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

This study is currently recruiting participants.

Verified by University Hospital, Angers, September 2005

First Received: September 12, 2005 Last Updated: January 8, 2007 History of Changes

Sponsor:	University Hospital, Angers
Collaborator:	Ministry of Health, France
Information provided by:	University Hospital, Angers
ClinicalTrials.gov Identifier:	NCT00188110

Purpose

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.

Condition	Intervention
Colon Cancer	Procedure: Water-Enema Computed Tomography

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Evaluation of the Water-Enema Computed Tomography for the Diagnosis of Colon Tumor

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Drinking Water

U.S. FDA Resources

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	March 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188110

Contacts

Contact: Christophe Aube, MD

00-2-41-35-42-76

chaube@chu-angers.fr

Locations

France
UH of Angers	Recruiting
Angers, France, 49033
Contact: Christophe Aube, MD 00-2-41-35-42-76 chaube@chu-angers.fr
Principal Investigator: Christophe Aube, MD
Sub-Investigator: Catherine Ridereau, MD
Sub-Investigator: Pascal Burtin, MD
Sub-Investigator: Jean Boyer, MD
UH of Lyon	Recruiting
Lyon, France, 69003
Contact: Jean Valette, MD 00-4-72-11-75-40 jean.valette@chu-lyon.fr
Principal Investigator: Pierre Jean Valette, MD
Sub-Investigator: Christophe Beziat, MD
Sub-Investigator: Frank Pilleul, MD
Sub-Investigator: Jérôme Dumortier, MD
Sub-Investigator: François Bailly, MD
UH of Montpellier	Active, not recruiting
Montpellier, France, 34295
UH of Besancon	Active, not recruiting
Besancon, France, 25030
UH of Rennes	Recruiting
Rennes, France, 35033
Contact: Yves Gandon, MD 00-2-99-28-43-67 yves-gandon@chu-rennes.fr
Principal Investigator: Yves Gandon, MD
Sub-Investigator: Damien Olivié, MD

Sponsors and Collaborators

University Hospital, Angers

Ministry of Health, France

Investigators

Principal Investigator:

Christophe Aube, MD

UH of Angers

More Information

No publications provided

Study ID Numbers:	PHRC-02-01, 2002/23 (CCPPRB)
Study First Received:	September 12, 2005
Last Updated:	January 8, 2007
ClinicalTrials.gov Identifier:	NCT00188110 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Angers:

Water-Enema Computed Tomography
colon tumor
coloscopy
suspicion of colon tumor
coloscopy or surgery

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010