Magnetic Resonance (MR) Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients
Primary Purpose
Short Bowel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Barium follow-through and MR-enterography
Sponsored by
About this trial
This is an interventional diagnostic trial for Short Bowel Syndrome focused on measuring Gastrointestinal Tract [A03.556]
Eligibility Criteria
Inclusion Criteria:
- Intraoperative small bowel length < 200 cm
- Males and females between 18 and 85 years of age
- Patient with social insurance
- Signature of informed consent
Exclusion Criteria:
- Allergy to contrast product
- Enterostomy closure expected within 2 months after randomization
- Pregnancy or breast feeding woman
- Swallowing disorders
- Deprivation of liberty
- Contraindications to magnetic resonance imaging (pace-maker, metal implant, known allergy to gadolinium)
Sites / Locations
- Service d'Hépato-Gastroentérologie et Nutrition Clinique - CHU Nice - hôpital Archet 2Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Bras pair
Bras impair
Arm Description
MR-enterography then barium follow through
Barium follow-through then MR-enterography
Outcomes
Primary Outcome Measures
Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test
Secondary Outcome Measures
Assessment of the lack of difference between surgical and barium follow through small bowel length measurement with a comparison sample test
Full Information
NCT ID
NCT01183793
First Posted
August 2, 2010
Last Updated
August 17, 2010
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01183793
Brief Title
Magnetic Resonance (MR) Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients
Official Title
MR Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is essential to know intestinal length and anastomotic type in post-operative short bowel syndrome patients. These parameters can help predict long-term intestinal failure with long-term parenteral nutrition usually needed for smallest lengths. Sometimes these parameters are unfortunately missing for lack of intraoperative measurement. Thus, it is necessary to develop non-invasive and reproducible techniques to assess small bowel length. This is the reason why the investigators will evaluate magnetic resonance (MR)-enterography and barium follow-through in this indication. There are at this time only two small studies evaluating barium follow-through for intestinal length measurement, and none evaluating MR-enterography. However, a major advantage of the latter is the lack of radiation exposure and possibility to perform 3D.
This will be an open labelled single center crossover study. Short bowel syndrome patients of the investigators center will be included after consent. The sequence of exams (MR enterography followed by barium follow-through or vice-versa) will be randomly assigned. Peroperative short bowel length measurement will be available for all patients. There will be one month between the two exams.
The main objective of this study is to assess the performance of MR-enterography in short bowel measurement in short bowel syndrome patients, the gold standard being peroperative length. Secondary objectives are to assess the performance of barium follow-through in short bowel measurement in these patients, and to show that barium follow-through does not perform better than MR-enterography. For that purpose the investigators will include 50 patients over 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
Gastrointestinal Tract [A03.556]
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bras pair
Arm Type
Other
Arm Description
MR-enterography then barium follow through
Arm Title
Bras impair
Arm Type
Other
Arm Description
Barium follow-through then MR-enterography
Intervention Type
Radiation
Intervention Name(s)
Barium follow-through and MR-enterography
Intervention Description
Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test
Primary Outcome Measure Information:
Title
Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Assessment of the lack of difference between surgical and barium follow through small bowel length measurement with a comparison sample test
Time Frame
at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Intraoperative small bowel length < 200 cm
Males and females between 18 and 85 years of age
Patient with social insurance
Signature of informed consent
Exclusion Criteria:
Allergy to contrast product
Enterostomy closure expected within 2 months after randomization
Pregnancy or breast feeding woman
Swallowing disorders
Deprivation of liberty
Contraindications to magnetic resonance imaging (pace-maker, metal implant, known allergy to gadolinium)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MALERBA Sylvie
Phone
0033 4 92 03 42 57
Email
malerba.s@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SCHNEIDER Stephane, PU-PH
Organizational Affiliation
Services d'Hépato-Gastroentérologie et Nutrition Clinique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Hépato-Gastroentérologie et Nutrition Clinique - CHU Nice - hôpital Archet 2
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SCHNEIDER Stephane, PU-PH
Phone
0033 4 92 03 60 18
Email
schneider.s@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
EVESQUE Ludovic, Ph
Email
evesque.l@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
SCNEIDER Stephane, PU-PH
12. IPD Sharing Statement
Learn more about this trial
Magnetic Resonance (MR) Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients
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