Biophysics and clinical practice for regenerative processes in cirrhosis of the liver/of liver cirrhosis assisted by Delta-S Entropy Variation Systems.
OBJECTIVE
The therapy in question uses an innovative bioengineering device denoted as ''Delta-S DVD Entropy Variation System''. Previous research indicated regression of cirrhosis as evaluated in its morphofunctional and symptomatological aspects. The aim of the study is to confirm and extend previous experimental observations by enhancing hemodynamic evaluation techniques. In order to clarify scar regression, it was decided to include in the endpoints a quantitative evaluation of portal hypertension called HVPG, which is sensitive to the breakdown of hepatic architecture and the influence of regeneration nodules and therefore the advance of cirrhosis.


METHODS
The experimental design consists of a self-controlled study carried out on Child A-B cirrhosis patients with portal hypertension (hepatic venous pressure gradient, HVPG > or = 10 mmHg). Five patients were enrolled, 4 HCV positive, one with autoimmune cirrhosis, all showing extensive symptoms.


RESULTS
At the end of the treatment all patients showed a reduction in portal hypertension (mean reduction HVPG = 40.2%, P<0.011), together with an improved ultrasound flowmeter pattern and a sharp decrease or disappearance of the symptoms. No adverse effects were reported. Efficacy on autoimmune cirrhosis was unaffected.


CONCLUSIONS
By means of a quantitative analysis of portal hypertension and of functional aspects, this study confirms that the Delta-S DVD system can lead to the regression of the scar component of cirrhosis, promote the regeneration of functioning liver tissue with positive effects on hepatic functionality and prevent symptoms and the risk of varicose vein rupture.
Marineo
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G
Delta Research and Development Medical Bioengineering Research Centre, Rome, Italy. g.marineo@mclink.it
Fesce
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D000368:Aged; D055592:Biophysical Phenomena; D001703:Biophysics; D001709:Biotechnology / Q000295:instrumentation*; D003627:Data Interpretation, Statistical; D019277:Entropy; D005260:Female; D005544:Forecasting; D006526:Hepatitis C / Q000150:complications; D006801:Humans; D006975:Hypertension, Portal / Q000628:therapy; D008103:Liver Cirrhosis / Q000150:complications / Q000209:etiology / Q000628:therapy*; D008115:Liver Regeneration; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D013816:Thermodynamics; D013997:Time Factors; D016896:Treatment Outcome