Are we awake yet? Conscious sedation is not enough for adequate ERCP quality: analysis of real-life tolerance and outcomes

Aims Unlike most developed countries, Endoscopic retrograde cholangiopancreatography (ERCP) under conscious sedation (Midazolam' Opioid) continues to be a standard practice in some countries like United Kingdom and in some specific centres mostly in Europe, Canada and Asia. We aimed to analyse quality criteria in regards of tolerance and procedural outcomes.

Methods Over 3-year period we evaluated the method of sedation, patient comfort scores, cannulation rates and completion frequency. All patients who underwent ERCP by a single independent ERCPist were included in the analysis using descriptive statistics. We identified two categories of suboptimal outcomes a) Failed procedures, in which cannulation was not achieved or was lost or b) Early termination: in which suboptimal tolerance significantly forced early finalising, compromising complete therapy or limited the capacity of the operator to successfully accomplish, e.g, duct clearance

Results The mean age of participants was 67.3 years, with the majority falling within the age range of 68 to 90 years. 58.3% were female and 41.7% male. Only 15 /438 ERCP were done under deep sedation or General Anaesthesia (GA) (3.42%). From all ERCP with conscious sedation, only 204 /423 (48.2%) were deemed comfortable. 174/423 (41.1%) had mild discomfort, 32/423 (7.5%) significant discomfort and 13/423 (3.07%) presented severe discomfort. Failed cannulation happened in 45/438 (10.27%), none of them under GA. Moderate-severe discomfort was an independent factor for unsuccessful cannulation:Odds ratio(OR) 2.47 (95% CI:1.10-5.55) Females had a higher risk of poor tolerance: OR 2.09 (95% CI:1.05-4.18) Inability to satisfactory complete ERCP due to poor tolerance was 44/426 (10.4%), in which lack of tolerance or prolonged procedure in a conscious sedated patient significantly forced early finalising or made the operator change mind regarding therapy (A decision that would not had been adopted had the patient been adequately sedated) e.g, biliary duct clearance vs leaving a stent. Comparison of outcomes across various indications showed no significant differences in complication rates or mortality in poor tolerance compared to good tolerance.

Conclusions Despite generally acceptable tolerance in most patients, this should not serve as justification for any percentage that suffered moderate or severe discomfort (1 in 10) considering ERCP is such a high-risk procedure with potential life threatening adverse events [1] [2] [3]. Female sex had an risk of high discomfort twice as high as male. Moderate-severe discomfort was an independent risk factor for failed cannulation but did not associated any other adverse event such as pancreatitis, perforation or mortality. Inadequate tolerance had an negative impact on the test in 10.4% (forced early finish or incomplete therapy)- This seems unacceptable in the era of Propofol.

Publication History

Article published online:
27 March 2025

• References

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