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

Crohn's Disease Clinical Trial

Official title:

Dual Energy Computerized Tomography (DE-CT) for Evaluation of Obstructive Intestinallesions in Patients With Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02341755
• Other study ID #: 47/12
• Status: Terminated
• Phase: N/A
• First received: January 11, 2015
• Last updated: January 16, 2015
• Start date: May 2012
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: November 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center affiliated with Hebrew University	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal surgery		3 months	No