Performance of the Water-Enema Computed Tomography (WE-CT) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 8, 2007

Start Date ^ICMJE

March 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To evaluate the performances of the WE-CT in patients suspected of having a colon tumor

Original Primary Outcome Measures ^ICMJE

To evaluate the performances of the WE-CT in patients suspected of colon tumor

Change History

Complete list of historical versions of study NCT00188110 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To show the CT findings in case of colon tumor and its pitfalls
To demonstrate the advantages of the WE-CT compared to the CT and magnetic resonance (MR) colonography for the diagnosis and local staging of colon tumors

Original Secondary Outcome Measures ^ICMJE

to show the CT findings in case of colon tumor and its pitfalls ;
To demonstrate the advantages of the WE-CT compared to the CT and MR colonography for the diagnosis and local staging of colon tumors

Descriptive Information

Brief Title ^ICMJE

Performance of the Water-Enema Computed Tomography (WE-CT)

Official Title ^ICMJE

Evaluation of the Water-Enema Computed Tomography for the Diagnosis of Colon Tumor

Brief Summary

The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and the entire abdomen.

The goal of the study is the evaluation of its performances for the diagnosis of colon tumors.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Control:  Active Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Diagnostic

Condition ^ICMJE

Colon Cancer

Intervention ^ICMJE

Procedure: Water-Enema Computed Tomography

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Written informed consent
WE-TC indication for colon tumor suspicion
Age > 18 years

Exclusion Criteria:

Pregnancy
Patients under 65 years old and for whom the only WE-TC indication is familial antecedents of colon tumor, without clinical or para-clinical personal signs for this pathology
Infected sigmoid diverticulosis
Occlusive syndrome
Anesthesia contraindications
Anal incontinence
Renal insufficiency (creatinine > 150 micromol/L)
Iode allergy
Visceralgine contraindications
Scania contraindications

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Christophe Aube, MD

00-2-41-35-42-76

chaube@chu-angers.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00188110

Responsible Party

Study ID Numbers ^ICMJE

PHRC-02-01, 2002/23 (CCPPRB)

Study Sponsor ^ICMJE

University Hospital, Angers

Collaborators ^ICMJE

Ministry of Health, France

Investigators ^ICMJE

Principal Investigator:

Christophe Aube, MD

UH of Angers

Information Provided By

University Hospital, Angers

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP