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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01183793
First received: August 2, 2010
Last updated: August 17, 2010
Last verified: June 2010
  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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183793

Contacts
Contact: MALERBA Sylvie 0033 4 92 03 42 57 malerba.s@chu-nice.fr

Locations
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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:
Syndrome
Short Bowel Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications

ClinicalTrials.gov processed this record on September 30, 2014