Bariatric Embolization of Arteries in Obese Patients With HCC to Allow Salvage Liver Transplantation

Trial details

Who runs it

St. Louis University

Trial code

NCT02935478

Record updated

6 February 2025

Original description

Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumor and has a grave prognosis. Obesity is an epidemic in the US.Patients with HCC and obesity are not candidates for liver transplantation, depriving them of the best option for cure from HCC.Read full original descriptionShow less

A Single Center, Non-randomized Study to Evaluate the Safety and Efficacy of Left Gastric Artery Embolization in Obese Patients With Hepatocellular Carcinoma to Achieve Appropriate Weight Loss That May Allow Them to be Transplanted

Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumor and has a grave prognosis. Obesity is an epidemic in the US.Patients with HCC and obesity are not candidates for liver transplantation, depriving them of the best option for cure from HCC.

Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with cirrhosis and HCC who are not transplant candidates due to morbid obesity, leads to clinically significant weight loss with eligibility for liver transplantation.

Inclusion: Male or Female, aged 18 years or older; Willing, able and mentally competent to provide written informed consent and willing to comply with all study procedures and be available for the duration of the study; BMI >35 kg/m2; Adequate hematological, hepatic and renal function as follows:; Hematological: Platelets > 50 x 109/L, INR <1.5; Hepatic : Total bilirubin <3 mg/dL; Renal: Estimated GFR > 60ml/min.1.73m2; Clinical, laboratory and radiographic evidence (ultrasound/ CT/MRI) of cirrhosis of any etiology with portal hypertension and concomitant HCC (treated or untreated); Besides a BMI >35 kg/m2, otherwise eligible for liver transplantation; Suitable for protocol therapy as determined by the interventional radiology Investigator.

Exclusion: prior surgical weight loss procedures including gastroplasty, jejunoileal, or jejunocolic bypass, total parenteral nutrition within the past 6 months; Prior history of gastric pancreatic, hepatic, and/or splenic surgery; Prior embolization to the stomach, spleen or liver; If review of available prior imaging studies (i.e. CT, MRI, or US) shows potential anatomical variations, presence of severe atheromatous disease, large arteriovenous shunting of blood; Significant psychiatric problems, severe enough to cause suffering or a poor ability to function in life. Center for Epidemiological Studies Depression (CESD) score < 16; Presence of systemic illness or other medical conditions relevant to survival .(Note that the presence of HCC will not be considered an exclusion criteria); Metastatic cancer; Evidence of decompensated liver disease (uncontrolled ascites, or uncontrolled spontaneous encephalopathy); Abnormal Endoscopy - large sliding hiatal hernia or paraesophageal hernia, active peptic ulcer disease, active H. pylori infection; History of abnormal Nuclear Gastric Motility examination-defined as delayed emptying of gastric contents > 90%, 60% and 10% at 1 hour, 2 hours, and 4 hours respectively; Pregnancy; Active substance abuse; Significant alcohol consumption ( >20 g/day in women, >30 g/day in men); Weight > 400 lbs; ASA Class 4 or 5; Child Pugh classification C.

ClinicalTrials.gov NCT02935478