Background and study aims Interventional endoscopic treatments including the application of glue are becoming more frequently used for the treatment of
esophageal fistulas. However, there are no prospective studies of endoscopic treatment for
esophageal fistulas. This prospective study aims to investigate the efficacy and safety of endoscopic injection of alpha-
cyanoacrylate monomer for intractable
esophageal fistulas. Patients and methods This single-center prospective phase II trial included patients with more than 1 wk of conservative medical treatment for intractable
esophageal fistulas after
esophagectomy. In the image-guided
therapy suite, a mixture of alpha-
cyanoacrylate monomer and oily
contrast agent in a ratio of 0.3 to 1.7 mL was endoscopically injected through the
fistula. Results Twenty-five patients who underwent
esophagectomy at Wakayama Medical University Hospital were enrolled in this study. The primary disease was
esophageal cancer in 16 patients (64 %) and
gastric cancer in the remaining 9 patients (36 %). Complete closure of the
esophageal fistula was performed in 22 patients after endoscopic injection of alpha-
cyanoacrylate monomer. The overall success rate was 88 %. There was no
fistula recurrence in any successful closure cases. Three patients with failed
esophageal fistula closure had
esophageal cancer with cervical
esophageal fistulas and required reoperation of the fistulectomy under
general anesthesia. No complications associated with this endoscopic treatment were detected. Conclusions Endoscopic treatment with injection of alpha-
cyanoacrylate monomer facilitated healing of post-
esophagectomy fistula in 88 % of patients without complications. This suggests that the treatment is effective and safe for patients with
esophageal fistulas.