NCT06060847Not yet recruiting
Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)
Liver Resection and Simultaneous Sleeve Gastrectomy for HCC Related to Metabolic Syndrome (LIRESS)
Source: ClinicalTrials.gov · Last updated 19 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 8 Sept 2023
- Start date
- 6 Mar 2024
- Primary completion date
- 6 Mar 2029
- Lead sponsor
- Ospedale V. Fazzi
- Diseases
- Obesity, Liver and biliary tract cancer
- NCT number
- NCT06060847
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 6 Mar 2024 to the primary completion date, 6 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have hepatocellular carcinoma related to other etiology, even in case of coexisting metabolic syndrome
- 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
Other
- Denial of the patient to undergo bariatric procedure
- Have BMI \< 30
- Have negative opinion of psychologic consultant
- Have an overall Child-Pugh score \> 7
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale Vito Fazzi Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.