Optivista : I-SCAN OE for Optical Diagnosis of Small Colon Polyps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Concordance of Optical diagnosis with the pathology based reference standard
研究概览
简要总结
This prospective randomized clinical trial aims to evaluate the new Optivista system compared to the iScan for his optical diagnosis and interval agreement monitoring with pathology. The Participants will be randomized to be diagnosed by either Optivista or Pentax iScan, and all polyps detected during the procedure, their size, location and morphology will be recorded according to the Paris classification after which all polyps will be resected per standard practices and sent for histopathologic evaluation. Further optical assessments will be performed for all polyps of 1-10 mm in size (WASP, NICE, SANO and SIMPLE classification) after with an analysis of comparison between optical diagnosis and pathology results will be performed.
详细描述
The benefit of colonoscopy screening is based on the detection and removal of polyps neoplastic. However, the vast majority of found polyps do not harbor any risk of non-cancer neoplastic. The resection evaluation and histopathology of these polyps are associated with costs while the contribution to cancer prevention is limited. A new technique (Pentax Optivista) based on visual diagnosis of polyps has been introduced to reduce the costs associated with over-screening, and seems to be more efficient than the Pentax iScan technique.
This research project aims to evaluate the new Optivista system compared to the iScan for his optical biopsy performance and interval agreement monitoring with pathology.
This is a prospective clinical trial for which participants are recruited directly from the colonoscopy clinic. The Participants will be randomized to be diagnosed by either Optivista or Pentax iScan. Endoscope withdrawal will be done in iScan 1 mode for patients randomized to iSan and in Optivista OE2 mode for patients randomized to Optivista.
For all polyps detected during the procedure, their size, location and morphology will be recorded according to the Paris classification after which all polyps will be resected per standard practices and sent for histopathologic evaluation.
Polyps that are between 1-10mm in size (diminutive and small polyps), there will be further assessed according to WASP, NICE, SANO and SIMPLE classifications using white light imaging and using an image-enhancing endoscopy technology that enhances visualisation of the polyp surface and vascular patterns.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Aged 45 to 80 years
- •Indication for full colonoscopy
排除标准
- •Known inflammatory bowel disease
- •Active colitis
- •Coagulopathy
- •Familial polyposis syndrome
- •Poor general health defined as an ASA class > 3
- •Emergency colonoscopies
结局指标
主要结局
Concordance of Optical diagnosis with the pathology based reference standard
时间窗: 12 months
The Optical diagnosis of polyps using Optivista or iScan will be compared with the pathology based reference standard.
Rate of polyps detected of both of the technologies (Optivista and iScan) for Optical diagnosis
时间窗: 12 months
次要结局
- Negative predictive value of rectosigmoid neoplastic polyps.(12 months)
- Concordance of biopsies and SANO classification(12 months)
- Evaluate Polyp-Based Resect and Discard model(12 months)
- Concordance of biopsies with WASP classification(12 months)
- Concordance of biopsies and SIMPLE classification(12 months)
- Concordance of biopsies and NICE classification(12 months)
- Surveillance recommendation following the colonoscopy(12 months)