Abstract
The aspiration rates of high-density barium meal were higher than low-density barium using the conventional method. To assess evidence-based cancer screening, the potential hazards of cancer screening should be evaluated. However, few studies have investigated the adverse effects of the upper gastrointestinal series using a high-density barium meal. This study compared the adverse effects rates reported by the Japanese Society of Gastrointestinal Cancer Screening (JSGCS) with estimates from the Pharmaceuticals and Medical Devices Agency (PMDA). We conducted sensitivity analysis of the number of cancer screening participants that was a denominator of the adverse effects rates.
In the scenario where JSGCS investigated half of the number of cancer screening participants, mortality rates per 100,000 were 0.036 from estimates based on the PMDA, and 0.032 from the JSGCS, showing no significant differences (P=0.91). Furthermore, PMDA-estimated aspiration rates per 100,000 population were significantly lower (P<0.05) and gastrointestinal perforation rates per 100,000 population were significantly higher (P<0.05) than those reported by the JSGCS. Although huge differences were found between the JSGCS reports and the PMDA estimates in both aspiration and gastrointestinal perforation rates, mortality rates were similar.
Although serious adverse effects, including death, have been monitored, minor adverse effects, including aspiration, have differed in each report. Adverse effects should be defined and continuously monitored.
