Short Bowel SyndromeNCT01183793
Magnetic Resonance (MR) Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients
A study testing Barium follow-through and MR-enterography in people with Short Bowel Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Barium follow-through and MR-enterography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intraoperative small bowel length < 200 cm
- Males and females between 18 and 85 years of age
- Patient with social insurance
- Signature of informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Hépato-Gastroentérologie et Nutrition Clinique - CHU Nice - hôpital Archet 2
Nice, 06000
SCHNEIDER Stephane, PU-PH, 0033 4 92 03 60 18, schneider.s@chu-nice.fr
EVESQUE Ludovic, Ph, evesque.l@chu-nice.fr
About this study
Official title: 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.
- Conditions
- Short Bowel Syndrome
- Being tested
- Barium follow-through and MR-enterography
- Keywords
- Gastrointestinal Tract [A03.556]
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barium follow-through and MR-enterographyRadiation
Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test
| Study group | Role | What they receive |
|---|---|---|
| Bras pair | Other | MR-enterography then barium follow through Receives: Radiation: Barium follow-through and MR-enterography |
| Bras impair | Other | Barium follow-through then MR-enterography Receives: Radiation: Barium follow-through and MR-enterography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test
Measured: 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
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2010 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Investigators
- SCHNEIDER Stephane, PU-PH, Principal investigator, Services d'Hépato-Gastroentérologie et Nutrition Clinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183793
- Sponsor's protocol ID
- 09-CIR-02
- Status last verified
- Jun 2010
- First submitted
- 2 Aug 2010
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients
- ClinicalTrials.gov ID
- NCT01183793
- Acronym / sponsor ID
- 09-CIR-02
- Conditions
- Short Bowel Syndrome
- Keywords
- Gastrointestinal Tract [A03.556]
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bras pair | Other | Radiation: Barium follow-through and MR-enterographyMR-enterography then barium follow through |
| Bras impair | Other | Radiation: Barium follow-through and MR-enterographyBarium follow-through then MR-enterography |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Intraoperative small bowel length < 200 cm
- Males and females between 18 and 85 years of age
- Patient with social insurance
- Signature of informed consent
Key exclusion criteria (6 listed)
- Allergy to contrast product
- Enterostomy closure expected within 2 months after randomization
- Pregnancy or breast feeding woman
- Swallowing disorders
- Deprivation of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barium follow-through and MR-enterographyAssessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test | Radiation | Bras impair, Bras pair |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SCHNEIDER Stephane, PU-PH principal investigator
Services d'Hépato-Gastroentérologie et Nutrition Clinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barium follow-through and MR-enterography in people with Short Bowel Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MALERBA Sylvie (0033 4 92 03 42 57, malerba.s@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2010; AzTrials last refreshed its copy on 8 Nov 2026.