Mucosal and Minimal Injuries Detected Through Digital Chromoendoscopy Using Optical Enhancement System™ Associated to High Definition Plus Optical Magnification in Non Erosive Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Digital chromoendoscopy and optical magnification in the diagnosis of intrapapillary loops (IPCLs) in esophagus. Number of participants with increased number of IPCLs, dilatation or tortuosity of IPCLs
研究概览
简要总结
White light endoscopy remains the gold standard technique to evaluate gastrointestinal tract. Gastroesophageal Reflux Disease (GERD) is defined as presence of reflux symptoms (heartburn and regurgitation) associated or not with lesions in esophageal mucosa. Based on findings at videoendoscopy GERD patients can have a complicated reflux disease (erosive esophagitis) or not and be considered as a non erosive reflux disease (NERD). 60% of GERD patients have normal endoscopy (NERD) and requires further studies to achieve a definitive diagnosis. Based on this fact is that the study will be focus on NERD patients.
Recently an image-enhanced endoscopic technology using a pre-processor band-limited light called Optical Enhancement system (OE system™), was developed (Pentax Medical). This new technology combines digital signal processing with optical filters that limit the spectral characteristics of the illumination light. The new innovated optical filters achieve higher overall transmittance by connecting the peaks of the hemoglobin absorption spectrum (415 nm, 540 nm and 570 nm) creating a continuous wavelength spectrum. There are two modes with different OE filters (Mode 1 and Mode 2). Mode 1 is designed to improve visualization of microvessels with a sufficient amount of light, and Mode 2 is designed to improve contrast of white-light observation by bringing the color tone of the overall image closer to that of natural color.
In addition, new scopes has been developed which combines high definition images with optical magnification called Magniview™. These scopes increase the image up to 136 times with a better quality of image than standard scopes without optical zoom. Sharma et al. evaluated esophageal changes in NERD patients using a similar pre-processor filter called Narrow Band Imaging (NBI). They found that a significantly higher proportion of patients with NERD had an increased number, dilation and tortuosity of the microscopic intrapapillary capillary loops (IPCLs), and were considered the best predictors for diagnosing NERD. They used optical chromoendoscopy technology (NBI) associated to magnification scopes (Olympus GIF Q240Z, 115x), but they did not evaluated if the contribution with this technology to the observations found in GERD patients were as a result of the NBI or the magnification scopes. The investigators opinion is that chromoendoscopy is useful but is the magnification what makes up the difference.
详细描述
Sharma et al. described in detail the changes of the intrapapillary capillaries seen with reflux inflammation. In the normal esophageal mucosa, submucosa all vessels are connected to the arborescent vascular network. Intrapapillary capillaries arise from the fourth branch of the arborescent vessels into the epithelial papillae and form single loops called IPCLs. It has been shown that IPCLs dilate and elongate along with an increase in the number and density of arborescent vessels in mucosal cancer. These changes are similar to those observed in inflammation.
Estimated enrollment: 100 patients (NERD group: 50 patients and control group: 50 patients)
Study design: This is an observational and analytical cross-section, population - based survey study, with prospective case collection, non-randomized and simple blind, performed in a Tertiary Academic Center.
Study Design
- Allocation: Non randomized, simple blind
- Endpoint Classification: Efficacy
- Intervention Model: Non interventional
- Primary Purpose: Diagnosis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Above 18 years old patients
- •Who agree to participate in the study
- •Patients with reflux symptoms (heartburn and regurgitation), with8 or more points at the GERD questionnaire and no evidence of ulcerative esophagitis, esophageal strictures, Barrett's esophagus or any erosive sign according to Los Angeles classification (Grade A to D) in the upper endoscopy using white light nor I-Scan™
排除标准
- •Patients with ulcerative esophagitis, esophageal strictures, Barrett's esophagus or any erosive sign according to Los Angeles classification (Grade A to D)
- •Patients with medical history of any kind of esophagitis (including actinic, caustic or eosinophilic), achalasia.
- •Esophageal varices
- •Patients with evidence of cancer or mass lesion in the esophagus
- •Protons bump inhibitor consumption for at least 3 weeks before endoscopy
- •Inability to discontinue non steroidal anti-inflammatory drugs or aspirin prior to the study
- •Severe uncontrolled coagulopathy
- •Gastric lesions (ulcer, polyp, cancer), severe gastroparesis
- •Prior history of esophageal or gastric surgery.
- •Pregnancy and lactation
结局指标
主要结局
Digital chromoendoscopy and optical magnification in the diagnosis of intrapapillary loops (IPCLs) in esophagus. Number of participants with increased number of IPCLs, dilatation or tortuosity of IPCLs
时间窗: two months
次要结局
- Number of patients in whom the minimal esophageal changes are diagnosed by the digital chromoendoscopy without using the magnification, or with the magnification without using the digital chromoendoscopy or using both.(two months)
- Number of patients with increased number, dilatation or tortuosity of the intrapapilary loops on endoscopic image and have a positive biopsy for inflammation of mucosa.(two months)