CompletedNot Applicable

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

France25 participantsStarted 2021-02-10

Plain-language 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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quantitative MRI parameters

Timeframe: 6 months after inclusion

Quantitative MRI parameters

Timeframe: 6 months after inclusion

Quantitative MRI parameters

Timeframe: 6 months after inclusion

Quantitative MRI parameters

Timeframe: 6 months after inclusion

Quantitative MRI parameters

Timeframe: 6 months after inclusion

Trial details

NCT IDNCT04746703

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-16

View on ClinicalTrials.gov More Bariatric Surgery trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Quantitative MRI parameters

Timeframe: 6 months after inclusion

Quantitative MRI parameters

Timeframe: 6 months after inclusion

Quantitative MRI parameters

Timeframe: 6 months after inclusion

Quantitative MRI parameters

Timeframe: 6 months after inclusion

Quantitative MRI parameters

Timeframe: 6 months after inclusion