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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2023-10-27

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

Detailed Description

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Conditions

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Bariatric Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type RADIATION

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.

Intervention Type RADIATION

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


* Patients who have undergone bariatric surgery other than a sleeve gastrectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre d'obésité et de physiologie

Colombes, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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LEDOUX Severine

Role: primary

01 47 60 62 56

Other Identifiers

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APHP201020

Identifier Type: -

Identifier Source: org_study_id

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