Jun Dai1, Yufeng Shen1, Xiaobo Li2, Yunjie Gao1, Yan Song1, Zhizheng Ge3. 1. Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai Institute of Digestive Diseases, Shanghai, China. 2. Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai Institute of Digestive Diseases, Shanghai, China. lxb_1969@163.com. 3. Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai Institute of Digestive Diseases, Shanghai, China. zhizhengge@yahoo.com.cn.
Abstract
AIM: To investigate the efficacy, safety and optimal duration of placement of modified retrievable metal stents for treatment of achalasia cardia. METHODS: Patients were randomly divided into groups A (N = 26, modified stents for 3 days), B (N = 26, modified stents for 2 days), C (N = 24, balloon dilation), and D (N = 25, regular stents for 2 days). Clinical symptom scores were recorded at baseline, 6 months, and during long-term follow-up. RESULTS:Seventy-seven patients with achalasia underwentstent placement (100 % success rate of implantation and extraction, no perforation). No stent migration or drop-off occurred in groups A and B. In group D, stent drop-off and migration was observed in 2 and 1 patients, respectively. Two patients in group C sustained esophageal perforation. Patients in the modified stent (A and B), balloon dilated (C) and regular stents (D) groups experienced significant improvement in dysphagia at 6 months, with recurrence in 1.92, 8.33 and 28 %, respectively. The clinical symptom score in the modified stent groups was significantly lower than that in the balloon dilated group (P = 0.01). During long-term follow-up, the symptom scores in modified stent groups were significantly lower than that in the balloon dilated (P < 0.01) and regular stent (P < 0.01) groups. CONCLUSION:Modified retrievable metal stents required an optimal placement duration of 2 days were safe with no incidence of migration or drop-off and had a lower recurrence of symptoms.
RCT Entities:
AIM: To investigate the efficacy, safety and optimal duration of placement of modified retrievable metal stents for treatment of achalasia cardia. METHODS:Patients were randomly divided into groups A (N = 26, modified stents for 3 days), B (N = 26, modified stents for 2 days), C (N = 24, balloon dilation), and D (N = 25, regular stents for 2 days). Clinical symptom scores were recorded at baseline, 6 months, and during long-term follow-up. RESULTS: Seventy-seven patients with achalasia underwent stent placement (100 % success rate of implantation and extraction, no perforation). No stent migration or drop-off occurred in groups A and B. In group D, stent drop-off and migration was observed in 2 and 1 patients, respectively. Two patients in group C sustained esophageal perforation. Patients in the modified stent (A and B), balloon dilated (C) and regular stents (D) groups experienced significant improvement in dysphagia at 6 months, with recurrence in 1.92, 8.33 and 28 %, respectively. The clinical symptom score in the modified stent groups was significantly lower than that in the balloon dilated group (P = 0.01). During long-term follow-up, the symptom scores in modified stent groups were significantly lower than that in the balloon dilated (P < 0.01) and regular stent (P < 0.01) groups. CONCLUSION: Modified retrievable metal stents required an optimal placement duration of 2 days were safe with no incidence of migration or drop-off and had a lower recurrence of symptoms.
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