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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
Sponsor study identifier
interventional
8
1 country
1
Study Start
October 18, 2017
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2016
Actual (reported)October 17, 2016
Actual (reported)October 18, 2017
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Weight
Total body weight loss \> 10 % in 12 months
12 months
Clinical parameter- Abdominal circumference
12 months
Clinical parameter-Blood pressure
12 months
Laboratory parameter-Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY)
Embospheres Microspheres as artificial embolic agent for left gastric artery embolization
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Saint Louis University
St Louis, Missouri, 63110, United States
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.
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.
Keith Pereira, MD
Assistant professor of radiology-Interventional radiology
Kirubahara Vaheesan, MD
Associate professor of radiology-Interventional radiology
Alex Befeler, MD
Professor of internal medicine- Gastreoenterology
Mustafa Nazzal, MD
Assistant Professor of Surgery- abdominal transplant
First Submitted
October 11, 2016
First Posted
October 17, 2016
Study Start
October 18, 2017
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Charge: A Text Messaging-based Weight Loss Intervention
12 months
Laboratory parameter-serum glucose
12 months
Laboratory parameters- HbA1c
12 months
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 6, 2025
Record last verified: 2025-02
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