Adverse events, success, and tolerability of biliary endoscopic retrograde cholangiopancreatography with conscious sedation vs anaesthesia: a multi-centre prospective study.

Background And Aims: Endoscopic retrograde cholangiopancreatography (ERCP) is performed using anaesthesia or conscious sedation, though the effectiveness, adverse events (AEs), and tolerability of each approach remain unclear. Thus, we compared these approaches prospectively.

Methods: We performed a multi-centre prospective cohort study including patients with native papillae undergoing ERCP for biliary indications between 2018 and 2023. The primary outcome was sedation-related AEs, defined as sustained hypoxaemia or hypotension, unplanned mask ventilation or intubation, vasopressor or reversal agent use, cardiorespiratory arrest, or death. Secondary outcomes included other AEs, technical success measures, and patient-reported tolerability using a validated scale. Multivariable logistic regression was performed in addition to propensity score-matched analyses.

Results: At 8 centres, a total of 3174 first-time biliary ERCPs were performed, 433 (13.6%) employing anaesthesia. Nine sedation-related AEs occurred with conscious sedation (0.3%), while 2 (0.5%) occurred with anaesthesia (odds ratio, OR, 0.35, 0.07-2.37). Only 25 (0.9%) conscious sedation-supported ERCPs were aborted due to the inability to appropriately sedate patients. There were no significant differences in other AE rates, cannulation success, time, or attempts, use of pre-cut or needle-knife access methods, or inadvertent pancreatic duct cannulation. Odds of significant patient-reported intra-procedural awareness and discomfort were both higher with conscious sedation (ORs 16.19, 4.81-54.53, and 21.25, 4.44-101.61, respectively). Propensity score-matched analyses yielded no differences in any outcome compared with primary analyses.

Conclusions: Routine biliary ERCP is equally safe and effective with conscious sedation (vs anaesthesia). Given regional resource limitations, conscious sedation is justified as a primary option for routine biliary ERCP.