Table 4. Additional surgery and procedure-related adverse events (n=5,269).
| Events | Values | |
|---|---|---|
| Adverse events | 240 (4.6) | |
| Intraprocedural bleeding* | 8 (0.2) | |
| Delayed bleeding† | 181 (3.4) | |
| Perforation | 46 (0.9) | |
| Others | 5 (0.1) | |
| Additional surgery (indication) | 614 (11.7) | |
| NCR | 599 (11.4) | |
| Complication | 5 (0.1) | |
| Others‡ | 10 (0.2) | |
Values are shown as number (%). Data are presented on a per-hospitalization basis, with multiple ESDs during a single hospitalization considered as one ESD session. Percentages were calculated based on the total number of ESD sessions (n=5,269).
NCR = non-curative resection; ESD = endoscopic submucosal dissection.
*Intraprocedural bleeding was defined as an event requiring transfusion.
†Delayed bleeding was defined as overt gastrointestinal bleeding, a decrease in hemoglobin of ≥2 g/dL, or the need for transfusion.
‡Additional surgery was performed in 9 patients classified as curative resection according to guideline-based criteria, based on cautious clinical judgment after discussion with the patient. These included lesions that met the expanded criteria but had potentially unfavorable features, including predominantly undifferentiated histology despite a size of ≤2 cm, lesions >2 cm with a minor undifferentiated component, or shallow submucosal invasion. One patient underwent surgery due to patient preference.