ABSTRACT
The assessment of the efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines in actual practice is extremely important, and monitoring efforts are being implemented worldwide. In Japan, a joint council in the Ministry of Health, Labour and Welfare is held every two to three weeks to summarise information on the adverse events following COVID-19 vaccination, with careful assessment of individual case safety reports and comparison with background incidence rates. In 2021, the joint council mainly reviewed anaphylaxis, death, myocarditis/pericarditis, and thrombosis with thrombocytopenia syndrome. These activities resulted in several safety-related regulatory actions, including the revision of vaccine package inserts with warnings about myocarditis/pericarditis. International sharing of vaccine safety information, as well as details of the evaluation systems, is important for international discussion and decision-making on better safety monitoring of COVID-19 vaccines.
ABSTRACT
BACKGROUND: Endoscopic balloon dilatation (EBD) is performed to treat strictures after esophagectomy. However, little is known about using EBD for benign strictures that occur after nonsurgical treatments for esophageal cancer such as chemoradiotherapy (CRT) or endoscopic mucosal resection (EMR). The aim of this study was to evaluate the safety and efficacy of EBD for benign strictures after nonsurgical treatment compared with those after surgery. METHODS: We identified 823 patients with esophageal cancer who completed definitive treatments between 2004 and 2007. Of these patients, 122 were enrolled in our study, including 60 who had surgery and 62 who did not have surgery (32 CRT, 30 EMR). The indication criteria for EBD were complaint of dysphagia and the inability to pass a conventional endoscope due to benign stricture. We retrospectively analyzed the safety and efficacy of EBD, and the measured outcomes were treatment success rate, time to treatment success, and refractory stricture rate. RESULTS: Perforation occurred in 3 (0.3 %) of 1,077 EBD sessions, with no bleeding. Efficacy was evaluated in 110 of the 122 patients. While the treatment success rate was over 90 % in both the surgery and the nonsurgery group, there was a significant difference in the median time to treatment success between both groups (2.3 vs. 5.6 months, p = 0.02: log-rank test). There was a significant difference in the median time to treatment success between CRT and surgery groups (7.0 months, p = 0.01), with no significant difference in the EMR group (4.4 months, p = 0.85). A significant difference in the refractory stricture rate was evident between the nonsurgery group (75 %) and the surgery group (45 %, p < 0.01). CONCLUSION: EBD for stricture after nonsurgical treatment of esophageal cancer was safe and effective. However, patients with benign strictures after nonsurgical treatment required significantly longer time to recover from dysphasia compared to those after surgery.