Table 2:
Incidence of the primary, secondary, and safety outcomes.*
| Intent-to-Treat Analysis N=1950 | Per Protocol Analysis N=1728 | ||||
|---|---|---|---|---|---|
| Primary Outcome | Indomethacin + Stent N=975 | Indomethacin Alone N=975 | Indomethacin + Stent N=777 | Indomethacin Alone N=951 | |
| Presence of Post-ERCP | N (%) | 110 (11.3%) | 145 (14.9%) | 90 (11.6%) | 137 (14.4%) |
| Acute Pancreatitis | 95% CI | (9.3%, 13.3%) | (12.6%, 17.1%) | (9.3%, 13.8%) | (12.2%, 16.6%) |
| RD (95% CI) | 3.6% (0.6%, 6.6%) | 2.8% (−0.3%, 6.0%) | |||
| Secondary and Safety Outcomes | |||||
| Moderate-Severe Post-ERCP Pancreatitis1 | 58 (6.0%) | 78 (8.0%) | 45 (5.8%) | 74 (7.8%) | |
| RD (95% CI) | 2.1% (−0.2%, 4.3%) | 2.0% (−0.4%, 4.4%) | |||
| Severe pancreatitis − n (%) | 14 (1.4%) | 20 (2.1%) | 12 (1.5%) | 19 (2.0%) | |
| RD (95% CI) | 0.6% (−0.5%, 1.8%) | 0.5% (−0.8%, 1.7%) | |||
| Pancreatitis-related Death − n (%) | 0 (0%) | 3 (0.3%) | 0 (0%) | 3 (0.3%) | |
| RD (95% CI) | 0.3% (0%, 0.7%) | 0.3% (0%, 0.7%) | |||
| ICU Admission− n (%) | 39 (4.0%) | 29 (3.0%) | 27 (3.5%) | 29 (3.0%) | |
| RD (95% CI) | −1% (−2.7%, 0.6%) | −0.4% (−2.1%, 1.3%) | |||
| Hospital length of stay | N | 975 | 975 | 777 | 951 |
| Mean (SD) | 2.9 (6.7) | 3.2 (7.2) | 2.8 (6.7) | 3.2 (7.1) | |
| Median (Min, Max) | 0.0 (0.0, 71.0) | 0.0 (0.0, 86.0) | 0.0 (0.0, 62.0) | 0.0 (0.0, 86.0) | |
| Difference in Means (95% CI) | 0.4 (−0.3, 1.0) | 0.3 (−0.3, 1.0) | |||
*
The intention-to-treat analysis included all randomized subjects; RD denotes risk difference for the indomethacin alone group minus the indomethacin plus stent group; CI denotes confidence interval.
*
The per protocol analysis excluded randomized subjects with any of the following predefined types of protocol deviations: eligibility violations, indomethacin not administered, treatment crossover, or missing outcome data.
1
Moderate-severe post-ERCP pancreatitis missing for 2 subjects (1 indomethacin + stent, 1 indomethacin alone) and excluded from percentage denominator.