NCT02175134|Terminated
Study Stopped
low enrollment rate
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low enrollment rate
Sponsor study identifier
interventional
2
1 country
1
Study Start
July 2014
Actual (reported)Primary Completion
June 2018
Actual (reported)Study Completion
June 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 25, 2014
Actual (reported)June 26, 2014
Actual (reported)July 2014
Actual (reported)June 2018
Actual (reported)June 2018
Actual (reported)the frequency of laparoscopic biopsy
1 week after the enrollment
the frequency of correct or wrong diagnosis
6 months after the enrollment
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Asan Medical Center
Seoul, 138-736, South Korea
Sung-Han Kim, MD
Asan Medical Center
2 participants (actual enrollment reported by the registry).
First Submitted
June 25, 2014
First Posted
June 26, 2014
Study Start
July 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 2018
Actual (reported)Study Completion
June 2018
Actual (reported)Last Updated
August 29, 2018
Record last verified: 2018-08
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Source: ClinicalTrials.gov.
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