Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates

The purpose of this study is to determine whether the Orbera Intragastric Balloon is a safe and effective means for weight loss and improved metabolic disease in patients with cirrhosis requiring liver transplantation.

Study Overview

• Status: Terminated
• Conditions: Liver Cirrhosis; Obesity
• Intervention / Treatment: Device: ORBERA Intragastric Balloon

Detailed Description

The prevalence of obesity and non-alcoholic steatohepatitis (NASH) in the general population is increasing. More and more patients with underlying NASH-related cirrhosis are now being referred to transplant centers but are not candidates for a potentially lifesaving liver transplantation due to their obesity and comorbidities related to the obesity.

The investigators proposed a clinical pilot study using the new FDA approved intragastric balloon in obese patients (BMI >35) with cirrhosis in need of liver transplantation, to assess weight loss and metabolic improvement.

The ORBERA™ Intragastric Balloon is an elastic spherical balloon made of silicone, filled with 650ml of saline solution. The deflated balloon comes preloaded on a catheter, which is advanced transorally into the stomach. An endoscope is then advanced alongside it to ensure accurate placement of the balloon in the fundus. Under direct visualization, the balloon is then inflated by injecting saline solution mixed with methylene blue through the external portion of the catheter. The ORBERA™ Intragastric Balloon is implanted for 6 months and then retrieved endoscopically by puncturing the balloon with a needle, emptying the fluid content, and removing it through the mouth. Both placement and removal of the ORBERA™ Balloon are done as an outpatient procedure with monitored or general anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults with end-stage liver disease who are listed for liver transplant
• Have failed the non-invasive approach to weight loss to be actively listed for transplant (requiring 2 clinical return visits without weight loss of >5 kg)
• Body Mass Index (BMI) >35
• Negative pregnancy test for females who are able to get pregnant and are of child-bearing age

Exclusion Criteria:

• A previous history of gastric or bariatric surgery
• Current or recent (within 6 months) gastric or duodenal ulcers
• Moderate to severe Portal hypertension defined as portal gastropathy graded as >= to moderate/severe, gastric varices, or esophageal varices graded > = moderate/large (Patients with varices which have been obliterated may be included).
• Calculated Model of End-stage Liver Disease (MELD) score >25 or childs score >10
• The presence of more than one gastric balloon at the same time
• Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
• A large hiatal hernia or >5 cm hernia or ≤5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope.
• Achalasia or any other severe motility disorder that may pose a safety risk during removal of the device.
• Gastric mass
• Severe coagulopathy
• Patients who are known to have or suspected to have an allergic reaction to materials contained in ORBERA.
• Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 6 months.
• Alcoholism or drug addiction
• Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant
• Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
• Patients receiving aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants, not under medical supervision.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Orbera Intragastric Balloon; All subjects will be receiving the ORBERA Intragastric Balloon	Device: ORBERA Intragastric Balloon; The ORBERA Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With >= 15% Excess Body Weight Loss at 6 Months	The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal	%TBWL at 6 months = Number of kg lost at 6 months/starting weight in kg	6 months
Mean Percentage of Excess Weight Loss (%EWL) After Balloon Removal	The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kymberly Watt, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ACTUAL): November 3, 2016
• Study Completion (ACTUAL): November 3, 2016

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: September 21, 2015
• First Posted (ESTIMATE): September 22, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Weight Loss; BMI >35; Intragastric Balloon; ORBERA Intragastric Balloon
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Body Weight; Fibrosis; Body Weight Changes; Liver Cirrhosis; Weight Loss
• Other Study ID Numbers: 15-003183

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes