NCT02963207

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 6, 2016

Last Update Submit

November 9, 2016

Conditions

Colorectal NeoplasmsColorectal Polyp

Keywords

colorectal polypcolorectal lesionModified Sano's ClassificationNICE classificationNBIPIVI guidelinesSSA/Psessile serrated adenomasessile serrated polyp

Outcome Measures

Primary Outcomes (3)

  • 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)

    After two weeks of the colonoscopy

  • 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)

    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)

    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 Outcomes (2)

  • Accuracy in regards to negative predictive value of diminutive distal colorectal polyps

    After two weeks of the colonoscopy

  • Agreement in predicting post-colonoscopy surveillance interval with final histopathology

    Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology)

Study Arms (2)

Modified Sano's Classification

EXPERIMENTAL

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

Other: Modified Sano's classification

NICE classification

ACTIVE COMPARATOR

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

Other: NICE classification

Interventions

Modified Sano's classificationOTHER

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

Also known as: MS classification
Modified Sano's Classification
NICE classificationOTHER

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

Also known as: NBI International Colorectal Endoscopic Classification
NICE classification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23617643BACKGROUND

  • 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.

    PMID: 22609383BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Leonardo ZC Pu, MD, MSc

    The Lyell McEwin and The University of Adelaide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

November 6, 2016

First Posted

November 15, 2016

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share