Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees (EMR-STAT)

April 23, 2026 updated by: AdventHealth

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Collaborators

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

Investigators

  • Principal Investigator: Dennis Yang, MD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Actual)

April 1, 2024

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1798538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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