Tomonori Yano1, Yusuke Yoda2, Satoru Nonaka3, Seiichiro Abe3, Noboru Kawata4, Toshiyuki Yoshio5, Takashi Sasaki5, Shinwa Tanaka6, Fumisato Sasaki7, Takao Maekita8, Masayuki Kitano8, Kenshi Matsumoto9, Hiroyuki Isayama9, Hiroyuki Ono4. 1. Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 288-8577, Japan. toyano@east.ncc.go.jp. 2. Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 288-8577, Japan. 3. Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan. 4. Division of Endoscopy, Shizuoka Cancer Center Hospital, Shizuoka, Japan. 5. Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan. 6. Department of Endoscopic Internal Medicine, Kobe University Hospital, Hyogo, Japan. 7. Department of Endoscopic Internal Medicine, Kagoshima University Hospital, Kagoshima, Japan. 8. Department of Gastroenterology, Wakayama Medical University, Wakayama, Japan. 9. Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Abstract
OBJECTIVE: Benign esophageal strictures (BES) cause dysphagia and decrease patients' quality of life. Although mechanical dilation is the standard of care for BES, in some patients, dysphagia is unrelieved despite repeated procedures. The biodegradable stent was developed to resolve refractory BES, with reported favorable outcomes, but it is unapproved in Japan. Thus, we evaluated the safety and efficacy of the biodegradable stent (BDS) for patients with refractory BES for regulatory approval. METHODS: This was a nonrandomized single-arm prospective trial conducted at eight institutions. We included patients with BES after ≥ 5 times of dilation or ≥ one time of radial incision and cutting whose dysphagia score (DS) was 2 or worse and an endoscope could not admit. The primary endpoint was the proportion of patients whose DS improvement of ≤ 1 was maintained at 3 months. RESULTS: Thirty patients (median age: 69 years, male/female: 27:3) were enrolled and treated; BDS placement failed in 1 patient. Fourteen patients maintained their DS improvement until 3 months after placement (proportion of DS improvement at 3 months 46.7% [95% CI: 28.3-65.7]), and the median dysphagia-free survival was 98 days [95% CI: 68-123]. Most adverse events could be managed conservatively; however, a patient with BES after chemoradiotherapy (CRT) developed an esophago-left atrium fistula and died approximately 4 months after stent placement. CONCLUSION: The BDS was effective for refractory BES and the safety was acceptable. However, the indication for this procedure in patients RECEIVING CRT for esophageal cancer should be carefully considered.
OBJECTIVE: Benign esophageal strictures (BES) cause dysphagia and decrease patients' quality of life. Although mechanical dilation is the standard of care for BES, in some patients, dysphagia is unrelieved despite repeated procedures. The biodegradable stent was developed to resolve refractory BES, with reported favorable outcomes, but it is unapproved in Japan. Thus, we evaluated the safety and efficacy of the biodegradable stent (BDS) for patients with refractory BES for regulatory approval. METHODS: This was a nonrandomized single-arm prospective trial conducted at eight institutions. We included patients with BES after ≥ 5 times of dilation or ≥ one time of radial incision and cutting whose dysphagia score (DS) was 2 or worse and an endoscope could not admit. The primary endpoint was the proportion of patients whose DS improvement of ≤ 1 was maintained at 3 months. RESULTS: Thirty patients (median age: 69 years, male/female: 27:3) were enrolled and treated; BDS placement failed in 1 patient. Fourteen patients maintained their DS improvement until 3 months after placement (proportion of DS improvement at 3 months 46.7% [95% CI: 28.3-65.7]), and the median dysphagia-free survival was 98 days [95% CI: 68-123]. Most adverse events could be managed conservatively; however, a patient with BES after chemoradiotherapy (CRT) developed an esophago-left atrium fistula and died approximately 4 months after stent placement. CONCLUSION: The BDS was effective for refractory BES and the safety was acceptable. However, the indication for this procedure in patients RECEIVING CRT for esophageal cancer should be carefully considered.