Status:
UNKNOWN
Efficacy and Safety of Endoscopic Sleeve Gastroplasty Versus Laparoscopic Sleeve Gastrectomy in Obese Subjects With NASH
Lead Sponsor:
Instituto de Investigación Marqués de Valdecilla
Conditions:
Non-alcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The primary objectives of this study are to evaluate the effect of ESG with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) compared to LSG on 1) histological improvement in NASH; 2) all-caus...
Eligibility Criteria
Inclusion
- Subjects aged between 18 and 60 years (inclusive) at first screening visit.
- Must provide signed written informed consent and agree to comply with the study protocol.
- BMI between 35 and 45 kg/m2 with or without metabolic risk factors (type 2 diabetes, arterial hypertension, dyslipidaemia), and BMI between 30 and 34,9 kg/m2 with type 2 diabetes.
- Histological confirmation of steatohepatitis in a diagnostic liver biopsy (biopsy obtained in the 6 months prior to randomization or during the selection period) with at least a score of 1 in each component of the NAS score (steatosis with a score of 0 to 3, degeneration by ballooning with a score of 0 to 2 and lobular inflammation with a score of 0 to 3) and:
- NAS score ≥ 4
- fibrosis \< 4 according to the staging system of CRN fibrosis on NASH
- For patients with fibrosis ≤ 1, must be associated at least one of the following conditions: metabolic syndrome (NCEP ATP III definition), type 2 diabetes, HOMA-IR \>6
- Absence of other well documented causes of chronic liver disease (alcoholic liver disease, viral hepatitis, cholestasis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha 1 antitrypsin deficiency)
- Patients agree to have 1 liver biopsy after 96 weeks after intervention
Exclusion
- Known heart failure (Grade I to IV of the classification of the New York Heart Association).
- History of efficient bariatric surgery within 10 years prior to Screening.
- Patients with a history of clinically significant acute cardiac event in the 6 months prior to selection, such as: acute cardiovascular event, cerebrovascular accident, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures).
- Weight loss of more than 5% in the 6 months prior to randomization.
- Recent or current background of significant consumption of alcoholic beverages (\<5 years). In the case of men, significant consumption is usually defined as more than 30 g of pure alcohol per day. In the case of women, it is usually defined as more than 20 g of pure alcohol per day.
- Liver cirrhosis.
- Non-cirrhotic portal hypertension.
- Esophagogastric varices.
- Hepatocellular carcinoma
- Portal thrombosis.
- Pregnancy.
- Refusal to give informed consent.
- Any medical condition that could reduce life expectancy to less than 2 years, including known cancers.
- Signs of any other unstable or clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease without treatment.
- Instability or mental incompetence, so that the validity of the informed consent or the ability to comply with the study are uncertain.
- Antibodies positive for the human immunodeficiency virus.
- Descompensated liver disease with the following hematologic and biochemical criteria:
- Aspartate aminotransferase (AST) and / or ALT\> 10 x upper limit of normal (ULN)
- Total bilirubin\> 25 μmol / l (1.5 mg / dl)
- Standardized international index\> 1.4
- Platelet count \<100 000 / mm3
- Serum creatinine levels\> 135 μmol / l (\> 1.53 mg / dl) in men and\> 110 μmol / l (\> 1.24 mg / dl) in women.
- Significant renal disease, including nephritic syndrome, chronic kidney disease (patients with markers of hepatic injury or estimated glomerular filtration rate \[eGFR\] of less than 60 ml / min / 1.73 m2). If an abnormal value is obtained at the first screening visit, the eGFR measurement may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the expected randomization. An abnormal repeated eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04060368
Start Date
June 1 2020
End Date
June 1 2023
Last Update
September 30 2020
Active Locations (1)
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1
Hospitl Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008