Magnetic Resonance (MR) Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Short Bowel Syndrome |
Radiation: Barium follow-through and MR-enterography |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | MR Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Bras pair
MR-enterography then barium follow through
|
Radiation: Barium follow-through and MR-enterography
Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test
|
|
Bras impair
Barium follow-through then MR-enterography
|
Radiation: Barium follow-through and MR-enterography
Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: MALERBA Sylvie | 0033 4 92 03 42 57 | malerba.s@chu-nice.fr |
| France | |
| Service d'Hépato-Gastroentérologie et Nutrition Clinique - CHU Nice - hôpital Archet 2 | Recruiting |
| Nice, France, 06000 | |
| Contact: SCHNEIDER Stephane, PU-PH 0033 4 92 03 60 18 schneider.s@chu-nice.fr | |
| Contact: EVESQUE Ludovic, Ph evesque.l@chu-nice.fr | |
| Principal Investigator: SCNEIDER Stephane, PU-PH | |
| Principal Investigator: | SCHNEIDER Stephane, PU-PH | Services d'Hépato-Gastroentérologie et Nutrition Clinique |
More Information
No publications provided
| Responsible Party: | Departement de la Recherche Clinique et de l'Innovation, CHU de NICE |
| ClinicalTrials.gov Identifier: | NCT01183793 History of Changes |
| Other Study ID Numbers: | 09-CIR-02 |
| Study First Received: | August 2, 2010 |
| Last Updated: | August 17, 2010 |
| Health Authority: | France: French Data Protection Authority France: Institutional Ethical Committee |
Keywords provided by Centre Hospitalier Universitaire de Nice:
|
Gastrointestinal Tract [A03.556] |
Additional relevant MeSH terms:
|
Short Bowel Syndrome Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013