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

ConditionsCarcinoma, HepatocellularMetabolic Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOspedale V. Fazzi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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/Surgery

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Patients affected by HCC induced by metabolic syndrome as unique risk factorExperimental treatment 1 intervention
Group B: Patients with HCC related to metabolic syndrome as unique risk factorActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

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

Time frame
1 year, 3 years, 5 years
2

Recurrence-free Survival

Calculated from the date of surgery to the date of recurrence

Time frame
1 year, 3 years, 5 years
3

90-day mortality

Mortality from any cause

Time frame
90 post-operative days
4

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

1

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
2

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
3

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
4

Body Mass Index

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

Time frame
After 3 months, up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ospedale V. Fazzi

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: