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Dual Energy Computerized Tomography (DE-CT) in Patients With Crohn's Disease

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ClinicalTrials.gov Identifier: NCT02341755
Recruitment Status : Terminated (Interim analysis was sufficient to demonstrate accuracy of the evaluated test)
First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Tomer Adar, Shaare Zedek Medical Center

Study Description
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Brief Summary:

This study aims to evaluate the accuracy of dual energy computerized tomography (DE-CT) in predicting the need for surgery in patients with Crohn's disease and intestinal lesions with obstructive symptoms.

Patients with known Crohn's disease which were scheduled to perform abdominal CT for obstructive symptoms preformed it in a dual energy protocol and then followed for an outcome of surgery. DE-CT parameters were then compared between patients who underwent surgery and those who did not.


Condition or disease
Crohn's Disease

Detailed Description:

INTRODUCTION Intestinal strictures are common in patients with Crohn's (CD) disease and may result in intestinal obstruction. Current available imaging studies can usually identify and locate the stricture, but can not reliably differentiate the patients who will require surgery from those who will respond to medical therapy.

Dual Energy computerized tomography (DE-CT) uses two energy sources using high and low tube voltage, thus creating two data sets. Dedicated software creates overlay of the low and high energy images, in which enhancement of tissues with iodine can be better appreciated and quantified compared to standard CT. The investigators hypothesize that dual energy can better visualize the iodine uptake in bowl wall as a marker of inflammation within intestinal lesions, and may help in identifying the patients who will or will not require surgery.

AIM To evaluate the efficacy of DE-CT studies in predicting need for surgery within 3 months.

METHODS Patients with known CD undergoing abdominal CT for possible obstructive presentation prospectively underwent a DE-CT using intravenous iodinated contrast material, and were followed for 3 months for an outcome of surgery.

The DE-CT was interpreted by a radiologist blinded to the clinical outcome, and the attending physicians of the patients were blinded to the interpretation of the DE-CT. DE-CT parameters were then compared between patients who underwent surgery and those who did not. Receiver operating characteristic (ROC) curve analysis was used to find the optimal cut off point to distinguish between patients which did or did not eventually underwent surgery. Based on the cut off points found from the ROC analysis, the negative and positive predictive values were calculated.

Study Design
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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dual Energy Computerized Tomography (DE-CT) for Evaluation of Obstructive Intestinallesions in Patients With Crohn's Disease
Study Start Date : May 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Abdominal surgery [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with known Crohn's disease undergoing abdominal CT for possible obstructive presentation
Criteria

Inclusion Criteria:

  • Age over 18 years,
  • known Crohn's disease (at least 3 moths prior)
  • obstructive symptoms
  • scheduled for abdominal CT for evaluation of symptoms (regardless of participation in the study)

Exclusion Criteria:

  • Pregnancy
  • Contraindication to perform CT with IV contrast media
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341755


Locations
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Israel
Shaare Zedek Medical Center affiliated with Hebrew University
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Tomer Adar, MD Shaare Zedek Medical Center affiliated with Hebrew University, Jerusalem, Israel.
More Information
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Responsible Party: Tomer Adar, Senior physician in internal medicine, senior gastroenterologist, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02341755    
Other Study ID Numbers: 47/12
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases