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MS Versus NICE for Colorectal Lesions

NCT ID: NCT02963207

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Colorectal Neoplasms Colorectal Polyp

Keywords

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colorectal polyp colorectal lesion Modified Sano's Classification NICE classification NBI PIVI guidelines SSA/P sessile serrated adenoma sessile serrated polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Modified Sano's Classification

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

Group Type EXPERIMENTAL

Modified Sano's classification

Intervention Type OTHER

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

NICE classification

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

Group Type ACTIVE_COMPARATOR

NICE classification

Intervention Type OTHER

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

Interventions

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Modified Sano's classification

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

Intervention Type OTHER

NICE classification

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

Intervention Type OTHER

Other Intervention Names

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MS classification NBI International Colorectal Endoscopic Classification

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Adelaide

OTHER

Sponsor Role collaborator

Lyell McEwin Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Leonardo Zorron Cheng Tao Pu

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leonardo ZC Pu, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

The Lyell McEwin and The University of Adelaide

References

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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.

Reference Type BACKGROUND
PMID: 23617643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22609383 (View on PubMed)

Other Identifiers

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2008128

Identifier Type: -

Identifier Source: org_study_id