Treatment with vonoprazan for 3 weeks is not inferior to 8 weeks for the management of gastric ESD: a multicenter noninferiority randomized study.

BACKGROUND: Vonoprazan, a potassium-competitive acid blocker (VPZ), significantly reduces postoperative bleeding after gastric ESD; however, there is no consensus on the appropriate treatment duration. We conducted a randomized controlled study to demonstrate that the 3-week administration of VPZ is not inferior to the 8-week administration for ulcer healing. METHODS: This is a prospective, open-label multicenter randomized controlled trial. Patients aged 20-85 years undergoing gastric ESD were included in this study. The key exclusion criteria were patients with bleeding tendencies and those taking NSAIDs, steroids, PPIs, or VPZ medications. Eligible patients were randomly assigned to the VPZ 3w or 8w treatment group. The primary endpoint was the proportion of patients with complete closure of the post-ESD wound at 24 weeks after ESD. The key secondary endpoints included the proportion of patients with complete closure of the post-ESD wound at 8 weeks and the proportion of bleeding or perforation more than 3 weeks after ESD. RESULTS: From May 2018 to October 2020, 234 patients were included. The proportion of patients with complete ulcer closure was significantly lower in the 3w group than in the 8w group (70.8% vs. 90.6%) at 8 weeks post-treatment. The complete closure rates at 24 weeks in the 3w and 8w groups were 99.1% and 99.2%, respectively. The absolute difference in the closure rate at 24 weeks was - 0.059% [95% confidence interval (CI) -3.4% to 3.2], and the lower limit of the 95% CI exceeded -10%, the preset threshold. None of the patients developed delayed bleeding 3 weeks after ESD. CONCLUSION: This multicenter randomized study demonstrated that 3 weeks of treatment with VPZ is sufficient for ulcer healing. Trial registry number. UMIN000031564.

Safety and usefulness of endoscopic submucosal dissection for early esophageal cancers in elderly patients aged 80 years or older.

BACKGROUND AND AIM: Endoscopic submucosal dissection (ESD) for early gastrointestinal (GI) cancers is widely performed as a standard treatment in Japan. Given the increasing life expectancy worldwide, it is naturally regarded that the rate of elderly patients diagnosed with early GI cancer has increased. Available guidelines do not specifically outline how to manage endoscopic therapy for the elderly. The aim of this study was to assess the safety and usefulness of ESD for superficial esophageal squamous cell carcinoma (SESCC) in elderly patients. METHODS: We retrospectively investigated 393 consecutive patients, who underwent 426 ESD for 444 SESCCs from January 2011 to August 2016 at our institution. For this study, patients were divided into 2 groups based on their age; ≥ 80 years (Group aged ≥ 80 years, n = 42) and < 80 years (group aged < 80 years, n = 351). Patient demographics, sedation methods, technical outcomes, adverse events, sedatives, dosages given, overall survival, and disease-specific survival were then examined. RESULTS: The ESD procedure time was significantly longer for group aged ≥ 80 years than for group aged < 80 years (110 min [range 29-260] vs 85 min [24-504], p = 0.006); however, there was no significant differences between other technical items and adverse events. The 3-year overall survival and disease-specific survival were favorable in both groups. CONCLUSIONS: Esophageal ESD for elderly patients aged ≥ 80 years can be safely performed. Mid-term outcome was favorable. Our study suggests that esophageal ESD might be a useful treatment for SESCCs.