New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg
NCT ID: NCT04746703
Last Updated: 2022-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2021-02-10
2023-10-27
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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MRI before and 6 months after bariatric surgery
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.
Magnetic Resonance Imaging
Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.
Interventions
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Magnetic Resonance Imaging
Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.
Eligibility Criteria
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Inclusion Criteria
* Patients with severe obesity (BMI≥35)
Exclusion Criteria
* 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
* Patients who have undergone bariatric surgery other than a sleeve gastrectomy
18 Years
65 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Centre d'obésité et de physiologie
Colombes, , France
Countries
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Facility Contacts
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Other Identifiers
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APHP201020
Identifier Type: -
Identifier Source: org_study_id
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