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Endoscopic sleeve gastroplasty | |
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Specialty | Gastroenterology, Bariatrics |
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. [1] The result is a more restricted stomach that forces patients to feel fuller sooner, eating fewer calories, which facilitates weight loss . [2] [3] [4]
Early iterations of endoscopic gastric remodeling for weight loss included the endoluminal vertical gastroplasty, which attempted to mimic the restricted stomach configuration of the vertical sleeve gastrectomy. [5] Around the same time, similar endoscopic remodeling along the stomach’s larger curvature was performed through tissue acquisition with a suction-based device, though this was limited by suture loss. [6] [7] In 2012, Dr. Christopher Thompson, a Harvard Medical School professor and later Co-founder of Bariendo, performed the first ESG case in humans. [8] This was modified and tissue was acquired with a full-thickness suturing device, which has been the basis of the present ESG procedure. [9] In July 2022, the creation of the ESG using the Apollo Overstitch device was authorized by the United States Food and Drug Administration for the treatment of obesity in patients with a body mass index between 30–50 kg/m2.
The ESG may be performed with slight variations by different physicians. It most commonly is performed using the Apollo ESG Device (formally Overstitch device). This device fits over a therapeutic double-channel endoscope to create a sutured row of stomach tissue. The tissue helix is advanced from the endoscope, put up against stomach tissue, and turned 2-4 rotations to access the gastric muscle layer. The helix is then retracted towards the scope, bringing the full-thickness acquired stomach tissue with it. Using the handle-operated needle driver, a needle attached to the suture wire is passed through the full-thickness tissue to the anchor exchange. This creates a full-thickness plication of stomach tissue. The needle is then passed back from the anchor exchange to the needle driver, and the process is repeated, threading the suture wire through each bite of stomach tissue. When enough full-thickness bites have been taken for a suture row, a cinch is passed through the scope over the suture. Typically, sutures are placed starting at the border of the antrum and gastric body at the incisura, then placed proximally up to the border of the gastric body and fundus. Each row of sutures can be a straight line or one of the variety of suture patterns reported in the literature, such as the “M,” “Z,” and “U” pattern as well as other novel patterns; nonetheless, to date, no suture pattern has been proven to be superior for weight loss. [10] [11] [12] [13] Regardless of suture pattern, creation of the ESG focuses on tissue imbrication along the greater curvature of the stomach. The fundus is typically avoided due to the relatively thinner wall compared to the gastric body to avoid complications from the procedure. [14]
Accredited advanced fellowship training programs in ESG and other endoscopic bariatric therapies are currently rare, and competency in ESG is typically achieved through proctoring by experts after completion of an accredited gastroenterology or surgical training program. Studies have reported that efficiency with performance of ESG and improved weight loss outcomes occur after approximately 35-38 cases. [15] [16] [17] Mastery was reported in one study to occur after 55 cases. [15] While early performance of the ESG has traditionally been carried out in university-affiliated/academic centers, ESG has been shown to be feasible and safe when performed in the community setting. [18]
The primary measures of weight loss outcomes for endoscopic bariatric therapies include total body weight loss (percentage of pre-procedure weight lost by a certain time point) and excess weight loss (percentage of pre-procedure weight above ideal body weight that is lost by a certain time point). The Preservation and Incorporation of Valuable Endoscopic Innovation thresholds is an expert panel with gastroenterologists and surgeons from the American Society for Gastrointestinal Endoscopy and The American Society for Metabolic and Bariatric Surgery, and in 2015, this panel recommended that any new endoscopic therapy for weight loss should have an excess weight loss exceeding 25% and a serious adverse event rate less than 5%. [19] Total body weight loss thresholds were not defined but are generally considered meaningful in novel endoscopic bariatric therapies if exceeding 5%. [20] [21] Multiple studies of ESG have shown that this therapy satisfies these criteria, as outlined below.
The recently published MERIT study is the first and only randomized controlled trial of the ESG for treatment of obesity and included 209 adult subjects with class I and II obesity (BMI 30–40 kg/m2). [22] It was conducted from Dec. 2017 to Jun. 2019, spanned nine centers in the United States, and comprised 85 adults in the ESG arm and 124 adults in the control arm (lifestyle modification only). Subjects in the ESG arm lost 13.6% of body weight and 49.2% of excess body weight at one year, compared to 0.8% total body weight loss and 3.2% excess weight loss in the control arm at the same time point.
Prior to the MERIT study, numerous meta-analyses of studies on ESG report a total body weight loss of approximately 16% at one year. [23] [24] [25] [26] [27] Excess weight loss was observed to be approximately 60% at one year. [23] [25] [27] [28] Weight loss reported from high volume community practices that have both expertise in ESG and robust longitudinal aftercare programs with dietitians have shown even greater outcomes, with total body weight loss approaching 30% and excess weight loss of 66% at one year. [18]
Patient selection is an important consideration for any weight loss therapy. The present published literature shows either no influence or conflicting results for patient age, sex, starting weight/BMI on weight loss from ESG. Long-term after care programs have demonstrated benefit for sustained weight loss after ESG, with one study showing that patients who continued after care visits following ESG had 20.5% total body weight loss compared to 16.9% total body weight loss in those who dropped out of long-term follow up programs. [29]
There are over 200 obesity-related comorbidities, and it has been reported that achieving a total body weight loss of 10% has a significant impact of such conditions. [30] Thus, the weight loss outcomes with ESG are unsurprisingly accompanied by an improvement in several obesity-related comorbidities. Weight loss facilitated by ESG has been observed to bring about benefits in or even cure of diabetes/insulin sensitivity, [31] [32] [33] dyslipidemia, [31] [32] blood pressure, [31] and fatty liver disease, [31] [33] [34] as well as quality of life. [35] [36] The MERIT study showed 80% of patients who underwent ESG had improvement in one or more comorbidities at one year. [22]
Mid-term durability from ESG appears promising. A total body weight loss of 17% and excess weight loss of between approximately 60-67% was observed to be sustained at 18–24 months. [23] [26] [28] This was later confirmed in the multicenter, randomized controlled MERIT study, which observed that 68% of subjects who underwent an ESG maintained 25% or more of their excess weight loss at two years. [22] As a novel therapy, ESG presently lacks studies assessing long-term durability, though more data on this component of ESG are anticipated as more ESGs are performed over time. One recent study observed at 5 years from ESG that at least 10% total body weight loss was maintained in 90% of patients and at least 15% total body weight loss was maintained in 61% of patients. [17]
Mild to moderate gastrointestinal side effects (such as nausea, cramping, bloating, and abdominal discomfort) are common after ESG (reported in over 70% of patients), but these are predictable, temporary, and can be managed with medications. [25] Most will resolve within one week after ESG. Due to the minimally invasive nature of ESG, serious complications are rare. These include pain or nausea requiring hospitalization (1.08%); upper gastrointestinal tract bleeding (0.56%); peri-gastric leak or infected fluid collection (0.48%); pulmonary embolism (0.06%); perforation (0.06%). [23] Similar rates of serious adverse events were reported in the multicenter, randomized controlled MERIT study. [22] No deaths have been observed in the published ESG literature.
Mechanisms of weight loss from ESG remains an area of active study. There are at least two mechanisms of peripheral appetite signaling thought to be mediated by ESG: first, increased sense of fullness during a meal leading to meal termination, potentially a result of the intact gastric fundus that serves as a food reservoir and the restriction to gastric expansion (accommodation) during a meal; [2] [4] and second, from delayed emptying of the stomach, which promotes a prolonged sensation of fullness after a meal. [4]
Unlike the surgical sleeve gastrectomy, the ESG does not appear to affect central appetite signaling through the hunger hormone, ghrelin. [29] This is thought to be because the surgical sleeve removes the fundus, the primary site of ghrelin production, and the relatively thinner-walled fundus is avoided in the ESG for safety concerns. Furthermore, in cases where the fundus was sutured in ESG, this did not benefit weight loss outcomes. [14]
ESG can safely be combined with weight loss medications to improve weight loss or prevent weight regain after the procedure. The daily injectable medication liraglutide showed greater total body weight loss when combined with ESG compared to ESG alone at 7 months (approximately 25% vs 20% respectively). [14] Similar results are anticipated with other incretin agents, such as semaglutide and tirzepatide, though no studies have directly assessed these combinations.
Weight regain after surgical sleeve gastrectomy has historically been managed with medications or a more invasive revisional surgery. [37] [38] [39] [40] Recent data suggested that an ESG can safely be performed after the surgical sleeve gastrectomy (sometimes referred to as a “revisional ESG”), with total body weight loss of approximately 16-18% at 12 months. [41] [42] While weight loss is not thought to be as robust as the initial weight loss surgery, the revisional ESG has an improved safety profile compared to a surgical revision and is therefore hypothesized to have greater patient acceptance. [37]
Laparoscopic sleeve gastrectomy (LSG) is one of the most common bariatric surgeries performed worldwide and shares a similar restricted stomach configuration with the ESG. However, it appears to operate with different weight loss mechanisms from the ESG, as it has been shown to reduce the hunger hormone ghrelin, [29] [43] as well as accelerate, rather than delay, stomach emptying. [3]
Large, prospective studies directly comparing LSG to ESG are lacking. Comparison of the two therapies has relied on retrospective analysis and findings are conflicting. In a recent propensity score-matched study, the difference in weight loss for LSG vs ESG was 9.7% at 1 year, 6.0% at 2 years, and 4.8% at 3 years in favor of LSG, though the authors described the ESG as non-inferior based on an a priori definition of non-inferiority as being within 10% total body weight loss of the surgical arm. [44] Advantages of the ESG over LSG include lack of incisions, shorter length of stay (same-day-discharge vs 3 days in hospital); [29] less gastroesophageal reflux (0-2% vs 15-31%); [36] [45] and lower morbidity and overall adverse event rate (1.9% vs 14.5%), [45] [46] though some studies have presented similar rates of adverse events between ESG and LSG. [47] [48] Despite less weight loss, one study found that patients who had undergone ESG had the same degree of comorbidity resolution and had higher quality of life scores at 6 months compared to those who had undergone LSG. [36]
Laparoscopy is an operation performed in the abdomen or pelvis using small incisions with the aid of a camera. The laparoscope aids diagnosis or therapeutic interventions with a few small cuts in the abdomen.
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.
Vertical banded gastroplasty (VBG), also known as stomach stapling, is a form of bariatric surgery for weight control. The VBG procedure involves using a band and staples to create a small stomach pouch. In the bottom of the pouch is an approximate one-centimeter hole through which the pouch contents can flow into the remainder of the stomach and hence on to the remainder of the gastrointestinal tract.
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.
Sleeve gastrectomy or vertical sleeve gastrectomy, is a surgical weight-loss procedure, typically performed laparoscopically, in which approximately 75 - 85% of the stomach is removed, along the greater curvature, which leaves a cylindrical, or "sleeve"-shaped stomach the size of a banana. Weight loss is affected not only through the reduction of the organ's size, but by the removal of the portion of it that produces ghrelin, the hormone that stimulates appetite. Patients can lose 50-70 percent of excess weight over the course of the two years that follow the surgery. The procedure is irreversible, though in some uncommon cases, patients can regain the lost weight, via resumption of poor dietary habits, or dilation of the stomach over time, which can require gastric sleeve revision surgery to either repair the sleeve or convert it to another type of weight loss method that may produce better results, such as a gastric bypass or duodenal switch.
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.
Single-port laparoscopy (SPL) is a recently developed technique in laparoscopic surgery. It is a minimally invasive surgical procedure in which the surgeon operates almost exclusively through a single entry point, typically the patient's navel. Unlike a traditional multi-port laparoscopic approach, SPL leaves only a single small scar.
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.
Single-incision laparoscopic surgery (SILS) is an advanced, minimally invasive (keyhole) procedure in which the surgeon operates almost exclusively through a single entry point, typically the patient's umbilicus (navel). Special articulating instruments and access ports eliminate the need to place trochars externally for triangulation, thus allowing the creation of a small, solitary portal of entry into the abdomen.
The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) is a 501c6 non-profit professional organization providing education on gastrointestinal minimally invasive surgery. It describes itself thus: The mission of the Society of American Gastrointestinal and Endoscopic Surgeons is to innovate, educate and collaborate to improve patient care.
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 by or recommended for the patient.
SADI-S is a bariatric surgical technique to address metabolic disorders and to lose weight. It is a variation on the Duodenal Switch surgery, incorporating a vertical sleeve gastrectomy with a gastric bypass technique.
Ileal Interposition is a Metabolic Surgery procedure, used to treat overweight diabetic patients through surgical means. First presented by the Brazilian surgeon Aureo De Paula in 1999, this technique is applied by placing ileum, which is the distal part of the small intestine, either between stomach and the proximal part of the small intestine or by placing the ileum to the proximal part of the small intestine without touching the natural connections of the stomach. There are 2 different versions of the operation. Sleeve gastrectomy procedure is standard for both of the versions.
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.
Michel Kahaleh is an American gastroenterologist and an expert in therapeutic endoscopy.
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.
Stomach reduction surgery, also known as bariatric surgery, is a medical procedure aimed at facilitating weight loss by reducing the size of the stomach, thereby limiting food intake and promoting satiety with smaller portions. It is frequently used for cases where traditional weight loss approaches, consisting of diet and physical activity, have proven insufficient, or when obesity already significantly affects well-being and general health.