2.9. Data collection
blood coagulation
ADVERSE EVENTS
Baseline assessment before ESD will include patient sex, date of birth, date of obtaining informed consent, history of gastrectomy or reconstructive surgery of the gastric tract, assessment of performance status, American Society of Anesthesiologists physical status, and current use of antithrombotic agents. Other assessments will include subjective findings; objective findings; and the results of hematologic examinations, blood coagulation tests, upper endoscopy, and X-ray examination of the chest. Treatment parameters will be assessed on the day of ESD, and adverse events (AEs) will be recorded from the day of ESD to discharge 15 days later (i.e., from −5 to + 15 days). The results of blood tests and X-ray examination of the chest will be evaluated the day after ESD. Parameters assessed at date of last evaluation will include physical findings and the results of blood tests, X-ray examinations, and pathological evaluations. The schedule for data collection is shown in Fig. Schedule for data collection. *1: If adverse events associated with the procedure are suspected to have occurred, an emergency medical examination is performed as necessary. *2: within 28 days before registration. *3: within 120 days before registration.