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

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

Interventions

DEVICE

Embospheres Microspheres

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

Sponsors & Collaborators

• St. Louis University

  lead OTHER

Principal Investigators

• 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

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-18

Primary Completion

2026-12-31

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations