Clinical trial NCT06499675: Prevalence of Steatosis and Steatohepatitis in Patients Undergoing Bariatric Surgery; a Biopsy-based Study
Official title: Prevalence of Steatosis and Steatohepatitis in Patients Undergoing Bariatric Surgery; a Biopsy-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Obesity, Morbid
Bariatric Surgery Candidate
Steatosis of Liver
Steatohepatitis, Nonalcoholic
Keywords: steatosis
bariatric surgery
liver biopsy
Lead sponsor: Egyptian Liver Hospital
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.
timeFrame: 55 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shirbīn
country: Egypt
facility: Egyptian Liver Research Institute and Hospital (ELRIAH)
state: Ad Daqahliyah
Study officials:
References: