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

July 7, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colombes, France, 92700
        • Recruiting
        • Centre d'obésité et de physiologie
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative MRI parameters
Time Frame: 6 months after inclusion
Pancreatic fat content
6 months after inclusion
Quantitative MRI parameters
Time Frame: 6 months after inclusion
diffusion parameters (mm² / s)
6 months after inclusion
Quantitative MRI parameters
Time Frame: 6 months after inclusion
transverse magnetization relaxation rate (Hz)
6 months after inclusion
Quantitative MRI parameters
Time Frame: 6 months after inclusion
longitudinal relaxation rate (Hz)
6 months after inclusion
Quantitative MRI parameters
Time Frame: 6 months after inclusion
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
Time Frame: 6 months after inclusion
BMI
6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
Time Frame: 6 months after inclusion
% fat mass in impedance
6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
Time Frame: 6 months after inclusion
weight loss in percent of preoperative body weight
6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
Time Frame: 6 months after inclusion
excess weight loss
6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
Time Frame: 6 months after inclusion
blood pressure
6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
Time Frame: 6 months after inclusion
HOMA-IR index
6 months after inclusion
lipids parameters
Time Frame: 6 months after inclusion
total cholesterol, HDL, LDL, triglycerides
6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Anticipated)

October 27, 2023

Study Completion (Anticipated)

October 27, 2023

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

February 6, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP201020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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