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NCT06060847: LIRESS
Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)
NA trial testing Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome in Carcinoma, Hepatocellular in 50 participants. Not yet recruiting.
6 March 2029
Quick facts
| Lead sponsor | Ospedale V. Fazzi |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 6 March 2024 |
| Primary completion | 6 March 2029 |
| Estimated completion | 6 March 2032 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome
- Liver resection for HCC induced by metabolic syndrome
Conditions studied
- Carcinoma, Hepatocellular — all drugs for Carcinoma, Hepatocellular →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
Sponsor
Ospedale V. Fazzi — full company profile →
Who can join
18 and older, any sex, with Carcinoma, Hepatocellular or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06060847
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06060847 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ospedale V. Fazzi
- Last refreshed: 19 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06060847.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing