Secondary outcomes reported in the FCSEMS cohort and the plastic stent and early surgery cohort in the preoperative drainage versus early surgery RCT
| FCSEMS cohort | Drainage vs early surgery RCT | Drainage vs early surgery RCT | |
|---|---|---|---|
| Metal stent | Plastic stent | Early surgery | |
| N=49 | N=102 | N=94 | |
| N (%) | N (%) | N (%) | |
| Overall protocol-specified complications | 25 (51) | 75 (74) | 37 (39) |
| Preoperative biliary drainage | 12 (24) | 47 (46) | 2 (2) |
| Surgery | 19 (39) | 48 (47) | 35 (37) |
| Other complication (outside protocol) | 9 (18) | 25 (25) | 30 (32) |
| Mortality 120 days | |||
| Due to protocol-specified complications | 1 (2) | 9 (9) | 4 (4) |
| Due to any cause | 3 (6) | 15 (15) | 12 (13) |
| Readmission* | 14 (29) | 34 (33) | 11 (12) |
| Due to PBD complications only | 10 (20) | 26 (25) | |
| Hospital stay, median (P25–P75) | 12 (8–18) | 16 (11–22) | 14 (10–21) |
*Due to preoperative and postoperative protocol-specified complications.
FCSEMS, fully covered self-expandable metal stent; PBD, preoperative biliary drainage; RCT, randomised controlled trial.