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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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
Show all 10Show fewer
  • 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:
Show all 11Show fewer
  • 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.

Annarita Libia contact

0039 0833335284

libiamd@me.com

Annarita Libia contact

0039 0833335285

libiamd@me.com

Italy1 site

  • Ospedale Vito Fazzi

    Lecce, 73100

    Annarita Libia, 0039 083333524, libiamd@me.com

    Annarita Libia

Other trials in Italy

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.

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 groups in NCT06060847
Study groupRoleWhat they receive
Patients affected by HCC induced by metabolic syndrome as unique risk factorExperimentalPatients 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 factorActive comparatorPatients 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.

  1. Overall Survival

    Calculated from the date of diagnosis to the date of death from any cause

    Measured: 1 year, 3 years, 5 years

  2. Recurrence-free Survival

    Calculated from the date of surgery to the date of recurrence

    Measured: 1 year, 3 years, 5 years

  3. 90-day mortality

    Mortality from any cause

    Measured: 90 post-operative days

  4. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. Weight loss

    Weight loss expressed in Kg

    Measured: After 3 months, up to 5 years

  6. 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

  7. Control of obesity-induced hypertension

    Change of antihypertensive therapy assessed by medical history questionnaire

    Measured: After 3 months, up to 5 years

  8. 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.

  1. First posted29 Sep 2023
  2. Study start6 Mar 2024 (estimated)
  3. Primary completion6 Mar 2029 (estimated)
  4. Study completion6 Mar 2032 (estimated)

Resources

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)
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 30617773

  • Cauchy 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 23147992

  • de 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 34118015

  • Hobeika 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Annarita Libia (0039 0833335284, libiamd@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 1 year, 3 years, 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06060847, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.

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