Suspected Tuberculous Peritonitis
Conditions
Keywords
tuberculosis, peritonitis, laparoscopy
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.
Interventions
OTHERBlood and Ascites ELISPOT
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all patients with suspected tuberculous peritonitis * age 16 or more * formal informed consent
Exclusion criteria
* not specified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the frequency of laparoscopic biopsy | 1 week after the enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the frequency of correct or wrong diagnosis | 6 months after the enrollment | the frequency of correct or wrong diagnosis |
Countries
South Korea
Outcome results
None listed