Magnetic Resonance (MR) Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients

Short Bowel Syndrome Clinical Trial

Official title:

MR Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01183793
• Other study ID #: 09-CIR-02
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2010
• Last updated: August 17, 2010
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: June 2010
• Source: Centre Hospitalier Universitaire de Nice
• Contact: MALERBA Sylvie
• Phone: 0033 4 92 03 42 57
• Email: malerba.s[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Service d'Hépato-Gastroentérologie et Nutrition Clinique - CHU Nice - hôpital Archet 2	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test		at 3 months	No
Secondary	Assessment of the lack of difference between surgical and barium follow through small bowel length measurement with a comparison sample test		at 3 months	No