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Development and Validation of a Deep Learning Algorithm for Bowel Preparation Quality Scoring

2019年4月8日 更新者:Xiuli Zuo、Shandong University
The purpose of this study is to develop and validate the performance of an artificial intelligence(AI) assisted Boston Bowel preparation Scoring(BBPS) system for evaluation of bowel cleanness, then testify whether this new scoring system can help physicians to improve the quality control parameters of colonoscopy in clinic practice.

研究概览

详细说明

Colonoscopy is recommended as a routine examination for colorectal cancer screening. Adequate bowel preparation is indispensable to ensure a clear vision of colonic mucosa,complete inspection of all colon segments, and furthermore improves the detection rates of small adenomas. Thus, the adequacy of bowel preparation should be accurately evaluated and documented. However, the accuracy of current bowel preparation quality scales greatly relies on intra-observer and inter-observer consistency for lack of objective measurements. Recently, deep learning based on central neural networks (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. While, no studies have been conducted to evaluate the performance of deep learning algorithm in bowel preparation quality scoring. This study aims to train an algorithm to assess bowel preparation quality using the BBPS, and testify whether the engagement of AI can improve the quality control parameters of colonoscopy.

研究类型

介入性

注册 (预期的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Shandong
      • Jinan、Shandong、中国、257000
        • Qilu hosipital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

• Patients aged 18-70 years undergoing afternoon colonoscopy

Exclusion Criteria:

  • Known or suspected bowel obstruction, stricture or perforation
  • Compromised swallowing reflex or mental status
  • Severe chronic renal failure(creatinine clearance < 30 ml/min)
  • Severe congestive heart failure (New York Heart Association class III or IV)
  • Uncontrolled hypertension (systolic blood pressure > 170 mm Hg, diastolic blood pressure > 100 mm Hg)
  • Dehydration
  • Disturbance of electrolytes
  • Pregnancy or lactation
  • Hemodynamically unstable
  • Unable to give informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:人工智能辅助评分组
本组患者在AI监控设备下进行结肠镜检查。
After receiving standard bowel preparation regimen, patients go through colonoscopy under the AI monitoring device. During the withdrawal process, bowel preparation quality is monitored by AI-associated scoring system. Whenever a sub-score below 2 points is detected, endoscopist will be alarmed up to three times to wash and suck the colonic contents. Videos will be recorded and re-evaluated by experts to determine the final BBPS score. The withdrawal time is targeted at least 6min in accordance with colonoscopy quality practice. All detected polyps will be removed and obtained for histological assessment, with the possible exception of diminutive(less than 5mm) rectal polyps.
有源比较器:传统人类评分组
本组患者在没有AI监控设备的情况下进行常规结肠镜检查。
After receiving standard bowel preparation regimen, patients go through conventional colonoscopy without the AI monitoring device. During the withdrawal process, after washing and sucking the colonic contents according to endoscopist's personal experience, bowel preparation quality is evaluated by human. Videos will be recorded and re-evaluated by experts to determine the final BBPS score. The withdrawal time is targeted at least 6min in accordance with colonoscopy quality practice. All detected polyps will be removed and obtained for histological assessment, with the possible exception of diminutive(less than 5mm) rectal polyps.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The rate of patients achieving adequate bowel preparation in each group.
大体时间:6 months
Bowel preparation quality was measured by BBPS. After fully washing or suctioning of colonic contents, three segments including right colon (containing cecum and ascending colon), transvers colon (containing hepatic and splenic flexures) and left colon (containing descending and sigmoid colon) were individually scored from 0 to 3. Point 0 refers to unprepared colon segment with obscured solid stool making mucosa cannot be seen; Point 1 refers to part of mucosa can be seen, but some areas are covered by staining, residual stool, and/or opaque liquid; Point 2 refers to entire mucosa is well-seen; Point 3 refers to clean colon segment without staining, fecal materials or liquids. A sub-score of each colon segment was used, ranging from minimum 0 to maximum 3. The highest score means the excellent bowel preparation. Adequate bowel preparation was defined as a total BBPS≥6 and sub-BBPS≥2 per segment.
6 months

次要结果测量

结果测量
措施说明
大体时间
Adenoma Detection Rate
大体时间:6 months
The proportion of patients from whom at least one adenoma can be detected.
6 months
Polyp Detection Rate
大体时间:6 months
The proportion of patients from whom at least one polyp can be detected.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年12月15日

初级完成 (预期的)

2019年12月15日

研究完成 (预期的)

2020年4月15日

研究注册日期

首次提交

2019年4月8日

首先提交符合 QC 标准的

2019年4月8日

首次发布 (实际的)

2019年4月9日

研究记录更新

最后更新发布 (实际的)

2019年4月9日

上次提交的符合 QC 标准的更新

2019年4月8日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2019SDU-QILU-G001

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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