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Completed

NCT Number: NCT01392365

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Final diagnostic criteria:

  • Crohn' disease (at least two of the following is met)
  • Clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding
  • Endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease
  • Radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration
  • Macroscopic appearance of bowel-wall induration, mesenteric lymphadenopathy, and "creeping fat" at laparotomy
  • Pathologic findings of transmural inflammation and/or epithelioid granulomas
  • Intestinal tuberculosis(at least one of the following is met)
  • Histologic evidence of caseating granulomas
  • Histologic demonstration of acid-fast bacilli
  • Growth of M. tuberculosis on tissue culture
  • Clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis with proved tuberculosis elsewhere
  • 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

Treatment and study plan

Primary outcomes

  1. 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)

    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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 12, 2011
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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