Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus - the Patients' Perspective: a Randomized Controlled Trial Assessing Procedural Acceptability and Safety (RATE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Level of late post-procedural pain (at day 30 after treatment)
研究概览
简要总结
This study compares patients' acceptability and safety of two established endoscopic methods for treating dysplastic Barrett's esophagus: radiofrequency ablation versus hybrid argon plasma coagulation.
详细描述
Both endoscopic radiofrequency ablation (RFA) and argon plasma coagulation (APC) are established treatment modalities for dysplastic Barrett's esophagus. Recently, a modification of the APC method has emerged, which involves a submucosal injection of saline preceding the thermal ablation (hybrid-APC; h-APC). This allows to increase the procedure's safety and presumably reduces the patients' post-procedural discomfort. Although both RFA and h-APC are characterized by high effectiveness in eradicating Barrett's segments, limited data compares the patient-related aspects of the procedures. To fill this knowledge gap, we set out a single-center randomized-controlled trial to compare procedural acceptability, safety, and impact on the quality of life, of the two methods.
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
- Single (Participant)
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
- •Male or female subjects over 18 years
- •Histologically and endoscopically proven Barrett's esophagus requiring ablation therapy according to the current guidelines
- •General health status sufficient to perform an endoscopic procedure (ASA I-III)
排除标准
- •Primary or secondary coagulopathy, with INR>1.5 and/or platelet count of <75,
- •Anticoagulation therapy (e.g. warfarin) for high-risk condition and unable to withhold the medication temporarily
- •Recent myocardial infraction or other significant cardiovascular event within 6 months prior to recruitment
- •Patients under long-term care and/or within nursing facilities (e.g. psychosocial disorders, mental retardation)
- •Any history of esophageal resection surgery
- •Esophageal varices
结局指标
主要结局
Level of late post-procedural pain (at day 30 after treatment)
时间窗: Measured at day 30 after the procedure
Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain)
Level of post-procedural pain at day 7 after treatment
时间窗: Measured at day 7 after the procedure
Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain)
Level of post-procedural pain
时间窗: Measured at any time point before given anesthesia for the procedure and immidietly after the procedure.
Change in chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain) before the procedure and immidietly after (30-60 minutes) the procedure.
次要结局
- Level of post-procedural dysphagia(Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.)
- Level of post-procedural quality of life(Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.)
- The rate of complications(Measured during the prcoedure, immidietly after the procedure and at day 7 and day 30 after the procedure during follow-up)