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
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
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
NCT ID
NCT02963207
First Posted
November 6, 2016
Last Updated
November 9, 2016
Sponsor
Lyell McEwin Hospital
Collaborators
University of Adelaide
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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