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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Asan Medical Center

Current Primary Outcome: the frequency of laparoscopic biopsy [ Time Frame: 1 week after the enrollment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: the frequency of correct or wrong diagnosis [ Time Frame: 6 months after the enrollment ]

Original Secondary Outcome: Same as current

Information By: Asan Medical Center

Dates:
Date Received: June 25, 2014
Date Started: July 2014
Date Completion: December 2018
Last Updated: July 4, 2014
Last Verified: July 2014