<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02247115</url>
  </required_header>
  <id_info>
    <org_study_id>14-0604</org_study_id>
    <nct_id>NCT02247115</nct_id>
  </id_info>
  <brief_title>Rapid Assessment of Trainee Endoscopy Skills (RATES) Study</brief_title>
  <acronym>RATES</acronym>
  <official_title>Rapid Assessment of Trainee Endoscopy Skills (RATES) Study: A Prospective Multicenter Study Evaluating Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatogram Among Advanced Endoscopy Trainees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Carolinas Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Virginia Mason Hospital/Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henry Ford Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New York Presbyterian Brooklyn Methodist Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University Feinberg School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The establishment of a number of training programs in therapeutic endoscopy, standardization&#xD;
      of the performance of endoscopic ultrasound (EUS) and endoscopy retrograde&#xD;
      cholangiopancreatography (ERCP) and definition of competence is of paramount importance. The&#xD;
      length of training and minimum number of procedures, requisite theoretical learning and&#xD;
      methodology to define competence in EUS and ERCP are not well defined. The investigators&#xD;
      research has demonstrated that individuals in training acquire skills at different rates and&#xD;
      the number of procedures completed alone is a suboptimal marker for competency in a given&#xD;
      procedure. Hence, emphasis needs to be shifted away from the number of procedures performed&#xD;
      to performance metrics with well-defined and validated thresholds of performance. Multicenter&#xD;
      prospective data are needed to help guide development of competency based medical education&#xD;
      that define learning curves in EUS and ERCP and set evidence-based benchmarks required to&#xD;
      achieve competence using a validated competency assessment tool.&#xD;
&#xD;
      Hypothesis: The central hypothesis is that a validated EUS and ERCP competency assessment&#xD;
      tool will allow for reliable and generalizable standardized learning curves, competency&#xD;
      benchmarks and creation of a centralized national database that compares a trainee's&#xD;
      performance amongst peers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Competency-based medical education and milestones: Given the increasing emphasis on quality&#xD;
      metrics and competency in health care, the Accreditation Council for Graduate Medical&#xD;
      Education (ACGME) recently announced plans to replace their current reporting system in 2014&#xD;
      with the Next Accreditation System (NAS). This reporting system focused on: 1) ensuring that&#xD;
      milestones are reached at various points in training, 2) ensuring that competence is achieved&#xD;
      by all trainees, and 3) making certain that these assessments are documented by their&#xD;
      programs.&#xD;
&#xD;
      Learning curves and competence in EUS: EUS is a vital tool in the diagnosis and staging of&#xD;
      gastrointestinal and certain non-gastrointestinal malignancies and diseases. EUS is operator&#xD;
      dependent and training in EUS requires the development of technical and cognitive skills&#xD;
      beyond that required for standard endoscopic procedures. It is intuitive that the quality of&#xD;
      EUS in provision of patient care is directly proportional to the training, skill and&#xD;
      experience of the endosonographer. Unfortunately, the intensity and length of training and&#xD;
      minimum number of procedures required, requisite curriculum and extent of theoretical&#xD;
      learning, and methodology to define competence are not well defined. There are limited data&#xD;
      on learning curves in EUS imaging. Based on expert opinion, the ACGME recommends a minimum of&#xD;
      150 total supervised procedures, 75 of which have a pancreatobiliary indication and 50 cases&#xD;
      of fine needle aspiration (FNA) (25 of which are pancreatic FNA) before competency can be&#xD;
      determined.&#xD;
&#xD;
      Similar guidelines were recently proposed by the British Society of Gastroenterology (BSG)&#xD;
      and the European Society of Gastrointestinal Endoscopy. However, these guidelines have not&#xD;
      been validated. This does not account for the different rates at which people learn and in&#xD;
      fact, many experts believe that the majority of trainees will require double the number of&#xD;
      proposed procedures to achieve competency in EUS.&#xD;
&#xD;
      Learning curves and competence in ERCP: ERCP is an effective modality in the evaluation and&#xD;
      management of pancreatobiliary diseases. This procedure can be technically demanding and&#xD;
      associated with a wide range of adverse events. Technically failed ERCP may result in&#xD;
      complications, need for additional procedures and their associated costs. Similar to EUS,&#xD;
      ERCP is operator dependent and requires acquisition of certain technical and cognitive&#xD;
      skills. There are limited data on learning curves and competence in ERCP, a cannulation rate&#xD;
      of &gt;80% (with some suggesting &gt;90%) has been considered a surrogate for trainee competency.&#xD;
      The American Society of Gastrointestinal Endoscopy (ASGE) recommends a minimum of 180 total&#xD;
      procedures, the majority of which are therapeutic before competency can be achieved. However,&#xD;
      this threshold is based predominantly on biliary cannulation success rate and does not take&#xD;
      into account procedure complexity and the different rates at which people learn. It is also&#xD;
      important to note that none of the previous studies have evaluated learning curves and&#xD;
      competency in other quality indicators such as successful stone extraction, traversing and&#xD;
      dilating a stricture, stent placement to name a few.&#xD;
&#xD;
      Competency assessment tools: Previous competency assessment tools have focused primarily on a&#xD;
      limited number of motor skills involved in EUS and ERCP with no procedure-related cognitive&#xD;
      skill assessment. The investigators have designed a prospective comprehensive competency&#xD;
      assessment tool using validated benchmarks to define competency thresholds. The EUS and ERCP&#xD;
      Skills Assessment Tool (TEESAT) can be used in a continuous fashion throughout the duration&#xD;
      of training to grade technical and cognitive skills in EUS and ERCP in a balanced manner.&#xD;
&#xD;
      Significance, Innovation and Impact on Training and Education With the launch of the ACGME's&#xD;
      NAS, advanced endoscopy training programs should utilize competency based medical education&#xD;
      and demonstrate that advanced endoscopy trainees (AETs) have attained the technical and&#xD;
      cognitive skills required for safe and effective unsupervised practice in advanced endoscopy.&#xD;
      Based on the investigators research, the investigators can draw two conclusions: a)&#xD;
      individuals in training in any technical procedure acquire skills at different rates and&#xD;
      emphasis needs to be shifted away from the number of procedures performed to performance&#xD;
      metrics with defined and validated competency thresholds of performance and b) current&#xD;
      guidelines of performing 150 EUS and 180 ERCPs are inadequate to achieve competence in EUS&#xD;
      and ERCP, respectively. With the expanding indications and applications of EUS and ERCP and&#xD;
      establishment of a number of &quot;third tier&quot; training programs in advanced endoscopy,&#xD;
      standardization of the performance of EUS and ERCP and definition of competence and training&#xD;
      among AETs is of paramount importance. The potential impacts of this study's results are&#xD;
      multifold: i) facilitate the ability of training programs to evolve with the new ACGME/NAS&#xD;
      reporting requirements, (ii) help program directors/trainers and trainees identify specific&#xD;
      skill deficiencies in training and allowing for tailored, individualized remediation, (iii)&#xD;
      create a centralized national database that would allow generation of &quot;on-demand&quot; detailed&#xD;
      reports on how individual trainees are progressing compared with their peers across the&#xD;
      nation, (iv) establish reliable and generalizable standardized learning curves (milestones)&#xD;
      and competency benchmarks that national GI societies and training programs can use to develop&#xD;
      credentialing guidelines.&#xD;
&#xD;
      APPROACH AND RESEARCH STRATEGY Setting and Subject Recruitment: Program directors and AETs at&#xD;
      all advanced endoscopy programs registered with the ASGE will be invited to participate in&#xD;
      this study and will be considered as study participants. AETs will complete a questionnaire&#xD;
      to determine baseline characteristics and prior experience with EUS and ERCP. AETs' prior&#xD;
      experience with EUS and ERCP will not be an exclusion criterion for this study.&#xD;
&#xD;
      Competency-assessment tool: TEESAT, a tool designed for competency assessment, will be used&#xD;
      in a continuous fashion throughout the duration of training to grade technical and cognitive&#xD;
      skills in EUS and ERCP. The investigators have demonstrated he feasibility and validity of&#xD;
      this tool in previous studies.3-5 This tool uses a 4-point scoring system: 1-no assistance,&#xD;
      2-achieves with minimal verbal cues, 3-multiple verbal cues or hands on assistance needed,&#xD;
      4-unable to complete. Setting these anchors for specifics skills and behaviors for what is&#xD;
      expected to achieve each score will ensure that the data collected are reproducible from one&#xD;
      evaluator to the next. Technical aspects during EUS exams include grading of individual EUS&#xD;
      stations and technical success in EUS-FNA. Cognitive aspects include identification of lesion&#xD;
      of interest, appropriate classification of malignant tumors (TNM) staging characterization of&#xD;
      subepithelial lesions. Technical aspects during biliary/pancreatic ERCP include endpoints&#xD;
      such as intubation, achieving the short position, identification of the papilla, cannulation&#xD;
      of desired duct, sphincterotomy, stone removal and stent placement. Cognitive aspects will&#xD;
      include clear demonstration of indication of the procedure, appropriate use of fluoroscopy&#xD;
      and logical plan based on cholangiogram/pancreatogram findings. This tool includes&#xD;
      documentation of immediate and post-procedure complications. Grading protocol: All AETs will&#xD;
      be introduced to both the cognitive and technical aspects of EUS and ERCP procedures at the&#xD;
      onset of training. Although TEESAT is self-explanatory, the program directors at each center&#xD;
      will ensure that the AETs and trainers are familiar with TEESAT's specific assessment&#xD;
      parameters and score explanations. After completion of 25 hands-on EUS and ERCP exams, AETs&#xD;
      will be graded on every ERCP and 3rd EUS exam by attending endoscopists (trainers) at each&#xD;
      center. This frequency of grading was chosen based on the investigators pilot data. Grading&#xD;
      of every 3rd EUS exam as opposed to every exam was chosen given the fairly homogenous&#xD;
      population undergoing EUS compared to ERCP. Procedures that the AETs have no hands-on&#xD;
      participation will be excluded for grading. If the exam eligible for grading is an incomplete&#xD;
      procedure for reasons such as medical instability, this exam will not be used for grading.&#xD;
      Trainers will complete the assessment immediately after the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall competency</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The proportion of advanced endoscopy trainees (AETs) that achieve overall competency in EUS and ERCP using a standardized competency assessment tool with a comprehensive data collection and reporting system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Competency in EUS</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The proportion of AETs that achieve competency in individual technical (EUS stations, and FNA) and cognitive (TMN staging) aspects of EUS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Competency in ERCP</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The proportion of trainees that achieve competency in individual technical (cannulation rate, stone removal and stent placement) and cognitive (proficient use of cholangiography) aspects of ERCP.</description>
  </secondary_outcome>
  <enrollment type="Actual">36</enrollment>
  <condition>Competency-Based Education</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Program directors and AETs at all advanced endoscopy programs registered with the ASGE will&#xD;
        be invited to participate in this study and will be considered as study participants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Program directors and AETs at all advanced endoscopy programs registered with the ASGE&#xD;
             will be invited to participate in this study and will be considered as study&#xD;
             participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sachin Wani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>March 17, 2017</last_update_submitted>
  <last_update_submitted_qc>March 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endoscopic ultrasound</keyword>
  <keyword>endoscopic retrograde cholangiopancreatography</keyword>
  <keyword>competency</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02247115
org study id: 14-0604
nct id: NCT02247115
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The establishment of a number of training programs in therapeutic endoscopy, standardization
      of the performance of endoscopic ultrasound (EUS) and endoscopy retrograde
      cholangiopancreatography (ERCP) and definition of competence is of paramount importance. The
      length of training and minimum number of procedures, requisite theoretical learning and
      methodology to define competence in EUS and ERCP are not well defined. The investigators
      research has demonstrated that individuals in training acquire skills at different rates and
      the number of procedures completed alone is a suboptimal marker for competency in a given
      procedure. Hence, emphasis needs to be shifted away from the number of procedures performed
      to performance metrics with well-defined and validated thresholds of performance. Multicenter
      prospective data are needed to help guide development of competency based medical education
      that define learning curves in EUS and ERCP and set evidence-based benchmarks required to
      achieve competence using a validated competency assessment tool.

      Hypothesis: The central hypothesis is that a validated EUS and ERCP competency assessment
      tool will allow for reliable and generalizable standardized learning curves, competency
      benchmarks and creation of a centralized national database that compares a trainee's
      performance amongst peers.
Competency-based medical education and milestones: Given the increasing emphasis on quality
      metrics and competency in health care, the Accreditation Council for Graduate Medical
      Education (ACGME) recently announced plans to replace their current reporting system in 2014
      with the Next Accreditation System (NAS). This reporting system focused on: 1) ensuring that
      milestones are reached at various points in training, 2) ensuring that competence is achieved
      by all trainees, and 3) making certain that these assessments are documented by their
      programs.

      Learning curves and competence in EUS: EUS is a vital tool in the diagnosis and staging of
      gastrointestinal and certain non-gastrointestinal malignancies and diseases. EUS is operator
      dependent and training in EUS requires the development of technical and cognitive skills
      beyond that required for standard endoscopic procedures. It is intuitive that the quality of
      EUS in provision of patient care is directly proportional to the training, skill and
      experience of the endosonographer. Unfortunately, the intensity and length of training and
      minimum number of procedures required, requisite curriculum and extent of theoretical
      learning, and methodology to define competence are not well defined. There are limited data
      on learning curves in EUS imaging. Based on expert opinion, the ACGME recommends a minimum of
      150 total supervised procedures, 75 of which have a pancreatobiliary indication and 50 cases
      of fine needle aspiration (FNA) (25 of which are pancreatic FNA) before competency can be
      determined.

      Similar guidelines were recently proposed by the British Society of Gastroenterology (BSG)
      and the European Society of Gastrointestinal Endoscopy. However, these guidelines have not
      been validated. This does not account for the different rates at which people learn and in
      fact, many experts believe that the majority of trainees will require double the number of
      proposed procedures to achieve competency in EUS.

      Learning curves and competence in ERCP: ERCP is an effective modality in the evaluation and
      management of pancreatobiliary diseases. This procedure can be technically demanding and
      associated with a wide range of adverse events. Technically failed ERCP may result in
      complications, need for additional procedures and their associated costs. Similar to EUS,
      ERCP is operator dependent and requires acquisition of certain technical and cognitive
      skills. There are limited data on learning curves and competence in ERCP, a cannulation rate
      of >80% (with some suggesting >90%) has been considered a surrogate for trainee competency.
      The American Society of Gastrointestinal Endoscopy (ASGE) recommends a minimum of 180 total
      procedures, the majority of which are therapeutic before competency can be achieved. However,
      this threshold is based predominantly on biliary cannulation success rate and does not take
      into account procedure complexity and the different rates at which people learn. It is also
      important to note that none of the previous studies have evaluated learning curves and
      competency in other quality indicators such as successful stone extraction, traversing and
      dilating a stricture, stent placement to name a few.

      Competency assessment tools: Previous competency assessment tools have focused primarily on a
      limited number of motor skills involved in EUS and ERCP with no procedure-related cognitive
      skill assessment. The investigators have designed a prospective comprehensive competency
      assessment tool using validated benchmarks to define competency thresholds. The EUS and ERCP
      Skills Assessment Tool (TEESAT) can be used in a continuous fashion throughout the duration
      of training to grade technical and cognitive skills in EUS and ERCP in a balanced manner.

      Significance, Innovation and Impact on Training and Education With the launch of the ACGME's
      NAS, advanced endoscopy training programs should utilize competency based medical education
      and demonstrate that advanced endoscopy trainees (AETs) have attained the technical and
      cognitive skills required for safe and effective unsupervised practice in advanced endoscopy.
      Based on the investigators research, the investigators can draw two conclusions: a)
      individuals in training in any technical procedure acquire skills at different rates and
      emphasis needs to be shifted away from the number of procedures performed to performance
      metrics with defined and validated competency thresholds of performance and b) current
      guidelines of performing 150 EUS and 180 ERCPs are inadequate to achieve competence in EUS
      and ERCP, respectively. With the expanding indications and applications of EUS and ERCP and
      establishment of a number of "third tier" training programs in advanced endoscopy,
      standardization of the performance of EUS and ERCP and definition of competence and training
      among AETs is of paramount importance. The potential impacts of this study's results are
      multifold: i) facilitate the ability of training programs to evolve with the new ACGME/NAS
      reporting requirements, (ii) help program directors/trainers and trainees identify specific
      skill deficiencies in training and allowing for tailored, individualized remediation, (iii)
      create a centralized national database that would allow generation of "on-demand" detailed
      reports on how individual trainees are progressing compared with their peers across the
      nation, (iv) establish reliable and generalizable standardized learning curves (milestones)
      and competency benchmarks that national GI societies and training programs can use to develop
      credentialing guidelines.

      APPROACH AND RESEARCH STRATEGY Setting and Subject Recruitment: Program directors and AETs at
      all advanced endoscopy programs registered with the ASGE will be invited to participate in
      this study and will be considered as study participants. AETs will complete a questionnaire
      to determine baseline characteristics and prior experience with EUS and ERCP. AETs' prior
      experience with EUS and ERCP will not be an exclusion criterion for this study.

      Competency-assessment tool: TEESAT, a tool designed for competency assessment, will be used
      in a continuous fashion throughout the duration of training to grade technical and cognitive
      skills in EUS and ERCP. The investigators have demonstrated he feasibility and validity of
      this tool in previous studies.3-5 This tool uses a 4-point scoring system: 1-no assistance,
      2-achieves with minimal verbal cues, 3-multiple verbal cues or hands on assistance needed,
      4-unable to complete. Setting these anchors for specifics skills and behaviors for what is
      expected to achieve each score will ensure that the data collected are reproducible from one
      evaluator to the next. Technical aspects during EUS exams include grading of individual EUS
      stations and technical success in EUS-FNA. Cognitive aspects include identification of lesion
      of interest, appropriate classification of malignant tumors (TNM) staging characterization of
      subepithelial lesions. Technical aspects during biliary/pancreatic ERCP include endpoints
      such as intubation, achieving the short position, identification of the papilla, cannulation
      of desired duct, sphincterotomy, stone removal and stent placement. Cognitive aspects will
      include clear demonstration of indication of the procedure, appropriate use of fluoroscopy
      and logical plan based on cholangiogram/pancreatogram findings. This tool includes
      documentation of immediate and post-procedure complications. Grading protocol: All AETs will
      be introduced to both the cognitive and technical aspects of EUS and ERCP procedures at the
      onset of training. Although TEESAT is self-explanatory, the program directors at each center
      will ensure that the AETs and trainers are familiar with TEESAT's specific assessment
      parameters and score explanations. After completion of 25 hands-on EUS and ERCP exams, AETs
      will be graded on every ERCP and 3rd EUS exam by attending endoscopists (trainers) at each
      center. This frequency of grading was chosen based on the investigators pilot data. Grading
      of every 3rd EUS exam as opposed to every exam was chosen given the fairly homogenous
      population undergoing EUS compared to ERCP. Procedures that the AETs have no hands-on
      participation will be excluded for grading. If the exam eligible for grading is an incomplete
      procedure for reasons such as medical instability, this exam will not be used for grading.
      Trainers will complete the assessment immediately after the procedure.
observational model: Cohort
time perspective: Prospective
measure: Overall competency
time frame: Up to 12 months
description: The proportion of advanced endoscopy trainees (AETs) that achieve overall competency in EUS and ERCP using a standardized competency assessment tool with a comprehensive data collection and reporting system.
measure: Competency in EUS
time frame: Up to 12 months
description: The proportion of AETs that achieve competency in individual technical (EUS stations, and FNA) and cognitive (TMN staging) aspects of EUS.
measure: Competency in ERCP
time frame: Up to 12 months
description: The proportion of trainees that achieve competency in individual technical (cannulation rate, stone removal and stent placement) and cognitive (proficient use of cholangiography) aspects of ERCP.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sachin Wani, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
responsible party type: Sponsor