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
About this trial
This is an interventional treatment trial for NAFLD
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
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
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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