NCT02797665Unknown不适用
Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical remission rate of obstructive jaundice
研究概览
简要总结
This study evaluates corticosteroids in the treatment of obstructive jaundice in autoimmune pancreatitis and/or immunoglobulin G4 (IgG4)-related sclerosing cholangitis in adults. Half of participants will receive corticosteroids alone, while the other half will receive corticosteroids with biliary stent at the beginning.
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 (Outcomes Assessor)
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
- •adults greater than 18 years-old;
- •autoimmune pancreatitis and/or IgG4-related sclerosing cholangitis;
- •obstructive jaundice
排除标准
- •malignancies; active infections;
- •pregnancy or breast feeding;
- •standard contraindications to ERCP;
- •unwillingness or inability to consent for the study
研究组 & 干预措施
Steroids group
Active Comparator
The patients will be treated with oral corticosteroids (prednisone 0.6mg/kg/d) alone.
干预措施: corticosteroids (Drug)
Stent group
Active Comparator
The patients will be treated with oral corticosteroids and biliary stent.
干预措施: corticosteroids (Drug)
Stent group
Active Comparator
The patients will be treated with oral corticosteroids and biliary stent.
干预措施: biliary stent (Procedure)
结局指标
主要结局
Clinical remission rate of obstructive jaundice
时间窗: Day 60
次要结局
未报告次要终点
研究者
研究点 (1)
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