Efficacy and Safety of Endoscopic Sleeve Gastroplasty Versus Laparoscopic Sleeve Gastrectomy in O… (NCT04060368) | Clinical Trial Compass
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Efficacy and Safety of Endoscopic Sleeve Gastroplasty Versus Laparoscopic Sleeve Gastrectomy in Obese Subjects With NASH
Spain30 participantsStarted 2020-06-01
Plain-language 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-cause mortality and liver-related outcomes In obese subjects with non-alcoholic steatohepatitis (NASH).
Condition or disease: Non-alcoholic steatohepatitis (NASH) with or without fibrosis Intervention/treatment: ESG with OverStitch® system vs LSG
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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 criteria
✕. 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).
What they're measuring
1
Proportion of subjects undergoing ESG relative to LSG achieving resolution of NASH without worsening of fibrosis
Timeframe: Measurement at 96 weeks
2
Proportion of subjects undergoing ESG relative to LSG with cardiovascular and liver-related death events
✕. 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.