IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- the frequency of laparoscopic biopsy
研究概览
简要总结
The diagnosis of tuberculous peritonitis (TBP) is still challenging, and largely dependent on invasive procedures such as laparoscopy. A recently developed RD-1 gene-based assay for diagnosing TBP shows has given promising results. The investigators thus created a 2-step algorithm using the Blood/Ascites ELISPOT assays and adenosine deaminase (ADA) in ascites for differentiation of TBP from other diagnoses (Blood ELISPOT ≥6 spots or ADA ≥ 21 U/L' as a rule-out test and 'Ascites/Blood ratio ≥3' as a rule-in test). This study is the randomized controlled trial on whether this 2-step algorithm-based approach can reduce the laparoscopic biopsy for the diagnosis of TBP in patients with suspected TBP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with suspected tuberculous peritonitis
- •age 16 or more
- •formal informed consent
排除标准
- •not specified
研究组 & 干预措施
conventional diagnostic flow arm
Perform the laparoscopic biopsy as a discretion of attending physician's decision
two-step algorithm-based approach
Perform the laparoscopic biopsy as a discretion of attending physician's decision, but if the below conditions are met, do not perform the laparoscopic biopsy.
- Blood ELISPOT >= 6 spots or ascites adenosine deaminase > 20 IU/L, and
- Ascites ELISPOT/Blood ELISPOT rato > 3
干预措施: Blood and Ascites ELISPOT (Other)
结局指标
主要结局
the frequency of laparoscopic biopsy
时间窗: 1 week after the enrollment
次要结局
- the frequency of correct or wrong diagnosis(6 months after the enrollment)
研究者
Sung-Han Kim
Associate Professor
Asan Medical Center