Table 3.
Adverse Events
| Adverse Event | Multiple Plastic Stents (n = 55)
|
cSEMS (n = 57)
|
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|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total No. of Events | No. of Patients With Event | No. of Severe AEs,a | No. of Patients With Severe AE | No. of Related AEsb | No. of PatientsWith Related AE | Total No. of Events | No. of PatientsWith Event | No. of Severe AEs, a | No. of Patients With Severe AE | No. of Related AEsb | No. of Patients With Related AE | |
| Stent migration | 10 | 9 | 1 | 1 | 5 | 5 | 16 | 14 | 2 | 2 | 16 | 14 |
|
| ||||||||||||
| Abdominal pain | 9 | 8 | 1 | 1 | 4 | 4 | 8 | 8 | 2 | 2 | 6 | 6 |
|
| ||||||||||||
| Premature stent occlusion | ||||||||||||
|
| ||||||||||||
| Cholangitis | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | 2 | 2 |
|
| ||||||||||||
| Bile duct obstruction | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 |
|
| ||||||||||||
| Jaundice | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 |
|
| ||||||||||||
| Stent-induced changes to the bile duct | 5 | 5 | 0 | 0 | 3 | 3 | 2 | 2 | 0 | 0 | 2 | 2 |
|
| ||||||||||||
| Post-ERCP pancreatitis | 3 | 3 | 0 | 0 | 3 | 3 | 3 | 3 | 0 | 0 | 2 | 2 |
|
| ||||||||||||
| All othersc | 7 | 7 | 5 | 5 | 0 | 0 | 9 | 6 | 5 | 4 | 1 | 1 |
|
| ||||||||||||
| Total | 37 | 27 | 8 | 8 | 16 | 14 | 42 | 28 | 12 | 9 | 30 | 23 |
Abbreviations: AE, adverse event; cSEMS, fully covered, self-expandable metallic stent; ERCP, endoscopic retrograde cholangiopancreatography.
a
Need for procedural intervention or hospitalization.
b
Definitely or possibly related to the bile duct stents or ERCP procedure.
c
Refer to eTable 2 in Supplement 2 for details.