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MS Versus NICE for Colorectal Lesions

Primary Purpose

Colorectal Neoplasms, Colorectal Polyp

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified Sano's classification
NICE classification
Sponsored by
Lyell McEwin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasms focused on measuring colorectal polyp, colorectal lesion, Modified Sano's Classification, NICE classification, NBI, PIVI guidelines, SSA/P, sessile serrated adenoma, sessile serrated polyp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients admitted in the Endoscopy Unit for a colonoscopy
  • Patients over 18 years-old
  • Patients or their caregivers that have understanding of the procedure and that have signed the consent form for the study

Exclusion Criteria:

  • Patients without colorectal polyps
  • Patients with poor bowel preparation
  • Patients that do not agree with or withdraw the consent form

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Modified Sano's Classification

    NICE classification

    Arm Description

    Modified Sano's Classification as described by Singh et al. 2013

    NBI International Colorectal Endoscopic Classification as described by Hewett et al. 2012

    Outcomes

    Primary Outcome Measures

    Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (neoplastic versus non-neoplastic)
    Comparison of NICE or MS with the final histopathology in regards to polyps' subtype (i.e. non-neoplastic = Hyperplastic Polyp (HP) and neoplastic = Sessile Serrated Adenoma/Polyp (SSA/P), Adenomatous Polyp (AP), Traditional Serrated Adenoma (TSA), superficial cancer and invasive cancer)
    Accuracy measures in comparison to the final histopathology in regards to polyps' invasiveness
    Comparison of NICE or MS with the final histopathology in regards to invasiveness (SSA/P, AP, TSA or superficial cancer versus invasive cancer)
    Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (SSA/P versus non-SSA/P)
    Comparison of MS with the final histopathology in regards to SSA/P (SSA/P versus non-SSA/P)

    Secondary Outcome Measures

    Accuracy in regards to negative predictive value of diminutive distal colorectal polyps
    Comparison of NICE or MS with the final histopathology in regards to <5 mm distal to the sigmoid polyps (NPV for HPs - according to the PIVI guidelines)
    Agreement in predicting post-colonoscopy surveillance interval with final histopathology
    Comparison of NICE or MS with the final histopathology in regards to prediction of surveillance interval (according to the PIVI guidelines)

    Full Information

    First Posted
    November 6, 2016
    Last Updated
    November 9, 2016
    Sponsor
    Lyell McEwin Hospital
    Collaborators
    University of Adelaide
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02963207
    Brief Title
    MS Versus NICE for Colorectal Lesions
    Official Title
    Prospective Randomised Study Comparing Modified Sano's (MS) Classification and NBI International Colorectal Endoscopic (NICE) for Differentiating Colorectal Lesions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lyell McEwin Hospital
    Collaborators
    University of Adelaide

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    OBJECTIVE: Our study aimed to compare a recently-developed endoscopic classification with an established one for colorectal lesions in a randomised trial between 2013 and 2015.
    Detailed Description
    OBJECTIVE: Current practice requires histopathological assessment to confirm diagnosis for colorectal lesions detected at colonoscopy. Advances in endoscopic imaging contribute for real-time diagnosis which, apart from being cost and time-saving, also guides decision-making and reduces risks. Our study aimed to compare a recently-developed endoscopic classification with an established one. DESIGN: The modified Sano's classification (MS) was compared to the Narrow Band Imaging (NBI) International Colorectal Endoscopic classification (NICE) in a randomised trial between 2013 and 2015. An experimented endoscopist classified each polyp, what was compared to histopathology.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Neoplasms, Colorectal Polyp
    Keywords
    colorectal polyp, colorectal lesion, Modified Sano's Classification, NICE classification, NBI, PIVI guidelines, SSA/P, sessile serrated adenoma, sessile serrated polyp

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    348 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Modified Sano's Classification
    Arm Type
    Experimental
    Arm Description
    Modified Sano's Classification as described by Singh et al. 2013
    Arm Title
    NICE classification
    Arm Type
    Active Comparator
    Arm Description
    NBI International Colorectal Endoscopic Classification as described by Hewett et al. 2012
    Intervention Type
    Other
    Intervention Name(s)
    Modified Sano's classification
    Other Intervention Name(s)
    MS classification
    Intervention Description
    Set of characteristics described by Singh et al. 2013 to evaluate colorectal lesions.
    Intervention Type
    Other
    Intervention Name(s)
    NICE classification
    Other Intervention Name(s)
    NBI International Colorectal Endoscopic Classification
    Intervention Description
    Set of characteristics described by Hewett et al. 2012 to evaluate colorectal lesions.
    Primary Outcome Measure Information:
    Title
    Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (neoplastic versus non-neoplastic)
    Description
    Comparison of NICE or MS with the final histopathology in regards to polyps' subtype (i.e. non-neoplastic = Hyperplastic Polyp (HP) and neoplastic = Sessile Serrated Adenoma/Polyp (SSA/P), Adenomatous Polyp (AP), Traditional Serrated Adenoma (TSA), superficial cancer and invasive cancer)
    Time Frame
    After two weeks of the colonoscopy
    Title
    Accuracy measures in comparison to the final histopathology in regards to polyps' invasiveness
    Description
    Comparison of NICE or MS with the final histopathology in regards to invasiveness (SSA/P, AP, TSA or superficial cancer versus invasive cancer)
    Time Frame
    After two weeks of the colonoscopy
    Title
    Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (SSA/P versus non-SSA/P)
    Description
    Comparison of MS with the final histopathology in regards to SSA/P (SSA/P versus non-SSA/P)
    Time Frame
    After two weeks of the colonoscopy
    Secondary Outcome Measure Information:
    Title
    Accuracy in regards to negative predictive value of diminutive distal colorectal polyps
    Description
    Comparison of NICE or MS with the final histopathology in regards to <5 mm distal to the sigmoid polyps (NPV for HPs - according to the PIVI guidelines)
    Time Frame
    After two weeks of the colonoscopy
    Title
    Agreement in predicting post-colonoscopy surveillance interval with final histopathology
    Description
    Comparison of NICE or MS with the final histopathology in regards to prediction of surveillance interval (according to the PIVI guidelines)
    Time Frame
    Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients admitted in the Endoscopy Unit for a colonoscopy Patients over 18 years-old Patients or their caregivers that have understanding of the procedure and that have signed the consent form for the study Exclusion Criteria: Patients without colorectal polyps Patients with poor bowel preparation Patients that do not agree with or withdraw the consent form
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leonardo ZC Pu, MD, MSc
    Organizational Affiliation
    The Lyell McEwin and The University of Adelaide
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23617643
    Citation
    Singh R, Jayanna M, Navadgi S, Ruszkiewicz A, Saito Y, Uedo N. Narrow-band imaging with dual focus magnification in differentiating colorectal neoplasia. Dig Endosc. 2013 May;25 Suppl 2:16-20. doi: 10.1111/den.12075.
    Results Reference
    background
    PubMed Identifier
    22609383
    Citation
    Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.
    Results Reference
    background

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    MS Versus NICE for Colorectal Lesions

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