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

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ClinicalTrials.gov Identifier: NCT02175134
Recruitment Status : Terminated (low enrollment rate)
First Posted : June 26, 2014
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Sung-Han Kim, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Suspected Tuberculous Peritonitis Other: Blood and Ascites ELISPOT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
Actual Study Start Date : July 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
No Intervention: conventional diagnostic flow arm
Perform the laparoscopic biopsy as a discretion of attending physician's decision
Experimental: 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
Other: Blood and Ascites ELISPOT



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

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



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175134


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Sung-Han Kim, MD Asan Medical Center

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Responsible Party: Sung-Han Kim, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02175134     History of Changes
Other Study ID Numbers: 2014-0616
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Keywords provided by Sung-Han Kim, Asan Medical Center:
tuberculosis
peritonitis
laparoscopy

Additional relevant MeSH terms:
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Peritonitis
Tuberculosis
Peritonitis, Tuberculous
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Interferon-gamma
Antiviral Agents
Anti-Infective Agents