Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically (GET LEAN)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Body Weight Average 6 Months Post-Procedure
Study Overview
Brief Summary
The purpose of this pilot study is to achieve the collection of safety and efficacy data in patients undergoing left gastric artery embolization for morbid obesity in the United States. As secondary goal, the pilot study seeks to obtain quality of life data. This pilot study is not designed to achieve new indications for this device.
Detailed Description
Beadblock will be used intraarterially to occlude in this case the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone ghrelin (one of the hormones responsible for appetite) is produced. Ghrelin is a 28 amino acid hunger stimulating peptide and hormone that is produced mainly by P/D1 cells lining the fundus of the stomach and epsilon cells of the pancreas. Ghrelin has emerged as the first identified circulating hunger hormone. Ghrelin is also the only known circulating orexigen, or appetite enhancing hormone.
Left gastric artery embolization may be a minimally invasive alternative to the current surgical treatment of gastric bypass or reduction surgery. These treatments have known serious complications including anastomotic leaks, bowel obstruction, paralytic ileus, deep vein thrombosis, pulmonary embolism, gastrointestinal bleeding, dumping syndrome, and anesthesia risks resulting in morbidity and mortality.
Literature review for gastric artery embolization
Transarterial embolization is a common interventional procedure used to treat a variety of medical conditions. In the image-guided procedure, an embolic, or obstructive, agent is inserted through a catheter and placed inside an artery to prevent blood flow in an artery or to a specific area of the body. Types of embolic agents include beads, coils, gel foam,as well as other materials and devices.
Gastric artery embolization has been used since the 1970's to treat life threatening gastric hemorrhage. This is commonly accepted as standard of care and has been life saving for thousands of patients. It is even deemed to be effective enough to be used empirically in the setting of angiographically negative life threatening hemorrhage (as a reflection of its safety margin).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Morbid obesity with a BMI ≥ 40 Age ≥ 22years Ability to lay supine on an angiographic table <400lbs due to table weight limits Appropriate anesthesia risk as determined by certified anesthesia provider evaluation preprocedure.
- •Willing, able and mentally competent to provide written informed consent (to ensure that all study subjects demonstrate an understanding of the risks of the procedure and also participate in the informed consent).
- •Subjects who have failed previous attempts at weight loss through diet, exercise, and behavior modification (as it is recommended that conservative options, such as supervised low calorie diets combined with behavior therapy and exercise, should be attempted prior to enrolling in this study).
Exclusion Criteria
- •Less than 22 years of age Major surgery within the past eight weeks Previous gastric, pancreatic, hepatic and splenic surgery Previous radiation therapy to the left or right upper quadrant Previous gastric, hepatic, or splenic embolization Any history of portal venous hypertension Serum creatinine > 1.8 mg/dL History of kidney problems Pregnant or intend to become pregnant within one year History of severe bleeding disorder (platelet count less than 40,000) Allergy to materials in the embolic agents (acrylamido polyvinyl alcohol macromer) Enrolled in another study Any patient who has a history of allergic reaction to iodinated contrast Abnormal baseline gastric emptying study Patients taking anti-coagulants or antiplatelet drugs Patients currently taking or requiring chronic use of NSAID or steroid medications Patients with any chronic upper gastrointestinal complaints such as pain, nausea or vomiting Patients with any history of peptic ulcer disease Patients with any indication of gastrointestinal bleeding as documented by positive stool guaiac and complete blood count with abnormalities.
- •Patients with any contraindications for monitored anesthesia care or general surgery Patients with secondary causes of obesity such as Cushing's disease and hypothyroidism Patients with active substance abuse or alcoholism Patients with defined noncompliance with previous medical care Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual's ability to understand the proposed therapy.
- •Subjects with mesenteric atherosclerotic disease or abdominal angina should be excluded due to safety concerns.
- •Patients with hiatal hernia Patients with known aortic disease, such as dissection or aneurysm Patients with comorbidity such as cancer, peripheral arterial disease or other cardiovascular disease Patients with any abnormality on their baseline EGD Patients with a CT Angiogram demonstrate an anatomical variant in left gastric artery anatomy
Outcomes
Primary Outcomes
Body Weight Average 6 Months Post-Procedure
Time Frame: 6-Month
The mean body weight of all 5 participants at 6-Months post-procedure.
Body Weight Average 12 Months Post-Procedure
Time Frame: 12-Month
The mean body weight of all 5 participants at 12-Months post-procedure.
Change in Average Body Weight From Baseline at 6 Months Post-Procedure
Time Frame: Baseline, 6 Months
Average change in body weight lost. Calculated as the average of participants: (6-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)
Change in Average Body Weight From Baseline at 12 Months Post-Procedure
Time Frame: Baseline, 12 Months
Average change in body weight lost. Calculated as the average of participants: (12-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)
Percentage of Excess Body Weight Loss at 6 Months Post-Procedure
Time Frame: Baseline, 6 Month
Calculated as the average of participants: (((Baseline Weight in lbs.) - (6 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))
Percentage of Excess Body Weight Loss at 12 Months Post-Procedure
Time Frame: Baseline, 12 Month
Calculated as the average of participants: (((Baseline Weight in lbs.) - (12 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))
Average Ghrelin Hormone Levels at 6 Months Post-Procedure
Time Frame: 6-Month
The mean of participant's 6-Month post-procedure Ghrelin levels.
Average Ghrelin Hormone Levels at 12 Months Post-Procedure
Time Frame: 12-Month
The mean of participant's 12-Month post-procedure Ghrelin levels.
Percentage Change in Ghrelin Hormone Levels From Baseline at 12 Months Post-Procedure
Time Frame: 12-Month, Baseline
Calculated as the average of participants: (((12-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) \* 100
Percentage Change in Ghrelin Hormone Levels From Baseline at 6 Months Post-Procedure
Time Frame: 6-Month, Baseline
Calculated as the average of participants: (((6-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) \* 100
Secondary Outcomes
- Average Leptin Hormone Levels at 12 Months Post-Procedure(12-Month)
- Average Leptin Hormone Levels at 6 Months Post-Procedure(6-Month)
- Quality of Life (QOL): Averaged Short Form (SF)-36 Version 2 Physical Component Summary (PCS) at 6 Months Post-Procedure(6 Month)
- Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 12 Months Post-Procedure(12 Month, Baseline)
- 6-Month Post-Procedure Hemoglobin-A1c (HgA1c) Levels(6-Month)
- 12-Month Post-Procedure HgA1c Levels(12-Month)
- Percentage Change in Leptin Hormone Levels From Baseline at 6 Months Post-Procedure(6-Month, Baseline)
- Percentage Change in Leptin Hormone Levels From Baseline at 12 Months Post-Procedure(12-Month, Baseline)
- Average Cholecystokinin (CCK) Hormone Levels at 6 Months Post-Procedure(6-Month)
- Average Cholecystokinin (CCK) Hormone Levels at 12 Months Post-Procedure(12-Month)
- Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 6 Months Post-Procedure(6-Month, Baseline)
- QOL: Averaged SF-36v2 PCS at 12 Months Post-Procedure(12 Month)
- QOL: Averaged SF-36v2 MCS at 6 Months Post-Procedure(6 Month)
- Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 6 Months Post-Procedure(6 Month, Baseline)
- Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 12 Months Post-Procedure(12-Month, Baseline)
- Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 6 Months Post-Procedure(6 Month, Baseline)
- Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 12 Months Post-Procedure(12 Month, Baseline)
- QOL: Averaged SF-36v2 MCS at 12 Months Post-Procedure(12 Month)