Skip to main content

Table 3 Secondary study outcomes

From: Infection control in ERCP using a duodenoscope with a disposable cap (ICECAP): rationale for and design of a randomized controlled trial

Secondary OutcomeDefinition
Clinical success rateTechnical 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 successDetermined by endoscopist, in binary fashion
Subjective assessment of duodenoscope ease of useDetermined 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 rateAny 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 rateNew 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 rateLipase rise above 3 times the upper limit of normal, within 30 days of the index procedure, not accompanied by classic pancreatitis abdominal pain
Bleeding rateHematemesis 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 rateRe-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 rateHospital admission or unplanned presentation to an acute healthcare facility within 30 days of the index procedure
Mortality ratePatient death within 30 days of the index procedure
Manual post-ERCP disinfection timeTime taken to manually swab and disinfect the duodenoscope in the endoscopy unit after completion of ERCP
Automated post-ERCP reprocessing timeTime taken to automatically reprocess the duodenoscope in the reprocessing department after completion of ERCP