CClinicalTrials.gg
Status unknownNCT01183793Updated Aug 18, 2010

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

An interventional study of Barium follow-through and MR-enterography in Short Bowel Syndrome, sponsored by Centre Hospitalier Universitaire de Nice. Status unknown at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-08-18.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Short Bowel Syndrome

Keywords

  • Gastrointestinal Tract [A03.556]
03

In context

Short Bowel Syndrome

149 studies on the registry are indexed under Short Bowel Syndrome; 25 are open to participants now.

This study's planned enrollment of 50 is above the median of 20 across 100 interventional studies indexed under Short Bowel Syndrome.

Browse Short Bowel Syndrome studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Bras pair

    MR-enterography then barium follow through

    Radiation: Barium follow-through and MR-enterography

  • Other
    Bras impair

    Barium follow-through then MR-enterography

    Radiation: Barium follow-through and MR-enterography

Interventions

  • RadiationBarium 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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Service d'Hépato-Gastroentérologie et Nutrition Clinique - CHU Nice - hôpital Archet 2
    Nice, 06000, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01183793
Lead sponsor
Centre Hospitalier Universitaire de Nice
First posted
Aug 18, 2010
Start date
Jul 2010
Primary completion
Oct 2010 (estimated)
Completion
Jul 2012 (estimated)
Last update
Aug 18, 2010

Study contacts

MALERBA Sylvie
Contact
malerba.s@chu-nice.fr
0033 4 92 03 42 57
SCHNEIDER Stephane, PU-PH
principal investigator · Services d'Hépato-Gastroentérologie et Nutrition Clinique

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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