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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188110
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : January 9, 2007
Ministry of Health, France
Information provided by:
University Hospital, Angers

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Water-Enema Computed Tomography Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Water-Enema Computed Tomography for the Diagnosis of Colon Tumor
Study Start Date : March 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To evaluate the performances of the WE-CT in patients suspected of having a colon tumor

Secondary Outcome Measures :
  1. To show the CT findings in case of colon tumor and its pitfalls
  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00188110

Contact: Christophe Aube, MD 00-2-41-35-42-76

UH of Angers Recruiting
Angers, France, 49033
Contact: Christophe Aube, MD    00-2-41-35-42-76   
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   
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   
Principal Investigator: Yves Gandon, MD         
Sub-Investigator: Damien Olivié, MD         
Sponsors and Collaborators
University Hospital, Angers
Ministry of Health, France
Principal Investigator: Christophe Aube, MD UH of Angers Identifier: NCT00188110     History of Changes
Other Study ID Numbers: PHRC-02-01
2002/23 (CCPPRB)
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 9, 2007
Last Verified: September 2005

Keywords provided by University Hospital, Angers:
Water-Enema Computed Tomography
colon tumor
suspicion of colon tumor
coloscopy or surgery