Status:
NOT_YET_RECRUITING
Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)
Lead Sponsor:
Ospedale V. Fazzi
Conditions:
Carcinoma, Hepatocellular
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 surge...
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 ob...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 6 2032
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06060847
Start Date
March 6 2024
End Date
March 6 2032
Last Update
December 19 2023
Active Locations (1)
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1
Ospedale Vito Fazzi
Lecce, Italy, 73100