IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Asan Medical Center
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- the frequency of laparoscopic biopsy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patients with suspected tuberculous peritonitis
- •age 16 or more
- •formal informed consent
Exclusion Criteria
- •not specified
Arms & Interventions
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
Intervention: Blood and Ascites ELISPOT (Other)
Outcomes
Primary Outcomes
the frequency of laparoscopic biopsy
Time Frame: 1 week after the enrollment
Secondary Outcomes
- the frequency of correct or wrong diagnosis(6 months after the enrollment)
Investigators
Sung-Han Kim
Associate Professor
Asan Medical Center