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

Официальное название

Liver Resection and Simultaneous Sleeve Gastrectomy for HCC Related to Metabolic Syndrome (LIRESS)

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура Liver resection for HCC induced by metabolic syndrome
  Patients in the active comparator arm will undergo liver resection for HCC

Первичные конечные точки

• Overall Survival [Срок оценки: 1 year, 3 years, 5 years]
• Recurrence-free Survival [Срок оценки: 1 year, 3 years, 5 years]
• 90-day mortality [Срок оценки: 90 post-operative days]
• Comprehensive Complication Index [Срок оценки: 90 post-operative days]

Вторичные конечные точки (8)

• Fibrosis-4 Index for Liver Fibrosis score [Срок оценки: After 6 months, up to 5 years]
• Non-Alcoholic Fatty Liver Disease Fibrosis Score [Срок оценки: After 6 months, up to 5 years]
• Fibroscan stiffness [Срок оценки: After 6 months, up to 5 years]
• Body Mass Index [Срок оценки: After 3 months, up to 5 years]
• Weight loss [Срок оценки: After 3 months, up to 5 years]
• Percent excess weight loss [Срок оценки: After 3 months, up to 5 years]
• Control of obesity-induced hypertension [Срок оценки: After 3 months, up to 5 years]
• Control of obesity-induced comorbidities [Срок оценки: After 3 months, up to 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Ospedale Vito Fazzi — Lecce

Публикации

• 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. PMID 30617773
• 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. PMID 23147992
• 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. PMID 34118015
• 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. PMID 31866269

Идентификаторы

NCT: NCT06060847 · 3/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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