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Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?

Primary Purpose

Pancreatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fine needle aspiration
Rapid on-site evaluation
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Neoplasms focused on measuring EUS-FNA, pancreatic solid lesions, sample adequacy, cytopathology, endosonography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • solid pancreatic lesions detected by trans abdominal ultrasound or cross-sectional image (CT or MRI).
  • formal indications to undergo EUS-FNA which were: differentiation between benign and malignant diseases, radiologic criteria of inoperability or unresectability, need for specific diagnosis which could modify therapeutic strategy and need for a diagnosis before neoadjuvant therapy.

Exclusion Criteria:

  • a cystic or solid cystic aspect of the pancreatic lesion on above mentioned image methods
  • lesions previously punctured on past EUS-FNA procedures
  • American Society of Anesthesiologist (ASA) Physical Status Classification System IV or V
  • cases of surveillance of solid pancreatic lesions
  • severe coagulation disorder (platelet count < 50000 or International Normalized Ratio > 2,0)
  • impossibility of previous suspension of antiplatelet agents (except acetylsalicylic acid) or anticoagulants (all)
  • patient unwillingness to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    ROSE by endosonographer

    non-ROSE

    Arm Description

    Submitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization

    Submitted to fine-needle aspiration.

    Outcomes

    Primary Outcome Measures

    Procedure duration
    Minutes

    Secondary Outcome Measures

    Specimen adequacy rate
    Cases with a sample suitable for a definitive diagnosis over the total number of cases
    Total number of passes
    total number of passes of all procedures
    Number of adverse events
    Total number of adverse events of all procedures
    Diagnostic yield
    Cases in which a final diagnostic could be established over the total number of cases

    Full Information

    First Posted
    May 20, 2019
    Last Updated
    June 28, 2019
    Sponsor
    Universidade Federal do Rio de Janeiro
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04002778
    Brief Title
    Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?
    Official Title
    Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio de Janeiro

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a highly sensitive and specific method in diagnosing solid pancreatic lesions. Rapid on-site evaluation (ROSE) of the aspirate by a cytopathologist improves specimen adequacy and diagnostic accuracy while reducing the number of needle passes. As this increases costs and implicates availability issues, the investigators aimed to evaluate the utility of ROSE by the endosonographer in guiding EUS-FNA of solid pancreatic lesions.
    Detailed Description
    Consecutive patients with a solid pancreatic lesion were included. Endosonographer was submitted to a basic pancreatic cythpatology training programme at two institutitions. The patients were randomly allocated to the ROSE group - in which the number of needle passes required to obtain a sample suitable for cytopathologic categorization was established by the endosonographer's on-site evaluation - or to the non-ROSE group - in whom adequacy of the specimen was evaluated macroscopically and up to five needle passes could be performed, assuring sample adequacy. The gold standard was the final cytopathologist's diagnosis. The number of needle passes, procedure duration, specimen adequacy, diagnostic yield and adverse events rates were compared between groups and the performance measures of ROSE by endosonographer were determined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Neoplasms
    Keywords
    EUS-FNA, pancreatic solid lesions, sample adequacy, cytopathology, endosonography

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ROSE by endosonographer
    Arm Type
    Active Comparator
    Arm Description
    Submitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization
    Arm Title
    non-ROSE
    Arm Type
    Other
    Arm Description
    Submitted to fine-needle aspiration.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Fine needle aspiration
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Rapid on-site evaluation
    Primary Outcome Measure Information:
    Title
    Procedure duration
    Description
    Minutes
    Time Frame
    Procedure
    Secondary Outcome Measure Information:
    Title
    Specimen adequacy rate
    Description
    Cases with a sample suitable for a definitive diagnosis over the total number of cases
    Time Frame
    Through study completion, an average of 18 months
    Title
    Total number of passes
    Description
    total number of passes of all procedures
    Time Frame
    Through study completion, an average of 18 months
    Title
    Number of adverse events
    Description
    Total number of adverse events of all procedures
    Time Frame
    Through study completion, an average of 18 months
    Title
    Diagnostic yield
    Description
    Cases in which a final diagnostic could be established over the total number of cases
    Time Frame
    Through study completion, an average of 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: solid pancreatic lesions detected by trans abdominal ultrasound or cross-sectional image (CT or MRI). formal indications to undergo EUS-FNA which were: differentiation between benign and malignant diseases, radiologic criteria of inoperability or unresectability, need for specific diagnosis which could modify therapeutic strategy and need for a diagnosis before neoadjuvant therapy. Exclusion Criteria: a cystic or solid cystic aspect of the pancreatic lesion on above mentioned image methods lesions previously punctured on past EUS-FNA procedures American Society of Anesthesiologist (ASA) Physical Status Classification System IV or V cases of surveillance of solid pancreatic lesions severe coagulation disorder (platelet count < 50000 or International Normalized Ratio > 2,0) impossibility of previous suspension of antiplatelet agents (except acetylsalicylic acid) or anticoagulants (all) patient unwillingness to participate

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?

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