MS Versus NICE for Colorectal Lesions

November 9, 2016 updated by: Leonardo Zorron Cheng Tao Pu, Lyell McEwin Hospital

Prospective Randomised Study Comparing Modified Sano's (MS) Classification and NBI International Colorectal Endoscopic (NICE) for Differentiating Colorectal Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

348

Phase

  • Not Applicable

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.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified Sano's Classification
Modified Sano's Classification as described by Singh et al. 2013
Other: Modified Sano's classification
Set of characteristics described by Singh et al. 2013 to evaluate colorectal lesions.
Other Names:
  • MS classification
Active Comparator: NICE classification
NBI International Colorectal Endoscopic Classification as described by Hewett et al. 2012
Other: NICE classification
Set of characteristics described by Hewett et al. 2012 to evaluate colorectal lesions.
Other Names:
  • NBI International Colorectal Endoscopic Classification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (neoplastic versus non-neoplastic)
Time Frame: After two weeks of the colonoscopy
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)
After two weeks of the colonoscopy
Accuracy measures in comparison to the final histopathology in regards to polyps' invasiveness
Time Frame: After two weeks of the colonoscopy
Comparison of NICE or MS with the final histopathology in regards to invasiveness (SSA/P, AP, TSA or superficial cancer versus invasive cancer)
After two weeks of the colonoscopy
Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (SSA/P versus non-SSA/P)
Time Frame: After two weeks of the colonoscopy
Comparison of MS with the final histopathology in regards to SSA/P (SSA/P versus non-SSA/P)
After two weeks of the colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy in regards to negative predictive value of diminutive distal colorectal polyps
Time Frame: After two weeks of the colonoscopy
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)
After two weeks of the colonoscopy
Agreement in predicting post-colonoscopy surveillance interval with final histopathology
Time Frame: Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology)
Comparison of NICE or MS with the final histopathology in regards to prediction of surveillance interval (according to the PIVI guidelines)
Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology)

Collaborators and Investigators

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

Sponsor

Lyell McEwin Hospital

Collaborators

University of Adelaide

Investigators

  • Principal Investigator: Leonardo ZC Pu, MD, MSc, The Lyell McEwin and The University of Adelaide

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 6, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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