A simple clinical score to stratify the risk of procedure-related adverse events in ERCP procedures with trainee involvement.

BACKGROUND : Optimal training strategies in endoscopic retrograde cholangiopancreatography (ERCP) remain controversial despite the shift toward competence-based training models, with limited data available on patient safety during training. We aimed to assess whether pre-procedural clinical predictors could identify patients at low risk of developing procedure-related adverse-events (AEs) in a training environment. METHODS : We performed a prospective, multicenter, cohort study in five training centers. A data collection system documenting indication, clinical data, trainee performance (assessed using a validated competence assessment tool), technical outcomes, and AEs over a 30-day follow-up was utilized. We developed a clinical risk score (Trainee Involvement in ERCP Risk Score [TIERS]) for patients undergoing ERCP and compared the rate of AEs in a training environment between low-risk and high-risk groups. The association between trainee performance and AE rate was also evaluated. RESULTS : 1283 ERCPs (409 [31.9 %, 95 %CI 29.3 %-34.4 %] with trainee involvement) performed by 11 trainers and 10 trainees were analyzed. AEs were more frequent in the high-risk compared with the low-risk group: 26.7 % (95 %CI 20.5 %-34.7 %) vs. 17.1 % (95 %CI 12.8 %-22.2 %). TIERS demonstrated a high negative predictive value for AEs (82.9 %, 95 %CI 79.4 %-85.8 %) and was the only predictor of AEs on multivariable analysis (odds ratio 1.38, 95 %CI 1.09-1.75). Suboptimal trainee performance was associated with an increase in AE rates. CONCLUSION : Simple, clinical-based predictive tools could improve ERCP training by selecting the most appropriate cases for hands-on training, with the aim of increasing patient safety.

Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial.

BACKGROUND: Training in advanced endoscopic techniques such as endoscopic retrograde cholangiopancreatography (ERCP) should be driven by key performance measures and standardized competence assessment in order to provide safe and high-quality interventions. We aimed to determine whether the involvement of trainees influences the outcome of the procedure and the incidence of ERCP-related adverse events. METHODS: This was an international, multicenter, prospective, observational study conducted at six high- and low-volume centers across Europe between October 2016 and October 2018, and included independent operators and their trainees. Standard report forms documenting indication, trainee involvement, technical outcome, and complications over a 30-day follow-up of consecutive ERCP procedures were included in the analysis. Technical success of the procedure and procedure-related adverse events were compared between procedures in the trainee group and the control group using bivariable and multivariable analysis. RESULTS: 21 trainees and 16 control endoscopists performed 1843 ERCPs during the study period. Trainee involvement in ERCP procedures did not decrease technical success (92.4 % vs. 93.7 %; P = 0.30) or increase the risk of adverse events (14.7 % vs. 14.6 %; P > 0.99). Conversely, there were significantly more moderate or severe adverse events in the control group compared with the trainee group (6.2 % vs. 3.4 %, P = 0.01). On multivariable analysis, only increased bilirubin levels, time to cannulation, and procedure difficulty level increased the risk of any procedure-related adverse event. CONCLUSION: Trainee involvement in ERCP interventions within a proper teaching setting is safe and does not compromise the success of the procedure.

Markers of cardiac dysfunction associated with inflammation in a cohort of patients with acute decompensation of cirrhosis.

BACKGROUND AND AIMS: Inflammation underpinning acute decompensation (AD) of liver disease is an important driver for the development of acute-on-chronic liver failure or death. We aimed to investigate associations between inflammatory biomarkers and impaired cardiac function in patients admitted for AD of cirrhosis. METHODS: This is a retrospective analysis of a well-characterized prospective cohort of patients with AD of liver disease admitted to a tertiary referral center. All patients had echocardiographic assessment of cardiac function and serum samples at admission. We reclassified patients according to the CLIF-C AD score, measured inflammatory (IL-6, IL-8, TNF-ɑ, CD206) and cardiac-specific (NT-proBNP, troponin T) biomarkers and tested for associations with echocardiographic parameters of cardiac function. We explored the impact on outcome of these factors in multivariate analysis. RESULTS: We included 70 patients (58 ±â€…10 years, 28 women), with a mean CLIF-C AD score of 47 ±â€…7. Thirty-nine patients (56%) fulfilled the echocardiographic criteria for cardiac dysfunction. We found associations between parameters of diastolic dysfunction and serum concentrations of IL-6 and CD206. Echocardiographic parameters of cardiac function were not associated with markers of liver dysfunction such as the CLIF-C AD score. In multivariate analysis higher MELD, higher NT-proBNP, and IL-8 concentrations as well as the absence of echocardiographic criteria for cardiac dysfunction significantly associated with death during follow-up. CONCLUSION: We found evidence in favor of a clinically relevant link between serum biomarkers of inflammation (IL-6, CD206) and echocardiographic signals of cardiac dysfunction in patients with acutely decompensated cirrhosis.