Noboru Hanaoka1, Ryu Ishihara1, Masaaki Motoori1, Yoji Takeuchi1, Noriya Uedo1, Noriko Matsuura1, Yoshito Hayashi1, Takuya Yamada1, Takeshi Yamashina1, Koji Higashino1, Tomofumi Akasaka1, Masahiko Yano1, Yuri Ito1, Hiroshi Miyata1, Keijiro Sugimura1, Kenta Hamada1, Yasushi Yamasaki1, Takashi Kanesaka1, Kenji Aoi1, Takashi Ito1, Hiroyasu Iishi1. 1. Department of Gastroenterology, Osaka Red Cross Hospital, Osaka, Japan. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan. Department of Surgery, Osaka General Medical Center, Osaka, Japan. Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Japan. Department of Gastroenterology, Osaka Rosai Hospital, Sakai, Japan. Department of Gastroenterology, National Hospital Organization Osaka National Hospital, Osaka, Japan. Department of Surgery, Osaka International Cancer Institute, Osaka, Japan. Department of Cancer Epidemiology and Prevention, Center for Cancer Control and Statistics, Osaka International Cancer Institute, Osaka, Japan. Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan. Department of Gastroenterology, Kaizuka City Hospital, Kaizuka, Japan. Department of Gastroenterology, Obihiro-Kosei General Hospital, Obihiro, Japan. Department of Gastroenterology, Itami City Hospital, Itami, Japan.
Abstract
OBJECTIVE:Endoscopic balloon dilation (EBD) is a standard treatment for anastomotic strictures after esophagectomy, and requires multiple dilations. We conducted a randomized controlled trial to assess the efficacy of adding a steroid injection to EBD to reduce restricture. METHODS: Patients were randomized to receive EBD combined with either triamcinolone or placebo injection. The primary endpoint was the number of dilations required to resolve the stricture. The secondary endpoints were restricture-free survival and adverse events. Patients with a dysphagia symptom score of ≥2 after esophagectomy with an endoscopy-confirmed anastomotic stricture were included. A total of 50 mg of triamcinolone acetonide (50 mg/5 mL) or an identical volume of normal saline solution as a placebo was injected per site using a 25-gauge needle immediately after EBD. Both the patient and treating physician were blinded to the treatment given. RESULTS: During the 4-year study period, 65 patients were randomized to either the steroid group (n = 33) or placebo group (n = 32). The median number of EBDs required to resolve strictures was 2.0 (interquartile range, 1.0-2.5) in the steroid group and 4.0 (interquartile range, 2.0-6.8) in the placebo group (p < 0.001). After 6 months of follow-up, 39% of patients who had received steroid injections remained recurrence free compared with 16% of those who had received saline injections (p = 0.002). No adverse events occurred during follow-up. CONCLUSIONS:Steroid injection shows promising results for the prevention of stricture recurrence in patients who underwent EBD for anastomotic strictures.
RCT Entities:
OBJECTIVE: Endoscopic balloon dilation (EBD) is a standard treatment for anastomotic strictures after esophagectomy, and requires multiple dilations. We conducted a randomized controlled trial to assess the efficacy of adding a steroid injection to EBD to reduce restricture. METHODS:Patients were randomized to receive EBD combined with either triamcinolone or placebo injection. The primary endpoint was the number of dilations required to resolve the stricture. The secondary endpoints were restricture-free survival and adverse events. Patients with a dysphagia symptom score of ≥2 after esophagectomy with an endoscopy-confirmed anastomotic stricture were included. A total of 50 mg of triamcinolone acetonide (50 mg/5 mL) or an identical volume of normal saline solution as a placebo was injected per site using a 25-gauge needle immediately after EBD. Both the patient and treating physician were blinded to the treatment given. RESULTS: During the 4-year study period, 65 patients were randomized to either the steroid group (n = 33) or placebo group (n = 32). The median number of EBDs required to resolve strictures was 2.0 (interquartile range, 1.0-2.5) in the steroid group and 4.0 (interquartile range, 2.0-6.8) in the placebo group (p < 0.001). After 6 months of follow-up, 39% of patients who had received steroid injections remained recurrence free compared with 16% of those who had received saline injections (p = 0.002). No adverse events occurred during follow-up. CONCLUSIONS:Steroid injection shows promising results for the prevention of stricture recurrence in patients who underwent EBD for anastomotic strictures.
Authors: Sung Ill Jang; Sungsoon Fang; Ji Hae Nahm; Jae Hee Cho; Min Young Do; Su Yeon Lee; Seok Jeong; Don Haeng Lee; Dong Ki Lee Journal: Sci Rep Date: 2022-05-25 Impact factor: 4.996