IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis

Asan Medical Center

Status: Terminated

Conditions: Suspected Tuberculous Peritonitis

Treatments: Other: Blood and Ascites ELISPOT

Study type: Interventional

Funder types: Other

Identifiers

NCT02175134

2014-0616

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients with suspected tuberculous peritonitis
• age 16 or more
• formal informed consent

Exclusion criteria

• not specified

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

conventional diagnostic flow arm

No Intervention group

Description:

Perform the laparoscopic biopsy as a discretion of attending physician's decision

two-step algorithm-based approach

Experimental group

Description:

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

Treatment:

Other: Blood and Ascites ELISPOT