Magnetic Resonance Imaging (MRI) Fat Quantification of the Liver

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University Hospital Basel

Status

Completed

Conditions

Obesity
Non-alcoholic Fatty Liver Disease

Treatments

Other: MR Abdomen

Study type

Interventional

Funder types

Other

Identifiers

NCT02682173
MRI Fat quantification

Details and patient eligibility

About

Fatty liver in the obese is a common finding; some cases develop steato-hepatosis which in the long-term can lead to liver cirrhosis. The effect of bariatric surgery on fat distribution in the liver has so far been studied with liver biopsies and single voxel MR techniques. With this trial investigators present a new, whole organ MR-quantification of liver fat and describe changes after bariatric surgery in visceral and subcutaneous fat.

Full description

Currently, liver biopsy is still regarded as the gold-standard in the diagnosis of non-alcoholic fatty liver disease and monitoring of progression. However, accuracy of diagnosis is not perfect with a certain risk of sampling error depending on biopsy quality and a more or less homogeneous distribution of liver tissue alterations. Complications are rare; however, the method is invasive and carries the risk of bleeding. Therefore, non-invasive methods (such as serum biomarkers or imaging techniques) are sought for accurate diagnosis and safe monitoring of disease progression. Unidimensional transient elastography (TE; FibroScan®) is a non-invasive technique, which can be a helpful tool here: however, accuracy of diagnosis is depending on the stage of fibrosis and lower grades of fibrosis (stage 1 and 2) are difficult to assess. Moreover, in obese patients this method cannot be applied. In recent years, the development of fat-water magnetic resonance imaging has enabled non-invasive assessment of fat and water content in tissues. In addition, modern MRI devices allow brief breath holding, which reduces motion artifacts and provides us with excellent data and therefore MRI has become an important tool for fat quantification. Up to date only a few studies have focused on fat quantification before and after bariatric surgery: patients treated with laparoscopic gastric banding (a purely restrictive procedure) and patients undergoing metabolic surgery such as sleeve gastrectomy and gastric bypass have been examined pre- and postoperatively by means of MRI fat quantification. However, in these studies single voxel spectroscopy was used. In contrast, in this current trial investigators aim to assess full organ volume, which hopefully will provide more accurate data.

Enrollment

15 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • morbidly obese patients with BMI over 35, scheduled for bariatric surgery (either sleeve gastrectomy or gastric bypass)

Exclusion criteria

  • Smoking
  • substance abuse
  • Diabetes
  • history of gastrointestinal disorders
  • pace-maker
  • claustrophobia

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Laparoscopic gastric bypass
Active Comparator group
Description:
MR Abdomen in morbidly obese patients receiving gastric bypass
Treatment:
Other: MR Abdomen
Laparoscopic sleeve gastrectomy
Active Comparator group
Description:
MR Abdomen morbidly obese patients receiving sleeve gastrectomy
Treatment:
Other: MR Abdomen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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