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

NCT01392365 | Completed

• 1 other identifier: 2011-0380
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease; Intestinal Tuberculosis

Keywords

Crohn's disease; Intestinal tuberculosis; Diagnosis, Differential

Outcome Measures

Primary Outcomes (1)

• Final diagnosis (Intestinal tuberculosis or Crohn's disease)

  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.

  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)

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (4)

• 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.

  PMID: 19240705 RESULT

• 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.

  PMID: 20087333 RESULT

• 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.

  PMID: 16673312 RESULT

• 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.

  PMID: 28682807 DERIVED

MeSH Terms

Conditions

Crohn Disease; Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 14, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)