Back to results

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

Primary Purpose

Colon Cancer

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Water-Enema Computed Tomography

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring Water-Enema Computed Tomography, colon tumor, coloscopy, suspicion of colon tumor, coloscopy or surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UH of AngersRecruiting
UH of Besancon
UH of LyonRecruiting
UH of Montpellier
UH of RennesRecruiting

Outcomes

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

Full Information

NCT ID

NCT00188110

First Posted

September 12, 2005

Last Updated

January 8, 2007

Sponsor

University Hospital, Angers

Collaborators

Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT00188110

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Angers

Collaborators

Ministry of Health, France

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Water-Enema Computed Tomography

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To show the CT findings in case of colon tumor and its pitfalls

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christophe Aube, MD

Phone

00-2-41-35-42-76

chaube@chu-angers.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christophe Aube, MD

Organizational Affiliation

UH of Angers

Official's Role

Principal Investigator

Facility Information:

Facility Name

UH of Angers

City

Angers

ZIP/Postal Code

49033

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christophe Aube, MD

Phone

00-2-41-35-42-76

chaube@chu-angers.fr

First Name & Middle Initial & Last Name & Degree

Christophe Aube, MD

First Name & Middle Initial & Last Name & Degree

Catherine Ridereau, MD

First Name & Middle Initial & Last Name & Degree

Pascal Burtin, MD

First Name & Middle Initial & Last Name & Degree

Jean Boyer, MD

Facility Name

UH of Besancon

City

Besancon

ZIP/Postal Code

25030

Country

France

Individual Site Status

Active, not recruiting

Facility Name

UH of Lyon

City

Lyon

ZIP/Postal Code

69003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean Valette, MD

Phone

00-4-72-11-75-40

jean.valette@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Pierre Jean Valette, MD

First Name & Middle Initial & Last Name & Degree

Christophe Beziat, MD

First Name & Middle Initial & Last Name & Degree

Frank Pilleul, MD

First Name & Middle Initial & Last Name & Degree

Jérôme Dumortier, MD

First Name & Middle Initial & Last Name & Degree

François Bailly, MD

Facility Name

UH of Montpellier

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Active, not recruiting

Facility Name

UH of Rennes

City

Rennes

ZIP/Postal Code

35033

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yves Gandon, MD

Phone

00-2-99-28-43-67

yves-gandon@chu-rennes.fr

First Name & Middle Initial & Last Name & Degree

Yves Gandon, MD

First Name & Middle Initial & Last Name & Degree

Damien Olivié, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs