Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of patients with at least one adenoma detected, confirmed by histopathological analysis, during colonoscopy, in the AI group vs. control group
研究概览
简要总结
The study aims to evaluate the effectiveness of artificial intelligence-assisted colonoscopy in increasing adenoma detection rate and the accuracy in the characterization of colorectal lesions, compared to standard colonoscopy, in a randomized controlled clinical trial setting.
详细描述
Colorectal cancer (CRC) currently shows, according to GLOBOCAN, an incidence of 19.5 individuals per 100,000 inhabitants in both sexes, being the third most common cancer in men and the second in women, representing the third leading cause of death in both men and women.
According to the GLOBOCAN registry of the World Health Organization (WHO), it is estimated that CRC is the third most common type of cancer worldwide, responsible for 10% of all newly diagnosed cancer cases, corresponding to 1,931,590 cases in 2020, preceded only by lung cancer (11.4%) and breast cancer (11.7%). CRC is the second leading cause of cancer mortality (9.4%; 935,173 cases in 2020), following only lung cancer, which accounts for 18% of cancer deaths globally.
In Brazil, according to data from the National Cancer Institute (INCA), CRC mirrors the global incidence, being the second most common cancer by sex.
Colonoscopy is the most accurate CRC screening method, with sensitivity reaching 100% in the detection of colorectal lesions. According to studies, for each 1% increase in adenoma detection rate, there is a 5% decrease in CRC mortality, highlighting the importance of performing colonoscopy to detect colorectal lesions, especially adenomas.
Consequently, with the advancement of technology, new high-definition endoscopes with virtual chromoscopy and image magnification have been developed to increase adenoma detection rates. More recently, AI-assisted colonoscopy has been gaining prominence in helping prevent CRC in some medical centers worldwide, such as in Japan.
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
- Single (Investigator)
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
- •All patients aged 18 years or older, with an elective indication for colonoscopy who sign the informed consent form agreeing to participate in the study.
排除标准
- •History of inflammatory bowel disease.
- •History of colorectal cancer.
- •Personal history of colorectal surgery.
- •Contraindication to endoscopic biopsies.
- •History of intestinal polyposis syndromes.
- •Urgent or emergency cases.
- •Presence of severe, decompensated comorbidities, or with a score of 3 or higher according to the American Society of Anesthesiologists (ASA) classification.
- •Incomplete colonoscopy that does not reach the cecum.
- •Insufficient or inadequate bowel preparation, with a score lower than 6 on the Boston Bowel Preparation Scale.
- •Patients who do not agree to participate in the study and do not sign the informed consent form (ICF).
研究组 & 干预措施
Colonoscopy with the aid of artificial intelligence
Stratum 1: Patients aged 18 to 44 years
Stratum 2: Patients aged 45 to 75 years
Stratum 3: Patients aged 76 years or older
干预措施: Colonoscopy (Procedure)
Colonoscopy without the aid of artificial intelligence
Stratum 1: Patients aged 18 to 44 years
Stratum 2: Patients aged 45 to 75 years
Stratum 3: Patients aged 76 years or older
干预措施: Colonoscopy (Procedure)
结局指标
主要结局
Number of patients with at least one adenoma detected, confirmed by histopathological analysis, during colonoscopy, in the AI group vs. control group
时间窗: 7 days after colonoscopy (estimated time for histopathological report release).
The measure will be expressed as the number and percentage (%) of patients with at least one adenoma detected during colonoscopy and confirmed by histopathological analysis, comparing the AI and non-AI groups (CAD EYE). Detection will be based on the analysis of biopsies performed and processed according to the standard protocol.
次要结局
- Diagnostic accuracy of CAD EYE for characterization of lesions as neoplastic (adenoma) or non-neoplastic (hyperplastic), compared to histopathological analysis as the gold standard.(7 days after colonoscopy)
研究者
ADRIANA VAZ SAFATLE RIBEIRO
Assistente - Endoscopia ICESP
Instituto do Cancer do Estado de São Paulo