CompetenceEMR-STATNCT06376006
Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees
An observational study of Competence and Assessment, Self, run by AdventHealth at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Competence, Assessment, Self
- What is being tested?
- EMR STAT - Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Advanced Endoscopy Trainees (AETs) who intend to train in colorectal Endoscopic Mucosal Reseaction (EMR) during their fellowship training.
Who may be able to join
- 1. 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)
- 2. Patients 18 years of age or older undergoing colonoscopy with EMR by the AET being evaluated for this study
Who cannot join
- 1. 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multicenter Study Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees Using A Standardized Assessment Tool: A Quality Improvement Initiative
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).
Read the detailed description
Baseline and Post-Training Questionnaires: The EMR-STAT Baseline Questionnaire is to better understand the participant's level of comfort with the C-EMR procedure. At the end of their training, the participant will complete the EMR-STAT Post-Training Questionnaire to evaluate their training experience.
Standardized Assessment tool (EMR-STAT) and Grading Protocol (Phase 1): The EMR-STAT is a tool designed for competence assessment. The tool will be used in a continuous fashion during the AETs training in colorectal EMR. The aim of the tool is to evaluate key concepts and core skills necessary for high-quality colorectal EMR as recently outlined by the US Multi-Society Task Force on Colorectal Cancer10. We have previously demonstrated the feasibility of this tool in a prior study9. The instrument evaluates for key cognitive and technical steps, including scope positioning, lesion assessment, submucosal lifting, endoscopic resection, adjunct resection/ablative techniques, management of adverse events, and elective defect closure. A 4-point scoring system was developed to grade each endpoint: 4 (superior), achieves task without instruction; 3 (advanced), achieves with minimal verbal cues; 2 (intermediate), achieves with multiple verbal cues or hands-on assistance; 1 (novice), unable to complete and requires trainer to take over. Setting these pre-defined anchors for specific individual cognitive and technical skills during grading ensures that the data collected are reproducible from one evaluator to the next. In addition, a 10-point overall assessment score (1-3, below average; 4-6, intermediate; 7-9, advanced; 10, superior) will be provided for each case. This grading format for endoscopic performance has been previously validated6,11,12
The trainees will be evaluated during live cases as part of the training experience. There will patient data that will be collected on the EMR_STAT but no patient identifiers will be documented. This data collection is integral to the study because these factors may play a role in the complexity of the procedure and impact trainees' EMR performance (ex. a cancerous lesion is more difficult to dissect than a non-cancerous lesion). This data will be analyzed as part of the learning curve for the trainees
- Conditions
- Competence, Assessment, Self
- Being tested
- EMR STAT - Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMR STAT - SurveyBehavioural
Surveys are completed before and after Advanced Fellow Training.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start11 May 2022
- Primary completion1 Apr 2024
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CompetenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University of South Florida, Stony Brook University, Atrium Medical Center, Hofstra University, Long Island Jewish Medical Center, Vanderbilt University, Yale University, Columbia University, Geisinger Clinic, University of Virginia, Baylor University, University of Kentucky, Cedars-Sinai Medical Center, University of Chicago, University of California, Irvine, University of Alabama at Birmingham, Beth Israel Deaconess Medical Center, Unity Health Toronto
- Responsible party
- Sponsor
- Investigators
- Dennis Yang, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376006
- Sponsor's protocol ID
- 1798538
- Acronym
- EMR-STAT
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30267866Bhurwal 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.
PubMed 27109458Rajendran 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.
PubMed 31925890Yang 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.
PubMed 32504699Wani 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.
PubMed 29709305Wani 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.
PubMed 28625816Klein 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.
PubMed 28061339ASGE 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.
PubMed 28089029Yang 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.
PubMed 32961243
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees Using A Standardized Assessment Tool: A Quality Improvement Initiative
- ClinicalTrials.gov ID
- NCT06376006
- Acronym / sponsor ID
- EMR-STAT / 1798538
- Conditions
- Competence, Assessment, Self
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Duke University, University of South Florida, Stony Brook University, Atrium Medical Center, Hofstra University, Long Island Jewish Medical Center, Vanderbilt University, Yale University, Columbia University, Geisinger Clinic, University of Virginia, Baylor University, University of Kentucky, Cedars-Sinai Medical Center, University of Chicago, University of California, Irvine, University of Alabama at Birmingham, Beth Israel Deaconess Medical Center, Unity Health Toronto
- Study start
- 11 May 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Baseline and Post-Training Questionnaires: The EMR-STAT Baseline Questionnaire is to better understand the participant's level of comfort with the C-EMR procedure. At the end of their training, the participant will complete the EMR-STAT Post-Training Questionnaire to evaluate their training experience.
Standardized Assessment tool (EMR-STAT) and Grading Protocol (Phase 1): The EMR-STAT is a tool designed for competence assessment. The tool will be used in a continuous fashion during the AETs training in colorectal EMR. The aim of the tool is to evaluate key concepts and core skills necessary for high-quality colorectal EMR as recently outlined by the US Multi-Society Task Force on Colorectal Cancer10. We have previously demonstrated the feasibility of this tool in a prior study9. The instrument evaluates for key cognitive and technical steps, including scope positioning, lesion assessment, submucosal lifting, endoscopic resection, adjunct resection/ablative techniques, management of adverse events, and elective defect closure. A 4-point scoring system was developed to grade each endpoint: 4 (superior), achieves task without instruction; 3 (advanced), achieves with minimal verbal cues; 2 (intermediate), achieves with multiple verbal cues or hands-on assistance; 1 (novice), unable to complete and requires trainer to take over. Setting these pre-defined anchors for specific individual cognitive and technical skills during grading ensures that the data collected are reproducible from one evaluator to the next. In addition, a 10-point overall assessment score (1-3, below average; 4-6, intermediate; 7-9, advanced; 10, superior) will be provided for each case. This grading format for endoscopic performance has been previously validated6,11,12
The trainees will be evaluated during live cases as part of the training experience. There will patient data that will be collected on the EMR_STAT but no patient identifiers will be documented. This data collection is integral to the study because these factors may play a role in the complexity of the procedure and impact trainees' EMR performance (ex. a cancerous lesion is more difficult to dissect than a non-cancerous lesion). This data will be analyzed as part of the learning curve for the trainees
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Advanced Endoscopy Trainees (AETs) who intend to train in colorectal Endoscopic Mucosal Reseaction (EMR) during their fellowship training.
Key inclusion criteria (2 listed)
- 1. 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)
- 2. Patients 18 years of age or older undergoing colonoscopy with EMR by the AET being evaluated for this study
Key exclusion criteria (1 listed)
- 1. 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMR STAT - SurveySurveys are completed before and after Advanced Fellow Training. | Behavioural | – |
Primary outcome
Primary Endpoint
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 30267866Yang 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.
- Background: PubMed 27109458Bhurwal 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.
- Background: PubMed 31925890Rajendran 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.
- Background: PubMed 32504699Yang 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.
- Background: PubMed 29709305Wani 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.
- Background: PubMed 28625816Wani 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.
- Background: PubMed 28061339Klein 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.
- Background: PubMed 28089029ASGE 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.
- Background: PubMed 32961243Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Yang, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Competence and Assessment, Self, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06376006, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.