Clinical trial · Observational
Resect and Discard Extension to FICE of NIcE Classification
Resect and Discard Extension to Fuji Intelligent Color Enhancement (FICE) of Narrow Band Imaging International Colorectal Endoscopic (NicE) Classification
NCT02263144CI-TRIAL-00015831FICE;NICEunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color Enhancement (FICE) technology with high-definition without optical magnification.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
| Hyperplastic Polyps | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| virtual chromo-endoscopy using FICE Fujifilm Technology | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- histologically-verified <10mm polyps
- description
- histologically-verified \<10mm polyps, analyzed by virtual chromo-endoscopy using FICE Fujifilm Technology
- interventionNames
- Procedure: virtual chromo-endoscopy using FICE Fujifilm Technology
Primary outcomes (2)
- measure
- accuracy of the NICE criteria using FICE technology for differentiating between the non-neoplastic and neoplastic histotypes in diagnoses with high-confidence on a video-library of 110 polyps reviewed by 7 experts.
- timeFrame
- up to 6 months
- description
- 7 experts will review videos from a video-library of subcentimetric polyps removed and histologically verified and will assess each of the three NICE criteria (colour/vascularization/surface), and classify the lesion as neoplastic or non-neoplastic with low or high confidence.
- measure
- Inter-observer agreement among the 7 experts
- timeFrame
- up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up; 2. The patient is at satisfactory risk to undergo abdominal surgery; 3. The patient must understand and provide written consent for the procedure. Exclusion Criteria: 1. Patients with inflammatory bowel disease; 2. Patients with a personal history of polyposis syndrome; 3. Patients with diverticulitis or toxic megacolon; 4. Patients with a history of radiation therapy to abdomen or pelvis. 5. Patients with a history of severe cardiovascular, pulmonary, liver or renal disease; 6. Personal history of coagulation disorders or use of anticoagulants 7. Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
References
Publications (1)
- BACKGROUNDHewett 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 22609383