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NCT00188110 Clinical Trial

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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00188110
Other study ID # PHRC-02-01
Secondary ID 2002/23 (CCPPRB)
Status Recruiting
Phase N/A
First received September 12, 2005
Last updated January 8, 2007
Start date March 2003

Study information
Verified date September 2005
Source University Hospital, Angers
Contact Christophe Aube, MD
Phone 00-2-41-35-42-76
Email chaube@chu-angers.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• Water-Enema Computed Tomography

Locations
Country Name City State
France UH of Angers Angers
France UH of Besancon Besancon
France UH of Lyon Lyon
France UH of Montpellier Montpellier
France UH of Rennes Rennes

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Angers Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the performances of the WE-CT in patients suspected of having a colon tumor
Secondary To show the CT findings in case of colon tumor and its pitfalls
Secondary 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
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