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Completed

NCT Number: NCT06499675

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Egyptian Liver Research Institute and Hospital (ELRIAH)

Sherbin, Dakahlia Governorate, 35111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleeve gastrectomy

Procedure

sleeve gastrectomy / bariatric surgery

Liver biopsy

Procedure

intraoperative liver biopsy

Primary outcomes

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

    Time frame: 55 months

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

Sponsors and collaborators

Lead sponsor

Egyptian Liver Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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