NCT02122263

Transient Elastography of the Liver ( Fibroscan ) and Bariatric Surgery

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Ziv Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of Bariatric surgery on the extent of liver fat and liver fibrosis and on different metabolic parameters in patients undergoing sleeve gastrectomy surgery.

Detailed description

The effect of bariatric surgery on the extent of fat and extent of liver fibrosis following sleeve gastrtrectomy is unknown. Methods : 60 obese NAFLD patients will undergo sleeve gastrectomy surgery. Measurements will be conducted at: baseline, and at 6 Month and will include: abdominal US, Fibroscan elastography , biochemical tests, anthropometric measurements, and questionnaires for demographic details, quality of life, food intake, food tolerance and habitual physical activity. Primary Outcome Measures: Liver fat quantification (controlled attenuation parameter;CAP ) and stiffness at baseline and at 6 months by fibroscan. The liver stiffness is measured by Fibroscan in a volume of approximates 1 cm wide and 4 cm long cylinder, representing 1/500 of liver tissue (100 times greater than a biopsy sample). The results of the Fibroscan will be expressed in KiloPascals (kPa). The Fibroscan XL probe reduces Fibroscan failure and facilitates reliable liver stiffness measurement in obese patients compared with the common M probe. Secondary Outcome Measures: metabolic parameters including insuline resistance, CRP, MDA, Paraoxonase, and bile acid levels. Quality of life and Food tolerance after bariatric surgery

Conditions

• NAFLD

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-04-24
• Last updated: 2014-04-24

Locations

1 site across 1 country: Israel