Development of a Score for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Byong Duk Ye, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01392365
First received: July 11, 2011
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

The aim of this study is to develop a score for differential diagnosis between intestinal tuberculosis and Crohn's disease.


Condition
Crohn's Disease
Intestinal Tuberculosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Development of a Score for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Final diagnosis(Crohn's disease or Intestinal tuberculosis) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    At 2 months after the first visit, we will analyze the results of laboratory, endoscopic, radiologic, microbiologic/histological tests.

    • History (age, gender, symptoms)
    • CBC, CRP, ESR
    • ASCA antibody (IgA, IgG)
    • QuantiFERON-TB Gold
    • Colonoscopic finding
    • Histological finding(including Acid Fast Bacilli stain/Culture)


Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Crohn' disease
The group of patients whose final diagnosis is Crohn's disease
Intestinal tuberculosis
The group of patients whose final diagnosis is intestinal tuberculosis

Detailed Description:

Crohn's disease and intestinal tuberculosis mimic each other in clinical, endoscopic, and histological features. In addition, the yield of microbiological/histological test (AFB stain, caseating granuloma) is not high in clinical setting. Therefore, distinguishing CD from ITB especially in highly endemic areas for TB is challenging. The aim of this study is to develop a score for differential diagnosis between intestinal tuberculosis and Crohn's disease

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who have common features of crohn's disease and intestinal tuberculosis

Criteria

Inclusion Criteria:

  • tentative diagnosis of Crohn' disease(at least two of the following is met)

    1. clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding
    2. endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease
    3. radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration
    4. macroscopic appearance of bowel-wall induration, mesenteric lymphadenopathy, and "creeping fat" at laparotomy
    5. pathologic findings of transmural inflammation and/or epithelioid granulomas
  • tentative diagnosis of Intestinal tuberculosis(at least one of the following is met)

    1. histologic evidence of caseating granulomas
    2. histologic demonstration of acid-fast bacilli
    3. growth of M. tuberculosis on tissue culture
    4. clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis with proved tuberculosis elsewhere
    5. response to antituberculous therapy without subsequent recurrence in patients with clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis

Exclusion Criteria:

  • Age younger than 16
  • Pregnancy
  • Combined with acute infectious diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392365

Contacts
Contact: Byong Duk Ye, M.D. 82-2-3010-3181 bdyemd@gmail.com
Contact: Sang Hyoung Park, M.D. 82-2-3010-5768 umdalpin@hanmail.net

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Byong Duk Ye, M.D.    82-2-3010-3181    bdyemd@gmail.com   
Principal Investigator: Byong Duk Ye, M.D.         
Sub-Investigator: Sang Hyoung Park, M.D.         
Sponsors and Collaborators
Asan Medical Center
  More Information

Publications:
Responsible Party: Byong Duk Ye, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01392365     History of Changes
Other Study ID Numbers: 2011-0380
Study First Received: July 11, 2011
Last Updated: November 8, 2013
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Asan Medical Center:
Crohn's disease
Intestinal tuberculosis
Diagnosis, Differential

Additional relevant MeSH terms:
Crohn Disease
Tuberculosis
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 28, 2014