Prospective Randomised Study Comparing Modified Sano's (MS) Classification and NBI International Colorectal Endoscopic (NICE) for Differentiating Colorectal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 348
- 主要终点
- Accuracy measures in comparison to the final histopathology in regards to polyps' invasiveness
研究概览
简要总结
OBJECTIVE: Our study aimed to compare a recently-developed endoscopic classification with an established one for colorectal lesions in a randomised trial between 2013 and 2015.
详细描述
OBJECTIVE
Current practice requires histopathological assessment to confirm diagnosis for colorectal lesions detected at colonoscopy. Advances in endoscopic imaging contribute for real-time diagnosis which, apart from being cost and time-saving, also guides decision-making and reduces risks. Our study aimed to compare a recently-developed endoscopic classification with an established one.
DESIGN: The modified Sano's classification (MS) was compared to the Narrow Band Imaging (NBI) International Colorectal Endoscopic classification (NICE) in a randomised trial between 2013 and 2015. An experimented endoscopist classified each polyp, what was compared to histopathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients admitted in the Endoscopy Unit for a colonoscopy
- •Patients over 18 years-old
- •Patients or their caregivers that have understanding of the procedure and that have signed the consent form for the study
排除标准
- •Patients without colorectal polyps
- •Patients with poor bowel preparation
- •Patients that do not agree with or withdraw the consent form
结局指标
主要结局
Accuracy measures in comparison to the final histopathology in regards to polyps' invasiveness
时间窗: After two weeks of the colonoscopy
Comparison of NICE or MS with the final histopathology in regards to invasiveness (SSA/P, AP, TSA or superficial cancer versus invasive cancer)
Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (neoplastic versus non-neoplastic)
时间窗: After two weeks of the colonoscopy
Comparison of NICE or MS with the final histopathology in regards to polyps' subtype (i.e. non-neoplastic = Hyperplastic Polyp (HP) and neoplastic = Sessile Serrated Adenoma/Polyp (SSA/P), Adenomatous Polyp (AP), Traditional Serrated Adenoma (TSA), superficial cancer and invasive cancer)
Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (SSA/P versus non-SSA/P)
时间窗: After two weeks of the colonoscopy
Comparison of MS with the final histopathology in regards to SSA/P (SSA/P versus non-SSA/P)
次要结局
- Accuracy in regards to negative predictive value of diminutive distal colorectal polyps(After two weeks of the colonoscopy)
- Agreement in predicting post-colonoscopy surveillance interval with final histopathology(Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology))
研究者
Leonardo Zorron Cheng Tao Pu
Research Fellow
Lyell McEwin Hospital