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

Completed

• Conditions: Obesity, Morbid; Steatosis of Liver; Steatohepatitis, Nonalcoholic; Obesity; Bariatric Surgery Candidate
• Interventions: Procedure: sleeve gastrectomy; Procedure: Liver Biopsy

• Registration Number: NCT06499675
• Lead Sponsor: Egyptian Liver Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-05-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-07
• Study First Submitted QC: 2024-07-07
• Last Update Submitted: 2024-07-07
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Liver Biopsy	obese patients
Group 1	sleeve gastrectomy	obese patients

Primary Outcome Measures

Name	Time	Method
Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.	55 months	Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.

Trial Locations

Locations (1)

Egyptian Liver Research Institute and Hospital (ELRIAH); 🇪🇬 Shirbīn, Ad Daqahliyah, Egypt