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

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

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.

Study Overview

• Status: Unknown
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Radiation: Barium follow-through and MR-enterography

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Service d'Hépato-Gastroentérologie et Nutrition Clinique - CHU Nice - hôpital Archet 2
    • Contact: SCHNEIDER Stephane, PU-PH; Phone Number: 0033 4 92 03 60 18; Email: schneider.s@chu-nice.fr
    • Contact: EVESQUE Ludovic, Ph; Email: evesque.l@chu-nice.fr
    • Principal Investigator: SCNEIDER Stephane, PU-PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test	at 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of the lack of difference between surgical and barium follow through small bowel length measurement with a comparison sample test	at 3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: SCHNEIDER Stephane, PU-PH, Services d'Hépato-Gastroentérologie et Nutrition Clinique

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): October 1, 2010
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: August 2, 2010
• First Submitted That Met QC Criteria: August 17, 2010
• First Posted (Estimate): August 18, 2010

Study Record Updates

• Last Update Posted (Estimate): August 18, 2010
• Last Update Submitted That Met QC Criteria: August 17, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Gastrointestinal Tract [A03.556]
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome
• Other Study ID Numbers: 09-CIR-02