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The Effects of Bariatric Surgeries on Non-Alcoholic Fatty Liver Disease

18 Years
60 Years
Open (Enrolling)
Obesity., Non-Alcoholic Fatty Liver Disease.

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Trial Information

The Effects of Bariatric Surgeries on Non-Alcoholic Fatty Liver Disease

35 consecutive patients referred for bariatric surgery will be recruited either at the
obesity clinic, or from inpatient (scheduled for bariatric surgery). A detailed history and
a complete physical examination will be done at the first visit along with anthropometric
measures; routine blood tests, liver function, hormonal assessment, and certain metabolic
and inflammatory markers will be evaluated. They will also have an abdominal ultrasound for
initial NAFLD assessment, fibroscan to detect liver fibrosis, and an MRI to measure hepatic
fat content and body fat composition including intra-abdominal and extra-abdominal fat.
These patients will be asked to lose a certain amount of kilos (depending on their BMI and
the surgeon preference) out of their original weight, in order to become candidates for
bariatric surgery at King Saud University Hospital (KKUH).

At the second visit, (if they lose the recommended amount weight) we will assess their
weight loss; obtain blood for the same hormonal and inflammatory markers assessment.
Nonetheless, if they did not lose weight and the treating surgeon gave them a third
appointment, we will consider their third visit as a second visit; preforming all the
investigations mentioned above. In this case we will interpret their results with respect to
the total duration of "before surgery" weight loss.

During the operation, tissue biopsy will be taken with a core needle biopsy for the liver
and a sharp non-thermal instrument for subcutaneous fat, visceral fat, and abdominal muscle
immediately after skin incision. A CAP certified tissue manager would process all tissues.
Liver biopsy will be sliced it to two parts; the first half is for histological evaluation,
but the other half will be stored for tissue studies. The histologic slides will be stained
with hematoxylin and eosin (H&E), and Masson Trichrome stains for microscopic evaluation.
This evaluation will be provided by a single histopathologist who will be blinded to the
patients' clinical condition, and the order of the biopsy.

Follow Up:

After the surgery follow up appointments will be scheduled 3 months, 6 months, 1 year, and
annually till 5 years. The followings will be done in each visit:

1. Thorough physical exam as per the CRF.

2. Take a blood sample to evaluate liver function, metabolic, and inflammatory changes
using the same parameters as those in the baseline.

3. Request for: fibroscan and abdominal ultrasound. Second, third and fourth liver
biopsies will be taken percutaneously 3 months, 1 year, and 5 years following the
initial biopsy respectively. These biopsies will be obtained using core tissue biopsy
with ultrasound guidance for the same histological assessment and tissue studies.
Another MRI will be schedule 1 year after the surgery.

Specimens collected under this trial will be part of the King Saud University Liver Disease
Research Centre Biobanking and will follow all policy and procedures within the biobanking
protocol as approved by the IRB committee.

Inclusion Criteria:

- Age between 18 to 60 years.

- Eligible for obesity surgery according to the following criteria:

- BMI > 30 kg/m2.

- Ability to demonstrate eating habit control by reducing 10% of the original
weight prior to surgery

- Pass the nutritional and the psychological assessment

- Pass the preoperative testing to determine the operative risk

- Ultrasound diagnosis of NAFLD prior to surgery.

- Written informed consent.

Exclusion Criteria:

- Unwilling to take part in the study, or asked to be removed from the study at any

- History of alcohol intake > 20 g/day for 5 or more years

- Evidence autoimmune hepatitis, chronic hepatitis B or C virus, HIV, genetic
hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease, or cirrhosis.

- Pregnancy.

- Currently taking known hepatotoxic medications.

- Failure to attend follow-up for a minimum of 1 year.

- Non-Saudi patients

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Assessment of NAFLD histological changes after bariatric surgery (adjustable gastric banding, sleeve gastrectomy, gastric bypass, and duodenal switch).

Outcome Description:

Histological evaluation is done by applying the NAFLD activity score (NAS). The stage of fibrosis will be determined by the five-point (stage 0 to 4) scale.

Outcome Time Frame:

Intra-operatively, 3 months and 1 year postoperatively.

Safety Issue:


Principal Investigator

Dr.Mazen Hassanain, MBBS FRCSC PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

King Khalid University Hospital,King Saud University,Riyadh,KSA.


Saudi Arabia: Ethics Committee

Study ID:




Start Date:

June 2012

Completion Date:

Related Keywords:

  • Obesity.
  • Non-Alcoholic Fatty Liver Disease.
  • Fatty Liver
  • Liver Diseases
  • Obesity