MS Versus NICE for Colorectal Lesions

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963207
• Other study ID #: 2008128
• Status: Completed
• Phase: N/A
• First received: November 6, 2016
• Last updated: November 9, 2016
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2016
• Source: Lyell McEwin Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Polyp

Intervention

Other:
• Modified Sano's classification
Set of characteristics described by Singh et al. 2013 to evaluate colorectal lesions.
• NICE classification
Set of characteristics described by Hewett et al. 2012 to evaluate colorectal lesions.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lyell McEwin Hospital	University of Adelaide

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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)	After two weeks of the colonoscopy	No
Secondary	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)	Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology)	No