Liver Resection and Simultaneous Sleeve Gastrectomy for HCC Related to Metabolic Syndrome (LIRESS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recurrence-free Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Recurrence-free Survival
时间窗: 1 year, 3 years, 5 years
Calculated from the date of surgery to the date of recurrence
Comprehensive Complication Index
时间窗: 90 post-operative days
Any deviation from the normal postoperative course measured on a scale from 0 (no complication) to 100 (death)
90-day mortality
时间窗: 90 post-operative days
Mortality from any cause
Overall Survival
时间窗: 1 year, 3 years, 5 years
Calculated from the date of diagnosis to the date of death from any cause
次要结局
- Control of obesity-induced comorbidities(After 3 months, up to 5 years)
- Percent excess weight loss(After 3 months, up to 5 years)
- Fibrosis-4 Index for Liver Fibrosis score(After 6 months, up to 5 years)
- Control of obesity-induced hypertension(After 3 months, up to 5 years)
- Fibroscan stiffness(After 6 months, up to 5 years)
- Weight loss(After 3 months, up to 5 years)
- Non-Alcoholic Fatty Liver Disease Fibrosis Score(After 6 months, up to 5 years)
- Body Mass Index(After 3 months, up to 5 years)
研究者
Annarita Libia
Doctor
Ospedale V. Fazzi