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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Suspected Tuberculous Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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conventional diagnostic flow arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

1. Blood ELISPOT \>= 6 spots or ascites adenosine deaminase \> 20 IU/L, and
2. Ascites ELISPOT/Blood ELISPOT rato \> 3

Group Type EXPERIMENTAL