Resect and Discard Extension to Fuji Intelligent Color Enhancement (FICE) of Narrow Band Imaging International Colorectal Endoscopic (NicE) Classification
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 7
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
- In order to create a video-library of endoscopic cases, patients undergoing screening or diagnostic colonoscopy will be considered for inclusion. Patients with at least one histologically verified <10 mm polyp will be included. A short video-clip (around 15-20 seconds) of each polyp both at white-light and FICE-light will be recorded and stored in an anonymized database.
- Once the video-library is completed, each of 7 experts will independently review all the cases. For each case, any observer will assess each of the three NICE criteria (colour/vascularization/surface), the degree of confidence (low/high), and classify the lesion as neoplastic or non-neoplastic. The primary outcomes are the accuracy of FICE technology with high-definition and without magnification, when adopting NICE classification, to differentiate between hyperplastic and adenomatous lesions, and the inter-observer agreement in such differentiation. Secondary end-points are to assess at multivariate measure the role of any individual criteria of NICE classification in the discrimination between the two histotypes, and possible adaptations of NICE classification in order to be applied with FICE.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up;
- •The patient is at satisfactory risk to undergo abdominal surgery;
- •The patient must understand and provide written consent for the procedure.
排除标准
- •Patients with inflammatory bowel disease;
- •Patients with a personal history of polyposis syndrome;
- •Patients with diverticulitis or toxic megacolon;
- •Patients with a history of radiation therapy to abdomen or pelvis.
- •Patients with a history of severe cardiovascular, pulmonary, liver or renal disease;
- •Personal history of coagulation disorders or use of anticoagulants
- •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.
结局指标
主要结局
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.
时间窗: up to 6 months
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.
Inter-observer agreement among the 7 experts
时间窗: up to 6 months
The inter-observer agreement, among the 7 experts, on the final diagnosis (neoplastic or non-neoplastic) and on each individual NICE criterion for each polyp will be determined by using K statistics .
次要结局
未报告次要终点
研究者
Michele Tedeschi
Responsabile Progetto Ricerca Clinica
Istituto Clinico Humanitas