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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

Patients in the experimental arm will undergo liver resection for HCC and sleeve gastrectomy for MS during the same surgical procedure.

Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome

Patients in the active comparator arm will undergo liver resection for HCC

Liver resection for HCC induced by metabolic syndrome

Annarita Libia

Hepatocellular carcinoma (HCC) related to metabolic syndrome (MS) as unique risk factor is gradually overpassing the more common viral and alcohol etiology, becoming a global health issue. Liver surgery for metabolic syndrome-related HCC in this frail subset of patients constitute a challenge, due to high morbidity and mortality rate reported in literature, and contrasting results in term of oncologic outcome. The present multicentric prospective study aims to ascertain if the combination of sleeve gastrectomy and liver surgery in the same surgical procedure may have benefit in terms of reduced perioperative morbidity and prolonged Overall Survival and Recurrence Free Survival. Secondary outcome will be the evaluation of the consequences induced by sleeve gastrectomy on liver disease, in particular liver fibrosis evaluated in term of NFS score (Non-Alcoholic Fatty Liver Disease Fibrosis score), FIB-4 (Fibrosis-4 Index for Liver Fibrosis) score and Fibroscan transient elastography.

Obesity is a worldwide epidemic, with more than 2 billion people currently overweight and an additional 1.12 billion projected to be overweight by 2030. HCC (hepatocellular carcinoma) associated to obesity and its comorbidity is overcoming Hepatitis C Virus (HCV) related cancer and is already the leading cause of liver transplant in USA. HCC remains the sixth most common cancer in the world and the third cause of cancer-related death. Considering these epidemiological evidence, the incidence of MS-HCC (metabolic syndrome-related hepatocellular carcinoma) is expected to increase with huge cost efforts for the global healthcare system. The impaired performance status of patients with HCC and metabolic syndrome seems to explain high perioperative morbidity rate reported in literature. Literature reports several experiences of bariatric surgery combined to liver transplant for chronic liver disease related induced by non alcoholic steatohepatitis (NASH), performed before or after liver surgery, or even at the same time. Even if evidences are weak, outcomes reported seem to be promising. Since sleeve gastrectomy is not only a mere restrictive bariatric procedure, but it produces hormonal and metabolic changes, with the present study the investigators want to ascertain if sleeve gastrectomy at time of liver resection for MS-HCC (metabolic syndrome-related hepatocellular carcinoma) can modify short perioperative outcomes and long-term oncologic results.

Patients 18 years old and older, affected by hepatocellular carcinoma (HCC) with metabolic syndrome (MS) as unique risk factor, with compensated liver function (Child A) who are deemed suitable for liver resection and comply with the criteria for bariatric surgery, will undergo liver resection of HCC and simultaneous sleeve gastrectomy for morbid obesity during the same surgical procedure.

Patients affected by HCC related to metabolic syndrome who fall within exclusion criteria, will undergo liver resection for HCC without sleeve gastrectomy.

Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)

Liver Resection and Simultaneous Sleeve Gastrectomy for HCC Related to Metabolic Syndrome (LIRESS)

Calculated from the date of diagnosis to the date of death from any cause

Calculated from the date of surgery to the date of recurrence

Any deviation from the normal postoperative course measured on a scale from 0 (no complication) to 100 (death)

Fibrosis-4 Index for Liver Fibrosis score (FIB-4 score) will be calculated using the following formula:

FIB-4 score= Age (years)× aspartate aminotransferase (AST) (U/L)/\[platelet count (109/L)×√alanine aminotransferase (ALT) (U/L)\]

Non-Alcoholic Fatty Liver Disease Fibrosis Score (NFS score) will be calculated using the following formula:

NFS = -1.675 + 0.037 - age (years) + 0.094 - BMI (kg/m2) + 1.13 × impaired fasting glucose/diabetes (yes = 1, no = 0) + 0.99 × aspartate aminotransferase/ alanine aminotransferase (AST/ALT) ratio - 0.013 × platelet count (×109/l) - 0.66 × albumin (g/dl).

The Fibroscan stiffness measurement relies on the propagation of elastic waves to assess the stiffness of the liver: the faster elastic waves propagates within the liver, the stiffer the organ is. The final liver stiffness value is the median of individual liver stiffness values using the valid measurements and is expressed in kilo Pascal (kPa).

Body Mass Index (BMI) is combination of bodyweight and body height and presented as kg/m\^2

Percent excess weight loss (%EWL) is calculated as follows: \[(initial weight - current weight) / (initial weight - ideal weight)\] × 100

Change of antihypertensive therapy assessed by medical history questionnaire

change of insulin therapy or oral hypoglycemics assessed by medical history questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)	NCT06060847	Carcinoma, Hepa... Metabolic Syndr...	Liver resection... Liver resection...	18 Years -	Ospedale V. Fazzi
Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)	NCT06060847	Carcinoma, Hepa... Metabolic Syndr...	Liver resection... Liver resection...	18 Years -	Ospedale V. Fazzi

Spots Global Cancer Trial Database for liver resection for hcc induced by metabolic syndrome