Download PDF
Endoscopy 2023; 55(09): 804-811
DOI: 10.1055/a-2042-6288
Original article

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

Theodor A. Voiosu
 1   Gastroenterology Department, Colentina Clinical Hospital, Bucharest, Romania
 2   Department of Internal Medicine, Carol Davila University of Medicine, Bucharest, Romania
,
Andreea Benguș
 1   Gastroenterology Department, Colentina Clinical Hospital, Bucharest, Romania
,
Michiel Bronswijk 
 3   Department of Gastroenterology and Hepatology, Imelda Hospital, Bonheiden, Belgium
 4   Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium
 5   Imelda GI Research Center, Bonheiden, Belgium
,
Ivan Lyutakov 
 6   Department of Gastroenterology, University Hospital “Tsaritsa Yoanna – ISUL”, Sofia, Bulgaria
 7   Department of Gastroenterology, Medical University Sofia, Sofia, Bulgaria
,
Ivo Klarin
 8   Department of Health Studies, University of Zadar, Zadar, Croatia
 9   Gastroenterology Department, General Hospital Zadar, Zadar, Croatia
,
Bianca Voiosu
10   Gastroenterology Department, Cantacuzino Hospital, Bucharest, Romania
,
Paul Bălănescu
11   Internal Medicine Department, Carol Davila School of Medicine, Bucharest, Romania
12   Clinical Immunology Department, Colentina Clinical Hospital, Bucharest, Romania
,
Claudia Diaconu 
 1   Gastroenterology Department, Colentina Clinical Hospital, Bucharest, Romania
,
Bogdan Busuioc
10   Gastroenterology Department, Cantacuzino Hospital, Bucharest, Romania
,
Ivo Boskoski
13   Gastroenterology, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy
14   Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore, Rome, Italy
,
Andrei M. Voiosu 
 1   Gastroenterology Department, Colentina Clinical Hospital, Bucharest, Romania
 2   Department of Internal Medicine, Carol Davila University of Medicine, Bucharest, Romania
,
Radu B. Mateescu
 1   Gastroenterology Department, Colentina Clinical Hospital, Bucharest, Romania
 2   Department of Internal Medicine, Carol Davila University of Medicine, Bucharest, Romania
,
Sachin Wani
15   University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
› Author Affiliations
› Further Information
Also available at
    Permissions and Reprints


Referred to by:

Author commentary on Theodor A. Voiosu et al.Endoscopy 2023; 55(09): v26-v26
DOI: 10.1055/a-2058-5570

Abstract

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.

Supplementary material



Publication History

Received: 24 October 2022

Accepted after revision: 24 February 2023

Accepted Manuscript online:
24 February 2023

Article published online:
03 May 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 Silviera ML, Seamon MJ, Porshinsky B. et al. Complications related to endoscopic retrograde cholangiopancreatography: a comprehensive clinical review. J Gastrointestin Liver Dis 2009; 18: 73-82
    PubMedGoogle Scholar
  • 2 Barakat MT, Girotra M, Thosani N. et al. Escalating complexity of endoscopic retrograde cholangiopancreatography over the last decade with increasing reliance on advanced cannulation techniques. World J Gastroenterol 2020; 26: 6391-6401
    CrossrefPubMedGoogle Scholar
  • 3 Voiosu T, Bălănescu P, Voiosu A. et al. Measuring trainee competence in performing endoscopic retrograde cholangiopancreatography: a systematic review of the literature. United European Gastroenterol J 2019; 7: 239-249
    CrossrefPubMedGoogle Scholar
  • 4 Wani S, Keswani R, Hall M. et al. A prospective multicenter study evaluating learning curves and competence in endoscopic ultrasound and endoscopic retrograde cholangiopancreatography among advanced endoscopy trainees: the Rapid Assessment of Trainee Endoscopy Skills Study. Clin Gastroenterol Hepatol 2017; 15: 1758-1767
    CrossrefPubMedGoogle Scholar
  • 5 Ekkelenkamp VE, Koch AD, Rauws EA. et al. Competence development in ERCP: the learning curve of novice trainees. Endoscopy 2014; 46: 949-955
    Article in Thieme ConnectPubMedGoogle Scholar
  • 6 Jorgensen J, Kubiliun N. ASGE Training Committee. et al. Endoscopic retrograde cholangiopancreatography (ERCP): core curriculum. Gastrointest Endosc 2016; 83: 279-289
    CrossrefPubMedGoogle Scholar
  • 7 Johnson G, Webster G, Boškoski I. et al. Curriculum for ERCP and endoscopic ultrasound training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy 2021; 53: 1071-1087
    Article in Thieme ConnectPubMedGoogle Scholar
  • 8 Pan Y, Zhao L, Leung J. et al. Appropriate time for selective biliary cannulation by trainees during ERCP – a randomized trial. Endoscopy 2015; 47: 688-695
    Article in Thieme ConnectPubMedGoogle Scholar
  • 9 Wang X, Luo H, Tao Q. et al. Difficult biliary cannulation in ERCP procedures with or without trainee involvement: a comparative study. Endoscopy 2022; 54: 447-454
    Article in Thieme ConnectPubMedGoogle Scholar
  • 10 Jowell PS, Baillie J, Branch MS. et al. Quantitative assessment of procedural competence. A prospective study of training in endoscopic retrograde cholangiopancreatography. Ann Intern Med 1996; 125: 983-989
    CrossrefPubMedGoogle Scholar
  • 11 Liao WC, Leung JW, Wang HP. et al. Coached practice using ERCP mechanical simulator improves trainees’ ERCP performance: a randomized controlled trial. Endoscopy 2013; 45: 799-805
    Article in Thieme ConnectPubMedGoogle Scholar
  • 12 Kalaitzakis E. All-cause mortality after ERCP. Endoscopy 2016; 48: 987-994
    Article in Thieme ConnectPubMedGoogle Scholar
  • 13 Cappell MS, Friedel DM. Stricter national standards are required for credentialing of endoscopic-retrograde-cholangiopancreatography in the United States. World J Gastroenterol 2019; 25: 3468-3483
    CrossrefPubMedGoogle Scholar
  • 14 Dumonceau JM, Kapral C, Aabakken L. et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2020; 52: 127-149
    Article in Thieme ConnectPubMedGoogle Scholar
  • 15 Voiosu T, Boskoski I, Voiosu AM. et al. Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial. Endoscopy 2020; 52: 115-122
    Article in Thieme ConnectPubMedGoogle Scholar
  • 16 Voiosu T, Boskoski I, Ladic A. et al. Getting the job done: how trainee involvement affects ERCP procedures: results from a multicenter observational trial. Dig Endosc 2020; 52 (Suppl. 01) 223-224
    PubMedGoogle Scholar
  • 17 Wani S, Keswani RN, Petersen B. et al. Training in EUS and ERCP: standardizing methods to assess competence. Gastrointest Endosc 2018; 87: 1371-1382
    CrossrefPubMedGoogle Scholar
  • 18 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
    CrossrefPubMedGoogle Scholar
  • 19 Jakobsen JC, Gluud C, Wetterslev J. et al. When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts. BMC Med Res Methodol 2017; 17: 162
    CrossrefPubMedGoogle Scholar
  • 20 Sterne JAC, White IR, Carlin JB. et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ 2009; 338: 157-160
    PubMedGoogle Scholar
  • 21 Voiosu T, Voiosu A, Boškoski I. et al. Technical and clinical outcomes of endoscopic retrograde cholangiopancreatography (ERCP) procedures performed in patients with COVID-19. Therap Adv Gastroenterol 2020; 13: 1756284820980671
    CrossrefPubMedGoogle Scholar
  • 22 Siau K, Dunckley P, Feeney M. et al. Joint Advisory Group on Gastrointestinal Endoscopy. ERCP assessment tool: evidence of validity and competency development during training. Endoscopy 2019; 51: 1017-1026
    Article in Thieme ConnectPubMedGoogle Scholar
  • 23 Elmunzer BJ, Walsh CM, Guiton G. SVI Study Group and the U.S. Cooperative for Outcomes Research in Endoscopy. et al. Development and initial validation of an instrument for video-based assessment of technical skill in ERCP. Gastrointest Endosc 2021; 93: 914-923
    CrossrefPubMedGoogle Scholar
  • 24 Voiosu T, Puscasu C, Orlandini B. et al. Motion training on a validated mechanical ERCP simulator improves novice endoscopist performance of selective cannulation: a multicenter trial. Endosc Int Open 2021; 9: E145-E151
    Article in Thieme ConnectPubMedGoogle Scholar
  • 25 Wani S, Hall M, Wang AY. et al. Variation in learning curves and competence for ERCP among advanced endoscopy trainees by using cumulative sum analysis. Gastrointest Endosc 2016; 83: 711-719
    CrossrefPubMedGoogle Scholar
  • 26 Wani S, Han S, Simon V. et al. Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees. Gastrointest Endosc 2019; 89: 1160-1168
    CrossrefPubMedGoogle Scholar
  • 27 Keswani RN, Qumseya BJ, O’Dwyer LC. et al. Association between endoscopist and center endoscopic retrograde cholangiopancreatography volume with procedure success and adverse outcomes: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2017; 15: 1866-1875
    CrossrefPubMedGoogle Scholar
  • 28 Sahar N, La Selva D, Gluck M. et al. The ASGE grading system for ERCP can predict success and complication rates in a tertiary referral hospital. Surg Endosc 2019; 33: 448-453
    CrossrefPubMedGoogle Scholar
  • 29 Siau K, Keane MG, Steed H. Joint Advisory Group on Gastrointestinal Endoscopy (JAG). et al. UK Joint Advisory Group consensus statements for training and certification in endoscopic retrograde cholangiopancreatography. Endosc Int Open 2022; 10: E37-E49
    Article in Thieme ConnectPubMedGoogle Scholar
  • 30 Weigt J, Kandulski A, Malfertheiner P. Technical improvement using ultra-slim gastroscopes for direct peroral cholangioscopy: analysis of the initial learning phase. J Hepatobiliary Pancreat Sci 2015; 22: 74-78
    CrossrefPubMedGoogle Scholar
  • 31 Testoni PA, Mariani A, Aabakken L. et al. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2016; 48: 657-683
    Article in Thieme ConnectPubMedGoogle Scholar
  • 32 Rodrigues-Pinto E, Morais R, Sousa-Pinto B. et al. Development of an online app to predict post-endoscopic retrograde cholangiopancreatography adverse events using a single-center retrospective cohort. Dig Dis 2021; 39: 283-293
    CrossrefPubMedGoogle Scholar
  • 33 Colton JB, Curran CC. Quality indicators, including complications, of ERCP in a community setting: a prospective study. Gastrointest Endosc 2009; 70: 457-467
    CrossrefPubMedGoogle Scholar