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

NCT02935478 | Suspended DMC FDA Device

• 1 other identifier: 27420- HCC
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Weight Loss; Body Weight; Hepatocellular Carcinoma; HCC; Hepatitis C; Cirrhosis

Keywords

bariatric surgery; minimally invasive; Embolization; ghrelin; gastric artery embolization

Outcome Measures

Primary Outcomes (1)

• Weight

  Total body weight loss \> 10 % in 12 months

  12 months

Secondary Outcomes (9)

• Clinical parameter- Abdominal circumference

  12 months

• Clinical parameter-Blood pressure

  12 months

• Laboratory parameter-Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY)

  12 months

• Laboratory parameter-serum glucose

  12 months

• Laboratory parameters- HbA1c

  12 months

Study Arms (1)

HCC-Left gastric artery embolization

EXPERIMENTAL

Embospheres Microspheres as artificial embolic agent for left gastric artery embolization

Device: Embospheres Microspheres

Interventions

Embospheres Microspheres DEVICE

Via a radial artery in the wrist or the femoral artery in the groin, arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery of the stomach (left gastric artery). A CT scan will be performed on the X ray table to confirm the placement of catheter. Once this is confirmed small micro spherical particles (Embosphere Microspheres beads) will be injected though the catheter to occlude the artery and cut off blood supply to the stomach. Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry

Also known as: Bariatric embolization

HCC-Left gastric artery embolization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Active substance abuse
• Significant psychiatric problems, severe enough to cause suffering or a poor ability to function in life. Center for Epidemiological Studies Depression (CESD) score \< 16.
• Significant alcohol consumption ( \>20 g/day in women, \>30 g/day in men)
• Weight \> 400 lbs.
• Metastatic cancer
• Evidence of decompensated liver disease (uncontrolled ascites, or uncontrolled spontaneous encephalopathy)
• 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.
• 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.
• ASA Class 4 or 5
• Child Pugh classification C

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Related Publications (13)

• Arepally A, Barnett BP, Montgomery E, Patel TH. Catheter-directed gastric artery chemical embolization for modulation of systemic ghrelin levels in a porcine model: initial experience. Radiology. 2007 Jul;244(1):138-43. doi: 10.1148/radiol.2441060790.

  PMID: 17581899 BACKGROUND

• Arepally A, Barnett BP, Patel TH, Howland V, Boston RC, Kraitchman DL, Malayeri AA. Catheter-directed gastric artery chemical embolization suppresses systemic ghrelin levels in porcine model. Radiology. 2008 Oct;249(1):127-33. doi: 10.1148/radiol.2491071232.

  PMID: 18796671 BACKGROUND

• Bawudun D, Xing Y, Liu WY, Huang YJ, Ren WX, Ma M, Xu XD, Teng GJ. Ghrelin suppression and fat loss after left gastric artery embolization in canine model. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1460-6. doi: 10.1007/s00270-012-0362-8. Epub 2012 Feb 25.

  PMID: 22367009 BACKGROUND

• Paxton BE, Alley CL, Crow JH, Burchette J, Weiss CR, Kraitchman DL, Arepally A, Kim CY. Histopathologic and immunohistochemical sequelae of bariatric embolization in a porcine model. J Vasc Interv Radiol. 2014 Mar;25(3):455-61. doi: 10.1016/j.jvir.2013.09.016. Epub 2014 Jan 21.

  PMID: 24462005 BACKGROUND

• Kipshidze N, Archvadze A, Bertog S, Leon MB, Sievert H. Endovascular Bariatrics: First in Humans Study of Gastric Artery Embolization for Weight Loss. JACC Cardiovasc Interv. 2015 Oct;8(12):1641-4. doi: 10.1016/j.jcin.2015.07.016. No abstract available.

  PMID: 26493259 BACKGROUND

• Syed MI, Morar K, Shaikh A, Craig P, Khan O, Patel S, Khabiri H. Gastric Artery Embolization Trial for the Lessening of Appetite Nonsurgically (GET LEAN): Six-Month Preliminary Data. J Vasc Interv Radiol. 2016 Oct;27(10):1502-8. doi: 10.1016/j.jvir.2016.07.010. Epub 2016 Aug 24.

  PMID: 27567998 BACKGROUND

• Gunn AJ, Oklu R. A preliminary observation of weight loss following left gastric artery embolization in humans. J Obes. 2014;2014:185349. doi: 10.1155/2014/185349. Epub 2014 Sep 30.

  PMID: 25349724 BACKGROUND

• Salsamendi J, Pereira K, Kang K, Fan J. Minimally invasive percutaneous endovascular therapies in the management of complications of non-alcoholic fatty liver disease (NAFLD): A case report. J Radiol Case Rep. 2015 Sep 30;9(9):36-43. doi: 10.3941/jrcr.v9i9.2557. eCollection 2015 Sep.

  PMID: 26629307 BACKGROUND

• Olshansky SJ, Passaro DJ, Hershow RC, Layden J, Carnes BA, Brody J, Hayflick L, Butler RN, Allison DB, Ludwig DS. A potential decline in life expectancy in the United States in the 21st century. N Engl J Med. 2005 Mar 17;352(11):1138-45. doi: 10.1056/NEJMsr043743.

  PMID: 15784668 RESULT

• Chavez-Tapia NC, Tellez-Avila FI, Barrientos-Gutierrez T, Mendez-Sanchez N, Lizardi-Cervera J, Uribe M. Bariatric surgery for non-alcoholic steatohepatitis in obese patients. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD007340. doi: 10.1002/14651858.CD007340.pub2.

  PMID: 20091629 RESULT

• Hanusch-Enserer U, Brabant G, Roden M. Ghrelin concentrations in morbidly obese patients after adjustable gastric banding. N Engl J Med. 2003 May 22;348(21):2159-60. doi: 10.1056/NEJM200305223482125. No abstract available.

  PMID: 12761382 RESULT

• Mosko JD, Nguyen GC. Increased perioperative mortality following bariatric surgery among patients with cirrhosis. Clin Gastroenterol Hepatol. 2011 Oct;9(10):897-901. doi: 10.1016/j.cgh.2011.07.007. Epub 2011 Jul 23.

  PMID: 21782772 RESULT

• Lassailly G, Caiazzo R, Pattou F, Mathurin P. Bariatric surgery for curing NASH in the morbidly obese? J Hepatol. 2013 Jun;58(6):1249-51. doi: 10.1016/j.jhep.2012.12.026. Epub 2013 Jan 15. No abstract available.

  PMID: 23333451 RESULT

MeSH Terms

Conditions

Obesity; Weight Loss; Body Weight; Carcinoma, Hepatocellular; Hepatitis C; Fibrosis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Pathologic Processes

Study Officials

• Keith Pereira, MD

  Assistant professor of radiology-Interventional radiology

  PRINCIPAL INVESTIGATOR

• Kirubahara Vaheesan, MD

  Associate professor of radiology-Interventional radiology

  PRINCIPAL INVESTIGATOR

• Alex Befeler, MD

  Professor of internal medicine- Gastreoenterology

  PRINCIPAL INVESTIGATOR

• Mustafa Nazzal, MD

  Assistant Professor of Surgery- abdominal transplant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 17, 2016
• Study Start: October 18, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)