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

Not Applicable

• Conditions: Bariatric Surgery
• Interventions: Radiation: Magnetic Resonance Imaging

• Registration Number: NCT04746703
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-02-06
• Study Start: 2021-02-10
• Study First Posted: 2021-02-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08
• Primary Completion: 2023-10-27
• Study Completion: 2023-10-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI before and 6 months after bariatric surgery	Magnetic Resonance Imaging	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.

Primary Outcome Measures

Name	Time	Method
Quantitative MRI parameters	6 months after inclusion	visco-elastic parameters by measure of tissue stiffness (kPa)

Secondary Outcome Measures

Name	Time	Method
Metabolic and anthropometric parameters before and after bariatric surgery	6 months after inclusion	HOMA-IR index
lipids parameters	6 months after inclusion	total cholesterol, HDL, LDL, triglycerides

Trial Locations

Locations (1)

Centre d'obésité et de physiologie; 🇫🇷 Colombes, France