Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-06 @ 5:34 AM
Study NCT ID:
NCT01183793
Status:
UNKNOWN
Last Update Posted:
2010-08-18
First Post:
2010-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance (MR) Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-17', 'studyFirstSubmitDate': '2010-08-02', 'studyFirstSubmitQcDate': '2010-08-17', 'lastUpdatePostDateStruct': {'date': '2010-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test', 'timeFrame': 'at 3 months'}], 'secondaryOutcomes': [{'measure': 'Assessment of the lack of difference between surgical and barium follow through small bowel length measurement with a comparison sample test', 'timeFrame': 'at 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastrointestinal Tract [A03.556]'], 'conditions': ['Short Bowel Syndrome']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intraoperative small bowel length \\< 200 cm\n* Males and females between 18 and 85 years of age\n* Patient with social insurance\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Allergy to contrast product\n* Enterostomy closure expected within 2 months after randomization\n* Pregnancy or breast feeding woman\n* Swallowing disorders\n* Deprivation of liberty\n* Contraindications to magnetic resonance imaging (pace-maker, metal implant, known allergy to gadolinium)'}, 'identificationModule': {'nctId': 'NCT01183793', 'briefTitle': 'Magnetic Resonance (MR) Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'MR Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients', 'orgStudyIdInfo': {'id': '09-CIR-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Bras pair', 'description': 'MR-enterography then barium follow through', 'interventionNames': ['Radiation: Barium follow-through and MR-enterography']}, {'type': 'OTHER', 'label': 'Bras impair', 'description': 'Barium follow-through then MR-enterography', 'interventionNames': ['Radiation: Barium follow-through and MR-enterography']}], 'interventions': [{'name': 'Barium follow-through and MR-enterography', 'type': 'RADIATION', 'description': 'Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test', 'armGroupLabels': ['Bras impair', 'Bras pair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'SCHNEIDER Stephane, PU-PH', 'role': 'CONTACT', 'email': 'schneider.s@chu-nice.fr', 'phone': '0033 4 92 03 60 18'}, {'name': 'EVESQUE Ludovic, Ph', 'role': 'CONTACT', 'email': 'evesque.l@chu-nice.fr'}, {'name': 'SCNEIDER Stephane, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Service d'Hépato-Gastroentérologie et Nutrition Clinique - CHU Nice - hôpital Archet 2", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'MALERBA Sylvie', 'role': 'CONTACT', 'email': 'malerba.s@chu-nice.fr', 'phone': '0033 4 92 03 42 57'}], 'overallOfficials': [{'name': 'SCHNEIDER Stephane, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Services d'Hépato-Gastroentérologie et Nutrition Clinique"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': "Departement de la Recherche Clinique et de l'Innovation", 'oldOrganization': 'CHU de NICE'}}}}