NCT03155308

Validation of the NICE Classification Using Pentax Chromoendoscopy

Completed Last updated 26 February 2019

What this trial tests

trial testing Pentax chromoendoscopy (i-scan and Optical Enhancement) in Colorectal Polyp in 95 participants. Completed in 1 July 2018.

Timeline

1 April 2017

Primary endpoint
1 May 2018

1 July 2018

Quick facts

Lead sponsor	Instituto Ecuatoriano de Enfermedades Digestivas
Status	Completed
Study type	OBSERVATIONAL
Enrollment	95
Start date	1 April 2017
Primary completion	1 May 2018
Estimated completion	1 July 2018
Sites	1 location across Ecuador

Drugs / interventions tested

• Pentax chromoendoscopy (i-scan and Optical Enhancement)

Conditions studied

• Colorectal Polyp — all drugs for Colorectal Polyp →

Sponsor

Instituto Ecuatoriano de Enfermedades Digestivas — full company profile →

Who can join

Adults 18 to 80, any sex, with Colorectal Polyp. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Colorectal cancer (CRC) is the most frequent gastrointestinal tumor and the second cause of cancer related death. Colonoscopy is currently the recommended method for detection of polyps and cancers in the colon. Removal of all adenomatous polyps during colonoscopy has become worldwide a standard procedure as it has been demonstrated to significantly reduce colorectal cancer incidence and mortality. It is routine practice to remove all the detected polyps for pathological evaluation, due to the low accuracy (59% to 84%) to differentiate non-neoplastic from neoplastic colorectal lesions with white-light endoscopy. The development of electronic or virtual chromoendoscopy (CE) has aimed to reliably predict histology of colorectal lesions based on endoscopic features. This technology differentiates between neoplastic and non-neoplastic lesions base on the analysis of the neo-angiogenesis and the mucosal pit pattern. Optical endoscopic diagnosis allows the real-time evaluation of polyp histology during colonoscopy and to determine the appropriate therapeutic strategy. This is important in clinical practice, since adenomas or superficial invasive submucosal carcinoma lesions can be curatively treated by endoscopic removal, unlike deeply invasive carcinomas, which requires surgery. The Narrow-band imaging (NBI) international colorectal endoscopic (NICE) classification is validated classification system proposed as a valid tool for not only differentiating hyperplastic from adenomatous polyps, but also predicting submucosal deep (SM-d) carcinomas. It was developed based on NBI technology, leaving uncertainty on its applicability to other systems. It was previously evaluated the application of the NICE classification to Fujinon spectral Imaging Color Enhancement (FICE) technology founding suboptimal results (accuracy 77%, sensitivity 77% and specificity 75%) and moderate inter-observer agreement (kappa: 0.51).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. UEG Week 2019 Poster Presentations.
   · 2019 · cited 5× · PMID 32213001 · DOI 10.1177/2050640619854671