Endoscopic retrograde cholangiopancreatography (ERCP) remains a technically challenging and operator dependent procedure and data regarding the safety of ERCP with trainee involvement have been limited and conflicting. A recently published stent versus indomethacin (SVI) trial demonstrated that indomethacin plus prophylactic pancreatic stenting was superior to indomethacin alone for preventing post-ERCP pancreatitis (PEP) in high-risk patients. In this secondary analysis, trainee involvement and the rates of PEP and serious adverse events were assessed. Among 1,950 total patients randomized in the trial, 1,101 (56.4%) underwent ERCP with trainee involvement. There was no difference in the proportion of PEP between ERCPs performed with and without any trainee involvement, moderate-severe PEP, any serious adverse event, intensive care unit admission, overall duration of hospital stay and death. Among ERCPs with trainee involvement, the PEP rate was 14.2% in the indomethacin alone arm and 11.7% in the indomethacin plus prophylactic stent arm [risk difference (RD) 2.5% (95% CI -1.5, 6.5)]. Potential predictors of PEP among ERCPs with trainee involvement included patient age (OR 0.98), suspected or known sphincter of Oddi dysfunction (OR 1.86), history of recurrent pancreatitis (OR 1.93), number of pancreatic wire passages, treatment with Indomethacin plus prophylactic stent (OR 0.66) and total cannulation time (OR 1.01).
In this secondary analysis of the SVI trial, trainee participation in high-risk ERCP did not increase the risk of PEP or any serious adverse events. Moreover, prophylactic pancreatic duct stenting with rectal indomethacin did not increase the risk of PEP. Although the study was not powered to demonstrate inferiority between the two PEP reduction strategies and inherent confounders such as trainee, trainer and technician experience exist, this is a systematically conducted study in patients at high risk for ERCP with trainee involvement supporting current training strategies. However, predictors of PEP may be studied further and incorporated into a tailored approach to refine future training strategies in ERCP.