IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
- Conditions
- Suspected Tuberculous Peritonitis
- Interventions
- Other: Blood and Ascites ELISPOT
- Registration Number
- NCT02175134
- Lead Sponsor
- Asan Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- all patients with suspected tuberculous peritonitis
- age 16 or more
- formal informed consent
- not specified
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description two-step algorithm-based approach Blood and Ascites ELISPOT 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. 1. Blood ELISPOT \>= 6 spots or ascites adenosine deaminase \> 20 IU/L, and 2. Ascites ELISPOT/Blood ELISPOT rato \> 3
- Primary Outcome Measures
Name Time Method the frequency of laparoscopic biopsy 1 week after the enrollment
- Secondary Outcome Measures
Name Time Method the frequency of correct or wrong diagnosis 6 months after the enrollment the frequency of correct or wrong diagnosis
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of