Near Focus NBI-Driven Artificial Intelligence for the Diagnosis of Gastro-Oesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- To develop an accurate and reliable artificial intelligence model for the diagnosis of Gastro-Oesophageal Reflux Disease (GORD)
研究概览
简要总结
Gastro-oesophageal reflux disease (GORD) is a chronic condition with symptoms arising secondary to the reflux of stomach contents (Vakil et al., 2006). It is divided into four phenotypes: Erosive Oesophagitis (EO), Non-Erosive Reflux Disease (NERD), Reflux Hypersensitivity (RH), Functional Heartburn (FH) (Nikaki, Woodland and Sifrim, 2016). The definition of these phenotype have evolved with the addition of diagnostic tests and methods of their interpretation, the most recent being the Lyon Consensus Statement (Gyawali et al., 2018). The majority of patients presenting with symptoms suggestive of GORD have no mucosal lesion seen at endoscopy (Nikaki, Woodland and Sifrim, 2016). Studies have shown a relation of increased IPCL numbers with GORD. This study aims to build a fully autmoated AI model using Near-Focus NBI images on patients with symptoms suggestive of GORD phenotyped in accordance with the Lyon Consensus.
详细描述
Gastro-oesophageal reflux disease (GORD) is a chronic condition with symptoms arising secondary to the reflux of stomach contents (Vakil et al., 2006). It is divided into four phenotypes: Erosive Oesophagitis (EO), Non-Erosive Reflux Disease (NERD), Reflux Hypersensitivity (RH), Functional Heartburn (FH) (Nikaki, Woodland and Sifrim, 2016). The definition of these phenotype have evolved with the addition of diagnostic tests and methods of their interpretation, the most recent being the Lyon Consensus Statement (Gyawali et al., 2018). The majority of patients presenting with symptoms suggestive of GORD have no mucosal lesion seen at endoscopy (Nikaki, Woodland and Sifrim, 2016). Complications of GORD, such as peptic stricture and Barrett's oesophagus, can be readily diagnosed using WLE. The diagnosis of reflux oesophagitis with standard-definition WLE is well described in the Los Angeles (LA) classification (Armstrong et al., 1996) and validated (Lundell et al., 1999) with LA grades C and D confirmatory of GORD (Gyawali et al., 2018). Furthermore, AET is demonstrated to increase with LA classification A to D (Lundell et al., 1999). There is, however, only a modest inter-observer agreement between LA grades (Kappa coefficient 0.4), especially A and B. Furthermore LA grade A oesophagitis is detected in up to 17.0% of asymptomatic patients (Nozu and Komiyama, 2008; Zagari et al., 2008). A diagnosis of GORD and decisions for anti-reflux surgery cannot be made on this basis, mandating pH testing to confirm GORD.
Narrow Band Imaging
Imaging of the gastro-oesophageal junction using high definition Olympus H260 scope using the LA classification of GORD with WLE and NBI demonstrated improvement in overall interobserver reproducibility when used in a combination compared with WLE alone; k 0.62 vs 0.45 (<0.05)(Lee et al., 2007). Features identified using digital magnification NBI at the squamo-columnar junction in cases of EO (n=41; LA grade A and B), NERD (n=36) and controls (n=32) include micro-erosions (100% EO; 52.8% NERD; 23.3% controls), increased vascularity (95.1% EO; 91.7% NERD; 36.7% controls) and round pit patterns (4.9% EO; 5.6% NERD; 70% controls). Increased vascularity combined with absence of round pit pattern distinguishes NERD from controls with sensitivity and specificity 86.1% and 83.3%. Inter-observer agreement in this single centre study was good for increased vascularity (k=0.95) and micro erosions (k=0.89) but low for pit pattern (k=0.59) (Fock et al., 2009).
Intra-papillary capillary loops (IPCLs) are mucosal capillaries arising from the submucosal vein to the papilla, usually arranged in a regular 'dot' like fashion approximately 100micrometres apart (Inoue, 2001). The visualisation of oesophageal IPCLs with NBI is well documented and form the basis of a NBI classification for squamous neoplasia (Inoue et al., 2015). IPCL morphology changes have been proposed in patients being investigated for NERD, in particular dilatation and elongation of IPCLs in patients with NERD with magnification NBI (Kato et al., 2006).
NBI with optical magnification for the diagnosis of GORD has been evaluated in 2 studies (Sharma et al., 2007; Lv et al., 2013). Sharma et al performed a feasibility trial with Olympus Q240Z with quadrantic examination of the distal 5cm by WLE then NBI in n=50 GORD (EO n=30; NERD n=20) and controls (n=30). Similar to Fock et al, the presence of microerosions and hypervascularity was significantly higher amongst GORD. IPCL number and morphology of tortuosity, dilatation were seen significantly more in GORD versus control. These findings were consistent in independent comparison of EO and NERD versus controls. ROC analysis thresholds for best sensitivity and specificity (respectively) for NERD were maximum ipcl/field 131 (90%, 70%), min 99 (85%, 70%) and average 117 (90%, 70%) (Sharma et al., 2007).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retaining capacity and medically fit for gastroscopy
- •Requiring gastroscopy by current BSG guidelines for the investigation of acid reflux/ dyspepsia
排除标准
- •Unable to give informed consent
- •History of oesophageal or gastric surgery
- •Allergy to proton-pump inhibitor
- •Known Barrett's Oesophagus/ oesophageal carcinoma/ oesophageal stricture/ known oesophageal dysmotility
- •Portal Hypertension
- •Pacemaker (BRAVO)
结局指标
主要结局
To develop an accurate and reliable artificial intelligence model for the diagnosis of Gastro-Oesophageal Reflux Disease (GORD)
时间窗: 3 months after completion of all data collection
Patient data split into training/validation and test dataset for computer assisted and deep learning model training and testing
To evaluate Intra-Papillary Capillary Loop (IPCL) changes secondary to oesophageal acid exposure.
时间窗: 6 weeks post completion of wireless capsule pH recording
Parameters of IPCLs: IPCLs/region of interest, morphology: IPCL length, density correlated to oesophageal acid exposure
次要结局
- To explore factors that may predict response to treatment.(6 weeks to include data of response to antacid treatment)
