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

NCT ID: NCT01392365

Last Updated: 2016-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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

Conditions

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Crohn's Disease Intestinal Tuberculosis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Crohn' disease

The group of patients whose final diagnosis is Crohn's disease

No interventions assigned to this group

Intestinal tuberculosis

The group of patients whose final diagnosis is intestinal tuberculosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Byong Duk Ye

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type RESULT
PMID: 19240705 (View on PubMed)

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.

Reference Type RESULT
PMID: 20087333 (View on PubMed)

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.

Reference Type RESULT
PMID: 16673312 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28682807 (View on PubMed)

Other Identifiers

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2011-0380

Identifier Type: -

Identifier Source: org_study_id

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