Bariatric SurgeryPACHIBANCT04746703
New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg
A study testing Magnetic Resonance Imaging in people with Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2021to 16 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (aged 18 to 65 years) with a planned for bariatric surgery (sleeve gastrectomy) according to HAS criteria
- Patients with severe obesity (BMI≥35)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Bariatric Surgery
- Being tested
- Magnetic Resonance Imaging
- Keywords
- bariatric surgery, pancreatic parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingRadiation
Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| MRI before and 6 months after bariatric surgery | Experimental | 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. Receives: Radiation: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative MRI parameters
Pancreatic fat content
Measured: 6 months after inclusion
Quantitative MRI parameters
diffusion parameters (mm² / s)
Measured: 6 months after inclusion
Quantitative MRI parameters
transverse magnetization relaxation rate (Hz)
Measured: 6 months after inclusion
Quantitative MRI parameters
longitudinal relaxation rate (Hz)
Measured: 6 months after inclusion
Quantitative MRI parameters
visco-elastic parameters by measure of tissue stiffness (kPa)
Measured: 6 months after inclusion
Secondary outcomes (7)
Metabolic and anthropometric parameters before and after bariatric surgery
BMI
Measured: 6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
% fat mass in impedance
Measured: 6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
weight loss in percent of preoperative body weight
Measured: 6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
excess weight loss
Measured: 6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
blood pressure
Measured: 6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
HOMA-IR index
Measured: 6 months after inclusion
lipids parameters
total cholesterol, HDL, LDL, triglycerides
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start10 Feb 2021
- Primary completion16 Sep 2023
- Study completion16 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746703
- Sponsor's protocol ID
- APHP201020
- Acronym
- PACHIBA
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 2021
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg
- ClinicalTrials.gov ID
- NCT04746703
- Acronym / sponsor ID
- PACHIBA / APHP201020
- Conditions
- Bariatric Surgery
- Keywords
- bariatric surgery, pancreatic parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 16 Sep 2023 (actual)
- Study completion
- 16 Sep 2023 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| MRI before and 6 months after bariatric surgery | Experimental | Radiation: Magnetic Resonance ImagingRecruitment 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (aged 18 to 65 years) with a planned for bariatric surgery (sleeve gastrectomy) according to HAS criteria
- Patients with severe obesity (BMI≥35)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingPancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery. | Radiation | MRI before and 6 months after bariatric surgery |
Primary outcome
Quantitative MRI parameters
Time frame: 6 months after inclusion
Pancreatic fat content
Quantitative MRI parameters
Time frame: 6 months after inclusion
diffusion parameters (mm² / s)
Quantitative MRI parameters
Time frame: 6 months after inclusion
transverse magnetization relaxation rate (Hz)
Quantitative MRI parameters
Time frame: 6 months after inclusion
longitudinal relaxation rate (Hz)
Quantitative MRI parameters
Time frame: 6 months after inclusion
visco-elastic parameters by measure of tissue stiffness (kPa)
7 secondary outcomes
Metabolic and anthropometric parameters before and after bariatric surgery
Time frame: 6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
Time frame: 6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
Time frame: 6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
Time frame: 6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
Time frame: 6 months after inclusion
Metabolic and anthropometric parameters before and after bariatric surgery
Time frame: 6 months after inclusion
lipids parameters
Time frame: 6 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Bariatric Surgery
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
Lifestyle Adherence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative MRI parameters (time frame: 6 months after inclusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.