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

NCT01183793 | Unknown

• 1 other identifier: 09-CIR-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Short Bowel Syndrome

Keywords

Gastrointestinal Tract [A03.556]

Outcome Measures

Primary Outcomes (1)

• Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test

  at 3 months

Secondary Outcomes (1)

• Assessment of the lack of difference between surgical and barium follow through small bowel length measurement with a comparison sample test

  at 3 months

Study Arms (2)

Bras pair

OTHER

MR-enterography then barium follow through

Radiation: Barium follow-through and MR-enterography

Bras impair

OTHER

Barium follow-through then MR-enterography

Radiation: Barium follow-through and MR-enterography

Interventions

Barium follow-through and MR-enterography RADIATION

Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test

Bras impair; Bras pair

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intraoperative small bowel length \< 200 cm
• Males and females between 18 and 85 years of age
• Patient with social insurance
• Signature of informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Service d'Hépato-Gastroentérologie et Nutrition Clinique - CHU Nice - hôpital Archet 2

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• SCHNEIDER Stephane, PU-PH

  Services d'Hépato-Gastroentérologie et Nutrition Clinique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MALERBA Sylvie

CONTACT

0033 4 92 03 42 57; malerba.s@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 18, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: July 1, 2012
• Last Updated: August 18, 2010

Record last verified: 2010-06

Locations

FR (1)