Trials / Terminated
TerminatedNCT02175134
IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Asan Medical Center · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Blood and Ascites ELISPOT |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2014-06-26
- Last updated
- 2018-08-29
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02175134. Inclusion in this directory is not an endorsement.