Endoscopic Mucosal Resection Versus Endoscopic subMucosal Dissection fOr Removal of Visible Lesions in Barrett's Esophagus With Early Neoplasia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 331
- 试验地点
- 6
- 主要终点
- Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.
研究概览
简要总结
Rationale:
The optimal technique for removal of visible dysplastic lesions in Barrett's esophagus remains controversial. Endoscopic mucosal resection (EMR) is safe, effective, easy to apply, and has been the most widely used technique since 2008. Endoscopic submucosal dissection (ESD) is a more controlled dissection method with potential improved efficacy, but at the cost of higher technical complexity.
Objective:
The investigators aim to compare EMR and ESD for removal of visible lesions in Barrett's esophagus.
Study design:
Randomized clinical trial
Study population:
Patients with Barrett's esophagus and a visible lesion with dysplasia and/or early cancer. Suspicion for submucosal invasion is an exclusion criterion.
Intervention:
Patients are randomized to receive either EMR or ESD, with follow-up and no ablation during 12 months after the resection.
Main study endpoint:
Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients age: ≥ 18 years
- •Willingness to undergo both EMR or ESD
- •Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
- •BE with at least one visible lesion ("target lesion") with absence of signs of submucosal invasion on endoscopy, after evaluation by the adjudication committee
- •Multiple lesions are allowed as long as the lesions are considered eligible for endoscopic treatment. Only the target lesion is evaluated for the study
- •Prior endoscopic resection is allowed
排除标准
- •Patients with visible lesions with suspicion of submucosal invasion based on assessment of the adjudication committee
- •Patients with HGD in at least one random biopsy, before inclusion (i.e. during endoscopy in the referring center <3 months before imaging, or during imaging endoscopy)
- •History of esophageal surgery other than fundoplication
- •History of esophageal ablation therapy
- •In case of prior endoscopic resection, the target lesion located within 1 cm of the prior resection site
- •Uncontrolled coagulopathy with INR >2.0, thrombocytopenia with platelet counts < 50,000
- •Esophageal varix or varices
- •Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
- •Life expectancy <2 years
研究组 & 干预措施
Endoscopic submucosal dissection
干预措施: ESD (Other)
Endoscopic mucosal resection
干预措施: EMR (Other)
结局指标
主要结局
Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.
时间窗: 12 months
次要结局
- Cost-effectiveness(12 months)
- Additional histopathologic evaluation may be performed to evaluate potential differences between the two techniques.(12 months)
- Incidence of complications(12 months)
- Procedure times(12 months)
- Proportion of patients with endoscopically radical resection(12 months)
- The total number of ER endoscopies per patient(12 months)
- The proportion of patients that shows neoplastic progression(12 months)
研究者
Sanne van Munster
Principal Investigator (Bas Weusten)
St. Antonius Hospital