| Gastric balloon | |
|---|---|
 A diagram of a gastric balloon. | |
| Other names | Stomach balloon, intragastric balloon |
A gastric balloon, also known as an intragastric balloon (IGB) or a stomach balloon, is an inflatable medical device that is temporarily placed into the stomach to help reduce weight. It is designed to help provide weight loss when diet and exercise have failed and surgery is not wanted or not recommended for the patient.
Intragastric balloons are an alternative to bariatric surgery (or weight loss surgery), which is not generally offered to patients with a body mass index of less than 35. Gastric balloons are also designed for patients who require weight-loss support but who do not want to commit to surgical interventions. [1]
Intragastric balloons help induce weight loss by increasing satiety, delaying gastric emptying, and reducing the amount of food eaten at each meal. [1] Gastric balloons take up space in the stomach, which limits the amount of food that can be held. This creates an early feeling of fullness and satiety. A reduced intake of food then results in weight loss.
Most balloons require endoscopy for removal or placement. They are usually placed for up to six months, though some devices are placed for twelve months. The device is then removed, again using endoscopy. Longer placement is not advised because of the danger of damage to the tissue wall and degradation of the balloon. The use of the balloon is complemented with counseling and nutritional support or advice.
Endoscopic placement of the balloon is temporary and reversible without surgical incisions. The gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding.
Gastric balloon uptake has until recently been limited due to the need for endoscopy for placement or removal. [2]
Procedureless, or non-endoscopic, intragastric balloons offer a promising alternative to historic endoscopic balloons. Non-endoscopic balloons are also a less invasive alternative to weight-loss surgery. [2]
In 2015, Allurion's Elipse gastric balloon became the world's first non-endoscopic swallowable gastric balloon when it gained approval in Europe. [3] [4] Except under exceptional circumstances, it does not require endoscopy or surgery for placement or removal. [2] The non-endoscopic gastric balloon capsule is swallowed for placement and, once in the stomach is filled with saline liquid. After 16 weeks, the non-endoscopic gastric balloon then automatically deflates and passes naturally at the end of placement. A recent meta analysis of 6 studies found the balloon was a safe device offering effective weight loss. Total pooled weight loss at the completion of treatment (4–6 months) was 12.8% and at 12 months was 10.9%. [4]
Adjustable gastric balloons are able to increase or decrease their volume. While non-adjustable gastric balloons have been successfully used for weight loss for the last 30 years, the adjustability function was developed to address the following issues: (1) variability of response and reduced efficacy after 3 months [5] [6] [7] and (2) intolerance necessitating early balloon extraction. [8] [9] Alleviating intolerance with a downward adjustment and renewing weight loss after balloon upward adjustment, are responsible for higher success rates compared with non-adjustable balloons. [10] [11] The Spatz3 adjustable gastric balloon is the first intragastric balloon approved for 1-year implantation (outside of the US), while featuring an adjustability function that provides balloon volume changes as needed.
The device is intended to be used by people with a body mass index of more than 27 kg/m2. [12] or between 30 and 40 kg/m2 [13] and have weight-related co-morbidity. It should not be applied to patients with certain intestinal problems such as inflammatory bowel disease or delayed gastric emptying, who are pregnant, or who are taking blood thinner medications such as Coumadin. Low dose aspirin (100 mg) is permitted. [13]
A 2016 meta analysis of studies showed short term weight loss without any mortality. [14] It was calculated that the weight loss was 1.59 and 1.34 kg/m2 for overall and 3-month body mass index (BMI) loss, respectively, and 4.6 and 4.77 kg for overall and 3-month weight loss, respectively. [14]
Results are influenced by the adherence to nutritional and dietary programs. Long-term studies show promise for patients who combine balloon treatment with exercise and a healthy diet. In a study on the 'Long-Term Efficacy of the Elipse Gastric Balloon System: An International Multicenter Study, Dr. Roberta Ienca and colleagues' report on 509 patients who received the non-endoscopic Elipse balloon and were followed for one year. After 4 months of treatment, patients achieved weight loss of 14.4 kg or 13.9% of total body weight. At one-year follow-up, 95% of this weight loss was maintained by patients included in the study. [2]
Gastric balloons are generally considered to be safe and effective in the short term. [15] Existing clinical data shows an acceptable safety profile. One of the largest intragastric balloon studies ever performed, which included 1770 patients, demonstrated an excellent safety profile. [2]
There can be procedure-related side effects due to endoscopy and anesthesia on balloons that require medical intervention for placement or removal. [13] On very rare occasions, the endoscopic placement of a balloon has led to death. [16] [17]
Several studies have demonstrated that the data on both the efficacy and safety for the non-endoscopic Allurion Elipse gastric balloon compares favorably with balloons that require endoscopy. [2] It showed an acceptable safety profile with 0.2% of serious adverse events, which is comparable to the Orbera balloon, which requires endoscopy. [4]
Post-placement side effects of gastric balloons are common and may include nausea, vomiting, reflux and stomach cramps. [18] Other side effects include indigestion, bloating, flatulence and diarrhea. [14] Rare side effects include esophagitis, gastric ulcer formation or gastric perforation. [19] The device can become deflated and slip into the lower intestines. Migration of a balloon can lead to bowel obstruction. [19]
Currently there are three FDA-approved balloons in the USA. These approved devices are placed via the esophagus using endoscopy. This can be done in an outpatient setting under sedation. One further balloon, Allurion's Ellipse, has European CE approval and does not require endoscopy for placement or removal. [1] [4]
Once in place the balloon is filled with saline and remains as a free-floating object in the stomach cavity, too big to pass through the pylorus. In addition to saline, the balloon that is made from silicone may contain some radio-opaque material as a radiographic marker and a dye such as methylene blue to alert the patient if the balloon leaks. [15] Studies have suggested that fluid is superior to air for distending gastric balloons. [14] Inflated balloons reduce the operative volume capacity of the stomach. While the typical gastric volume is about 900 ml, an inflated balloon may take up most of the space, about 700 (+/-100) ml.
Gastric balloon devices have been approved in many countries, among them Australia, Canada, Mexico, India, Guatemala and several European and South American countries. [20] They became available in the United States in 2015 when two different balloon devices were approved by the FDA. [21] [13]
Costs for the gastric balloon are surgeon-specific and vary by region. Average cost in the US is $8,150 USD, and generally less in other countries. Average cost in Europe is around €3,000. Insurance coverage is usually not provided in the US. [24] There are three cost categories for the intragastric balloon: pre-operative (e.g. professional fees, lab work and testing), the procedure itself (e.g. surgeon, surgical assistant, anesthesia and hospital fees) and post-operative (e.g. follow-up physician office visits, vitamins and supplements).
The first person to use a gastric balloon for the treatment of obesity was A. Henning 1979. (Inn. Med.6(1979),149) He and his wife used it in a self-experiment.
The use of gastric filling devices to induce weight loss is not new. DeBakey's review in 1938 showed that bezoars led to weight loss. [25] Free floating intragastric balloons were used by Nieben and Harboe in 1982. [26] Percival presented a “balloon diet” in 1984 when he placed inflated mammary implants as gastric balloons. [27] Elipse mide Balonu In 1985 the Garren-Edwards Bubble was introduced as the first FDA-approved device, but the approval was withdrawn seven years later because of complications. [28] Analysis of its problems led to recommendations for safer designs. [12] While a number of further developed devices were used outside of the US, mostly in Europe and South America, the FDA did not approve any new devices until 2015. [28] In October 2017, ReShape Medical, which makes gastric balloons, was acquired by EnteroMedics in $38m cash-and-stock deal. [29] [30]
Esophagogastroduodenoscopy (EGD) or oesophagogastroduodenoscopy (OGD), also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. It is considered a minimally invasive procedure since it does not require an incision into one of the major body cavities and does not require any significant recovery after the procedure. However, a sore throat is common.
Gastric bypass surgery refers to a technique in which the stomach is divided into a small upper pouch and a much larger lower "remnant" pouch and then the small intestine is rearranged to connect to both. Surgeons have developed several different ways to reconnect the intestine, thus leading to several different gastric bypass procedures (GBP). Any GBP leads to a marked reduction in the functional volume of the stomach, accompanied by an altered physiological and physical response to food.
Gastric varices are dilated submucosal veins in the lining of the stomach, which can be a life-threatening cause of bleeding in the upper gastrointestinal tract. They are most commonly found in patients with portal hypertension, or elevated pressure in the portal vein system, which may be a complication of cirrhosis. Gastric varices may also be found in patients with thrombosis of the splenic vein, into which the short gastric veins that drain the fundus of the stomach flow. The latter may be a complication of acute pancreatitis, pancreatic cancer, or other abdominal tumours, as well as hepatitis C. Gastric varices and associated bleeding are a potential complication of schistosomiasis resulting from portal hypertension.
A laparoscopic adjustable gastric band, commonly called a lap-band, A band, or LAGB, is an inflatable silicone device placed around the top portion of the stomach to treat obesity, intended to decrease food consumption.
Endoscopic foreign body retrieval refers to the removal of ingested objects from the esophagus, stomach and duodenum by endoscopic techniques. It does not involve surgery, but rather encompasses a variety of techniques employed through the gastroscope for grasping foreign bodies, manipulating them, and removing them while protecting the esophagus and trachea. It is of particular importance with children, people with mental illness, and prison inmates as these groups have a high rate of foreign body ingestion.
A vagotomy is a surgical procedure that involves removing part of the vagus nerve. It is performed in the abdomen.
Gastric outlet obstruction (GOO) is a medical condition where there is an obstruction at the level of the pylorus, which is the outlet of the stomach. Individuals with gastric outlet obstruction will often have recurrent vomiting of food that has accumulated in the stomach, but which cannot pass into the small intestine due to the obstruction. The stomach often dilates to accommodate food intake and secretions. Causes of gastric outlet obstruction include both benign causes, as well as malignant causes, such as gastric cancer.
Bariatric surgery is a medical term for surgical procedures used to manage obesity and obesity-related conditions. Long term weight loss with bariatric surgery may be achieved through alteration of gut hormones, physical reduction of stomach size, reduction of nutrient absorption, or a combination of these. Standard of care procedures include Roux en-Y bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch, from which weight loss is largely achieved by altering gut hormone levels responsible for hunger and satiety, leading to a new hormonal weight set point.
StomaphyX is an endoscopic suturing system designed to treat patients who have had previous Roux-en-Y gastric bypass surgery. Following this surgery, the stomach pouch and stomach outlet (stoma) becomes enlarged in some patients. The StomaphyX device can be used to restrict the size of the stoma without exposing the patient to further surgical risk.
Revision weight loss surgery is a surgical procedure that is performed on patients who have already undergone a form of bariatric surgery, and have either had complications from such surgery or have not achieved significant weight loss results from the initial surgery. Procedures are usually performed laparoscopically, though open surgery may be required if prior bariatric surgery has resulted in extensive scarring.
Therapeutic endoscopy is the medical term for an endoscopic procedure during which treatment is carried out via the endoscope. This contrasts with diagnostic endoscopy, where the aim of the procedure is purely to visualize a part of the gastrointestinal, respiratory or urinary tract in order to aid diagnosis. In practice, a procedure which starts as a diagnostic endoscopy may become a therapeutic endoscopy depending on the findings, such as in cases of upper gastrointestinal bleeding, or the finding of polyps during colonoscopy.
Management of obesity can include lifestyle changes, medications, or surgery. Although many studies have sought effective interventions, there is currently no evidence-based, well-defined, and efficient intervention to prevent obesity.
Gastric electrical stimulation, also known as implantable gastric stimulation, is the use of specific devices to provide electrical stimulation to the stomach to try to bring about weight loss in those who are overweight or improve gastroparesis.
A duodenal-jejunal bypass liner, commonly called an EndoBarrier, is an implantable medical device in the form of a thin flexible 60 cm-long tube that creates a physical barrier between ingested food and the duodenum/proximal jejunum. The duodenal-jejunal bypass liner prevents the interaction of food with enzymes and hormones in the proximal intestine to treat type 2 diabetes and obesity. The duodenal-jejunal bypass liner is delivered endoscopically and has been tested on the morbidly obese as well as obese patients with a BMI less than 40, particularly those with difficult-to-manage type 2 diabetes. Despite a handful of serious adverse events such as gastrointestinal bleeding, abdominal pain, and device migration — all resolved with device removal — initial clinical trials have produced promising results in the treatment's ability to improve weight loss and glucose homeostasis outcomes.
Aspiration therapy is a bariatric approach to siphon ingested food from the stomach via an implanted tube and port to the outside of the body to be discarded. The device for this approach was developed by researchers at Washington University in St. Louis to treat obesity and has been named AspireAssist. The device has also been termed a reverse feeding tube. It was approved by the Food and Drug Administration (FDA) on June 14, 2016.
Stomach Intestinal Pylorus-Sparing (SIPS) surgery is a type of weight-loss surgery. It was developed in 2013 by two U.S. surgeons, Daniel Cottam from Utah and Mitchell S. Roslin from New York.
In medicine, endoscopic sleeve gastroplasty (ESG) is a minimally-invasive, non-surgical (incisionless), endoscopic weight loss procedure that is part of the field of endoscopic bariatric therapies. To perform ESG, a physician sutures a patient’s stomach into a narrower, smaller tube-like configuration. The result is a more restricted stomach that forces patients to feel fuller sooner, eating fewer calories, which facilitates weight loss.
Buried bumper syndrome (BBS) is a condition that affects feeding tubes placed into the stomach through the abdominal wall. Gastrostomy tubes include an internal bumper, which secures the inner portion of the tube inside the stomach, and external bumper, which secures the outer portion of the tube and opposes the abdomen. Buried bumper syndrome occurs when the internal bumper of a gastrostomy tube erodes into the wall of the stomach. The internal bumper may become entirely buried within the fistulous tract. The main causative factor is excessive tightening of the external bumper, leading to increased pressure of the internal bumper on the wall of the stomach. Additional risk factors include: obesity, weight gain, malnutrition, corticosteroid therapy, and poor wound healing.
Kenneth Frank Binmoeller is a medical doctor and author of multiple scientific contributions and over 300 publications, as well as the inventor of the lumen-apposing metal stent (LAMS) and AXIOS System. These are medical devices used to relieve blockages while creating a direct connection between two bodily structures. He practices in the field of Gastroenterology with a specialty of Advanced Endoscopic Intervention. Binmoeller has been published for his innovations in medical devices and training in the field of Endoscopy.
Antrectomy, also called distal gastrectomy, is a type of gastric resection surgery that involves the removal of the stomach antrum to treat gastric diseases causing the damage, bleeding, or blockage of the stomach. This is performed using either the Billroth I (BI) or Billroth II (BII) reconstruction method. Quite often, antrectomy is used alongside vagotomy to maximise its safety and effectiveness. Modern antrectomies typically have a high success rate and low mortality rate, but the exact numbers depend on the specific conditions being treated.
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