Clinical trial · Interventional
Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)
Liver Resection and Simultaneous Sleeve Gastrectomy for HCC Related to Metabolic Syndrome (LIRESS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Metabolic Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome | Procedure | — | UNRESOLVED |
| Liver resection for HCC induced by metabolic syndrome | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients affected by HCC induced by metabolic syndrome as unique risk factor
- description
- Patients aged 18 years old and older, affected by HCC with MS (metabolic syndrome) as unique risk factor who comply with the criteria for bariatric surgery, will undergo liver resection and sleeve gastrectomy with minimally-invasive technique in the same surgical procedure
- interventionNames
- Procedure: Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome
- type
- ACTIVE_COMPARATOR
- label
- Patients with HCC related to metabolic syndrome as unique risk factor
- description
- Patients aged 18 years old and older, affected by HCC (hepatocellular carcinoma) with MS (metabolic syndrome) as unique risk factor who will undergo liver resection only
- interventionNames
- Procedure: Liver resection for HCC induced by metabolic syndrome
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be willing and able to provide written informed consent/assent for the trial 2. Be ≥ 18 years of age on day of signing informed consent. 3. Have hepatocellular carcinoma with metabolic syndrome as unique risk factor 4. Have an overall Child-Pugh score = A 5. Be eligible for liver resection with laparoscopic or robotic technique 6. Be eligible for bariatric surgery as defined below * BMI ≥ 40 kg/m2 * BMI ≥ 35-40 kg/m2 with associated comorbidities * BMI 30-35 kg/m2 and type 2 diabetes * BMI 30-35 kg/m2 and arterial hypertension with poor control despite optimal medical therapy. Exclusion Criteria: 1. Have hepatocellular carcinoma related to other etiology, even in case of coexisting metabolic syndrome 2. Denial of the patient to undergo bariatric procedure 3. Have BMI \< 30 4. Have negative opinion of psychologic consultant 5. Have an overall Child-Pugh score \> 7 6. Evidence of clinical significant portal hypertension as followed: * esophageal varices * gastric varices * portal hypertensive gastropathy * gastric vascular ectasia Of note: 1) Conversion to open surgery for any reason does not represent a reason of data exclusion from the analysis; 2) any type of hepatic resection, according to Brisbane classification, is included, also major hepatectomy requiring preoperative intervention to achieve adequate volume remnant
References
Publications (4)
- BACKGROUNDYang T, Hu LY, Li ZL, Liu K, Wu H, Xing H, Lau WY, Pawlik TM, Zeng YY, Zhou YH, Gu WM, Wang H, Chen TH, Han J, Li C, Wang MD, Wu MC, Shen F. Liver Resection for Hepatocellular Carcinoma in Non-alcoholic Fatty Liver Disease: a Multicenter Propensity Matching Analysis with HBV-HCC. J Gastrointest Surg. 2020 Feb;24(2):320-329. doi: 10.1007/s11605-018-04071-2. Epub 2019 Jan 7. PMID 30617773
- BACKGROUNDCauchy F, Zalinski S, Dokmak S, Fuks D, Farges O, Castera L, Paradis V, Belghiti J. Surgical treatment of hepatocellular carcinoma associated with the metabolic syndrome. Br J Surg. 2013 Jan;100(1):113-21. doi: 10.1002/bjs.8963. Epub 2012 Nov 12. PMID 23147992
- BACKGROUNDde Barros F, Cardoso Faleiro Uba PH. Liver transplantation and bariatric surgery: a new surgical reality: a systematic review of the best time for bariatric surgery. Updates Surg. 2021 Oct;73(5):1615-1622. doi: 10.1007/s13304-021-01106-3. Epub 2021 Jun 12. PMID 34118015
- BACKGROUNDHobeika C, Ronot M, Beaufrere A, Paradis V, Soubrane O, Cauchy F. Metabolic syndrome and hepatic surgery. J Visc Surg. 2020 Jun;157(3):231-238. doi: 10.1016/j.jviscsurg.2019.11.004. Epub 2019 Dec 19. PMID 31866269