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

Ospedale V. Fazzi

Status: Not yet enrolling

Conditions: Carcinoma, Hepatocellular; Metabolic Syndrome

Treatments: Procedure: Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome; Procedure: Liver resection for HCC induced by metabolic syndrome

Study type: Interventional

Funder types: Other

Identifiers

NCT06060847

3/2023

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Patients affected by HCC induced by metabolic syndrome as unique risk factor

Experimental group

Description:

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

Treatment:

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

Patients with HCC related to metabolic syndrome as unique risk factor

Active Comparator group

Description:

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

Treatment:

Procedure: Liver resection for HCC induced by metabolic syndrome