Health Economic Comparisonof Retrievable Self-expanding Full-covered Film Metal Stent and Endoscopic Dilation for Benign Anastomotic Stenosis after Esophagectomy of Esophageal Cancer: A Randomized Controlled Trial

Abstract

Abstract Background: Endoscopic dilation (ED) is common and effective for improving strictures in patients with benign esophageal anastomotic stenosis (BEAS) after esophagectomy. A retrievable self-expanding metal stent has also been proven effective in treating strictures. However, evaluations comparing health economics of stent placement and ED for BEAS are lack. Methods: In this prospective, randomized, controlled, multicenter study, BEAS patients between October 2020 and October 2021 at six centers were included. Patients were randomized into stent replacement (SR) or water balloon dilation (WBD) groups, and re-treatment interval times, body mass index (BMI) changes, dysphagia score, quality of life (QOL), treatment fees/times, total cost, daily cost, restenosis, and adverse effects assessed. Mann-Whitney U test was used for continuous variable analysis and Kaplan-Meier to calculate cumulative percentage and effective rate; significance was set at P<0.05. Results: Re-treatment interventions were more frequent in the WBD group (3 vs. 1.2, p<0.05) and re-treatment interval times longer (60-days vs. 7-days, p<0.05). Patient compliance was lower in the WBD group (p<0.001), while treatment cost was higher in SR patients (5001 vs. 1812 yuan, p <0.001). Daily treatment cost was lower in SR patients (78.57 vs 86.29 yuan, p<0.05). QOL (97 vs. 86, p<0.05), changes in posttreatment BMI (0 vs -0.72, p<0.05), and posttreatment dysphagia score (1 vs. 2, p<0.05) were higher in SR patients. There were three adverse events, two stent migrations, and one patient died following ED. Conclusions: SR patients had higher QOL due to longer retreatment intervals, fewer endoscopic interventions, and lower daily treatment costs. Trial registration: The study was registered in the Chinese Clinical Trial Registry, number ChiCTR2000037864.