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Training Endoscopists to Perform On-site Rapid Cytological Evaluation for EUS-FNA of Solid Pancreatic Lesions


2019-12-01


2020-09-30


2020-11-01


60

Study Overview

Training Endoscopists to Perform On-site Rapid Cytological Evaluation for EUS-FNA of Solid Pancreatic Lesions

In China, there is a serious shortage of pathologists who can perform on-site cytological diagnosis. As a result, there are few centers that can conduct ROSE in China, which limits the diagnostic accuracy of EUS-FNA to a certain extent. Previous research reports on whether endoscopists could be trained for ROSE were controversial, which may be related to the lack of standardization of the training of endoscopists. There is no training program for training endoscopists to systematically process pathological specimens, operate microscopes, read the adequacy of cytological specimens, and evaluate the atypia of cytological specimens in China. Therefore, our center intends to carry out a training for endoscopists to compare the improvement of endoscopists' ROSE operating ability before and after the training, and to evaluate the practice of each endoscopist to perform on-site rapid cytology specimens of solid pancreatic lesions.

N/A

  • Pancreatic Cancer
    • ROSE

    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 Registration Dates Results Reporting Dates Study Record Updates

    2020-08-10  

    N/A  

    2020-08-10  

    2020-08-10  

    N/A  

    2020-08-12  

    2020-08-12  

    N/A  

    2020-08  

    Study Plan

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

    Design Details

    Primary Purpose:
    N/A


    Allocation:
    N/A


    Interventional Model:
    N/A


    Masking:
    N/A


    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    Primary Outcome MeasuresMeasure DescriptionTime Frame
    Accuracy of endoscopists for interpretation of cytologic specimen adequacy and primary diagnosis of malignancyThe interpretation results of endoscopists will be compared with that of cytopathologist.10 months
    Secondary Outcome MeasuresMeasure DescriptionTime Frame
    The results of standard specimens-processing, microscope-operating training on endoscopistsComparison of the score that endoscopists are graded before and after the standard training3 months

    Contacts and Locations

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

    Study Contact

    Name: Shi-yu Li, M.D.

    Phone Number: +8615521243639

    Email: lizfish@126.com

    Study Contact Backup

    Name: Kai-xuan Wang, Dr./M.D.

    Phone Number: +8613585673477

    Email: wangkaixuan224007@163.com

    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.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:
    18 Years

    Accepts Healthy Volunteers:

      Inclusion Criteria:
      1. age ≥18 years 2. diagnosis or suspected of solid pancreatic mass based on previous imaging examination; 3. EUS-FNA is achievable. 4. signed informed consent letter
      Exclusion Criteria:
      1. pregnant female 2. pancreatic cystic lesions 3. anticoagulant/antiplatelet therapy cannot be suspended 4. unable or refuse to provide informed consent 5. coagulopathy (platelet count <50 ×103/uL, international normalized ration >1.5) 6. severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia 7. with history of mental disease 8. other medical conditions that are not suitable for EUS-FNA

    Collaborators and Investigators

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

    Publications

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    General Publications

    No publications available