Table 3.
Severe adverse events and their management
| Type of SAE | No./no. SAEs (%) | No. of patients | Treatment type | Treatment modality |
|---|---|---|---|---|
| Duodenal ulcer | 2/20 (10) | 2 | Endoscopy | PPI and definitive or temporary (nine days) J tube removal |
| Buried bumper syndrome | 2/20 (10) | 2 | Endoscopy | Needle knife excision |
| J-tube impaction in the jejunum | 1/20 (5) | 1 | Endoscopy | Endoscopic release with a guidewire |
| J-tube migration | 6/20 (30) | 5 | Endoscopy | J tube replacement |
| J-tube dysfunction | 6/20 (30) | 5 | ||
| Leakage | 1/20 (5) | 1 | Endoscopy | J tube replacement |
| Kinking | 1/20 (5) | 1 | J tube replacement | |
| Clogging | 4/20 (20) | 3 | Guidewire recanalization (2/4) and replacement (2/4) | |
| Covered duodenal perforation | 1/20 (5) | 1 | Conservative | Antibiotic (amoxicillin/clavulanic acid, 2 g 3 times/day, i.v.) |
| Multiple jejunal fistulas | 1/20 (5) | 1 | Surgery | Intestinal resection |
| Infected intra-abdominal collection | 1/20 (5) | 1 | Conservative | Antibiotic (piperacillin-tazobactam, 4 g 4 times/day, i.v.) |
SAE: severe adverse event