Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Negative Predictive Value of histology prediction on diminutive (≤5 mm) rectosigmoid polyps
研究概览
简要总结
Diminutive colorectal polyps (≤ 5 mm) represent most of the polyps detected during colonoscopy, especially in the rectum-sigmoid tract. The characterization of these polyps by virtual chromoendoscopy is recognized as a key element for innovative imaging techniques. As a matter of facts diminutive colorectal polyps are very frequent and, if located in the rectosigmoid colon, they present a very low malignant risk (0.3% of evolution towards advanced adenoma and up to 0.08% of evolution towards invasive carcinoma). The real-time characterization would allow to identify the lowest risk polyps (hyperplastic subtype), to leave them in situ or, if resected, not to send them for histological examination, allowing a huge saving in healthcare associated costs.
Recently, the American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee established the Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document, specific for real-time histological assessment for tiny colorectal polyps, to establish reference quality thresholds. Two performance standards have been developed to guide the use of advanced imaging:
- for diminutive polyps to be resected and discarded without pathologic assessment, endoscopic technology (when used with high confidence) used to determine histology of polyps ≤ 5mm in size, when combined with the histopathology assessment of polyps > 5 mm in size, should provide a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps;
- in order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps ≤ 5 mm in size in place (without resection), the technology should provide ≥ 90% negative predictive value (when used with high confidence) for adenomatous histology.
Computer-Aided-Diagnosis (CAD) is an artificial intelligence-based tool that would allow rapid and objective characterization of these lesions. The GI Genius CADx was developed to help endoscopists in their clinical practices for polyps characterization.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40-80 undergoing screening colonoscopy for CRC
- •Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation.
排除标准
- •subjects positive to Fecal Immunochemical Test or Fecal Occult Blood Test;
- •subjects undergoing CRC surveillance colonoscopy
- •subject at high risk for CRC
- •subjects with a personal history of CRC, IBD or hereditary polyposic or non-polyposic syndromes;
- •patients with previous resection of the sigmoid rectum;
- •patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings;
- •patients who perform an emergency colonoscopy.
结局指标
主要结局
Negative Predictive Value of histology prediction on diminutive (≤5 mm) rectosigmoid polyps
时间窗: 1 day
次要结局
- Agreement in assignment of post-polypectomy surveillance intervals(1 day)