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NOT YET RECRUITING
NCT06060847
NA

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

Sponsor: Ospedale V. Fazzi

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-03-06

Completion Date

2032-03-06

Last Updated

2023-12-19

Healthy Volunteers

No

Interventions

PROCEDURE

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

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

PROCEDURE

Liver resection for HCC induced by metabolic syndrome

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

Locations (1)

Ospedale Vito Fazzi

Lecce, Italy