝对风险差，3.5%；95% CI -6.3%至13.3%）；未达到预设的非劣效性标准。切除术组的纵隔解剖时间显著更长（48 ± 28 vs 22 ± 8 分钟；p < 0.001）。然而，总手术时间、失血量、颈部吻合口漏发生率、喉返神经麻痹以及住院时间在两组间相当。切除术组发生1例死亡（0.7%），原因为结肠-结肠吻合口漏。在12个月时，切除术后的平均GIQLI评分更高（118.6 ± 11.2 vs. 111.2 ± 12.8；p=0.08）。
结论： 在腐蚀性食管狭窄患者中，食管切除术与单纯替代术的围手术期结局相当。尽管未正式确立食管切除术的非劣效性，但未观察到PPC的显著差异。切除术后较高的HRQOL评分应被视为探索性结果。
试验注册： 印度临床试验注册中心（CTRI/2015/10/006237）。
英文摘要
OBJECTIVE: To compare perioperative safety and long-term functional outcomes of esophageal resection versus substitution-alone in patients with corrosive esophageal strictures refractory to endoscopic dilatation.
METHODS: This prospective, single-center, open-label, parallel-group, non-inferiority randomized controlled trial was conducted at a tertiary referral center in India. Patients aged 14-60 years with corrosive esophageal strictures unresponsive to serial dilatation were included. Participants were randomized in a 1:1 ratio to either esophageal resection or substitution-alone group. The primary outcome was incidence of postoperative pulmonary complications (PPC) within 30 days. Secondary outcomes included operative parameters, postoperative morbidity, mortality, and health-related quality-of-life (HRQOL) assessed using the Gastrointestinal-Quality-of-Life-Index (GIQLI).
RESULTS: Between September 2012 and December 2023, 143 patients were randomized (resection, n=69; substitution-alone, n=74), and all were analyzed. PPC occurred in 11.6% of the resection group and 8.1% of the substitution-alone group (absolute risk difference, 3.5%; 95% CI -6.3% to 13.3%); the prespecified non-inferiority criterion was not met. Mediastinal dissection time was significantly longer in the resection group (48 ± 28 vs 22 ± 8 min; p < 0.001). However, total operative duration, blood loss, cervical anastomotic leak rates, recurrent laryngeal nerve palsy, and length of hospital stay were comparable between groups. One mortality (0.7%) occurred in the resection group due to a colo-colic anastomotic leak. At 12-months, mean GIQLI scores were higher following resection (118.6 ± 11.2 vs. 111.2 ± 12.8; p=0.08).
CONCLUSIONS: Esophageal resection and substitution-alone were associated with comparable perioperative outcomes in patients with corrosive esophageal strictures. Although formal non-inferiority of esophageal resection was not established, no significant difference in PPC was observed. The higher HRQOL scores following resection should be considered exploratory.
TRIAL REGISTRATION: Clinical Trials Registry of India (CTRI/2015/10/006237).