Method for obesity treatment

Abstract

FIELD: surgical gastroenterology; bariatric surgery.SUBSTANCE: used for endoscopic treatment of obesity. At the first stage, an entrance to the submucosal tunnel is made in the lower third of the stomach along the greater curvature. A submucosal tunnel is formed up to the pylorus, and a partial peroral myotomy is performed in the proximal direction, preserving the muscular layer of the pylorus. Clipping of the mucosal defect in the area of the tunnel entrance is performed. At the second stage, an endoscope with an endoscopic suturing system mounted on it is inserted into the lumen of the stomach. At the border of the cardiac region and the body of the stomach, starting from the anterior wall along the greater curvature towards the posterior wall, and then in the opposite direction, a continuous suture is applied, dividing the lumen of the stomach into two unequal parts in the form of an “hourglass” with the formation of an upper pocket of small volume.EFFECT: method ensures weight loss by forming an intra-sternal cuff, which ensures early saturation, and also by weakening the muscular “pump” of the antral region, which slows down the evacuation of the stomach contents.1 cl, 2 dwg, 1 tbl, 1 ex

Description

[0001] Technical area

[0002] The method relates to medicine, in particular to endoscopy, gastroenterology, bariatric surgery, and is intended for the treatment of obesity by acting on the stomach.

[0003] Prior Art

[0004] Obesity is a global non-communicable pandemic, leading to a significant increase in the incidence of type 2 diabetes, cardiovascular disease, and reduced life expectancy. Despite the availability of conservative and surgical treatments, the search for the optimal balance between effectiveness, safety, and affordability continues.

[0005] Surgical treatment methods for obesity are known, including bypass operations on the stomach and small intestine and restrictive interventions on the stomach (source [1]: Yu.I.Sedletsky, K.K.Mirchuk. Surgical treatment of obesity. Bulletin of surgery. - 1996. - No. 5. - P. 100-104; source [2]: RU 2138201). Surgical treatment requires an extremely responsible approach and is associated with the risk of complications related to both the extent of the intervention and the postoperative wound.

[0006] Laparoscopic gastric banding operations are known (source [3]: Yashkov Yu. I. Obesity surgery: current status and prospects / / Obesity and metabolism. 2005. No. 2. URL: https: / / cyberleninka.ru / article / n / hirurgiya-ozhireniya-sovremennoe-sostoyanie-i-perspektivy ; source [4]: ​​Balandov S. G., Vasilevsky D. I., Anisimova K. A., Khamid Z. M., Shkredov D. V. Principles of choosing bariatric interventions (literature review) / / Scientific notes of the I. P. Pavlov St. Petersburg State Medical University. 2020. No. 4. URL: (https: / / cyberleninka.ru / article / n / printsipy-vybora-bariatricheskih-vmeshatelstv-obzor-literatury) in which a silicone ring is placed on the stomach, which constricts the stomach and limits the amount of food the patient can eat at one meal. This procedure promotes gradual weight loss, as the patient begins to feel full faster and with smaller amounts of food, and its mechanism of action is based on early saturation of the stomach.The bandage can be adjusted, which allows you to control the rate of weight loss. The most widespread method is adjustable bandaging, which allows you to control the degree of tension of the bandage.

[0007] Longitudinal gastrectomy [3] is a procedure in which a portion of the stomach is removed, leaving a narrow, sleeve-like tube. This procedure reduces the volume of the stomach and limits the amount of food consumed, which promotes weight loss.

[0008] A known technique for gastric balloon implantation [3; 4] is a temporary, minimally invasive endoscopic procedure aimed at weight loss. Under sedation, a folded silicone balloon is inserted into the stomach through the mouth and esophagus using a flexible endoscope. Under visual control, through the endoscope's camera, the balloon is filled with 400 to 700 ml of sterile saline. The filled balloon occupies a significant portion of the stomach's volume, mechanically limiting its capacity and creating a feeling of early satiety and fullness. The balloon remains in the stomach for up to 6 months. During this period, the patient must strictly adhere to the doctor's prescribed diet and eating regimen (eating small, frequent meals) and also work with a nutritionist and psychologist to develop healthy eating habits.After the specified period, an endoscopic procedure is performed to remove the balloon. Under endoscopic guidance, the balloon is punctured, the fluid is aspirated, and the empty balloon is removed through the mouth. This procedure is contraindicated for patients with gastroesophageal junction hernias. The balloon must also be removed and, if necessary, reinserted due to the aggressive effects of gastric juice on the balloon, which can lead to spontaneous rupture and balloon migration.

[0009] Despite effective weight loss, studies show that less than 1% of the eligible population undergoes surgical treatment. This is most often due to fear of surgery and complications, as well as a lack of insurance coverage.

[0010] Conservative treatments, including lifestyle changes (exercise and diet) and drug therapy, often fail to produce significant weight loss results or are temporary. Drug therapy, in the long term, becomes more costly than surgical interventions, as courses of drug therapy require prolonged use.

[0011] Finally, the above-described technique of endoscopic balloon placement in the stomach, until recently, was the only minimally invasive endoscopic technique available in Russia, which, despite its effectiveness, is a temporary technique and is associated with certain risks of complications.

[0012] In the context of all the problems and challenges facing bariatric therapeutic methods, the development of endoscopic methods for the treatment of obesity in our time can become a key factor in the effective fight against obesity.

[0013] Since September 2024, endoscopic reduction gastroplasty (ERG) has been used in Russia following the registration of a suturing device. This technique, described in 2013, has proven highly attractive to patients due to its minimally invasive nature, effectiveness, and safety.

[0014] However, the high cost of consumables is a significant barrier to the widespread use of ERG, making this technique inaccessible to many people suffering from obesity.

[0015] Another modern endoscopic bariatric technique is bariatric endoscopic antral myotomy, described in 2024 in the United States (BEAM pilot) on October 1, 2024 (updated by: Stephen KK Ng, Chinese University of Hong Kong https: / / ichgcp.net / ru / clinical-trials-registry / NCT06622382) is an endoscopic technique performed using a gastroscope under general anesthesia. It involves dissecting the muscle fibers in the antrum of the stomach, thereby weakening the antral pump, delaying gastric emptying and inducing satiety.

[0016] The described method is poorly studied, and the results are preliminary. However, the technique is attractive and promising due to its low cost, minimally invasive nature, and safety. Furthermore, the absence of significant anatomical changes during this procedure allows this technique to be considered in combination with other endoscopic techniques, which may enhance the effectiveness of surgical treatment.

[0017] A known method described by Sampath K. et al. (Gastroplasty with endoscopic myotomy as a revision procedure after weight regain after remote endoscopic sleeve gastroplasty. VideoGIE. 2025 Apr 6;10(8):398-401), which is gastroplasty with endoscopic myotomy (GEM), used as a revision procedure after previous endoscopic sleeve gastroplasty (ESG). The method includes two main components: pylorus-preserving antral myotomy and suturing of the stomach with a reduction in its volume. In the first stage, a submucosal tunnel is formed at a distance of 8 cm proximal to the pylorus using a hybrid knife, which is dissected 2 cm to the pylorus, after which a partial full-thickness myotomy is performed with dissection of submucosal fibrosis.In the second stage, gastroplasty is performed: a linear continuous suture is placed at the incisura level to align the anterior and posterior walls of the stomach. Eight sutures are then placed in a modified U-shaped pattern, repeated from distal to proximal to plicate the stomach and reduce its volume. According to the authors, in the presented clinical case, weight loss was 11 kg three months after the procedure, and 20 kg after one year.

[0018] Myotomy is associated with risks typical of endoscopic dissections (bleeding, perforation, scar tissue formation in the dissection area), and the long-term consequences of antral pump weakening and delayed gastric emptying remain poorly understood.

[0019] The above-described methods of treating obesity have a number of limitations associated with high trauma, effectiveness, safety and availability of therapy, which requires further research in search of optimal methods for combating obesity.

[0020] Brief Summary of the Invention

[0021] The technical task is to ensure early saturation of the stomach, thanks to the formation of an intraluminal cuff, and to ensure a slow evacuation of the contents, thanks to the weakening of the muscular “pump” of the antral part of the stomach

[0022] The technical result is weight loss due to the development of early satiety and slower gastric emptying. Another technical result is the expansion of the arsenal of methods and the provision of an affordable alternative demonstrating results comparable to endoscopic reduction gastroplasty, at a lower cost.

[0023] The technical result is achieved by the fact that in the method for treating obesity, including performing peroral endoscopic antral myotomy, at the first stage, an entrance to the submucosal tunnel is made in the lower third of the stomach along the greater curvature, then a submucosal tunnel is formed up to the pylorus, in the proximal direction, a partial peroral myotomy is performed, preserving the muscular layer of the pylorus, then clipping of the mucosal defect in the area of ​​​​the tunnel entrance is performed; at the second stage, an endoscope together with an endoscopic suturing system mounted on it is inserted into the lumen of the stomach, at the border of the cardiac region and the body of the stomach, starting from the anterior wall along the greater curvature towards the posterior wall, and then in the opposite direction, a continuous suture is applied, dividing the lumen of the stomach into two unequal parts in the form of an "hourglass" with the formation of an upper pocket of small volume.

[0024] The above set of features allows us to solve the stated problem and ensures the stated technical result.

[0025] The cuff divides the stomach into two chambers of unequal volume, ensuring that each chamber is filled with a smaller volume of food and achieving a feeling of satiety earlier. Myotomy of the antrum and pylorus slows gastric emptying, allowing for a longer feeling of satiety.

[0026] Thus, the proposed method represents a potentially promising, minimally invasive, and less expensive alternative to existing approaches. It offers advantages related to efficacy and accessibility, and is a minimally invasive (the surgery is performed intraluminally without external incisions and scars) and affordable (using fewer consumables than ERG) method for treating obesity.

[0027] Brief description of drawings

[0028] The technical solution is explained by this description and diagrams, which show:

[0029] Fig. 1 – photographs taken during the first stage of bariatric endoscopic antral myotomy;

[0030] Fig. 2 – photographs taken during the second stage.

[0031] Implementation of technical solution

[0032] Indications for use of the method: body mass index from 27 kg / m 2 in the presence of concomitant diseases associated with excess body weight; body mass index from 30 kg / m 2 .

[0033] Contraindications for use of the method: type 1 diabetes mellitus; unstable coronary heart disease; heart failure; heart rhythm disturbances; heart valve defects; obstructive or interstitial lung diseases; mental disorders and addiction that may affect compliance with recommendations; pregnant or breastfeeding women; Mallampati score - 4; ASA score 3 or higher; history of stomach surgery; peptic ulcer; gastroparesis; hernia of the esophageal opening of the diaphragm more than 5 cm; congenital anomalies of the gastrointestinal tract.

[0034] A two-stage gastric obesity treatment. The procedure is performed under endotracheal anesthesia. A CO2 insufflator, an endoscopic stand with an endoscope, an endoscopic suturing system (such as the Apollo Overstitch), a water pump, an electrosurgical unit, an endoscopic injector, a knife, hot forceps, and clips are used.

[0035] The method includes bariatric endoscopic antral myotomy and intraluminal gastric banding, wherein the first step is to perform bariatric endoscopic antral myotomy to weaken the antral pump and delay gastric emptying.

[0036] In the first stage, an entrance to the submucosal tunnel is formed in the lower third of the stomach along the greater curvature, which is extended to the pylorus, then a parallel partial peroral myotomy is performed, preserving the muscular layer of the pylorus, in the proximal direction with a length of about 10-12 cm, after performing the myotomy, clipping of the mucosal defect (entrance to the tunnel) is performed in the lower third of the stomach.

[0037] The second stage involves intraluminal gastric banding. A single continuous suture is placed intraluminally in the cardiofundal region of the stomach, dividing the lumen into two unequal parts and creating a small upper pouch. To do this, rows of continuous sutures are placed through an endoscope using an endoscopic suturing system at the border of the cardia and body of the stomach, forming an intraluminal cuff. This cuff gives the stomach an "hourglass" shape, where the upper small pouch fills, leading to early saturation.

[0038] The method was applied to three patients. The results are presented in the table.

[0039] № Floor Weight before surgery, kg Weight after 1 month, kg Weight after 3 months, kg 1 m 171 154 150 2 m 170 152 145 3 and 122,6 112,5 111,8

[0040] Experience using the method in patients with morbid obesity has shown its technical feasibility and satisfactory safety profile, and the data on weight loss are encouraging.

[0041] Clinical example of using the method

[0042] A 28-year-old man (patient #2) presented with complaints of progressive weight gain, decreased quality of life, lumbar spine pain, and shortness of breath with minimal physical activity. He had made repeated attempts to lose weight through diet and exercise without achieving sustained weight loss.

[0043] During physical examination, height is 182 cm, weight is 170 kg, BMI is 51.3 kg / m 2 .

[0044] After a comprehensive examination, the patient was diagnosed with: Obesity III (Weight: 170 kg, Height: 182 cm, BMI 51.3 kg / m 2 ) chronic, previously known, and treatment was carried out using the stated method.

[0045] Under endotracheal anesthesia, the first stage was bariatric endoscopic antral myotomy (Fig.1): in the lower third of the body of the stomach, along the greater curvature closer to the posterior wall, submucosal infiltration was performed, forming a "cushion" for entering the submucosal tunnel; then, using an endoscopic knife type "Q", an initiating incision was made, and an entrance to the submucosal tunnel was formed; dissection of the submucosal layer was performed with coagulation of the feeding vessels to the level of the pylorus, extending the tunnel to the pylorus; after which, along the greater curvature in the lumen of the tunnel, parallel partial peroral antral myotomy was performed, while preserving the muscular layer of the pylorus, in the proximal direction with a length of about 11 cm (from 10 to 12 cm); hemostasis was performed using endoscopic forceps for "hot" biopsy (hemostasis was controlled - dry); The mucosal defect in the lower third of the stomach body, in the area of ​​the entrance to the tunnel, was closed using a ligature and six endoclips (Fig. 1).

[0046] The second stage involved performing intraluminal gastric banding (Fig. 2): the endoscope with the endoscopic suturing system mounted on it was inserted into the gastric lumen; a continuous suture was placed in several rows at the border of the cardiac region and the body of the stomach, starting from the anterior wall along the greater curvature towards the posterior wall and then in the opposite direction, aimed at dividing the lumen into two unequal parts and creating an upper pocket of small volume, thus forming an intraluminal cuff that gave the stomach an hourglass shape, where the upper small pocket of the stomach, when filled, leads to early satiety during meals.

[0047] The suture constricts the stomach, limits the amount of food the patient can eat at one meal, and ensures a rapid feeling of satiety by mechanically reducing the stomach's volume. Myotomy of the antrum and pylorus slows gastric emptying.

[0048] The postoperative period was uneventful. Two hours after the procedure, the patient was in satisfactory condition. He was discharged home on the fourth day without any serious adverse events. Due to the development of early satiety, the patient consumed less food, resulting in weight loss. One month after surgery, the patient's weight was 152 kg, and three months after surgery, it was 145 kg. The total body weight loss after three months was 14.7%, and the reduction in excess body weight was 26.6%. The patient also noted improved well-being and quality of life, as well as greater tolerance to physical activity.

[0049] After 3 months, a control EGDS was performed to assess the condition of the cuff - the suture is sound and performs its function.

[0050] Patient weight loss rates after 3 months demonstrate comparable results to endoscopic reduction gastroplasty, while the significantly lower material costs during intraluminal gastric banding in combination with bariatric endoscopic antral myotomy are noteworthy, making this bariatric technique an attractive alternative.

Claims

A method for treating obesity involving peroral endoscopic antral myotomy characterized in that, in the first stage, an entrance to a submucosal tunnel is made in the lower third of the stomach along the greater curvature, followed by the formation of a submucosal tunnel up to the pylorus, a partial peroral myotomy is performed proximally, preserving the muscular layer of the pylorus, and then clipping of the mucosal defect in the area of ​​the tunnel entrance; in the second stage, an endoscope with an endoscopic suturing system mounted thereon is inserted into the lumen of the stomach, and a continuous suture is applied at the border of the cardiac region and the body of the stomach, starting from the anterior wall along the greater curvature towards the posterior wall, and then in the opposite direction, dividing the lumen of the stomach into two unequal parts in the form of an "hourglass" with the formation of a small-volume upper pocket.

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