High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of Barrett's Esophagus: Impact on the Detection of High-grade Dysplasia and Adenocarcinoma Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 15
- 主要终点
- Rate of both high grade dysplasia and esophageal adenocarcinoma lesions detected by electronic chromoendoscopy versus rate of such lesions detected by white light endoscopy plus systemic biopsies according to Seattle protocol.
研究概览
简要总结
The investigators hypothesize that careful examination of Barrett's esophagus by high-resolution endoscopy combined with virtual chromoendoscopy could replace the Seattle protocol for Barrett's esophagus monitoring and detection of dysplasic lesions, and thus modify existing recommendations.
详细描述
Barrett's esophagus (BE) is a pre-neoplastic condition that predisposes to dysplasia and adenocarcinoma of the esophagus, a cancer with an increasing incidence and poor prognosis. However, when detected at an early stage, superficial lesions can be effectively treated by endoscopic resection. Although BE degeneration remains a rare event, the European Society for Gastrointestinal Endoscopy recommends that BE be followed according to its size. Follow-up consists of a digestive endoscopy with white light examination of the esophagus, targeted biopsies of any visible lesions and quadrantic biopsies every 2 centimeters from the esogastric junction to the top of the BE, at a frequency that depends on the presence of dysplasia and the size of the BE. However, physician adherence to this procedure, known as the Seattle Protocol, is low because : 1) it increases the time required for the endoscopist to examine the patient and therefore the duration of sedation, as well as the time needed to interpret the pathology, 2) the risk of sampling error is high because only a small portion of the esophageal mucosa can be biopsied and 3) this approach is costly because of the time spent on the Seattle protocol in the operating room and in the pathology department.
New optical tools such as high-resolution endoscopy combined with magnification and electronic chromoendoscopy can reveal subtle mucosal and microvascular changes in the BE, which could improve the detection of early neoplastic lesions. However, there is still insufficient evidence to recommend its use in routine BE surveillance.
The investigators hypothesize that careful examination of Barrett's Esophagus by high-resolution endoscopy combined with virtual chromoendoscopy could replace the Seattle protocol for BE monitoring and detection of dysplasic lesions, and thus modify existing recommendations.
In this study, each patient will be his(her) own control and have the two procedures :
- Firstly, an endoscopist called A will perform high-resolution endoscopy combined with virtual chromoendocopy and note on a scheme the biopsies/resection he would have done with this procedure.
- Secondly, another endoscopist called B will do the examination using white light modality of the endoscope and process as follows :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
The two endoscopists will be blinded to each other's findings when searching the lesions.
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
- •Male or Female with Age above ≥ years old;
- •Female of childbearing potential must use appropriate method(s) of contraception during the clinical trial (i.e.: Intrauterine Device, pill, implant,sexual abstinence);
- •Dysplastic Barrett's Esophagus preferably labelled "flat mucosal dysplasia";
- •Patient requiring esophageal endoscopy as part of their regular monitoring;
- •Affiliated to social security;
- •Patient received Patient Information Form and accepted to participate to the study.
排除标准
- •Previously treated Barrett's Esophagus;
- •Known invasive esophageal adenocarcinoma;
- •Contraindication to general anesthesia;
- •Ongoing clopidogrel or anticoagulant therapy or coagulation disorder (platelet count < 50 000/mm3, Prothrombin time ratio <50%);
- •Poor general health status precluding subsequent follow up of Barrett's Esophagus ;
- •For female: pregnancy or breastfeeding;
- •Adults under a legal protection regime (guardianship, trusteeship, "under judicial protection").
- •Ongoing participation in another study requiring an intervention on Barrett's Esophagus during patient's participation in Converse study
研究组 & 干预措施
Electronic chromoendoscopy
High-resolution endoscopy combined with virtual chromoendocopy to detect esophageal displasic lesions
干预措施: Electronic chromoendoscopy (Procedure)
White light endoscopy with Seattle protocol
White light endoscopy to detect esophageal displasic lesions, and then systemic quadrantic biopsies every 2 centimeters from the esogastric junction to the top of the Barett's esophagus (Seattle protocol)
干预措施: White light endoscopy with Seattle protocol (Procedure)
结局指标
主要结局
Rate of both high grade dysplasia and esophageal adenocarcinoma lesions detected by electronic chromoendoscopy versus rate of such lesions detected by white light endoscopy plus systemic biopsies according to Seattle protocol.
时间窗: Day 1
次要结局
- Rate of missed lesions (both high grade dysplasia and esophageal adenocarcinoma) diagnosed by an adjudication committee reviewing videos from the procedure.(Day 1)
- Rate of low grade displasia lesions detected by electronic chromoendoscopy versus rate of such lesions detected by white light endoscopy plus systemic biopsies according to Seattle protocol.(Day 1)
- Rate of resected lesions (both high grade dysplasia and esophageal adenocarcinoma) that were detected by endoscopist performing electronic chromoendoscopy, but missed by endoscopist performing white light endoscopy and Seattle protocol.(Day 1)
- Rate of both high grade dysplasia and esophageal adenocarcinoma lesions detected by electronic chromoendoscopy versus rate of such lesions detected by white light endoscopy.(Day 1)
- Number of adverse events(Day 30)
- Cost effectiveness of the detection of both early esophageal adenocarcinoma and high grade dysplasia with electronic chromoendoscopy versus cost effectiveness of Seattle protocol.(Day 30)
- Duration (in minutes) of each procedure: white light endoscopy, electronic chromoendoscopy, Seattle protocol.(Day 1)