Prevalence of Steatosis and Steatohepatitis in Patients Undergoing Bariatric Surgery; a Biopsy-based Study

Egyptian Liver Hospital

Status: Completed

Conditions: Steatosis of Liver; Bariatric Surgery Candidate; Obesity; Steatohepatitis, Nonalcoholic; Obesity, Morbid

Treatments: Procedure: sleeve gastrectomy; Procedure: Liver Biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT06499675

Steatosis2019

Details and patient eligibility

About

To study the prevalence of steatosis, steatohepatitis, and their associated risk factors in obese patients undergoing bariatric surgery.

Full description

A prospective single-center biopsy-based study was conducted on 162 sleeve gastrectomy patients. Patient characteristics, including age, sex, diabetes mellitus (DM) status, body mass index (BMI), liver function tests, lipogram, homeostatic model assessment of insulin resistance (HOMA-IR), and steatosis were also assessed using controlled attenuation parameter (CAP), and intra operative liver biopsies were obtained. , The presence of steatosis and steatohepatitis were histologically assessed by two expert pathologists.

Enrollment: 272 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing laparoscopic sleeve gastrectomy ≥18 years of age.
• 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

• Patients with ascites.
• 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

Trial design

272 participants in 1 patient group

Group 1

Description:

obese patients

Treatment:

Procedure: Liver Biopsy

Procedure: sleeve gastrectomy