Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees

NCT06376006 | Active Not Recruiting

• 1 other identifier: 1798538
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Quality improvement project with the aim to use a standardized assessment tool (EMR-STAT) to establish learning curves and competence thresholds for key cognitive and technical colorectal EMR core skills among advanced endoscopy trainees (AETs).

Conditions

Competence; Assessment, Self

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The primary endpoint will be the establishment of minimum thresholds in colorectal EMR training, including benchmarks for pre-defined cognitive and technical core skills based on the survey responses from study participants.

  12 months

Interventions

EMR STAT - Survey BEHAVIORAL

Surveys are completed before and after Advanced Fellow Training.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced Endoscopy Trainees (AETs) who intend to train in colorectal Endoscopic Mucosal Reseaction (EMR) during their fellowship training.

You may qualify if:

• \. All AETs from the participating centers starting their advanced endoscopy fellowship training in the academic year of 2022 (regardless of prior experience with colorectal EMR)
• \. Patients 18 years of age or older undergoing colonoscopy with EMR by the AET being evaluated for this study

You may not qualify if:

• \. AETs in Advanced endoscopy programs that do not train AETs in colorectal EMR or AETs who do not intend to train in colorectal EMR during their fellowship will be excluded

Sponsors & Collaborators

• AdventHealth: lead
• Duke University: collaborator
• University of South Florida: collaborator
• Stony Brook University: collaborator
• Atrium Medical Center: collaborator
• Hofstra University: collaborator
• Long Island Jewish Medical Center: collaborator
• Vanderbilt University: collaborator
• Yale University: collaborator
• Columbia University: collaborator
• Geisinger Clinic: collaborator
• Unity Health Toronto: collaborator
• University of Virginia: collaborator
• Baylor University: collaborator
• University of Kentucky: collaborator
• Cedars-Sinai Medical Center: collaborator
• University of Chicago: collaborator
• University of California, Irvine: collaborator
• University of Alabama at Birmingham: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Related Publications (9)

• Yang D, Othman M, Draganov PV. Endoscopic Mucosal Resection vs Endoscopic Submucosal Dissection For Barrett's Esophagus and Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2019 May;17(6):1019-1028. doi: 10.1016/j.cgh.2018.09.030. Epub 2018 Sep 26.

  PMID: 30267866 BACKGROUND

• Bhurwal A, Bartel MJ, Heckman MG, Diehl NN, Raimondo M, Wallace MB, Woodward TA. Endoscopic mucosal resection: learning curve for large nonpolypoid colorectal neoplasia. Gastrointest Endosc. 2016 Dec;84(6):959-968.e7. doi: 10.1016/j.gie.2016.04.020. Epub 2016 Apr 22.

  PMID: 27109458 BACKGROUND

• Rajendran A, Pannick S, Thomas-Gibson S, Oke S, Anele C, Sevdalis N, Haycock A. Systematic literature review of learning curves for colorectal polyp resection techniques in lower gastrointestinal endoscopy. Colorectal Dis. 2020 Sep;22(9):1085-1100. doi: 10.1111/codi.14960. Epub 2020 Jan 30.

  PMID: 31925890 BACKGROUND

• Yang D, Wagh MS, Draganov PV. The status of training in new technologies in advanced endoscopy: from defining competence to credentialing and privileging. Gastrointest Endosc. 2020 Nov;92(5):1016-1025. doi: 10.1016/j.gie.2020.05.047. Epub 2020 Jun 3.

  PMID: 32504699 BACKGROUND

• Wani S, Keswani RN, Petersen B, Edmundowicz SA, Walsh CM, Huang C, Cohen J, Cote G. Training in EUS and ERCP: standardizing methods to assess competence. Gastrointest Endosc. 2018 Jun;87(6):1371-1382. doi: 10.1016/j.gie.2018.02.009. Epub 2018 Apr 27. No abstract available.

  PMID: 29709305 BACKGROUND

• Wani S, Keswani R, Hall M, Han S, Ali MA, Brauer B, Carlin L, Chak A, Collins D, Cote GA, Diehl DL, DiMaio CJ, Dries A, El-Hajj I, Ellert S, Fairley K, Faulx A, Fujii-Lau L, Gaddam S, Gan SI, Gaspar JP, Gautamy C, Gordon S, Harris C, Hyder S, Jones R, Kim S, Komanduri S, Law R, Lee L, Mounzer R, Mullady D, Muthusamy VR, Olyaee M, Pfau P, Saligram S, Piraka C, Rastogi A, Rosenkranz L, Rzouq F, Saxena A, Shah RJ, Simon VC, Small A, Sreenarasimhaiah J, Walker A, Wang AY, Watson RR, Wilson RH, Yachimski P, Yang D, Edmundowicz S, Early DS. 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 Nov;15(11):1758-1767.e11. doi: 10.1016/j.cgh.2017.06.012. Epub 2017 Jun 16.

  PMID: 28625816 BACKGROUND

• Klein A, Bourke MJ. How to Perform High-Quality Endoscopic Mucosal Resection During Colonoscopy. Gastroenterology. 2017 Feb;152(3):466-471. doi: 10.1053/j.gastro.2016.12.029. Epub 2017 Jan 3. No abstract available.

  PMID: 28061339 BACKGROUND

• ASGE Standards of Practice Committee; Faulx AL, Lightdale JR, Acosta RD, Agrawal D, Bruining DH, Chandrasekhara V, Eloubeidi MA, Gurudu SR, Kelsey L, Khashab MA, Kothari S, Muthusamy VR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, DeWitt JM. Guidelines for privileging, credentialing, and proctoring to perform GI endoscopy. Gastrointest Endosc. 2017 Feb;85(2):273-281. doi: 10.1016/j.gie.2016.10.036. No abstract available.

  PMID: 28089029 BACKGROUND

• Yang D, Perbtani YB, Wang Y, Rumman A, Wang AY, Kumta NA, DiMaio CJ, Antony A, Trindade AJ, Rolston VS, D'Souza LS, Corral Hurtado JE, Gomez V, Pohl H, Draganov PV, Beyth RJ, Lee JH, Cheesman A, Uppal DS, Sejpal DV, Bucobo JC, Wallace MB, Ngamruengphong S, Ajayeoba O, Khara HS, Diehl DL, Jawaid S, Forsmark CE; C-EMR STAT Study Group. Evaluating learning curves and competence in colorectal EMR among advanced endoscopy fellows: a pilot multicenter prospective trial using cumulative sum analysis. Gastrointest Endosc. 2021 Mar;93(3):682-690.e4. doi: 10.1016/j.gie.2020.09.023. Epub 2020 Sep 19.

  PMID: 32961243 BACKGROUND

Study Officials

• Dennis Yang, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 19, 2024
• Study Start: May 11, 2022
• Primary Completion: April 1, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)