NCT04746703

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

2.7 years

First QC Date

January 7, 2021

Last Update Submit

July 7, 2022

Conditions

Bariatric Surgery

Keywords

bariatric surgerypancreatic parameters

Outcome Measures

Primary Outcomes (5)

  • Quantitative MRI parameters

    Pancreatic fat content

    6 months after inclusion

  • Quantitative MRI parameters

    diffusion parameters (mm² / s)

    6 months after inclusion

  • Quantitative MRI parameters

    transverse magnetization relaxation rate (Hz)

    6 months after inclusion

  • Quantitative MRI parameters

    longitudinal relaxation rate (Hz)

    6 months after inclusion

  • Quantitative MRI parameters

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

    6 months after inclusion

Secondary Outcomes (7)

  • Metabolic and anthropometric parameters before and after bariatric surgery

    6 months after inclusion

  • Metabolic and anthropometric parameters before and after bariatric surgery

    6 months after inclusion

  • Metabolic and anthropometric parameters before and after bariatric surgery

    6 months after inclusion

  • Metabolic and anthropometric parameters before and after bariatric surgery

    6 months after inclusion

  • Metabolic and anthropometric parameters before and after bariatric surgery

    6 months after inclusion

  • +2 more secondary outcomes

Study Arms (1)

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.

Radiation: Magnetic Resonance Imaging

Interventions

Magnetic Resonance ImagingRADIATION

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

MRI before and 6 months after bariatric surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (aged 18 to 65 years) with a planned for bariatric surgery (sleeve gastrectomy) according to HAS criteria
  • Patients with severe obesity (BMI≥35)

You may not qualify if:

  • 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
  • Patients who have undergone bariatric surgery other than a sleeve gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'obésité et de physiologie

Colombes, 92700, France

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

February 10, 2021

Study Start

February 10, 2021

Primary Completion

October 27, 2023

Study Completion

October 27, 2023

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)