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

Primary Purpose

NAFLD, Bariatric Surgery Candidate

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bariatric Surgery
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Obese Patients With NAFALD Undergoing Bariatric Surgeries

    Arm Description

    Outcomes

    Primary Outcome Measures

    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
    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
    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.
    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
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2019
    Last Updated
    October 12, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04127370
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    November 1, 2020 (Anticipated)
    Study Completion Date
    November 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NAFLD, Bariatric Surgery Candidate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    95 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Obese Patients With NAFALD Undergoing Bariatric Surgeries
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Bariatric Surgery
    Intervention Description
    The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease
    Primary Outcome Measure Information:
    Title
    change in the degree of steatosis by The Controlled Attenuation Parameter Score
    Description
    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
    Time Frame
    one year
    Title
    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.
    Description
    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
    Time Frame
    one year
    Title
    change in the degree of Fibrosis by NAFLD fibrosis(NFS) score
    Description
    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.
    Time Frame
    one year
    Title
    change in the degree of Fibrosis by FIB-4 score
    Description
    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
    Time Frame
    one year
    Title
    Pathological change by liver biopsy
    Description
    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).
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Above 20 years of age morbid obesity 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    shimaa abo bakr, Msc
    Phone
    01066635612
    Email
    shimaabakr85@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Shawkait
    Phone
    01028030669
    Email
    shawkatahmed84@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31512035
    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.
    Results Reference
    background
    PubMed Identifier
    31477248
    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.
    Results Reference
    background

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

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