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

December 18, 2023 updated by: Annarita Libia, Ospedale V. Fazzi

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Annarita Libia
  • Phone Number: 0039 0833335284
  • Email: libiamd@me.com

Study Contact Backup

  • Name: Annarita Libia
  • Phone Number: 0039 0833335285
  • Email: libiamd@me.com

Study Locations

  • Italy
      • Lecce, Italy, 73100
        • Ospedale Vito Fazzi
        • Contact:
        • Principal Investigator:
          • Annarita Libia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients affected by HCC induced by metabolic syndrome as unique risk factor
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
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.
Active Comparator: Patients with HCC related to metabolic syndrome as unique risk factor
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
Procedure: Liver resection for HCC induced by metabolic syndrome
Patients in the active comparator arm will undergo liver resection for HCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 1 year, 3 years, 5 years
Calculated from the date of diagnosis to the date of death from any cause
1 year, 3 years, 5 years
Recurrence-free Survival
Time Frame: 1 year, 3 years, 5 years
Calculated from the date of surgery to the date of recurrence
1 year, 3 years, 5 years
90-day mortality
Time Frame: 90 post-operative days
Mortality from any cause
90 post-operative days
Comprehensive Complication Index
Time Frame: 90 post-operative days
Any deviation from the normal postoperative course measured on a scale from 0 (no complication) to 100 (death)
90 post-operative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibrosis-4 Index for Liver Fibrosis score
Time Frame: After 6 months, up to 5 years

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)]
After 6 months, up to 5 years
Non-Alcoholic Fatty Liver Disease Fibrosis Score
Time Frame: After 6 months, up to 5 years

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).
After 6 months, up to 5 years
Fibroscan stiffness
Time Frame: After 6 months, up to 5 years
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).
After 6 months, up to 5 years
Body Mass Index
Time Frame: After 3 months, up to 5 years
Body Mass Index (BMI) is combination of bodyweight and body height and presented as kg/m^2
After 3 months, up to 5 years
Weight loss
Time Frame: After 3 months, up to 5 years
Weight loss expressed in Kg
After 3 months, up to 5 years
Percent excess weight loss
Time Frame: After 3 months, up to 5 years
Percent excess weight loss (%EWL) is calculated as follows: [(initial weight - current weight) / (initial weight - ideal weight)] × 100
After 3 months, up to 5 years
Control of obesity-induced hypertension
Time Frame: After 3 months, up to 5 years
Change of antihypertensive therapy assessed by medical history questionnaire
After 3 months, up to 5 years
Control of obesity-induced comorbidities
Time Frame: After 3 months, up to 5 years
change of insulin therapy or oral hypoglycemics assessed by medical history questionnaire
After 3 months, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale V. Fazzi

Investigators

  • Principal Investigator: Annarita Libia, Ospedale Vito Fazzi, Lecce

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 6, 2024

Primary Completion (Estimated)

March 6, 2029

Study Completion (Estimated)

March 6, 2032

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 23, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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