Liver Cirrhosis, Obesity
Conditions
Keywords
Intragastric Balloon, ORBERA Intragastric Balloon, Weight Loss, BMI >35
Brief summary
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.
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.
Interventions
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With >= 15% Excess Body Weight Loss at 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal | 6 months | %TBWL at 6 months = Number of kg lost at 6 months/starting weight in kg |
| Mean Percentage of Excess Weight Loss (%EWL) After Balloon Removal | 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. |
Countries
United States
Participant flow
Recruitment details
All subjects were recruited at the Mayo Clinic in Rochester, Minnesota.
Participants by arm
| Arm | Count |
|---|---|
| Orbera Intragastric Balloon All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Orbera Intragastric Balloon | — |
|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 4.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 8 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 6 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
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.
Time frame: 6 months
Population: Intent to treat analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Orbera Intragastric Balloon | Number of Subjects With >= 15% Excess Body Weight Loss at 6 Months | 8 Participants |
Secondary
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.
Time frame: 6 months
Population: Intent to treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orbera Intragastric Balloon | Mean Percentage of Excess Weight Loss (%EWL) After Balloon Removal | 26.3 percentage of weight loss | Standard Deviation 16.8 |
Secondary
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
Time frame: 6 months
Population: Intent to treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orbera Intragastric Balloon | Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal | 12.3 percentage of weight loss | Standard Deviation 8.1 |