Real-life Prospective Evaluation of Computer-aided Detection (CAD) of Barrett's Neoplasia: MetaVision Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Number of additional Barrett's neoplasia found on quadrantic biopsies
研究概览
简要总结
Barrett's oesophagus is a pre-cancerous condition in which normal cells in the lining of gullet undergo cell changes and this increases the risk of developing adenocarcinoma (a type of cancer) of the gullet. This type of cancer is the 5th most common type of cancer in the UK. To minimise this risk of developing cancer, patients with Barret's oesophagus have regular gastroscopy (a small camera at the tip of the slim tube) every 2-5 years to detect early cancer cell changes. During the procedure, the whole of oesophagus is carefully inspected, and small tissue samples (biopsies) are taken from visible abnormal area within Barrett's oesophagus and sent to the lab to check for cell changes. This is called targeted biopsies. As the endoscopist cannot always tell during gastroscopy where cells are changing, biopsies from each quarter of the gullet (called quadrantic biopsies) are also taken to reduce the risk of pre-cancerous cells being missed. However, this process is time consuming and expensive as numerous biopsies are required.
Recently, there has been a huge development in artificial intelligence (AI). One of these developments is the aid of computer to detect (called computer-aided detection - CAD) the abnormal cell changes within Barrett's during gastroscopy. This system has recently been trained and tested on videos and photos to prove that its performance is as good as expert endoscopists. This system has been already approved to use in the UK. However, this system needs to be tested further and incorporated into real life use to prove that the CAD is useful in detecting cell changes during gastroscopy for targeted biopsies and therefore, the random biopsies can be avoided.
A sample of patients with Barrett's oesophagus will be invited to participate in this study. Participants will have a gastroscopy as part of their usual care for Barrett's oesophagus. Endoscopist will inspect Barrett's oesophagus using AI and will take both targeted biopsies if clinically deemed appropriate along with quadrantic biopsies. Participants will continue to receive usual care and no additional follow up or procedures will be required as part of the study.
详细描述
Barrett's oesophagus is precursor to oesophageal adenocarcinoma and it affects 0.5-2% of the western population. It has 0.5-3% risk of yearly progression to cancer from which <20% will survive at 5 years after diagnosis of cancer. Diagnosing early cancer including dysplasia in Barrett's oesophagus improves survival. Current surveillance practice for Barrett's neoplasia includes regular gastroscopy with careful inspection of Barrett's mucosa along with quadrantic biopsies every 2 cm of Barrett's length as per Seattle protocol. This practice of non-targeted biopsies is labour intensive, expensive and still misses neoplasia. Recently, multiple computer-aided detection (CAD) systems with the use of deep learning have been developed and validated in vitro studies to detect neoplasia. However, further real-life studies are required to determine the efficacy and practicality of CAD in detecting Barrett's neoplasia.
The investigators hypothesise that WISE VISION® CAD system to detect Barrett's neoplasia can improve the detection rate of targeted biopsies, hence making protocol-guided biopsy unnecessary.
Study Procedure
This will be a real-life prospective study using WISE VISION®, NEC Japan, CAD system which is already validated and approved for use in the UK and EU. Gastroscopy will be performed on Barrett's oesophagus patients, who are willing to participate, for surveillance or assessment of neoplasia as per the clinical need.
Necessary preparations to achieve a good mucosal view of oesophagus will be advised during procedure. This may include the use mucolytic drink (simeticone + N-acetylcystine) for mucosal toileting, washing with a water jet and aspiration and the use of hyoscine butylbromide to reduce oesophageal contractions as it would be performed as a standard practice during routine gastroscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anyone aged 18 years and above
- •Known Barrett's oesophagus and having a gastroscopy for Barrett's surveillance or assessment of known neoplasia.
- •Participant is willing and able to give informed consent for participation in the study
排除标准
- •Recent ablation therapy (HALO, APC) to Barrett's oesophagus in the last 6 weeks
- •Oesophageal disorder and patient's factors which impairs the ability of endoscopist to adequately assess of Barrett's neoplasia. This includes but not just limiting to severe oesophagitis, candidiasis, and poor patient tolerance.
结局指标
主要结局
Number of additional Barrett's neoplasia found on quadrantic biopsies
时间窗: From enrolment to end of follow up at 2 month when histology results are available.
The primary endpoint of the study is the number of additional neoplasia found on quadrantic biopsies. This will be collected and calculated from histology data of the targeted and quadrantic biopsies.
次要结局
- Impact of AI (WISE VISION) in real-life(From enrolment to end of follow up at 2 month when histology results are available.)