Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion in Colon Lesions. Prospective Multicenter Study in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,171
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of NICE classification to predict deep submucosal invasion
研究概览
简要总结
The purpose of this study is to evaluate the diagnostic accuracy of NICE classification to predict deep submucosal invasion of colonic polyps > 1 cm, considering histology as the gold standard, in a group of endoscopists who previously performed a training program.
详细描述
In the first phase of the study, a learning program of NICE classification based on examples will be performed. Forty images will be evaluated before and after the learning program.
In the second phase of the study, all consecutive patients who underwent to a colonoscopy will be included if a lesion greater than 1 cm is found and the endoscopy is performed with a high definition colonoscope with Narrow Band Imaging (NBI). Patients, lesions and endoscopy equipment characteristics will be recorded.
Subsequently, histological diagnosis of the lesion will also be recorded. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology). In case of adenocarcinomas, histological predictors of lymph node metastases, with predefined assessment criteria, will also be recorded.
Finally, histological preparations of adenocarcinomas will be sent to the reference center and two experienced pathologists will examine them again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion patients criteria:
- •Patients> 18 years
- •Lesion Type 0 of Paris classification, greater than 1 cm, found in a colonoscopy performed by any medical indication with a high definition endoscope with Narrow Band Imaging.
- •Achievable histology by endoscopic or surgical resection.
- •Writing informed consent given.
- •Exclusion patients criteria:
- •Age <18 years.
- •Refusal to give informed consent.
- •Contraindication for endoscopic or surgical resection.
- •Urgent colonoscopy indication (eg severe rectorrhagia.).
- •Patients with inflammatory bowel disease.
- •Suspected metastatic neoplasia by previous imaging tests.
- •Exclusion lesions criteria:
- •Polyp previously biopsied or resected.
- •Poor preparation that does not allow a proper assessment of the lesion.
- •NBI not performed.
- •Unavailable or indefinite histology (endoscopic or surgical resection).
排除标准
- 未提供
研究组 & 干预措施
NBI used by trained endoscopists
Assessment with NICE classification and NBI technology of colonic lesions (Paris classification type 0) greater than 1 cm found in a routine colonoscopy. This assessment was performed by previously trained endoscopists.
干预措施: NBI used by trained endoscopists (Device)
结局指标
主要结局
Diagnostic accuracy of NICE classification to predict deep submucosal invasion
时间窗: 1 year
Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion during routine colonoscopies. Gold standard (histology): * positive means adenocarcinoma with deep submucosal invasion (\>1 mm) * negative means non adenocarcinoma or superficial adenocarcinoma (\<1 mm) Evaluated test (NICE classification): * Positive means NICE type 3. * Negative means NICE type 1 and 2. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology)
次要结局
- Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the pre-learning test(0)
- Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the post-learning test(0)
- Preplanned potential factors that could influence diagnostic accuracy of NICE classification(1 year)
- Histological predictors of lymph node metastases of pT1(1 year)