COLO-DETECT: A Randomised Controlled Trial of Lesion Detection at Colonoscopy Using the GI Genius Artificial Intelligence Platform
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,032
- 试验地点
- 19
- 主要终点
- Number of adenomas per participant detected at colonoscopy as indicated by the Mean Number of Adenomas per Procedure (MAP)
研究概览
简要总结
COLO-DETECT is a clinical trial to evaluate whether an Artificial Intelligence device ("GI Genius", manufactured by Medtronic) can identify more polyps (pre-cancerous growths of the bowel lining) during colonoscopy (large bowel camera test) than during colonoscopy without it.
详细描述
Colorectal cancer is common, affecting 1 in 15 men and 1 in 18 women in the UK in their lifetime. Many colorectal cancers develop from polyps via the adenoma-carcinoma sequence: there is a pre-cancerous stage (adenoma) during which it is possible to remove the polyp and therefore prevent it from progressing to colorectal cancer. The gold standard tool for doing this is colonoscopy. However, colonoscopy does not pick up all polyps, particularly flat polyps.
Missed polyps can result in colorectal cancer, so it is imperative to detect and remove as many polyps as possible. Many different interventions have been introduced to improve polyp detection, the most recent of which is artificial intelligence devices. GI Genius is an artificial intelligence device which integrates with existing colonoscopy equipment and analyses the video feed from the colonoscope camera in real time. Any areas that may represent an abnormality are then highlighted (without any lag) within a green box, alerting the colonoscopist to its presence. The potential abnormality can then be assessed more closely by the colonoscopist to decide whether it needs to be removed or not.
COLO-DETECT is a 2-arm, prospective, randomised controlled trial to assess whether GI Genius is able to detect more polyps (specifically, adenomas) during colonoscopy than standard colonoscopy without GI Genius. The primary outcome will be the mean number of adenomas per procedure (MAP) and the key secondary outcome will be the proportion of colonoscopies in which one or more adenomas is detected (Adenoma Detection Rate - ADR). These are both important quality markers for colonoscopy; the study will be powered to detect a clinically meaningful difference in ADR, which will by default detect a meaningful difference in MAP as the sample size required for ADR is larger.
In addition to measuring the effect of GI Genius on polyp detection, COLO-DETECT will provide a health economics analysis concerning the use of GI Genius, perform long-term passive follow-up to examine for future outcomes related to colorectal polyps and colorectal cancer, and perform additional nested studies (subject to ethical approval) that examine the effect upon users (for example through a visual scanning study) and their experience of using the GI Genius.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The patient and colonoscopist (care provider) cannot be blinded to the allocation. The investigator and statistician will remain blinded to the allocation until analysis has been conducted.
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
- •Able to give informed consent
- •Patients attending for colonoscopy
- •Through standard National Health Service (NHS) care (most commonly due to iron deficiency anaemia, altered bowel habit, weight loss, rectal bleeding, positive FIT (faecal immunohistochemical test) based on symptoms, those referred on basis of family history, abnormal cross- sectional imaging, polyp surveillance or post CRC surveillance)
- •Through Bowel Cancer Screening Programme (FIT positive, surveillance)
- •Colonoscopy to be performed by colonoscopist trained to perform GGC as part of the study
排除标准
- •Absolute contraindications to colonoscopy
- •Patients lacking capacity to give informed consent
- •Confirmed or expected pregnancy
- •Established or suspected large bowel obstruction or pseudo-obstruction
- •Known presence of colorectal cancer or polyposis syndromes
- •Known colonic strictures (meaning that the colonoscopy maybe incomplete)
- •Known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
- •Inflammatory Bowel Disease (IBD) surveillance procedures
- •Patients who are on clopidogrel, warfarin, or other antiplatelet agents or anticoagulants who have not stopped this for the procedure (as polyps cannot be removed and thus histology cannot be confirmed)
- •Patients who are attending for a planned therapeutic procedure or assessment of a known lesion
- •Patients referred with polyps identified on Bowel Scope procedure
结局指标
主要结局
Number of adenomas per participant detected at colonoscopy as indicated by the Mean Number of Adenomas per Procedure (MAP)
时间窗: The number of adenomas detected in each procedure will be counted at 14 days post-procedure
The number of adenomas identified during each colonoscopy will be summed and divided by the total number of colonoscopies performed. MAP is usually expressed as a number to one decimal place (e.g. 1.2).
次要结局
- Number of polyps per participant detected at colonoscopy in the 'symptomatic' participant population,as indicated by the Mean number of Polyps per Procedure (MPP)(Total number of polyps detected at colonoscopy will be determined at the end of the procedure)
- Number of polyps per participant detected at colonoscopy in the 'screening' participant population, as indicated by the Mean number of Polyps per Procedure (MPP)(Total number of polyps detected at colonoscopy will be determined at the end of the procedure)
- Number of adenomas per participant detected at colonoscopy in the 'screening' participant population, as indicated by MAP for that participant population.(The number of adenomas detected will be counted at 14 days post-procedure)
- Number of adenomas per participant detected at colonoscopy in the 'symptomatic' participant population, as indicated by MAP for that participant population(The number of adenomas detected will be counted at 14 days post-procedure)
- Number of polyps per participant detected at colonoscopy, as indicated by the Mean number of Polyps per Procedure (MPP)(Total number of polyps detected at colonoscopy will be determined at the end of the procedure)
- Proportion of participants in whom at least one adenoma is detected at colonoscopy, as indicated by the Adenoma Detection Rate (ADR)(The presence or absence of any adenomas will be determined at 14 days post-procedure)
- Proportion of participants in the 'screening' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population(The presence or absence of any adenomas will be determined at 14 days post-procedure)
- Proportion of participants in the 'symptomatic' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population(The presence or absence of any adenomas will be determined at 14 days post-procedure)
- Advanced Adenoma (AA) detection rate(AA Detection Rate will be calculated at the time of study completion, expected to be 18 months)
- Insertion time to caecum(Measured during colonoscopy within the study.)
- Colonoscopist-assessed patient comfort score(Measured during colonoscopy within the study.)
- Patient-Reported Experience(Assessed one day after the procedure)
- Change in number of adenomas detected per participant, for each participating colonoscopist, from pre-study to intra-study (SC arm only)(At the time of 14-day review)
- Proportion of participants in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)(The presence or absence of at least one polyp will be determined at the end of the procedure)
- Sessile Serrated Polyp (SSP) detection rate(SSP Detection Rate will be calculated at the time of study completion, expected to be 18 months)
- Proportion of participants in the 'screening' participant population in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)(The presence or absence of at least one polyp will be determined at the end of the procedure)
- Proportion of participants in the 'symptomatic' participant population in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)(The presence or absence of at least one polyp will be determined at the end of the procedure)
- Polyp characteristics and location(Assessed over duration of colonoscopy procedure and at time of 14 day post-colonoscopy review (once histology is known))
- Caecal Intubation Rate(Caecal Intubation Rate will be calculated at the time of study completion, expected to be 18 months)
- Total Withdrawal Time (in absence of polyps)(Measured during colonoscopy within the study.)
- Patient-Reported Health-Related Quality of Life(Assessed one day after the procedure)
- ADR according to BCSP status of colonoscopist(At the time of 14-day review)
- Change in proportion of participants in whom at least one adenoma is detected during colonoscopy, for each colonoscopist, over the course of the study, as indicated by ADR.(At the time of 14-day review)
- Colorectal Cancer (CRC) detection rate(CRC Detection Rate will be calculated at the time of study completion, expected to be 18 months)
- Total Procedure Time(Measured during colonoscopy within the study.)
- Nurse-assessed patient comfort score(Measured during colonoscopy within the study.)
- Projected future endoscopy workload(Assessed immediately after colonoscopy)
- MAP according to BCSP status of colonoscopist(At the time of 14-day review)
- Change in number of adenomas detected per colonoscopy, for each colonoscopist, over the course of the study, as indicated by MAP(At the time of 14-day review)
- Proportion of participants in whom at least one adenoma is detected during colonoscopy, for each participating colonoscopist, from pre-study to intra-study (SC arm only)(At the time of 14-day review)