Validation of the NICE Classification Using Pentax Chromoendoscopy

NCT03155308 | Completed DMC

• 1 other identifier: MAY 2-2017
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Colorectal Polyp

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of Pentax chromoendoscopy (i-scan and Optical Enhancement system) for differentiating between the three types of NICE classification.

  colorectal polypoid lesions will be evaluated using Pentax chromoendoscopy (i-scan and OE system) in order to classified the lesions by NICE classification. The histopathology will be evaluated from all lesions as Gold Standard and finally accuracy, sensitivity, specificity, positive predictive value and negative predictive value will be calculated.

  4 month

Secondary Outcomes (3)

• assessment of inter- and intra-observer agreement

  4 month

• Diagnostic accuracy of the individual criteria of NICE classification using i-scan and OE system.

  4 month

• Diagnostic accuracy according to the level of confidence.

  4 month

Study Arms (1)

Polyp group

Consecutive adult patients between 18 and 80 years of age, referred for elective outpatient colonoscopy and in whom polypectomy or biopsy is perform will be enrolled to be evaluated using Pentax chromoendoscopy (i-scan and Optical Enhancement)

Device: Pentax chromoendoscopy (i-scan and Optical Enhancement)

Interventions

Pentax chromoendoscopy (i-scan and Optical Enhancement) DEVICE

All lesions will be evaluated using the 3 i-scan modes and the 2 OE modes without magnification. The lesion size data, location and macroscopic shape of the lesions based on the Paris classification will be recorded. Finally all lesions will be classified in real-time into 3 types based on NICE classification (NICE 1, hyperplastic polyps; NICE 2, adenoma and superficial submucosal carcinoma; NICE 3, SM-d invasive carcinoma). A level of confidence (high or low) will be assign in each stage. Polyp's images will be photographically and videotape recorded. All polyps will be resected or biopsied for histopathological examination used as the criterion standard for the analysis.

Polyp group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients between 18 and 80 years of age, referred for elective outpatient colonoscopy and in whom polypectomy or biopsy is performed will be enrolled.

You may not qualify if:

• Patients with polyps but in whom histopathology has not been evaluated or with a poor bowel preparation (Boston Bowel Preparation Scale ≤6) will be excluded from the analysis but included in the intention to treat.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Ecuadorian Institute of Digestive Diseases, Omnihospital

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (25)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

colorectal polyps will be resected y biopsed

Study Officials

• Carlos A Robles-Madranda, MD

  Ecuadorian Institute of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 16, 2017
• Study Start: April 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)