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Completed

NCT Number: NCT02963207

MS Versus NICE for 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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Colorectal Polyp Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Sano's classification

Other

Set of characteristics described by Singh et al. 2013 to evaluate colorectal lesions.

Other names: MS classification

NICE classification

Other

Set of characteristics described by Hewett et al. 2012 to evaluate colorectal lesions.

Other names: NBI International Colorectal Endoscopic Classification

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Lyell McEwin Hospital

Other Gov

Collaborators

  • University of Adelaide

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 15, 2016
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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