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NCT Number: NCT06060847

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Liver resection for HCC induced by metabolic syndrome

Procedure

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

Primary outcomes

  1. Overall Survival

    Time frame: 1 year, 3 years, 5 years

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

  2. Recurrence-free Survival

    Time frame: 1 year, 3 years, 5 years

    Calculated from the date of surgery to the date of recurrence

  3. 90-day mortality

    Time frame: 90 post-operative days

    Mortality from any cause

  4. Comprehensive Complication Index

    Time frame: 90 post-operative days

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

Secondary outcomes

  1. Fibrosis-4 Index for Liver Fibrosis score

    Time frame: After 6 months, up to 5 years

    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)]

  2. Non-Alcoholic Fatty Liver Disease Fibrosis Score

    Time frame: After 6 months, up to 5 years

    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).

  3. Fibroscan stiffness

    Time frame: After 6 months, up to 5 years

    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).

  4. Body Mass Index

    Time frame: After 3 months, up to 5 years

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

  5. Weight loss

    Time frame: After 3 months, up to 5 years

    Weight loss expressed in Kg

  6. Percent excess weight loss

    Time frame: After 3 months, up to 5 years

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

  7. Control of obesity-induced hypertension

    Time frame: After 3 months, up to 5 years

    Change of antihypertensive therapy assessed by medical history questionnaire

  8. Control of obesity-induced comorbidities

    Time frame: After 3 months, up to 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Annarita Libia

CONTACT

[email protected]

0039 0833335284

Annarita Libia

CONTACT

[email protected]

0039 0833335285

Sponsors and collaborators

Lead sponsor

Ospedale V. Fazzi

Other

Registry information

Official study title

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

Acronym: LIRESS

Important dates

Study start
2024
Primary completion
2029
Study completion
2032
First posted
Sep 29, 2023
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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