Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
Clin Gastroenterol Hepatol. 2013 Jul;11(7):795-801.e1. doi: 10.1016/j.cgh.2013.01.016. Epub 2013 Jan 30.
BACKGROUND & AIMS: Benign anastomotic strictures are often difficult to treat. We assessed the efficacy of adding corticosteroid injections to endoscopic dilation therapy with Savary bougienage.
In a multicenter, double-blind trial, 60 patients (mean age, 63 ± 9 years; 78% male) with an untreated cervical anastomotic stricture after esophagectomy with gastric tube reconstruction and dysphagia for at least solid food were randomly assigned to groups given 4 quadrant injections of 0.5 mL triamcinolone (40 mg/mL, n = 29) or saline (controls, n = 31) into the stricture, followed by Savary dilation to 16 mm. Dysphagia, complications, and quality of life were assessed after 1 and 2 weeks and 1, 3, and 6 months. The primary end point was a dysphagia-free period of 6 months.
In the corticosteroid group, 45% of the patients remained dysphagia-free for 6 months, compared with 36% of controls (relative risk, 1.26; 95% confidence interval, 0.68-2.36; P = .46). Median time to repeat dilation was 108 days (range, 15-180 days) in the corticosteroid group vs 42 days (range, 17-180 days) for controls (P = .11). A median number of 2 dilations (range, 1-7) was performed in the corticosteroid group vs 3 dilations (range, 1-9) in controls (relative risk, 0.76; 95% confidence interval, 0.42-1.38; P = .36). Two major intervention-related complications occurred, 1 submucosal laceration in the corticosteroid group and 1 hemorrhage in the control group. Four patients in the corticosteroid group, but none of the controls, developed Candida esophagitis (P = .03).
Corticosteroid injections do not provide a statistically significant decrease in frequency of repeat dilations or prolongation of the dysphagia-free period in patients with benign anastomotic esophagogastric strictures. Dutch Trial Registration Number 2236.
良性吻合口狭窄通常难以治疗。我们评估了在 Savary 扩张器内镜扩张治疗中加入皮质类固醇注射治疗的效果。
在一项多中心、双盲试验中,60 名(平均年龄,63 ± 9 岁;78%为男性)因胃管重建后食管切除术导致未经治疗的颈段吻合口狭窄且存在至少固体食物吞咽困难的患者被随机分配到两组,分别向狭窄处的 4 个象限注射 0.5 mL 曲安奈德(40 mg/mL,n = 29)或生理盐水(对照组,n = 31),然后用 Savary 扩张器扩张至 16 mm。在第 1、2 周和第 1、3、6 个月评估吞咽困难、并发症和生活质量。主要终点是 6 个月无吞咽困难的时间。
在皮质类固醇组中,45%的患者 6 个月后仍无吞咽困难,而对照组为 36%(相对风险,1.26;95%置信区间,0.68-2.36;P =.46)。皮质类固醇组再次扩张的中位时间为 108 天(范围,15-180 天),而对照组为 42 天(范围,17-180 天)(P =.11)。皮质类固醇组行中位数为 2 次扩张(范围,1-7 次),而对照组为 3 次扩张(范围,1-9 次)(相对风险,0.76;95%置信区间,0.42-1.38;P =.36)。皮质类固醇组发生 2 例与干预相关的主要并发症,1 例为黏膜下裂伤,对照组发生 1 例出血。皮质类固醇组有 4 例患者发生念珠菌性食管炎,而对照组无此并发症(P =.03)。
在良性吻合口食管胃狭窄患者中,皮质类固醇注射不能在重复扩张的频率或无吞咽困难期的延长方面提供统计学意义上的降低。荷兰试验注册号 2236。