Prevalence of Steatosis and Steatohepatitis in Patients Undergoing Bariatric Surgery; a Biopsy-based Study
NCT ID: NCT06499675
Last Updated: 2024-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
272 participants
OBSERVATIONAL
2019-05-01
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group 1
obese patients
sleeve gastrectomy
sleeve gastrectomy / bariatric surgery
Liver Biopsy
intraoperative liver biopsy
Interventions
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sleeve gastrectomy
sleeve gastrectomy / bariatric surgery
Liver Biopsy
intraoperative liver biopsy
Eligibility Criteria
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Inclusion Criteria
* Able to give written informed consent.
* Scheduled, independently from this study, to have a liver biopsy (LB).
* Negative for hepatitis B surface antigen, anti-hepatitis C virus, hepatitis C virus-RNA, and hepatitis B virus DNA.
* BMI greater than or equal to 40, or BMI greater than or equal to 35 with at least one obesity-related comorbid condition (including type 2 diabetes, hypertension, hyperlipidemia, obstructive sleep apnea (OSA), GERD, asthma, venous stasis disease, severe osteoarthritis, or considerably impaired quality of life).
* Unsuccessful nonoperative weight loss attempts.
* Mental health clearance.
* Recent updates have included patients with a BMI of 30-35 with uncontrollable type 2 diabetes or metabolic syndrome as an indication for a laparoscopic sleeve gastrectomy.
Exclusion Criteria
* Pregnant women.
* Patients with any active implantable medical device (such as pacemaker or defibrillator).
* Patients who had undergone liver transplantation.
* Patients with cardiac failure and significant valvular disease.
* Patients with hemochromatosis.
* Patients who refused to undergo liver biopsy or blood tests.
* Patients with alcohol consumption above recommended limits (\>14 units/week for women and \>21 units/week for men; 1 unit = 8 g of ethanol).
* Patients with a confirmed diagnosis of active malignancy or another terminal disease.
* Patients participating in another clinical trial within the preceding 30 days
18 Years
ALL
No
Sponsors
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Egyptian Liver Hospital
OTHER
Responsible Party
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Locations
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Egyptian Liver Research Institute and Hospital (ELRIAH)
Sherbin, Dakahlia Governorate, Egypt
Countries
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Other Identifiers
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Steatosis2019
Identifier Type: -
Identifier Source: org_study_id
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