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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Byong Duk Ye, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01392365
First received: July 11, 2011
Last updated: June 12, 2016
Last verified: June 2016
  Purpose
The aim of this study is to develop a scoring system and a prediction model 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 Prediction Model 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 (Intestinal tuberculosis or Crohn's disease) [ Time Frame: 6 months (In a subset of patients, for diagnosis of intestinal tuberculosis, final colonoscopic evaluation after completion of 6-months anti-tuberculous medication is needed) ] [ Designated as safety issue: No ]
    Patients with suspected diagnosis of intestinal tuberculosis or Crohn's disease will be invited to participate in this study. Study variables including past medical history, clinical symptoms and signs, laboratory variables, radiologic findings (Chest X-ray and small bowel follow-through, colonoscopic features) will be gathered at study enrollment. Final diagnosis of intestinal tuberculosis or Crohn's disease will be made according to the diagnostic criteria previously described (Lee YJ, et al. Endoscopy 2006;38:592-597). A prediction model using various variables for intestinal tuberculosis or Crohn's disease will be constructed in the development group and will be validated in the validation group.


Enrollment: 117
Study Start Date: July 2011
Study Completion Date: February 2015
Primary Completion Date: February 2015 (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 and to validate a scoring system and a prediction model for differential diagnosis between intestinal tuberculosis and Crohn's disease
  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suspected to have intestinal tuberculosis or Crohn's disease based on clinical history, symptoms, and/or colonoscopic findings are invited to participate in this study.
Criteria

Final diagnostic criteria:

  • 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
  • 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:

  • Refusal to participate in the study
  • Age: 15 years or younger
  • Comorbidity with acute infectious disease
  • Pregnancy
  • Previous history of medication including anti-TB drugs, immunosuppressive drugs, and chemotherapeutic agents\
  • Use of antibiotics within the previous three months
  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

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
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: June 12, 2016
Health Authority: Korea: Ministry for Health and Welfare
Individual Participant Data  
Plan to Share IPD: No

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 21, 2016