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

Suspected Tuberculous Peritonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02175134
• Other study ID #: 2014-0616
• Status: Terminated
• Phase: N/A
• Start date: July 2014
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• all patients with suspected tuberculous peritonitis

• age 16 or more

• formal informed consent

Exclusion Criteria:

• not specified

Related Conditions & MeSH terms

• Peritonitis
• Suspected Tuberculous Peritonitis
• Tuberculosis

Intervention

Other:
• Blood and Ascites ELISPOT

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the frequency of laparoscopic biopsy		1 week after the enrollment
Secondary	the frequency of correct or wrong diagnosis	the frequency of correct or wrong diagnosis	6 months after the enrollment