Clinical trial NCT04127370: The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease
Official title: The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NAFLD
Bariatric Surgery Candidate
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 95
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

Detailed description: The overall global prevalence of Nonalcoholic Fatty Liver Disease diagnosed by imaging is around 25.24%. The highest prevalence of NAFLD is reported from the Middle East 31.79% and South America 30.45% whereas the lowest prevalence rate is reported from Africa 13.48%.

Unlike NAFLD, Nonalcoholic steatohepatitis is more aggressive and is associated with a risk of approximately 10 to 29% of progression to cirrhosis within10 years. Therefore, early-stage NASH represents a group of patients that is most likely to benefit from treatments in order to prevent progression to cirrhosis and its complications. Obesity is the most common and well documented risk factor for NAFLD, the majority (\>95%) of patients with severe obesity undergoing bariatric surgery will have NAFLD. To date, weight loss achieved via lifestyle intervention remains the mainstay of treatment of NASH.

Bariatric surgery contributes to weight loss in two main ways: restrictive procedures and malabsorptive procedures.

In 2018, the AASLD board stated that it is premature to consider foregut bariatric surgery as an established option to specifically treat NASH. Accordingly, the effects of bariatric surgery on hepatic fibrosis are still unclear. In Egypt there is lack in such type of study thus this research will conducted to evaluate the prevalence of NAFLD and NASH in obese patients undergoing bariatric surgery and to assess the role of bariatric surgery in management of NAFLD related hepatic morbidity in our locality.

Eligibility criteria: Inclusion Criteria:

1. Above 20 years of age
2. morbid obesity
3. severe obesity with as arterial hypertension or type 2 diabetes mellitus (T2DM),

Exclusion Criteria:

* 1- chronic liver diseases 2-Long term consumption of hepatotoxic drugs. 3-Active alcohol abuse 4-Medical or psychological contraindications for bariatric Surgery. 5-Refusal of giving a consent

Primary outcomes:
measure: change in the degree of steatosis by The Controlled Attenuation Parameter Score
timeFrame: one year
measure: change in the degree of Fibrosis by Transient elastography (TE), change in the degree of Fibrosis by Transient elastography (TE), of NAFALD Patients after Bariatric Surgery NAFLD fibrosis(NFS) score and FIB-4 score.
timeFrame: one year
measure: change in the degree of Fibrosis by NAFLD fibrosis(NFS) score
timeFrame: one year
measure: change in the degree of Fibrosis by FIB-4 score
timeFrame: one year
measure: Pathological change by liver biopsy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Di Palma A, Alhabdan S, Maeda A, Mattu F, Chetty R, Serra S, Quereshy F, Jackson T, Okrainec A. Unexpected histopathological findings after sleeve gastrectomy. Surg Endosc. 2020 May;34(5):2158-2163. doi: 10.1007/s00464-019-07002-7. Epub 2019 Sep 11.
citation: Papasavas P, Seip RL, Stone A, Staff I, McLaughlin T, Tishler D. Robot-assisted sleeve gastrectomy and Roux-en-y gastric bypass: results from the metabolic and bariatric surgery accreditation and quality improvement program data registry. Surg Obes Relat Dis. 2019 Aug;15(8):1281-1290. doi: 10.1016/j.soard.2019.04.003. Epub 2019 Apr 13.