PDF(Pubmed)
Abstract：
OBJECTIVE: Current treatments for refractory benign esophageal strictures (BESs) often take several years and have poor effects. The authors propose a novel method of self-help inflatable balloon (SHIB) and evaluate its efficacy and safety.
METHODS: A prospective, multicenter study was conducted from January 2019 to March 2022. All enrolled patients were diagnosed with refractory BESs and received SHIB. The primary endpoint was the clinical success rate at 12 months after removing SHIB. The secondary endpoints were the number of days of placing SHIB, and changes from baseline in BMI and health-related quality of life at 1, 3, 6, and 12 months.
RESULTS: The clinical success rate was 51.2% (21/41) with the median days of placing SHIB being 104.0 days (range: 62.0-134.5 days), which was higher in the endoscopic group compared to the caustic and surgery groups (63.3 vs. 28.6% vs. 0, P=0.025). All patients (100%) showed significant improvement in dysphagia scores during placing SHIB. Although 20 patients (48.8%) experienced recurrent stricture, the median stricture length was decreased (P<0.001) and the median intervention-free interval was prolonged (P<0.001). In all patients, the mean BMI at and health-related quality of life at 1, 3, 6, and 12 months were significantly increased compared with baseline (P<0.05). On multivariate analysis, stricture etiology and wearing time were independent predictors of recurrent stricture.
CONCLUSIONS: The SHIB has high efficacy and safety in treating refractory BESs of different origins, especially for endoscopic resection. Stricture etiology and wearing time were independent predictors of recurrent stricture.
METHODS: A prospective, multicenter study was conducted from January 2019 to March 2022. All enrolled patients were diagnosed with refractory BESs and received SHIB. The primary endpoint was the clinical success rate at 12 months after removing SHIB. The secondary endpoints were the number of days of placing SHIB, and changes from baseline in BMI and health-related quality of life at 1, 3, 6, and 12 months.
RESULTS: The clinical success rate was 51.2% (21/41) with the median days of placing SHIB being 104.0 days (range: 62.0-134.5 days), which was higher in the endoscopic group compared to the caustic and surgery groups (63.3 vs. 28.6% vs. 0, P=0.025). All patients (100%) showed significant improvement in dysphagia scores during placing SHIB. Although 20 patients (48.8%) experienced recurrent stricture, the median stricture length was decreased (P<0.001) and the median intervention-free interval was prolonged (P<0.001). In all patients, the mean BMI at and health-related quality of life at 1, 3, 6, and 12 months were significantly increased compared with baseline (P<0.05). On multivariate analysis, stricture etiology and wearing time were independent predictors of recurrent stricture.
CONCLUSIONS: The SHIB has high efficacy and safety in treating refractory BESs of different origins, especially for endoscopic resection. Stricture etiology and wearing time were independent predictors of recurrent stricture.
摘要：
目的：目前难治性良性食管狭窄（BES）的治疗通常需要数年时间，效果较差。作者提出了一种新型的自助充气气球（SHIB）的方法，并评估了其有效性和安全性。
方法：前瞻性，多中心研究于2019年1月至2022年3月进行。所有入选患者均诊断为难治性BES并接受SHIB治疗。主要终点是去除SHIB后12个月的临床成功率。次要终点是放置SHIB的天数，以及1,3,6和12个月时BMI和健康相关生活质量的基线变化。
结果：临床成功率为51.2％（21/41），放置SHIB的中位天数为104.0天（范围：62.0-134.5天），与苛性和手术组相比，内镜组较高(63.3vs.28.6%与0,P=0.025)。所有患者（100％）在放置SHIB期间吞咽困难评分显着改善。尽管有20例患者（48.8％）经历了复发性狭窄，中位狭窄长度缩短(P<0.001),中位无干预间期延长(P<0.001).在所有患者中，与基线相比,1,3,6和12个月时的平均BMI和健康相关生活质量显著升高(P<0.05).在多变量分析中，狭窄的病因和佩戴时间是复发狭窄的独立预测因素。
结论：SHIB在治疗不同来源的难治性BES方面具有很高的疗效和安全性，尤其是内窥镜切除。狭窄的病因和佩戴时间是复发狭窄的独立预测因素。
方法：前瞻性，多中心研究于2019年1月至2022年3月进行。所有入选患者均诊断为难治性BES并接受SHIB治疗。主要终点是去除SHIB后12个月的临床成功率。次要终点是放置SHIB的天数，以及1,3,6和12个月时BMI和健康相关生活质量的基线变化。
结果：临床成功率为51.2％（21/41），放置SHIB的中位天数为104.0天（范围：62.0-134.5天），与苛性和手术组相比，内镜组较高(63.3vs.28.6%与0,P=0.025)。所有患者（100％）在放置SHIB期间吞咽困难评分显着改善。尽管有20例患者（48.8％）经历了复发性狭窄，中位狭窄长度缩短(P<0.001),中位无干预间期延长(P<0.001).在所有患者中，与基线相比,1,3,6和12个月时的平均BMI和健康相关生活质量显著升高(P<0.05).在多变量分析中，狭窄的病因和佩戴时间是复发狭窄的独立预测因素。
结论：SHIB在治疗不同来源的难治性BES方面具有很高的疗效和安全性，尤其是内窥镜切除。狭窄的病因和佩戴时间是复发狭窄的独立预测因素。
