Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT04746703
Status:
UNKNOWN
Last Update Posted:
2022-07-08
First Post:
2021-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-10-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-02-06', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative MRI parameters', 'timeFrame': '6 months after inclusion', 'description': 'Pancreatic fat content'}, {'measure': 'Quantitative MRI parameters', 'timeFrame': '6 months after inclusion', 'description': 'diffusion parameters (mm² / s)'}, {'measure': 'Quantitative MRI parameters', 'timeFrame': '6 months after inclusion', 'description': 'transverse magnetization relaxation rate (Hz)'}, {'measure': 'Quantitative MRI parameters', 'timeFrame': '6 months after inclusion', 'description': 'longitudinal relaxation rate (Hz)'}, {'measure': 'Quantitative MRI parameters', 'timeFrame': '6 months after inclusion', 'description': 'visco-elastic parameters by measure of tissue stiffness (kPa)'}], 'secondaryOutcomes': [{'measure': 'Metabolic and anthropometric parameters before and after bariatric surgery', 'timeFrame': '6 months after inclusion', 'description': 'BMI'}, {'measure': 'Metabolic and anthropometric parameters before and after bariatric surgery', 'timeFrame': '6 months after inclusion', 'description': '% fat mass in impedance'}, {'measure': 'Metabolic and anthropometric parameters before and after bariatric surgery', 'timeFrame': '6 months after inclusion', 'description': 'weight loss in percent of preoperative body weight'}, {'measure': 'Metabolic and anthropometric parameters before and after bariatric surgery', 'timeFrame': '6 months after inclusion', 'description': 'excess weight loss'}, {'measure': 'Metabolic and anthropometric parameters before and after bariatric surgery', 'timeFrame': '6 months after inclusion', 'description': 'blood pressure'}, {'measure': 'Metabolic and anthropometric parameters before and after bariatric surgery', 'timeFrame': '6 months after inclusion', 'description': 'HOMA-IR index'}, {'measure': 'lipids parameters', 'timeFrame': '6 months after inclusion', 'description': 'total cholesterol, HDL, LDL, triglycerides'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bariatric surgery', 'pancreatic parameters'], 'conditions': ['Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI.\n\nPancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.\n\nTo assess the impact of bariatric surgery on pancreatic Magnetic Resonance Imaging (MRI) parameters in severe-obese patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (aged 18 to 65 years) with a planned for bariatric surgery (sleeve gastrectomy) according to HAS criteria\n* Patients with severe obesity (BMI≥35)\n\nExclusion Criteria:\n\n* Patients with problem of alcohol abuse (previous or current)\n* Patients with problems of understanding\n* Patients with previous acute or chronic pancreatitis\n* Patients with contraindication to MRI (active implantable medical devices, pacemaker, claustrophobia …)\n* Inability to undergo MRI due to weight excess\n* Pregnant or breastfeeding woman\n* Absence of free and informed consent\n* Non affiliation to a social security regime or CMU (Universal health coverage)\n* Patient under AME (State medical aid)\n* Patient deprived of freedom, subject under a legal protective measure\n* Patients who have already had bariatric surgery\n\nSecondary exclusion criteria :\n\n* Patients who have undergone bariatric surgery other than a sleeve gastrectomy'}, 'identificationModule': {'nctId': 'NCT04746703', 'acronym': 'PACHIBA', 'briefTitle': 'New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg', 'orgStudyIdInfo': {'id': 'APHP201020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI before and 6 months after bariatric surgery', 'description': 'Recruitment of patient with planned bariatric surgery in Louis Mourier Hospital by the nutritionist, during the preoperative day hospitalisation (performed during the multidisciplinary preparation for bariatric surgery) when patients are deemed eligible for bariatric surgery according to HAS (High Authority of Health) criteria.\n\nProgramming of MRI in the month between preoperative visit and surgery. During this exam without injection of contrast agents in the radiology department of Louis Mourier Hospital, additional sequences with specific acquisitions as previously validated in humans will be performed for the study.\n\nBariatric surgery will be performed as in usual care in Louis Mourier hospital. The same MRI will be performed in day hospitalization scheduled 6 months after surgery.', 'interventionNames': ['Radiation: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'RADIATION', 'description': 'Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.', 'armGroupLabels': ['MRI before and 6 months after bariatric surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92700', 'city': 'Colombes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'LEDOUX Severine', 'role': 'CONTACT', 'email': 'severine.ledoux@aphp.fr', 'phone': '01 47 60 62 56'}], 'facility': "Centre d'obésité et de physiologie", 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}