Predicting What Can Go Wrong at Endoscopic Ultrasound
Predicting What Can Go Wrong at Endoscopic Ultrasound
Objective Although prior studies have evaluated complications following endoscopic ultrasound (EUS), data on the incidence of unplanned events at EUS, defined as any deviation from the preprocedure plan, are lacking. The aim of this study was to define the incidence, nature, clinical predictors and implications of unplanned events at EUS.
Design Case control study.
Setting Tertiary referral centre.
Patients 4624 consecutive patients undergoing EUS during a 6 year period were enrolled. For each patient with an unplanned event, two patients with a successful EUS in the same calendar year were randomly selected as controls.
Main outcome measurements Unplanned events occurring prior to, during or after EUS procedures were prospectively recorded in a database.
Results 192/4624 patients had an unplanned event (4.1%). In all, 2.1% had a failed procedure for anatomical reasons, 1.3% because of restlessness despite standard sedation and 0.5% for technical reasons. Adverse events occurred in 0.2%. There was no mortality but 4/6 patients with adverse events had to be admitted to hospital (2/4 operated). Eighty-two per cent of patients with an unplanned event had incomplete examinations, 14% had no procedure performed and 4% had complete procedures. In a multivariate analysis, only Afro-Caribbean patient origin, inpatient procedure and cancer staging procedure were independently related to unplanned events (p<0.05 for all).
Conclusions Unplanned events at EUS are mainly due to anatomical reasons and restlessness, despite sedation. They commonly result in incomplete examination and are related to Afro-Caribbean origin, inpatient procedure and cancer staging.
Endoscopic ultrasound (EUS) is one of the most accurate imaging technologies for the diagnosis and staging of gastrointestinal malignancies as well as for the diagnostic work-up of patients with pancreaticobiliary disorders. Also, EUS is frequently undertaken to obtain tissue for histological diagnosis and it is being increasingly used to perform interventional procedures such as EUS guided drainage of pancreatic pseudocysts.
EUS shares the risks and complications of other endoscopic procedures, including (but not limited to) cardiovascular events and complications of conscious sedation. Certain features of echoendoscopes which have a long rigid tip and EUS guided interventions may be related to the complication risk at EUS. Prior studies have evaluated complications following EUS, and severe and even lethal complications have rarely been reported. EUS is generally considered to be a safe procedure.
Unplanned events, defined as any deviation from the preprocedure plan, are known to have potentially important clinical and financial implications in gastrointestinal endoscopy. Unplanned events, a broader term that includes—but is not limited to—adverse events or complications, may be related to equipment malfunction, sedation issues or procedure failure because of unexpected findings (eg, failure to perform EUS–fine needle aspiration (FNA) due to intervening blood vessels); they may be related to adverse events as a result of the direct effect of the endoscope on sites or organs transversed or treated during the procedure (eg, perforation, bleeding, pancreatitis) or indirect effects in organs not directly involved in the endoscopic procedure (eg, heart or lungs). Data on the incidence and nature of unplanned events (other than complications) at EUS and their potential clinical implications are largely lacking.
The aim of the current study was to define the incidence and nature of early unplanned events at EUS. A secondary aim was to study the clinical predictors and implications of unplanned events.
Abstract and Introduction
Abstract
Objective Although prior studies have evaluated complications following endoscopic ultrasound (EUS), data on the incidence of unplanned events at EUS, defined as any deviation from the preprocedure plan, are lacking. The aim of this study was to define the incidence, nature, clinical predictors and implications of unplanned events at EUS.
Design Case control study.
Setting Tertiary referral centre.
Patients 4624 consecutive patients undergoing EUS during a 6 year period were enrolled. For each patient with an unplanned event, two patients with a successful EUS in the same calendar year were randomly selected as controls.
Main outcome measurements Unplanned events occurring prior to, during or after EUS procedures were prospectively recorded in a database.
Results 192/4624 patients had an unplanned event (4.1%). In all, 2.1% had a failed procedure for anatomical reasons, 1.3% because of restlessness despite standard sedation and 0.5% for technical reasons. Adverse events occurred in 0.2%. There was no mortality but 4/6 patients with adverse events had to be admitted to hospital (2/4 operated). Eighty-two per cent of patients with an unplanned event had incomplete examinations, 14% had no procedure performed and 4% had complete procedures. In a multivariate analysis, only Afro-Caribbean patient origin, inpatient procedure and cancer staging procedure were independently related to unplanned events (p<0.05 for all).
Conclusions Unplanned events at EUS are mainly due to anatomical reasons and restlessness, despite sedation. They commonly result in incomplete examination and are related to Afro-Caribbean origin, inpatient procedure and cancer staging.
Introduction
Endoscopic ultrasound (EUS) is one of the most accurate imaging technologies for the diagnosis and staging of gastrointestinal malignancies as well as for the diagnostic work-up of patients with pancreaticobiliary disorders. Also, EUS is frequently undertaken to obtain tissue for histological diagnosis and it is being increasingly used to perform interventional procedures such as EUS guided drainage of pancreatic pseudocysts.
EUS shares the risks and complications of other endoscopic procedures, including (but not limited to) cardiovascular events and complications of conscious sedation. Certain features of echoendoscopes which have a long rigid tip and EUS guided interventions may be related to the complication risk at EUS. Prior studies have evaluated complications following EUS, and severe and even lethal complications have rarely been reported. EUS is generally considered to be a safe procedure.
Unplanned events, defined as any deviation from the preprocedure plan, are known to have potentially important clinical and financial implications in gastrointestinal endoscopy. Unplanned events, a broader term that includes—but is not limited to—adverse events or complications, may be related to equipment malfunction, sedation issues or procedure failure because of unexpected findings (eg, failure to perform EUS–fine needle aspiration (FNA) due to intervening blood vessels); they may be related to adverse events as a result of the direct effect of the endoscope on sites or organs transversed or treated during the procedure (eg, perforation, bleeding, pancreatitis) or indirect effects in organs not directly involved in the endoscopic procedure (eg, heart or lungs). Data on the incidence and nature of unplanned events (other than complications) at EUS and their potential clinical implications are largely lacking.
The aim of the current study was to define the incidence and nature of early unplanned events at EUS. A secondary aim was to study the clinical predictors and implications of unplanned events.