Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery
试验速览
- 阶段
- 1 期
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of treatment discontinuations, modifications, and interruptions due to adverse events
研究概览
简要总结
This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.
详细描述
Esophageal strictures are common complications after surgery and aggressive endoscopic submucosal dissection (ESD) for early-stage esophageal cancer and adenocarcinoma. However, patients, who develop esophageal strictures after extensive operations, usually develop refractory strictures. Although there are several treatments for refractory strictures, their utility is limited.
Yamaguchi and colleagues have developed new treatments using oral prednisolone. They have shown the safety and potential efficacy to prevent esophageal strictures after ESD. However, the efficacy and safety of oral prednisolone is not evaluated to esophageal stricture after esophageal surgery.
This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who develop the severe esophageal strictures from 28 days after esophageal surgery
排除标准
- •Pulmonary and cardiac disorders
- •Liver and renal dysfunctions
- •Pregnancy
- •infectious disease
- •Unsuitable condition
研究组 & 干预措施
Patients after esophageal surgery
Oral Prednisone for 12 weeks
干预措施: Oral Prednisone (Drug)
结局指标
主要结局
Incidence of treatment discontinuations, modifications, and interruptions due to adverse events
时间窗: for 12 weeks after the intervention
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification
时间窗: for 12 weeks after the intervention
Incidence of Adverse Events of Grade 3 and Grade 4 of CTCAE v4.0
时间窗: for 12 weeks after the intervention
physical conditions, clinical laboratory abnormalities, and ECG abnormalities
次要结局
- Rate of re-strictures at 85 postoperative days(for 12 weeks after the intervention)
- Number of participants with endoscopic classification of strictures before intervention(before the intervention)
- Session of the dilatation(for 12 weeks after the intervention)
- Dysphagia score(for 12 weeks after the intervention)
研究者
Kobayashi Shinichiro
Assistant professor
Nagasaki University