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 greater risk of cardiovascular and hepatic death, and higher rates of neoplasms, both gastrointestinal and extra-intestinal. The standard treatment is weight loss with diet and physical exercise, which has shown a histological and analytical improvement in patients who achieve a 5-10% reduction in body weight. However, less than 25% of subjects achieve this goal. Restrictive surgical treatments and gastric bypass have achieved, in obese patients, an improvement in metabolic syndrome, insulin resistance and liver histology, but in patients with liver cirrhosis the morbidity-mortality of this surgery is high. Currently, endoscopic techniques are being developed, which are less invasive and have fewer complications, and which also achieve gastric restriction with similar characteristics to those obtained by the surgical method. Among them is the tubulization or vertical gastroplasty with the OverStitch system (Apollo Endosurgery, Austin, TX, USA). However, this method has not been evaluated in patients with obesity and/or metabolic syndrome and NASH cirrhosis. For this reason, the main objective of the investigators study is to evaluate the safety and efficacy of endoscopic gastroplasty in improving metabolic factors and liver histology in patients with obesity with or without metabolic syndrome and NASH-compensated cirrhosis.
Study Type
OBSERVATIONAL
Enrollment
10
endoscopic vertical gastroplasty + lifestyle modification
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Number of adverse events resulting from the procedure during the study
Time frame: 96 weeks
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Number of events related to liver disease: ascites, bleeding secondary to PTH, encephalopathy, SBP, or renal failure
Time frame: 96 weeks
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Number of cardiovascular events during follow-up: Ischemic heart disease, stroke, peripheral arterial disease, heart failure, cardiomyopathy.
Time frame: 96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Death from all causes
Time frame: 96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Liver transplant
Time frame: 96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Model for end-stage liver disease (MELD) ≥ 15.
Time frame: 96 weeks
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Worsening of the Child-Pugh score by at least 2 points
Time frame: 96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Appearance of hepatocellular carcinoma (HCC)
Time frame: 96 weeks
To evaluate the efficacy of endoscopic vertical gastroplasty + lifestyle modification in the histological improvement of fibrosis
using the percentage of subjects with improvement in at least 1 stage in fibrosis without worsening of NASH
Time frame: 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
Changes in fibrosis including: improvement, not worsening, and progression
Time frame: after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
Resolution of NASH defined as the presence or not of steatosis, without ballooning and with no or minimal inflammation.
Time frame: after 96 weeks
Reduction the following histological changes of treatment according to NASH-CRN criteria
Improvement of at least 1 point in the different components of the NASH-CRN score (steatosis, liver ballooning, and lobular inflammation)
Time frame: after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
Improvement of fibrosis in at least 1 stage along with NASH improvement, defined as at least 1 stage improvement in fibrosis and at least 2 points less in NAFLD activity score (NAS) with at least 1 point improvement in ballooning and lobular swelling.
Time frame: after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
NAS score changes.
Time frame: after 96 weeks
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