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

June 12, 2016 updated by: Byong Duk Ye, Asan Medical Center
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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 12, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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