Clinical trial NCT01392365: Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease
Official title: Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Intestinal Tuberculosis
Keywords: Crohn's disease
Intestinal tuberculosis
Diagnosis, Differential
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 117
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: Final diagnosis (Intestinal tuberculosis or Crohn's disease)
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Almadi MA, Ghosh S, Aljebreen AM. Differentiating intestinal tuberculosis from Crohn's disease: a diagnostic challenge. Am J Gastroenterol. 2009 Apr;104(4):1003-12. doi: 10.1038/ajg.2008.162. Epub 2009 Feb 24.
citation: Makharia GK, Srivastava S, Das P, Goswami P, Singh U, Tripathi M, Deo V, Aggarwal A, Tiwari RP, Sreenivas V, Gupta SD. Clinical, endoscopic, and histological differentiations between Crohn's disease and intestinal tuberculosis. Am J Gastroenterol. 2010 Mar;105(3):642-51. doi: 10.1038/ajg.2009.585. Epub 2010 Jan 19.
citation: Lee YJ, Yang SK, Byeon JS, Myung SJ, Chang HS, Hong SS, Kim KJ, Lee GH, Jung HY, Hong WS, Kim JH, Min YI, Chang SJ, Yu CS. Analysis of colonoscopic findings in the differential diagnosis between intestinal tuberculosis and Crohn's disease. Endoscopy. 2006 Jun;38(6):592-7. doi: 10.1055/s-2006-924996. Epub 2006 Apr 27.
citation: Bae JH, Park SH, Ye BD, Kim SO, Cho YK, Youn EJ, Lee HS, Hwang SW, Yang DH, Kim KJ, Byeon JS, Myung SJ, Yang SK. Development and Validation of a Novel Prediction Model for Differential Diagnosis Between Crohn's Disease and Intestinal Tuberculosis. Inflamm Bowel Dis. 2017 Sep;23(9):1614-1623. doi: 10.1097/MIB.0000000000001162.