Carcinoma, HepatocellularLIRESSNCT06060847
Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)
A study testing Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome and Liver resection for HCC induced by metabolic syndrome in people with Carcinoma, Hepatocellular and Metabolic Syndrome, run by Ospedale V. Fazzi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Metabolic Syndrome
- What is being tested?
- Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome and Liver resection for HCC induced by metabolic syndrome
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2024to 6 Mar 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Be eligible for liver resection with laparoscopic or robotic technique
- Be eligible for bariatric surgery as defined below
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- 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.
Who cannot join
- 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
- Have an overall Child-Pugh score > 7
- Evidence of clinical significant portal hypertension as followed:
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Ospedale Vito Fazzi
Lecce, 73100
Annarita Libia, 0039 083333524, libiamd@me.com
Annarita Libia
About this study
Official title: Liver Resection and Simultaneous Sleeve Gastrectomy for HCC Related to Metabolic Syndrome (LIRESS)
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.
Read the detailed description
Obesity is a worldwide epidemic, with more than 2 billion people currently overweight and an additional 1.12 billion projected to be overweight by 2030. HCC (hepatocellular carcinoma) associated to obesity and its comorbidity is overcoming Hepatitis C Virus (HCV) related cancer and is already the leading cause of liver transplant in USA. HCC remains the sixth most common cancer in the world and the third cause of cancer-related death. Considering these epidemiological evidence, the incidence of MS-HCC (metabolic syndrome-related hepatocellular carcinoma) is expected to increase with huge cost efforts for the global healthcare system. The impaired performance status of patients with HCC and metabolic syndrome seems to explain high perioperative morbidity rate reported in literature. Literature reports several experiences of bariatric surgery combined to liver transplant for chronic liver disease related induced by non alcoholic steatohepatitis (NASH), performed before or after liver surgery, or even at the same time. Even if evidences are weak, outcomes reported seem to be promising. Since sleeve gastrectomy is not only a mere restrictive bariatric procedure, but it produces hormonal and metabolic changes, with the present study the investigators want to ascertain if sleeve gastrectomy at time of liver resection for MS-HCC (metabolic syndrome-related hepatocellular carcinoma) can modify short perioperative outcomes and long-term oncologic results.
- Conditions
- Carcinoma, Hepatocellular, Metabolic Syndrome
- Being tested
- Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome, Liver resection for HCC induced by metabolic syndrome
- Keywords
- hepatocellular carcinoma, sleeve gastrectomy, morbid obesity
- Medical subject headings
- Carcinoma, Hepatocellular, Metabolic Syndrome, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndromeProcedure or surgery
Patients in the experimental arm will undergo liver resection for HCC and sleeve gastrectomy for MS during the same surgical procedure.
Liver resection for HCC induced by metabolic syndromeProcedure or surgery
Patients in the active comparator arm will undergo liver resection for HCC
| Study group | Role | What they receive |
|---|---|---|
| Patients affected by HCC induced by metabolic syndrome as unique risk factor | Experimental | 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 Receives: Procedure: Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome |
| Patients with HCC related to metabolic syndrome as unique risk factor | Active comparator | 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 Receives: Procedure: Liver resection for HCC induced by metabolic syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Calculated from the date of diagnosis to the date of death from any cause
Measured: 1 year, 3 years, 5 years
Recurrence-free Survival
Calculated from the date of surgery to the date of recurrence
Measured: 1 year, 3 years, 5 years
90-day mortality
Mortality from any cause
Measured: 90 post-operative days
Comprehensive Complication Index
Any deviation from the normal postoperative course measured on a scale from 0 (no complication) to 100 (death)
Measured: 90 post-operative days
Secondary outcomes (8)
Fibrosis-4 Index for Liver Fibrosis score
Fibrosis-4 Index for Liver Fibrosis score (FIB-4 score) will be calculated using the following formula:
FIB-4 score= Age (years)× aspartate aminotransferase (AST) (U/L)/[platelet count (109/L)×√alanine aminotransferase (ALT) (U/L)]
Measured: After 6 months, up to 5 years
Non-Alcoholic Fatty Liver Disease Fibrosis Score
Non-Alcoholic Fatty Liver Disease Fibrosis Score (NFS score) will be calculated using the following formula:
NFS = -1.675 + 0.037 - age (years) + 0.094 - BMI (kg/m2) + 1.13 × impaired fasting glucose/diabetes (yes = 1, no = 0) + 0.99 × aspartate aminotransferase/ alanine aminotransferase (AST/ALT) ratio - 0.013 × platelet count (×109/l) - 0.66 × albumin (g/dl).
Measured: After 6 months, up to 5 years
Fibroscan stiffness
The Fibroscan stiffness measurement relies on the propagation of elastic waves to assess the stiffness of the liver: the faster elastic waves propagates within the liver, the stiffer the organ is. The final liver stiffness value is the median of individual liver stiffness values using the valid measurements and is expressed in kilo Pascal (kPa).
Measured: After 6 months, up to 5 years
Body Mass Index
Body Mass Index (BMI) is combination of bodyweight and body height and presented as kg/m^2
Measured: After 3 months, up to 5 years
Weight loss
Weight loss expressed in Kg
Measured: After 3 months, up to 5 years
Percent excess weight loss
Percent excess weight loss (%EWL) is calculated as follows: [(initial weight - current weight) / (initial weight - ideal weight)] × 100
Measured: After 3 months, up to 5 years
Control of obesity-induced hypertension
Change of antihypertensive therapy assessed by medical history questionnaire
Measured: After 3 months, up to 5 years
Control of obesity-induced comorbidities
change of insulin therapy or oral hypoglycemics assessed by medical history questionnaire
Measured: After 3 months, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start6 Mar 2024 (estimated)
- Primary completion6 Mar 2029 (estimated)
- Study completion6 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients 18 years old and older, affected by hepatocellular carcinoma (HCC) with metabolic syndrome (MS) as unique risk factor, with compensated liver function (Child A) who are deemed suitable for liver resection and comply with the criteria for bariatric surgery, will undergo liver resection of HCC and simultaneous sleeve gastrectomy for morbid obesity during the same surgical procedure. Patients affected by HCC related to metabolic syndrome who fall within exclusion criteria, will undergo liver resection for HCC without sleeve gastrectomy.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale V. Fazzi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annarita Libia, Ospedale V. Fazzi
- Investigators
- Annarita Libia, Principal investigator, Ospedale Vito Fazzi, Lecce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060847
- Sponsor's protocol ID
- 3/2023
- Acronym
- LIRESS
- Status last verified
- Dec 2023
- First submitted
- 8 Sep 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang 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.
PubMed 30617773Cauchy 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.
PubMed 23147992de 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.
PubMed 34118015Hobeika 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.
PubMed 31866269