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临床试验/NCT04838951
NCT04838951已完成不适用

Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training: a Single-blind Randomized Study

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 856 人开始时间: 2021年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
856
试验地点
1
主要终点
ADR

研究概览

简要总结

The investigator's hypothesis is that a CADe system (ENDO-AID) would improve the adenoma detection rate in junior endoscopists.

详细描述

Colorectal cancer (CRC) is the most common and second most lethal cancer in Hong Kong with more than 5,600 new cases and 2,300 deaths annually. Colonoscopy with polypectomy has shown to reduce CRC-related mortality by 53%. However, high polyp miss rates were reported to be up to 26% for adenomas and 9% for advanced adenomas in standard colonoscopies. Risk factors included proximal location, serrate or flat lesions, poor bowel preparation and short withdrawal time (<6 minutes). Insufficient trainee experience was also associated with a higher adenoma miss rate. A significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy leading to adverse patient outcomes.

As a result, various techniques were developed to improve adenoma detection rate (ADR) during colonoscopies. Techniques including water exchange method, second examination of the right colon (retroflexion or second forward view)and cap/cuff-assisted colonoscopies were proven to increase ADR effectively. However, these techniques were operator-dependent requiring certain level of expertise.

Recently, artificial intelligence and computer-aided polyp detection (CADe) systems have developed rapidly around the globe. These systems can provide real-time CADe by flagging the suspected lesions to endoscopists, with the adoption of deep learning or convoluted neural networks. A number of prospective randomized clinical trials reported a significant increase in ADR in CADe group. The number of adenoma detected per colonoscopy was consistently higher among different polyp sizes, location and morphology. The ADR increment was particularly higher for diminutive adenomas smaller than 5mm.

Nevertheless, most of the aforementioned studies only involved senior endoscopists for the procedures. Theoretically, the senior endoscopists were more skillful to expose colonic mucosa and more experienced to distinguish the false positive computer signals, leading to an enhanced performance of CADe in real-time colonoscopies. The effect of CADe on inexperienced junior endoscopists performing colonoscopies remains largely unknown.

In this single-blind randomized study, the investigators aim to evaluate the effect of a new CADe system (ENDO-AID) on adenoma detection and quality improvement in junior endoscopists.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Endoscopist wil not be blinded to treatment. Treatment arm allocation will be concealed to patients, data collector and data analysts.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years old or above;
  • They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or gastrointestinal bleeding;
  • Written informed consent obtained.

排除标准

  • Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
  • Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, significant bleeding tendency, uninterrupted anticoagulation or dual antiplatelets)
  • Scheduled staged procedure for polypectomy or biopsy
  • Previous colonic resection
  • Personal history of colorectal cancer
  • Personal history of polyposis syndrome
  • Personal history of inflammatory bowel disease
  • Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
  • Unable to obtain informed consent

结局指标

主要结局

ADR

时间窗: During the colonoscopy

adenoma detection rate

次要结局

  • Total procedural time(During the colonoscopy)
  • ADR for adenomas of different sizes(During the colonoscopy)
  • ADR for adenomas of different colonic segments(During the colonoscopy)
  • Mean number of adenomas per colonoscopy(During the colonoscopy)
  • Advanced adenoma detection rate(During the colonoscopy)
  • Sessile serrate lesion (SSL) detection rate(During the colonoscopy)
  • Polyp detection rate(During the colonoscopy)
  • Non-neoplastic resection rate(During the colonoscopy)
  • Missed polyp rate(During the colonoscopy)
  • False positive rate(During the colonoscopy)
  • Cecal intubation time(During the colonoscopy)
  • Withdrawal time(During the colonoscopy)
  • Percentage of change in ADR in relation to the personal experience in colonoscopy(During the colonoscopy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Louis Ho Shing Lau

Resident Specialist

Chinese University of Hong Kong

研究点 (1)

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