Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Prevalence of low grade dysplasia 3 years after randomization
研究概览
简要总结
Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.
详细描述
Background: The occurrence of low grade dysplasia (LGD) in Barrett oesophagus (BE) is known as a pre-cancerous state. Current recommendation in case of LGD is a close endoscopic surveillance every 6 to 12 month and continuous Proton pomp inhibitor (PPI) treatment. Endoscopic radiofrequency ablation (RFA) has been demonstrated as an efficient treatment to eradicate high grade dysplasia (HGD) and most of LGD and BE.
Main aim of this study: To demonstrate that the prevalence of patients with LGD 3 years after a RFA treatment is lower than in a surveillance group.
Patients & Methods: French multicentric randomized controlled trial for patients with BE with confirmed LGD: RFA vs endoscopic surveillance.
120 patients are planned to be included for at least 40 patients randomized in each group.
Primary endpoint: Prevalence of LGD in each group 3 years after randomization
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BE with certain LGD in at least one endoscopic biopsy sample
- •BE with maximal length of 12cm (Prague classification ≤ C12)
- •BE with minimal length of 1cm circumferentially or 3cm in case of a unique zone (Prague classification ≥ C1 or C0M3)
- •Patients aged between 18 and 80 years
- •Patients' consent for study enrollment
- •No contra-indications to general anaesthesia
- •Patients ability to take PPI oral medication
- •Patient affiliated to a social security system
- •No pregnancy and active contraceptions for women in age to procreate
- •In case of previous endoscopic mucosal resection for HGD in BE: at least one year of surveillance and 2 biopsy series with LGD without HGD
排除标准
- •BE length > 12cm or < 1cm circumferentially (< C1) or < 3cm focally (<M3)
- •HGD or adenocarcinoma needing a specific endoscopic or surgical treatment
- •Active peptic oesophagitis (Savary III or IV)
- •Presence of surgical staples on the area to be treated
- •Radiation oesophagitis of radiotherapy whose field includes the lower oesophagus
- •previous oesophagus cancer
- •previous endoscopic destruction treatment such as photodynamic therapy or plasma argon coagulation
- •previous Heller surgery
- •oesophagus stenosis
- •oesophagus varices
- •oesophagus pathology associated with sclerodermia
- •Severe coagulation disorders or thrombopenia
- •Anaesthesia contra-indications (ASA 4)
- •Hypersensitivity to fluorescein or any component of the fluorescein
- •Life expectancy < 2 years
- •Disability to take PPI oral medication or follow the protocol surveillance Schedule
结局指标
主要结局
Prevalence of low grade dysplasia 3 years after randomization
时间窗: 3 years after randomization
次要结局
- Rate of complete eradication of Barrett oesophagus(1, 3 and 5 years after randomization)
- Cost - efficacy comparison of the 2 strategies(5 years)
- Prevalence of low grade dysplasia in each group(1 and 5 years after randomization)
- Detection rate of dysplasia and Barrett's oesophagus with the confocal endomicroscopy technique(before treatment, during treatment (Month 3, Month 6, Month 9, Month 12) and after treatment (1, 3 and 5 years after randomization))
- Incidence of high grade dysplasia and adenocarcinoma(3, 5 years after randomization)
- Rate of complications in radiofrequency ablation group(5 years after randomization)