Consensus-based development of a causal attribution system for post-ERCP adverse events

Forbes, Nauzer; Elmunzer, B. Joseph; Keswani, Rajesh N.; Hilsden, Robert J.; Hall, Matt; Anderson, John T.; Arvanitakis, Marianna; Chen, Yen-I.; Duloy, Anna; Elta, Grace H.; Maranki, Jennifer; Mergener, Klaus; Petersen, Bret T.; Sethi, Amrita; Siersema, Peter D.; Smith, Zachary L.; Telford, Jennifer J.; Tse, Frances; Cotton, Peter B.; Wani, Sachin

doi:10.1136/gutjnl-2022-328059

Cited by 12 publications

(10 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Secondary outcomes included mortality, patient tolerability, and adverse events within 30 days of ERCP, as defined by the ASGE Lexicon and with only events deemed definitely or probably related to ERCP being included. Adverse events included cholangitis, pancreatitis, bleeding, perforation, and cardiopulmonary adverse events.…”

Section: Methodsmentioning

confidence: 99%

“…definitely or probably related to ERCP being included. 22 Adverse events included cholangitis, pancreatitis, bleeding, perforation, and cardiopulmonary adverse events.…”

Section: Key Pointsmentioning

confidence: 99%

“…There were no differences in infectious outcomes including cholangitis (0.8% vs 1.2%, P > .99) according to a recently updated classification system incorporating clinical criteria such as fever and leukocytosis. 22 There were no differences in other adverse events, including pancreatitis (3.1% vs 3.5%, P > .99), bleeding (1.9% vs 1.2%, P = .72), perforation (0.4% vs 0.0%, P > .99), cardiorespiratory adverse events (1.5% vs 0.8%, P = .69), or 30-day mortality (0.4% vs 0.4%, P > No adverse events were related to the study device. Full results of technical and safety outcomes are provided in Table 2.…”

Section: Technical and Safety Outcomesmentioning

confidence: 99%

See 2 more Smart Citations

Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography

et al. 2023

Self Cite

View full text Add to dashboard Cite

ImportanceInfection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level disinfection to completely eliminate microorganisms on the instrument.ObjectiveTo determine (1) contamination rates after high-level disinfection and (2) technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs.Design, Setting, and ParticipantsIn this parallel-arm multicenter randomized clinical trial at 2 tertiary ERCP centers in Canada, all patients 18 years and older and undergoing ERCP for any indication were eligible.InterventionThe intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design.Main Outcomes and MeasuresCoprimary outcomes were persistent microbial contamination of the duodenoscope elevator or channel, defined as growth of at least 10 colony-forming units of any organism or any growth of gram-negative bacteria following high-level disinfection (superiority outcome), and technical success of ERCP according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers.ResultsFrom December 2019 to February 2022, 518 patients were enrolled (259 disposable elevator cap duodenoscopes, 259 standard duodenoscopes). Patients had a mean (SD) age of 60.7 (17.0) years and 258 (49.8%) were female. No significant differences were observed between study groups, including in ERCP difficulty. Persistent microbial contamination was detected in 11.2% (24 of 214) of standard duodenoscopes and 3.8% (8 of 208) of disposable elevator cap duodenoscopes (P = .004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75) and number needed to treat of 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination. Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs 90.7%, P = .13). There were no differences between study groups in adverse events and other secondary outcomes.Conclusions and RelevanceIn this randomized clinical trial, disposable elevator cap duodenoscopes exhibited reduced contamination following high-level disinfection compared with standard scope designs, without affecting the technical performance and safety of ERCP.Trial RegistrationClinicalTrials.gov Identifier: NCT04040504

show abstract

Section: Methodsmentioning

confidence: 99%

“…definitely or probably related to ERCP being included. 22 Adverse events included cholangitis, pancreatitis, bleeding, perforation, and cardiopulmonary adverse events.…”

Section: Key Pointsmentioning

confidence: 99%

Section: Technical and Safety Outcomesmentioning

confidence: 99%

See 1 more Smart Citation

Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography

et al. 2023

Self Cite

View full text Add to dashboard Cite

show abstract

“…All patients have routine follow-up via phone call 30 days after ERCP, with any unplanned primary care visits, emergency department visits, and/or hospitalizations captured along with all relevant associated details by a combination of patient history and review of the medical record [ 13 ]. Thus, all occurrences of suspected PEP are reviewed and (a) either confirmed as PEP and attributed a likelihood of procedural causality or (b) rejected as not meeting the definition of PEP based on a recently published classification system [ 4 ]. Furthermore, the occurrence of self-recalled intra- and/or post-procedural pain is also captured prospectively as part of the registry according to a validated scale designed to capture patient-reported experiences in endoscopy [ 8 ].…”

Section: Methodsmentioning

confidence: 99%

“…ERCP is highly effective, but its performance is associated with several adverse events (AEs), with the most well-described being post-ERCP pancreatitis (PEP) [ 3 ]. A diagnosis of PEP is made when abdominal pain characteristic of pancreatitis is accompanied by pancreatic enzyme (lipase or amylase) elevation, typical imaging findings, or both [ 4 , 5 , 6 ].…”

Section: Introductionmentioning

confidence: 99%

Incidence and Predictors of Incidental Biochemical and Radiologic Pancreatic Alterations Following Uncomplicated ERCP

Chau

Samnani

Bazerbachi

et al. 2023

JCM

Self Cite

View full text Add to dashboard Cite

Background: Despite post-ERCP pancreatitis (PEP) being a major focus of outcomes research in endoscopic retrograde cholangiopancreatography (ERCP), little is known regarding the frequency with which asymptomatic biochemical and/or radiologic pancreatic alterations occur in patients following ERCP. Methods: Adult inpatients undergoing ERCP were identified from a prospective ERCP registry. Patients with any abdominal pain, confirmed PEP, or pancreatitis or abnormal pancreatic enzymes preceding ERCP were excluded. Primary outcomes were asymptomatic lipase elevation on bloodwork within 24 h of ERCP or asymptomatic cross-sectional imaging findings consistent with acute pancreatitis in the absence of clinical PEP within 14 days. Multinomial logistic regression and multiple logistic regression were used to examine associations between exposures and lipase levels and between PEP or imaging findings, respectively. Results: In total, 646 and 187 patients were analyzed as part of the biochemical and radiologic cohorts, respectively. A total of 26.0% of patients had asymptomatic elevations in lipase above the upper limit of normal (ULN) within 24 h, and 9.4% had elevations >3× ULN. A total of 20.9% of patients had incidental findings of enlargement, inflammation/edema/fat stranding, peri-pancreatic fluid collections, and/or necrosis on cross-sectional imaging within 14 days. Pancreatic contrast injection was associated with higher odds of asymptomatic lipasemia (adjusted odds ratio, AOR, 7.22; 95% confidence intervals, CI, 1.13 to 46.02), as was the use of the double-wire technique (AOR 15.74; 95% 1.15 to 214.74) and placement of a common bile duct stent (AOR 4.19; 95% CI 1.37 to 12.77). Over 10 cannulation attempts were associated with the presence of one or more radiologic finding(s) (AOR 33.95; 95% CI 1.64, to 704.13). Conclusions: Significant rates of incidental biochemical and/or radiologic pancreatic abnormalities are present following ERCP. Clinicians should be aware of our findings to minimize misclassification and better direct healthcare utilization.

show abstract

Development and validation of a practical clinical risk prediction model for post‐endoscopic retrograde cholangiopancreatography pancreatitis

Meng,

Ruan,

Fisher

et al. 2024

DEN Open

Self Cite

View full text Add to dashboard Cite

BackgroundPancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) can lead to significant morbidity and mortality. We aimed to develop an accurate post‐ERCP pancreatitis risk prediction model using easily obtainable variables.MethodsUsing prospective multi‐center ERCP data, we performed logistic regression using stepwise selection on several patient‐, procedure‐, and endoscopist‐related factors that were determined a priori. The final model was based on a combination of the Bayesian information criterion and Akaike's information criterion performance, balancing the inclusion of clinically relevant variables and model parsimony. All available data were used for model development, with subsequent internal validation performed on bootstrapped data using 10‐fold cross‐validation.ResultsData from 3021 ERCPs were used to inform models. There were 151 cases of post‐ERCP pancreatitis (5.0% incidence). Variables included in the final model included female sex, pancreatic duct cannulation, native papilla status, pre‐cut sphincterotomy, increasing cannulation time, presence of biliary stricture, patient age, and placement of a pancreatic duct stent. The final model was discriminating, with a receiver operating characteristic curve statistic of 0.79, and well‐calibrated, with a predicted risk‐to‐observed risk ratio of 1.003.ConclusionsWe successfully developed and internally validated a promising post‐ERCP pancreatitis clinical prediction model using easily obtainable variables that are known at baseline or observed during the ERCP procedure. The model achieved an area under the curve of 0.79. External validation is planned as additional data becomes available.

show abstract

Consensus-based development of a causal attribution system for post-ERCP adverse events

Cited by 12 publications

References 7 publications

Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography

Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography

Incidence and Predictors of Incidental Biochemical and Radiologic Pancreatic Alterations Following Uncomplicated ERCP

Development and validation of a practical clinical risk prediction model for post‐endoscopic retrograde cholangiopancreatography pancreatitis

Contact Info

Product

Resources

About