Abstract
BackgroundEsophageal stenosis following endoscopic submucosal dissection (ESD) is a serious adverse event that makes subsequent management more difficult.MethodsThis parallel, randomized, controlled, open-label study was designed to examine whether local steroid injection is an effective prophylactic treatment for esophageal stenoses following extensive ESD. This single center trial was conducted at the Keiyukai Hospital, a tertiary care center for gastrointestinal disease in Japan [University Hospital Medical Network Clinical Trial Registry (UMIN-CTR) on 15 September 2011 (UMIN000006327)]. Thirty-two patients with mucosal defects involving ≥75% of the esophageal circumference were randomized to receive a single dose of triamcinolone acetonide injections (n = 16) or be treated conventionally (n = 16). The primary outcome was the frequency of stricture requiring endoscopic dilatation; the surrogate primary endpoint was the number of dilatation sessions needed. Secondary outcomes included adverse event rates, the minimum diameter of the stenotic area and the duration of the course of dilatation treatments.ResultsThe frequency of stricture was not significantly different between the groups because of insufficient statistical power, but the number of dilatation sessions required was significantly less in the steroid group (6.1 sessions [95% confidence interval, CI 2.8–9.4] versus 12.5 [95% CI 7.1–17.9] sessions in the control group; P = 0.04). The perforation rate was similar in both groups. The minimum diameter of stenotic lumens was significantly greater in the treatment group than controls (11.0 mm versus 7.1 mm, respectively; P = 0.01). The perforation rate was not significantly different between the groups (1.0% versus 0.5% in the treatment and control group, respectively). Steroid injection was effective in cases of mucosal defects encompassing the entire esophageal circumference.ConclusionsProphylactic endoscopic steroid injection appears to be a safe means of relieving the severity of esophageal stenoses following extensive ESD.
Highlights
Esophageal stenosis following endoscopic submucosal dissection (ESD) is a serious adverse event that makes subsequent management more difficult
Mucosal defects extending over three-quarters of the circumference of the esophagus after endoscopic resection are closely associated with the subsequent development of esophageal stenosis [2], which can cause dysphagia and impair quality of life
209 patients with 256 lesions underwent ESD in our hospital, 42 of whom (20.1%) were enrolled in the study because they were expected to have mucosal defects extending over three-quarters of the esophageal circumference due to the ESD
Summary
Esophageal stenosis following endoscopic submucosal dissection (ESD) is a serious adverse event that makes subsequent management more difficult. In Japan, endoscopic submucosal dissection (ESD) is widely accepted as a standard treatment for early esophageal squamous cell carcinomas without documented metastasis. The ESD technique has been shown to reduce the risk of local recurrence, and perforations arising as a consequence of treatment are generally well tolerated [1]. Mucosal defects extending over three-quarters of the circumference of the esophagus after endoscopic resection are closely associated with the subsequent development of esophageal stenosis [2], which can cause dysphagia and impair quality of life. Patients with esophageal stenosis are frequently treated by endoscopic dilatation therapy. It is important to identify ways of preventing esophageal stenosis after ESD, and minimizing the complications associated with treatment when it does arise. Simple, safe, reliable and inexpensive approaches are needed to cope with iatrogenic esophageal stenoses
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