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Completed

NCT Number: NCT04746703

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

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

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Key information

Conditions

Bariatric Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'obésité et de physiologie

Colombes, France, 92700

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic resonance imaging

Radiation

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

Primary outcomes

  1. Quantitative MRI parameters

    Time frame: 6 months after inclusion

    Pancreatic fat content

  2. Quantitative MRI parameters

    Time frame: 6 months after inclusion

    diffusion parameters (mm² / s)

  3. Quantitative MRI parameters

    Time frame: 6 months after inclusion

    transverse magnetization relaxation rate (Hz)

  4. Quantitative MRI parameters

    Time frame: 6 months after inclusion

    longitudinal relaxation rate (Hz)

  5. Quantitative MRI parameters

    Time frame: 6 months after inclusion

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

Secondary outcomes

  1. Metabolic and anthropometric parameters before and after bariatric surgery

    Time frame: 6 months after inclusion

    BMI

  2. Metabolic and anthropometric parameters before and after bariatric surgery

    Time frame: 6 months after inclusion

    % fat mass in impedance

  3. Metabolic and anthropometric parameters before and after bariatric surgery

    Time frame: 6 months after inclusion

    weight loss in percent of preoperative body weight

  4. Metabolic and anthropometric parameters before and after bariatric surgery

    Time frame: 6 months after inclusion

    excess weight loss

  5. Metabolic and anthropometric parameters before and after bariatric surgery

    Time frame: 6 months after inclusion

    blood pressure

  6. Metabolic and anthropometric parameters before and after bariatric surgery

    Time frame: 6 months after inclusion

    HOMA-IR index

  7. lipids parameters

    Time frame: 6 months after inclusion

    total cholesterol, HDL, LDL, triglycerides

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PACHIBA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2021
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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