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

• Sponsor: Asan Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02175134
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Actual Duration (Months): 47
• Patients Per Site Per Month: 0

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jul 1, 2014
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the frequency of laparoscopic biopsy [1 week after the enrollment]

Secondary Outcome Measures

1. the frequency of correct or wrong diagnosis [6 months after the enrollment]

   the frequency of correct or wrong diagnosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all patients with suspected tuberculous peritonitis

• age 16 or more

• formal informed consent

Exclusion Criteria:

• not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	138-736

Sponsors and Collaborators

• Asan Medical Center

Investigators

• Principal Investigator: Sung-Han Kim, MD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sung-Han Kim, Associate Professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT02175134
• Other Study ID Numbers: 2014-0616
• First Posted: Jun 26, 2014
• Last Update Posted: Aug 29, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Sung-Han Kim, Associate Professor, Asan Medical Center: tuberculosis; peritonitis; laparoscopy
• Additional relevant MeSH terms: Peritonitis; Tuberculosis; Peritonitis, Tuberculous

Study Results

No Results Posted as of Aug 29, 2018