Informations générales (source: ClinicalTrials.gov)
MR Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients
Interventional
N/A
Centre Hospitalier Universitaire de Nice (Voir sur ClinicalTrials)
juillet 2010
juillet 2012
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service d'Hépato-Gastroentérologie et Nutrition Clinique - CHU Nice - hôpital Archet 2 - 06000 - Nice - France | SCHNEIDER Stephane, PU-PH | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- Intraoperative small bowel length < 200 cm
- Males and females between 18 and 85 years of age
- Patient with social insurance
- Signature of informed consent
- 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)