Table 6.
Summary of primary and secondary outcome measurement results
| SA (n = 60) | SH (n = 62) | P | |
|---|---|---|---|
| Primary outcome measure | |||
| Efficacy rate, % (n) | 91.7 (55) | 88.7 (55) | <0.001a |
| En bloc complete resection | 100.0 (60) | 96.8 (60) | 0.496b |
| Additional counts of injection | |||
| 0 | 83.3 (50) | 83.9 (52) | 0.994c |
| 1 | 8.3 (5) | 6.5 (4) | |
| ≥2 | 8.3 (5) | 9.7 (6) | |
| Secondary outcome measures | |||
| Mucosal resection ease, % (n) | |||
| Extremely easy | 38.3 (23) | 33.9 (21) | 0.678c |
| Easy | 46.7 (28) | 51.6 (32) | |
| Ordinary | 13.3 (8) | 9.7 (6) | |
| Difficult | 1.7 (1) | 4.8 (3) | |
| Mucosal elevation shape, % (n) | |||
| Steep | 66.7 (40) | 59.7 (37) | 0.426c |
| Gentle elevation | 33.3 (20) | 40.3 (25) | |
| No elevation | 0.0 (0) | 0.0 (0) | |
| Unable to determine | 0.0 (0) | 0.0 (0) | |
| Time required for mucosal resection (min) | |||
| Mean (SD) | 39.2 (26.4) | 36.2 (22.4) | 0.847c |
| Injection volume (mL) | |||
| Mean (SD) | 23.3 (11.7) | 24.5 (11.6) | 0.506c |
a
Hypothesis test that the lower limit of 95% confidence interval (CI) of the difference in efficacy rate does not fall below the non‐inferiority margin (difference in the efficacy rate: 3.0%; 95% CI, −9.35% to 15.26%; non‐inferiority margin, −16.8%).
b
Fisher's exact test.
c
Wilcoxon two‐sample test.
SA, sodium alginate; SD, standard deviation; SH, sodium hyaluronate.