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

N/ANot Yet RecruitingNCT06060847

Ospedale V. Fazzi50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be willing and able to provide written informed consent/assent for the trial 2. Be ≥ 18 years of age on day of signing informed consent. 3. Have hepatocellular carcinoma with metabolic syndrome as unique risk factor 4. Have an overall Child-Pugh score = A 5. Be eligible for liver resection with laparoscopic or robotic technique 6. 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: 1. Have hepatocellular carcinoma related to other etiology, even in case of coexisting metabolic syndrome 2. Denial of the patient to undergo bariatric procedure 3. Have BMI \< 30 4. Have negative opinion of psychologic consultant 5. Have an overall Child-Pugh score \> 7 6. 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

Outcomes

Primary Outcomes

Overall Survival

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

Time frame: 1 year, 3 years, 5 years

Recurrence-free Survival

Calculated from the date of surgery to the date of recurrence

Time frame: 1 year, 3 years, 5 years

90-day mortality

Mortality from any cause

Time frame: 90 post-operative days

Comprehensive Complication Index

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

Time frame: 90 post-operative days

Secondary Outcomes

Fibrosis-4 Index for Liver Fibrosis score

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)/\[platelet count (109/L)×√alanine aminotransferase (ALT) (U/L)\]

Time frame: After 6 months, up to 5 years

Non-Alcoholic Fatty Liver Disease Fibrosis Score

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).

Time frame: After 6 months, up to 5 years

Fibroscan stiffness

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).

Time frame: After 6 months, up to 5 years

Body Mass Index

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