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

Bariatric Surgery Clinical Trial

— PACHIBA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04746703
• Other study ID #: APHP201020
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: October 27, 2023

Study information

• Verified date: July 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

To assess the impact of bariatric surgery on pancreatic Magnetic Resonance Imaging (MRI) parameters in severe-obese patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 27, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Radiation:
• Magnetic Resonance Imaging
Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.

Locations

Country	Name	City	State
France	Centre d'obésité et de physiologie	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative MRI parameters	Pancreatic fat content	6 months after inclusion
Primary	Quantitative MRI parameters	diffusion parameters (mm² / s)	6 months after inclusion
Primary	Quantitative MRI parameters	transverse magnetization relaxation rate (Hz)	6 months after inclusion
Primary	Quantitative MRI parameters	longitudinal relaxation rate (Hz)	6 months after inclusion
Primary	Quantitative MRI parameters	visco-elastic parameters by measure of tissue stiffness (kPa)	6 months after inclusion
Secondary	Metabolic and anthropometric parameters before and after bariatric surgery	BMI	6 months after inclusion
Secondary	Metabolic and anthropometric parameters before and after bariatric surgery	% fat mass in impedance	6 months after inclusion
Secondary	Metabolic and anthropometric parameters before and after bariatric surgery	weight loss in percent of preoperative body weight	6 months after inclusion
Secondary	Metabolic and anthropometric parameters before and after bariatric surgery	excess weight loss	6 months after inclusion
Secondary	Metabolic and anthropometric parameters before and after bariatric surgery	blood pressure	6 months after inclusion
Secondary	Metabolic and anthropometric parameters before and after bariatric surgery	HOMA-IR index	6 months after inclusion
Secondary	lipids parameters	total cholesterol, HDL, LDL, triglycerides	6 months after inclusion