Table 3.
Secondary study outcomes
| Secondary Outcome | Definition |
|---|---|
| Clinical success rate | Technical success, in addition to a lack of repeat unplanned endoscopy, imaging, emergency department presentation or admission within 30 days of the index procedure for reasons related to ongoing pancreatico-biliary pathology that was initially thought to be resolved after the index ERCP |
| Subjective presence technical success | Determined by endoscopist, in binary fashion |
| Subjective assessment of duodenoscope ease of use | Determined by endoscopist, using Likert scale of 1–10 |
| Dislodgement rate of the disposable cap (for interventional arm only) | Loss of the duodenoscope cap inside the patient |
| Overall adverse event rate | Any adverse event(s) occurring within 30 days of the index procedure; divided into intraprocedural, early and late in terms of timing, and characterized in terms of severity by the ASGE Lexicon |
| Pancreatitis rate | New or distinct abdominal pain after ERCP in addition to lipase rise above 3 times the upper limit of normal, within 30 days of the index procedure |
| Asymptomatic lipase rate | Lipase rise above 3 times the upper limit of normal, within 30 days of the index procedure, not accompanied by classic pancreatitis abdominal pain |
| Bleeding rate | Hematemesis and/or melena and/or hematochezia, or drop in hemoglobin by ≥2 g following ERCP with either sphincterotomy or sphincteroplasty (or both) within 30 days of the index procedure |
| Cholangitis and/or sepsis rate | Re-presentation, readmission or prolongation of admission for any suspicion of biliary sepsis, indicated by any of: positive bacterial blood culture(s), leukocytosis, fever, or other features of systemic inflammatory response syndrome (SIRS), within 30 days of the index procedure |
| Unplanned presentation rate | Hospital admission or unplanned presentation to an acute healthcare facility within 30 days of the index procedure |
| Mortality rate | Patient death within 30 days of the index procedure |
| Manual post-ERCP disinfection time | Time taken to manually swab and disinfect the duodenoscope in the endoscopy unit after completion of ERCP |
| Automated post-ERCP reprocessing time | Time taken to automatically reprocess the duodenoscope in the reprocessing department after completion of ERCP |