Back to resultsIFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
Primary Purpose
Suspected Tuberculous Peritonitis
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Blood and Ascites ELISPOT
Sponsored by
About this trial
This is an interventional other trial for Suspected Tuberculous Peritonitis focused on measuring tuberculosis, peritonitis, laparoscopy
Eligibility Criteria
Inclusion Criteria:
- all patients with suspected tuberculous peritonitis
- age 16 or more
- formal informed consent
Exclusion Criteria:
- not specified
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
conventional diagnostic flow arm
two-step algorithm-based approach
Arm Description
Perform the laparoscopic biopsy as a discretion of attending physician's decision
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
Outcomes
Primary Outcome Measures
the frequency of laparoscopic biopsy
Secondary Outcome Measures
the frequency of correct or wrong diagnosis
the frequency of correct or wrong diagnosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02175134
Brief Title
IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
Official Title
IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
low enrollment rate
Study Start Date
July 2014 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suspected Tuberculous Peritonitis
Keywords
tuberculosis, peritonitis, laparoscopy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional diagnostic flow arm
Arm Type
No Intervention
Arm Description
Perform the laparoscopic biopsy as a discretion of attending physician's decision
Arm Title
two-step algorithm-based approach
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Blood and Ascites ELISPOT
Primary Outcome Measure Information:
Title
the frequency of laparoscopic biopsy
Time Frame
1 week after the enrollment
Secondary Outcome Measure Information:
Title
the frequency of correct or wrong diagnosis
Description
the frequency of correct or wrong diagnosis
Time Frame
6 months after the enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients with suspected tuberculous peritonitis
age 16 or more
formal informed consent
Exclusion Criteria:
not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Han Kim, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
We'll reach out to this number within 24 hrs