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

NCT06060847 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-12-19

No results posted yet for this study

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.

Conditions

  • Carcinoma, Hepatocellular
  • Metabolic Syndrome

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

Sponsors & Collaborators

  • Ospedale V. Fazzi

    lead OTHER

Principal Investigators

  • Annarita Libia · Ospedale Vito Fazzi, Lecce

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2029-03-06
Completion
2032-03-06

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06060847 on ClinicalTrials.gov