Sixty-seven patients with superficial esophageal squamous cell carcinomas with mucosal defects that exceeded one half of the circumference of the esophagus after ESD treatment were enrolled and randomly divided into 2 groups (group A, n = 33; group B, n = 34). Patients in group A (BTX-A group) were immediately injected with BTX-A after ESD, whereas patients in group B (control group) received ESD only. Endoscopy was performed when patients reported dysphagia symptoms and at 12 weeks post-ESD in patients without symptoms. Patients who experienced post-ESD esophageal strictures in both groups received bougie dilation.
The number of patients who experienced esophageal strictures in group A (per protocol analysis, 6.1%, 2/33; intention to treat analysis, 11.4%, 4/35) was significantly less than that seen in group B (per protocol analysis, 32.4%, 11/34; intention to treat analysis, 37.8%, 14/37) (P < .05). Moreover, the number of bougie dilation procedures was significantly lower in group A (mean, 1.5; range, 0-2) than in group B (mean, 2.8; range, 0-5) (P < .05).
Endoscopic injection of BTX-A was effective in preventing post-ESD esophageal strictures and decreasing the times of bougie dilation procedures. (Clinical trial registration number: ChiCTR-TRC-12003188.)