Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)
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
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
Treatments tested in this trial
- Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome
- Liver resection for HCC induced by metabolic syndrome
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov