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

Primary Purpose

Carcinoma, Hepatocellular, Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome
Liver resection for HCC induced by metabolic syndrome
Sponsored by
Ospedale V. Fazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring hepatocellular carcinoma, sleeve gastrectomy, morbid obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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: 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: 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

Sites / Locations

  • Ospedale Vito FazziRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients affected by HCC induced by metabolic syndrome as unique risk factor

Patients with HCC related to metabolic syndrome as unique risk factor

Arm 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

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

Outcomes

Primary Outcome Measures

Overall Survival
Calculated from the date of diagnosis to the date of death from any cause
Recurrence-free Survival
Calculated from the date of surgery to the date of recurrence
90-day mortality
Mortality from any cause
Comprehensive Complication Index
Any deviation from the normal postoperative course measured on a scale from 0 (no complication) to 100 (death)

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2023
Last Updated
September 23, 2023
Sponsor
Ospedale V. Fazzi
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1. Study Identification

Unique Protocol Identification Number
NCT06060847
Brief Title
Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)
Acronym
LIRESS
Official Title
Liver Resection and Simultaneous Sleeve Gastrectomy for HCC Related to Metabolic Syndrome (LIRESS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
September 6, 2028 (Anticipated)
Study Completion Date
September 6, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale V. Fazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular, Metabolic Syndrome
Keywords
hepatocellular carcinoma, sleeve gastrectomy, morbid obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients affected by HCC induced by metabolic syndrome as unique risk factor
Arm Type
Experimental
Arm 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
Arm Title
Patients with HCC related to metabolic syndrome as unique risk factor
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome
Intervention Description
Patients in the experimental arm will undergo liver resection for HCC and sleeve gastrectomy for MS during the same surgical procedure.
Intervention Type
Procedure
Intervention Name(s)
Liver resection for HCC induced by metabolic syndrome
Intervention Description
Patients in the active comparator arm will undergo liver resection for HCC
Primary Outcome Measure Information:
Title
Overall Survival
Description
Calculated from the date of diagnosis to the date of death from any cause
Time Frame
1 year, 3 years, 5 years
Title
Recurrence-free Survival
Description
Calculated from the date of surgery to the date of recurrence
Time Frame
1 year, 3 years, 5 years
Title
90-day mortality
Description
Mortality from any cause
Time Frame
90 post-operative days
Title
Comprehensive Complication Index
Description
Any deviation from the normal postoperative course measured on a scale from 0 (no complication) to 100 (death)
Time Frame
90 post-operative days
Secondary Outcome Measure Information:
Title
Fibrosis-4 Index for Liver Fibrosis score
Description
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)]
Time Frame
After 6 months, up to 5 years
Title
Non-Alcoholic Fatty Liver Disease Fibrosis Score
Description
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).
Time Frame
After 6 months, up to 5 years
Title
Fibroscan stiffness
Description
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).
Time Frame
After 6 months, up to 5 years
Title
Body Mass Index
Description
Body Mass Index (BMI) is combination of bodyweight and body height and presented as kg/m^2
Time Frame
After 3 months, up to 5 years
Title
Weight loss
Description
Weight loss expressed in Kg
Time Frame
After 3 months, up to 5 years
Title
Percent excess weight loss
Description
Percent excess weight loss (%EWL) is calculated as follows: [(initial weight - current weight) / (initial weight - ideal weight)] × 100
Time Frame
After 3 months, up to 5 years
Title
Control of obesity-induced hypertension
Description
Change of antihypertensive therapy assessed by medical history questionnaire
Time Frame
After 3 months, up to 5 years
Title
Control of obesity-induced comorbidities
Description
change of insulin therapy or oral hypoglycemics assessed by medical history questionnaire
Time Frame
After 3 months, up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annarita Libia
Phone
0039 0833335284
Email
libiamd@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Annarita Libia
Phone
0039 0833335285
Email
libiamd@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annarita Libia
Organizational Affiliation
Ospedale Vito Fazzi, Lecce
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Vito Fazzi
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annarita Libia
Phone
0039 083333524
Email
libiamd@me.com
First Name & Middle Initial & Last Name & Degree
Annarita Libia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30617773
Citation
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.
Results Reference
background
PubMed Identifier
23147992
Citation
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.
Results Reference
background
PubMed Identifier
34118015
Citation
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.
Results Reference
background
PubMed Identifier
31866269
Citation
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.
Results Reference
background

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

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