The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

NCT04127370 | Unknown

• 1 other identifier: Bariatric Surgery in NAFLD
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

Conditions

NAFLD; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (5)

• change in the degree of steatosis by The Controlled Attenuation Parameter Score

  change in the degree of steatosis of NAFLD patient Post Bariatric Surgery by CAP Score The Controlled Attenuation Parameter;( CAP™) This is a quantitative measurement expressed in dB/m. It varies continuously between 150 and 400 dB/m. A healthy liver will produce a measurement around 150-200, whilst a fatty liver will be measured at around 300-400 dB/m. CAP Score ----Steatosis Grade ------Amount of Liver with Fatty Change 238 to 260 dB/m --S1 ----11 to 33% 260 to 290 dB/m---- ---S2 -------34 to 66% Higher than 290 dB/m ----S3 ---67% or more

  one year

• 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.

  FibroScan® is a non-invasive device that assesses the 'hardness' (or stiffness) of the liver via the technique of transient elastography FibroScan® results range from 2.5 kPa to 75 kPa * Fibrosis score F0 to F1: No liver scarring or mild liver scarring * Fibrosis score F2: Moderate liver scarring * Fibrosis score F3: Severe liver scarring * Fibrosis score F4: Advanced liver scarring (cirrhosis) Assessment of liver fibrosis by TE in NAFLD is shown in table (1) F0 to F1- F2- F3 -F4 2 to 7 kPa 7.5 to 10 kPa 10 to 14 kPa 14 kPa or higher ,respectively

  one year

• change in the degree of Fibrosis by NAFLD fibrosis(NFS) score

  change in the degree of Fibrosis by NAFLD fibrosis(NFS) score The NFS is calculated based on six readily available parameters (age, BMI, hyperglycemia, platelet count, albumin, and AST/ALT ratio) The NFS is then divided into three groups: \< 1.455 which represent F0-F2, between 1.455 and 0.675 represent indeterminate, and \> 0.675 represent F3-F4.

  one year

• change in the degree of Fibrosis by FIB-4 score

  change in the degree of Fibrosis by FIB-4 score FIB-4 index uses a combination of age, AST, ALT, and platelet count and offers dual cut-off values score \< 1.45 represent unlikely advanced fibrosis and score \> 3.25 represent likely advanced fibrosis, respectively

  one year

• Pathological change by liver biopsy

  pre and post operative liver biopsy will be taken to assess the degree of liver steatosis,inflammation and fibrosis Histological re-evaluation will be planned approximately 1 year after surgery for patient with steatohepatitis only(NAS score\>3) , The histological variables will be investigated by a single specialized hepatopathologist and will be scored according to the NAFLD Activity Score (NAS recently published by the Pathology Committee of the NASH Clinical Research Network) The NAS score represents the sum of scores for steatosis (0-3), ballooning (0-2), and lobular inflammation (0-3). The score ranges from 0 to 8 with the NAS score of 5-8 considered diagnostic of NASH, the NAS score of 3-4 considered borderline NASH, and the NAS score of 0-2 considered not diagnostic of NASH. Additionally, there is a separate fibrosis stage ranging from 0 to 4 (0: no fibrosis, 1: perisinusoidal or periportal, 2: perisinusoidal and portal/periportal, 3: bridging fibrosis, 4: cirrhosis).

  one year

Study Arms (1)

Obese Patients With NAFALD Undergoing Bariatric Surgeries

EXPERIMENTAL

Procedure: Bariatric Surgery

Interventions

Bariatric Surgery PROCEDURE

The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

Obese Patients With NAFALD Undergoing Bariatric Surgeries

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 31512035 BACKGROUND

• 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.

  PMID: 31477248 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

shimaa abo bakr, Msc

CONTACT

01066635612; shimaabakr85@gmail.com

Ahmed Shawkait

CONTACT

01028030669; shawkatahmed84@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist( M. Sc)in Gastroenterology and Infectious Diseases Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 15, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: October 15, 2019

Record last verified: 2019-10