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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by University Hospital, Angers. Recruitment status was Recruiting

First Received on September 12, 2005. Last Updated on 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:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
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

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 Besancon	Active, not recruiting
Besancon, France, 25030
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 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

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

Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012