An interventional study of Blood and Ascites ELISPOT in Suspected Tuberculous Peritonitis, sponsored by Asan Medical Center. Terminated at 1 site in Korea, Republic of. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by Asan Medical Center · Not applicable, Interventional, and Other
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.
185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.
This study's enrollment of 2 is below the median of 95 across 118 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Perform the laparoscopic biopsy as a discretion of attending physician's decision
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
Other: Blood and Ascites ELISPOT
the frequency of laparoscopic biopsy
Time frame: 1 week after the enrollment
the frequency of correct or wrong diagnosis
the frequency of correct or wrong diagnosis
Time frame: 6 months after the enrollment
This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Asan Medical Center