New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg

Study Overview
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Brief Summary
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The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI. Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery. To assess the impact of bariatric surgery on pancreatic Magnetic Resonance Imaging (MRI) parameters in severe-obese patients

Official Title
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New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg

Conditions
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Bariatric Surgery

Intervention / Treatment
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* Radiation: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (aged 18 to 65 years) with a planned for bariatric surgery (sleeve gastrectomy) according to HAS criteria Patients with severe obesity (BMI≥35) Exclusion Criteria: Patients with problem of alcohol abuse (previous or current) Patients with problems of understanding Patients with previous acute or chronic pancreatitis Patients with contraindication to MRI (active implantable medical devices, pacemaker, claustrophobia …) Inability to undergo MRI due to weight excess Pregnant or breastfeeding woman Absence of free and informed consent Non affiliation to a social security regime or CMU (Universal health coverage) Patient under AME (State medical aid) Patient deprived of freedom, subject under a legal protective measure Patients who have already had bariatric surgery Secondary exclusion criteria : Patients who have undergone bariatric surgery other than a sleeve gastrectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI before and 6 months after bariatric surgery<br>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. Programming 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. Bariatric 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. | Radiation: Magnetic Resonance Imaging<br>* Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative MRI parameters | Pancreatic fat content | 6 months after inclusion | 
| Quantitative MRI parameters | diffusion parameters (mm² / s) | 6 months after inclusion | 
| Quantitative MRI parameters | transverse magnetization relaxation rate (Hz) | 6 months after inclusion | 
| Quantitative MRI parameters | longitudinal relaxation rate (Hz) | 6 months after inclusion | 
| Quantitative MRI parameters | visco-elastic parameters by measure of tissue stiffness (kPa) | 6 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic and anthropometric parameters before and after bariatric surgery | BMI | 6 months after inclusion | 
| Metabolic and anthropometric parameters before and after bariatric surgery | % fat mass in impedance | 6 months after inclusion | 
| Metabolic and anthropometric parameters before and after bariatric surgery | weight loss in percent of preoperative body weight | 6 months after inclusion | 
| Metabolic and anthropometric parameters before and after bariatric surgery | excess weight loss | 6 months after inclusion | 
| Metabolic and anthropometric parameters before and after bariatric surgery | blood pressure | 6 months after inclusion | 
| Metabolic and anthropometric parameters before and after bariatric surgery | HOMA-IR index | 6 months after inclusion | 
| lipids parameters | total cholesterol, HDL, LDL, triglycerides | 6 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, pancreatic parameters