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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04746703
Collaborator
(none)
25
1
1
32.5
0.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: Magnetic Resonance Imaging
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Diagnostic
Official Title:
New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg
Actual Study Start Date :
Feb 10, 2021
Anticipated Primary Completion Date :
Oct 27, 2023
Anticipated Study Completion Date :
Oct 27, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Quantitative MRI parameters [6 months after inclusion]

    Pancreatic fat content

  2. Quantitative MRI parameters [6 months after inclusion]

    diffusion parameters (mm² / s)

  3. Quantitative MRI parameters [6 months after inclusion]

    transverse magnetization relaxation rate (Hz)

  4. Quantitative MRI parameters [6 months after inclusion]

    longitudinal relaxation rate (Hz)

  5. Quantitative MRI parameters [6 months after inclusion]

    visco-elastic parameters by measure of tissue stiffness (kPa)

Secondary Outcome Measures

  1. Metabolic and anthropometric parameters before and after bariatric surgery [6 months after inclusion]

    BMI

  2. Metabolic and anthropometric parameters before and after bariatric surgery [6 months after inclusion]

    % fat mass in impedance

  3. Metabolic and anthropometric parameters before and after bariatric surgery [6 months after inclusion]

    weight loss in percent of preoperative body weight

  4. Metabolic and anthropometric parameters before and after bariatric surgery [6 months after inclusion]

    excess weight loss

  5. Metabolic and anthropometric parameters before and after bariatric surgery [6 months after inclusion]

    blood pressure

  6. Metabolic and anthropometric parameters before and after bariatric surgery [6 months after inclusion]

    HOMA-IR index

  7. lipids parameters [6 months after inclusion]

    total cholesterol, HDL, LDL, triglycerides

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre d'obésité et de physiologie Colombes France 92700

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04746703
Other Study ID Numbers:
  • APHP201020
First Posted:
Feb 10, 2021
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris

Study Results

No Results Posted as of Jul 8, 2022