Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS) (LIRESS)
Carcinoma, Hepatocellular, Metabolic Syndrome
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring hepatocellular carcinoma, sleeve gastrectomy, morbid obesity
Eligibility Criteria
Inclusion Criteria: Be willing and able to provide written informed consent/assent for the trial Be ≥ 18 years of age on day of signing informed consent. Have hepatocellular carcinoma with metabolic syndrome as unique risk factor Have an overall Child-Pugh score = A Be eligible for liver resection with laparoscopic or robotic technique Be eligible for bariatric surgery as defined below BMI ≥ 40 kg/m2 BMI ≥ 35-40 kg/m2 with associated comorbidities BMI 30-35 kg/m2 and type 2 diabetes BMI 30-35 kg/m2 and arterial hypertension with poor control despite optimal medical therapy. Exclusion Criteria: Have hepatocellular carcinoma related to other etiology, even in case of coexisting metabolic syndrome Denial of the patient to undergo bariatric procedure Have BMI < 30 Have negative opinion of psychologic consultant Have an overall Child-Pugh score > 7 Evidence of clinical significant portal hypertension as followed: esophageal varices gastric varices portal hypertensive gastropathy gastric vascular ectasia Of note: 1) Conversion to open surgery for any reason does not represent a reason of data exclusion from the analysis; 2) any type of hepatic resection, according to Brisbane classification, is included, also major hepatectomy requiring preoperative intervention to achieve adequate volume remnant
Sites / Locations
- Ospedale Vito FazziRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Patients affected by HCC induced by metabolic syndrome as unique risk factor
Patients with HCC related to metabolic syndrome as unique risk factor
Patients aged 18 years old and older, affected by HCC with MS (metabolic syndrome) as unique risk factor who comply with the criteria for bariatric surgery, will undergo liver resection and sleeve gastrectomy with minimally-invasive technique in the same surgical procedure
Patients aged 18 years old and older, affected by HCC (hepatocellular carcinoma) with MS (metabolic syndrome) as unique risk factor who will undergo liver resection only