Status:
UNKNOWN
Endoscopic Bariatric Therapy in NASH Cirrhosis
Lead Sponsor:
Instituto de Investigación Marqués de Valdecilla
Conditions:
Non-alcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18-65 years
Brief Summary
Non-alcoholic steatohepatitis (NASH) is a growing public health problem that affects more than 5% of the population and can lead to cirrhosis and hepatocellular carcinoma. These patients are at greate...
Eligibility Criteria
Inclusion
- 1\) Subjects between the ages of 18 and 65 (inclusive) at the time of the first selection visit 2) They must provide a signed written informed consent and agree to comply with the study protocol.
- 3\) Subjects with a BMI greater than 30 kg/m2 whether or not associated with metabolic risk factors (MD, hypertension, dyslipemia).
- 4\) Confirmed diagnosis of non-alcoholic steatohepatitis with a degree of fibrosis 4 according to the NASH CRN staging system in a liver biopsy obtained in the 12 months prior to the endoscopic procedure or during the screening period.
- 5\) Absence of other causes of chronic liver disease (alcoholic, viral, autoimmune, cholestatic disease, Wilson's disease, α1AT deficit, hemochromatosis)
Exclusion
- Current or past history of any liver decompensation event (ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome, hepatopulmonary syndrome).
- Child-Pugh Scale ≥ 7 points.
- MELD scale \> 12
- Documented presence of varicose veins based on a previous endoscopy performed in the 6 months prior to the intervention.
- Documented presence of collateral circulation based on an echoendoscopy and/or thoraco-abdominal CT with 3D reconstruction performed in the selection period.
- Presence of a hepatic venous pressure gradient (HVPG) ≥ 10 mmHg in a hemodynamic study performed in the 4 months prior to surgery or in the selection period.
- Known heart failure (Grade I-IV of the New York Heart Association classification).
- History of bariatric surgery
- Patients with a history of clinically significant cardiovascular events in the 6 months prior to the endoscopic procedure, such as an acute cardiovascular event, stroke, transient ischemic attack, or coronary heart disease (angina, myocardial infarction, revascularization procedures).
- Weight loss of more than 5 % in the 6 months prior to the operation.
- Recent or current history of significant consumption of alcoholic beverages (\< 5 years) For men, significant consumption is usually defined as more than 30 g of pure alcohol per day. For women, it is normally defined as more than 20 g of pure alcohol per day.
- Hepatocarcinoma. (13) Portal thrombosis.
- 14\) Pregnancy. 15) Refusal to give informed consent. 16) Any medical condition that could reduce life expectancy to less than 2 years, including known cancers.
- 17\) Indications of any other untreated, unstable or clinically significant immunological, endocrine, haematological, gastrointestinal, neurological, neoplastic or psychiatric disease.
- 18\) Mental instability or incompetence such that the validity of the informed consent or the ability to comply with the study is uncertain.
- 19\) Positive antibodies to human immunodeficiency virus. 20) Data on decompensated liver disease:
- Aspartate aminotransferase (AST) and/or ALT \> 10 x upper limit of normality (LSN)
- Total bilirubin \> 2 mg/dL
- International Normalized Ratio (INR) \> 1,4
- Platelet count ≤ 100 000/mm3.
- Albumin \< 3.5 g/dL. 21) Serum creatinine levels \> 135 μmol/l (\> 1.53 mg/dl) in men and \> 110 μmol/l (\> 1.24 mg/dl) in women 22) Significant renal disease, including nephrotic syndrome, chronic renal disease (patients with markers of liver 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, eGFR measurement may be repeated before randomisation within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the intended randomisation. Repeated abnormal eGFR (less than 60 ml/min/1,73 m2 ) leads to exclusion from the study.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04281303
Start Date
April 1 2020
End Date
April 1 2022
Last Update
February 25 2020
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