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CompletedNCT04746703PACHIBAUpdated Aug 13, 2026

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

An interventional study of Magnetic Resonance Imaging in Bariatric Surgery, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Bariatric Surgery

Keywords

  • bariatric surgery
  • pancreatic parameters
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • 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

Interventions

  • RadiationMagnetic Resonance Imaging

    Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.

06

What researchers measure

Primary outcomes

  1. Quantitative MRI parameters

    Pancreatic fat content

    Time frame: 6 months after inclusion

  2. Quantitative MRI parameters

    diffusion parameters (mm² / s)

    Time frame: 6 months after inclusion

  3. Quantitative MRI parameters

    transverse magnetization relaxation rate (Hz)

    Time frame: 6 months after inclusion

  4. Quantitative MRI parameters

    longitudinal relaxation rate (Hz)

    Time frame: 6 months after inclusion

  5. Quantitative MRI parameters

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

    Time frame: 6 months after inclusion

Secondary outcomes

  1. Metabolic and anthropometric parameters before and after bariatric surgery

    BMI

    Time frame: 6 months after inclusion

  2. Metabolic and anthropometric parameters before and after bariatric surgery

    % fat mass in impedance

    Time frame: 6 months after inclusion

  3. Metabolic and anthropometric parameters before and after bariatric surgery

    weight loss in percent of preoperative body weight

    Time frame: 6 months after inclusion

  4. Metabolic and anthropometric parameters before and after bariatric surgery

    excess weight loss

    Time frame: 6 months after inclusion

  5. Metabolic and anthropometric parameters before and after bariatric surgery

    blood pressure

    Time frame: 6 months after inclusion

  6. Metabolic and anthropometric parameters before and after bariatric surgery

    HOMA-IR index

    Time frame: 6 months after inclusion

  7. lipids parameters

    total cholesterol, HDL, LDL, triglycerides

    Time frame: 6 months after inclusion

07

Study locations

1 site
  • Centre d'obésité et de physiologie
    Colombes, France 92700, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04746703
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Feb 10, 2021
Start date
Feb 10, 2021
Primary completion
Sep 16, 2023
Completion
Sep 16, 2023
Last update
Aug 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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