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

NCT06499675 | Completed

• 1 other identifier: Steatosis2019
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

steatosis; bariatric surgery; liver biopsy

Outcome Measures

Primary Outcomes (1)

• Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.

  Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.

  55 months

Study Arms (1)

Group 1

obese patients

Procedure: sleeve gastrectomy; Procedure: Liver Biopsy

Interventions

sleeve gastrectomy PROCEDURE

sleeve gastrectomy / bariatric surgery

Group 1

Liver Biopsy PROCEDURE

intraoperative liver biopsy

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a cross-sectional prospective single-center study conducted between May 2019 and December 2023. The study included consecutive patients receiving sleeve gastrectomy at the Egyptian Liver Research Institute and Hospital (ELRIAH), Sherbin, El-Mansoura, Egypt

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Egyptian Liver Hospital: lead

Study Sites (1)

Egyptian Liver Research Institute and Hospital (ELRIAH)

Sherbin, Dakahlia Governorate, 35111, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Liver Biopsy slides

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Fatty Liver; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 12, 2024
• Study Start: May 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

EG (1)