Automatic endoscopic gastroplasty for the treatment of obesity: results from a prospective multicenter study (with video).

BACKGROUND AND AIMS: EndoZip (Nitinotes Ltd, Cesarea, Israel) is a fully automated, operator-independent robotic endoscopic suturing device developed for gastric volume reduction and treatment of obesity. We aim to assess the efficacy and safety of EndoZip to treat patients with obesity. METHODS: We conducted a prospective multicenter study and recruited 45 patients with a body mass index of 30 to 40 kg/m2. Our primary outcome was to assess the percentage of total body weight loss (%TBWL) at 12 months. The secondary outcome was to determine the safety and change in quality of life using the Influence of Weight on the Quality of Life questionnaire at 1 year. RESULTS: The mean ± standard deviation age was 44.2 ± 8.8 years, and the mean ± standard deviation body mass index was 34.5 ± 2.9 kg/m2. A majority (90.7%) of patients were female. The procedure was technically successful in all patients (100%). A median of 4 (range, 3-5) full-thickness sutures were placed, and the mean procedure time was 30.8 ± 15.8 minutes. At 12 months, the mean %TBWL was 13.21 (95% confidence interval, 10.11-16.31), and 76.6% of patients achieved ≥5% TBWL. We observed significant reduction in waist circumference, glycated hemoglobin, and alanine aminotransferase levels at 12 months (P < .001). We found a significant improvement in quality of life at 12 months (51.28 ± 16.22 vs 35.8 ± 11.9, P < .001). Serious adverse events occurred in 2 patients (4.4%). The average length of stay was 1 day. CONCLUSIONS: Our first-in-human study showed that the EndoZip device is safe and effective in treating obesity. The weight loss led to changes in comorbidities and improvement in quality of life. (Clinical trial registration number: NCT04773795.).

Prospective, single-arm multicenter, international, observational postmarket study to assess the safety and efficacy of a triangulation platform for treating patients requiring endoscopic gastroplasty.

BACKGROUND AND AIMS: Gastric restriction techniques have recently emerged as minimally invasive bariatric procedures. Endoscopic sutured gastroplasty (ESG) with the Endomina (Endo Tools Therapeutics, Gosselies, Belgium) triangulation platform proved to be safe and effective for the treatment of class I and II obesity in prospective studies. In this registry, we aimed to further assess on a larger scale the safety and efficacy of the procedure in routine practice with a dedicated device. METHODS: This was a multicenter, observational, prospective post-market study including patients with obesity undergoing Endomina ESG. The primary safety outcome was the occurrence of serious adverse device effects (SADEs) at 12 months. The primary efficacy outcome was the technical success defined by completing the procedure without premature abortion owing to technical issues. The rates of procedure-related adverse events, weight loss outcomes, and quality of life changes were collected. RESULTS: A total of 142 patients underwent ESG in 3 centers from July 2020 to March 2023. Of these, 67 (mean body mass index, 38.5 ± 6.3 kg/m2) reached at least 12 months of follow-up up to October 2022. Technical success was 100%. No SADEs occurred. Seven mild procedure-related adverse events were reported overall. Mean percentage of excess weight loss and total body weight loss at 12 months' follow-up were 48.5% ± 38.6 and 15.3% ± 10.6, respectively (n = 67). Improved quality of life was observed following ESG. CONCLUSIONS: ESG is safe and effective, thus offering a satisfactory therapeutic option for a wide range of obese patients on a large scale.

Curriculum for bariatric endoscopy and endoscopic treatment of the complications of bariatric surgery: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

Obesity is a chronic, relapsing, degenerative, multifactorial disease that is associated with many co-morbidities. The global increasing burden of obesity has led to calls for an urgent need for additional treatment options. Given the rapid expansion of bariatric endoscopy and bariatric surgery across Europe, the European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize and enhance training in bariatric endoscopy and the endoscopic treatment of bariatric surgical adverse events. This manuscript represents the outcome of a formal Delphi process resulting in an official Position Statement of the ESGE and provides a framework to develop and maintain skills in bariatric endoscopy and the endoscopic treatment of bariatric surgical adverse events. This curriculum is set out in terms of the prerequisites prior to training, minimum number of procedures, the steps for training and quality of training, and how competence should be defined and evidenced before independent practice. 1: ESGE recommends that every endoscopist should have achieved competence in upper gastrointestinal endoscopy before commencing training in bariatric endoscopy and the endoscopic treatment of bariatric surgical adverse events. 2: Trainees in bariatric endoscopy and the endoscopic treatment of the complications of bariatric surgery should have basic knowledge of the definition, classification, and social impact of obesity, its pathophysiology, and its related co-morbidities. The recognition and management of gastrointestinal diseases that are more common in patients with obesity, along with participation in multidisciplinary teams where obese patients are evaluated, are mandatory. 3 : ESGE recommends that competency in bariatric endoscopy and the endoscopic treatment of the complications of bariatric surgery can be learned by attending validated training courses on simulators initially, structured training courses, and then hands-on training in tertiary referral centers.

The evolution and current state of bariatric endoscopy in Western countries.

With the alarmingly increasing prevalence of obesity in the Western world, it has become necessary to provide more acceptable treatment options for patients with obesity. Minimally invasive endoscopic techniques are continuously evolving. Currently, metabolic and bariatric endoscopies encompass several different techniques that can offer significant weight loss and improvement in comorbidities with a favorable safety profile. Restrictive bariatric procedures include the use of intragastric balloons and gastric remodeling techniques with different suturing devices. Several studies have demonstrated the efficacy and safety of these techniques that are widely used in clinical practice. Small intestine-targeted metabolic endoscopy is an intriguing and rapidly evolving field of research, although it is not widespread in routine practice. These techniques include duodenal-jejunal bypass liners, duodenal mucosal resurfacing, and incisionless anastomoses. The aim of this review article is to provide a detailed update on the currently available bariatric endoscopy techniques in Western countries.

Impenetrable Abdomen: A Case Report of Endoscopic Sleeve Gastroplasty Performed in Patient with Huge Paramedian Laparocele.

INTRODUCTION: Bariatric surgical techniques have demonstrated scientific efficacy and interventional safety; however, these approaches are not universally appropriate for all patients. The term "impenetrable abdomen" refers to the inability to achieve surgical access to the abdominal cavity, a condition that may arise from several underlying factors. Endoscopic sleeve gastroplasty (ESG) is proposed as a safe and effective technique in this subgroup of patients with obesity. MATERIALS AND METHODS: A 56-year-old Caucasian woman with an impenetrable abdomen due to the presence of a large left paramedian laparocele underwent ESG (Fig. 1) to our unit. An abdominal computed tomography (CT) scan revealed a substantial laparocele in the left paramedian region, involving the tenuous loops, mesentery, and part of the transverse colon. The patient body mass index (BMI) at presentation was 47.15 kg/m2 (116 kg per 1.57 m). Comorbidities included obstructive sleep apnea syndrome (OSAS), requiring nocturnal continuous positive airway pressure (CPAP) therapy, hepatic steatosis, hypertension, hypertriglyceridemia, and hypovitaminosis D. The case was discussed with our multidisciplinary board team (MDT), who agreed to proceed with the ESG. The endoscopic procedure was performed in the supine position, using the Overstitch device and lasted 58 min. No intraprocedural or post-procedural complications/adverse events have been observed. The patient resumed a liquid diet on the first postoperative day and was discharged from the hospital 24 h after the procedure in good clinical condition. RESULTS: Regular outpatient follow-up visits showed significant reduction of the BMI at 6 months post-procedure with a value of 34.9 kg/m2 compared with the initial value of 47.1 kg/m2. Additionally, the patient's use of nocturnal CPAP for OSAS was successfully discontinued suggesting an improvement in her respiratory condition as a result of weight loss. Moreover, there was a notable reduction in the pharmacological management required for arterial hypertension. These outcomes underscore the positive impact of selecting the most appropriate therapeutic strategy for each patient with obesity through a multidisciplinary team approach. CONCLUSION: In our experience, we confirm that endoscopic sleeve gastroplasty is both feasible and safe in patients presenting with an impenetrable abdomen. Despite the minimally invasive approach, this technique has proven effective in terms of body weight loss and reduction of obesity related compared with bariatric surgery.

Endoscopic sleeve gastroplasty for metabolic dysfunction-associated steatotic liver disease.

INTRODUCTION: Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly nonalcoholic fatty liver disease - NAFLD) is a chronic liver condition linked to obesity and metabolic syndrome. It affects one-third of people globally and, in some cases, can lead to metabolic dysfunction-associated steatohepatitis (MASH, formerly nonalcoholic steatohepatitis, NASH) and fibrosis. Weight loss is crucial for the treatment of MASLD, but diet and lifestyle modifications often fail. AREAS COVERED: In recent years, endoscopic sleeve gastroplasty (ESG) has gained popularity as an effective and minimally invasive option for obesity treatment, with widespread use worldwide. We present a current overview of the most significant studies conducted on ESG for the management of obesity and MASLD. Our report includes data from published studies that have evaluated the impact of ESG on noninvasive hepatic parameters used to estimate steatosis and fibrosis. However, at present, there are no data available on liver histology. EXPERT OPINION: ESG has shown promising results in treating MASLD evaluated by noninvasive tests, but current data is limited to small, nonrandomized studies. More research is needed, particularly on the effects of ESG on histologically proven MASH. If future research confirms its efficacy, ESG may be incorporated into treatment guidelines in the future.

Management of fistulas in the upper gastrointestinal tract.

Fistulas in the upper gastrointestinal (GI) tract are complex conditions associated with elevated morbidity and mortality. They may arise as a result of inflammatory or malignant processes or following medical procedures, including endoscopic and surgical interventions. The management of upper GI is often challenging and requires a multidisciplinary approach. Accurate diagnosis, including endoscopic and radiological evaluations, is crucial to build a proper and personalized therapeutic plan, that should take into account patient's clinical conditions, time of onset, size, and anatomical characteristics of the defect. In recent years, several endoscopic techniques have been introduced for the minimally invasive management of upper GI fistulas, including through-the-scope and over-the-scope clips, stents, endoscopic suturing, endoluminal vacuum therapy (EVT), tissue adhesives, endoscopic internal drainage. This review aims to discuss and detail the current available endoscopic techniques for the treatment of upper GI fistulas.

Efficacy and safety of a single-use cholangioscope for percutaneous transhepatic cholangioscopy.

Background and study aims Percutaneous transhepatic cholangioscopy (PTCS) is a management option for patients in whom peroral cholangioscopy or endoscopic retrograde cholangiopancreatography (ERCP) fail. We conducted a case series on the efficacy and safety of PTCS using a cholangiopancreatoscope cleared by the US Food and Drug Administration in 2020. Patients and methods Fifty adult patients scheduled for PTCS or other cholangioscopic procedure were enrolled at seven academic medical centers and followed for 30 days after the index procedure. The primary efficacy endpoint was achievement of clinical intent by 30 days after the index PTCS procedure. Secondary endpoints included technical success, procedure time, endoscopist ratings of device attributes on a scale of 1 to 10 (best), and serious adverse events (SAEs) related to the device or procedure. Results Patients had a mean age of 64.7±15.9 years, and 60.0% (30/50) were male. Forty-four patients (88.0%) achieved clinical intent by 30 days post-procedure. The most common reasons for the percutaneous approach were past (38.0%) or anticipated (30.0%) failed ERCP. The technical success rate was 96.0% (48/50), with a mean procedure time of 37.6 minutes (SD, 25.1; range 5.0-125.0). The endoscopist rated the overall ability of the cholangioscope to complete the procedure as a mean 9.2 (SD, 1.6; range 1.0-10.0). Two patients (4.0%) experienced related SAEs, one of whom had a fatal periprocedure aspiration. Conclusions PTCS is an important endoscopic option for selected patients with impossible retrograde access or in whom ERCP fails. Because of the associated risk, this technique should be practiced by highly trained endoscopists at high-volume centers. (ClinicalTrials.gov number, NCT04580940).

Success Predictors of Endoscopic Sleeve Gastroplasty.

OBJECTIVE: Endoscopic sleeve gastroplasty (ESG) is a minimally invasive procedure that proved to be safe and effective in obesity treatment. However, not all subjects respond to treatment in the same way, and, with a view to personalized care, it is essential to identify predictors of success or failure. METHODS: A retrospective 2-year followed-up cohort of ESG subjects was analyzed to investigate the presence of any baseline or early indicators of long-term optimal or suboptimal ESG outcomes. RESULTS: A total of 315 subjects (73% women) were included, with 73% of patients exhibiting an Excess weight loss percentage (%EWL) >25% at the 24 months. Neither demographic parameters (age and sex), smoking habits, and menopause in women nor the presence of comorbidities proved potential predictive value. Interestingly, the %EWL at 1 month after ESG was the strongest predictor of 24-month therapeutic success. Subsequently, we estimated an "early threshold for success" for 1 month-%EWL by employing Youden's index method. CONCLUSIONS: ESG is a safe and effective bariatric treatment that can be offered to a wide range of subjects. Early weight loss seems to impact long-term ESG results significantly and may allow proper early post-operative care optimization.

Long-term Outcomes of Transoral Outlet Reduction (TORe) for Dumping Syndrome and Weight Regain After Roux-en-Y Gastric Bypass.

BACKGROUND: Both weight regain and dumping syndrome (DS) after Roux-en-Y gastric bypass (RYGB) have been related to the dilation of gastro-jejunal anastomosis. The aim of this study is to assess the safety and long-term efficacy of endoscopic transoral outlet reduction (TORe) for DS and/or weight regain after RYBG. MATERIALS AND METHODS: A retrospective analysis was performed on a prospective database. Sigstad's score, early and late Arts Dumping Score (ADS) questionnaires, absolute weight loss (AWL), percentage of total body weight loss (%TBWL), and percentage of excess weight loss (%EWL) were assessed at baseline and at 6, 12, and 24 months after TORe. RESULTS: Eighty-seven patients (median age 46 years, 79% female) underwent TORe. The median baseline BMI was 36.2 kg/m2. Out of 87 patients, 58 were classified as "dumpers" due to Sigstad's score ≥ 7. The resolution rate of DS (Sigstad's score < 7) was 68.9%, 66.7%, and 57.2% at 6, 12, and 24 months after TORe, respectively. A significant decrease in Sigstad's score as well as in early and late ADS questionnaires was observed (p < 0.001). The median Sigstad's score dropped from 15 (11-8.5) pre-operatively to 2 (0-12) at 24 months. The %TBWL was 10.5%, 9.9%, and 8.1% at 6, 12, and 24 months, respectively. Further, "dumpers" with resolution of DS showed better weight loss results compared with those with persistent DS (p < 0.001). The only adverse event observed was a perigastric fluid collection successfully managed conservatively. CONCLUSION: TORe is a minimally invasive treatment for DS and/or weight regain after RYGB, with evidence of long-term efficacy.

Impact of Pregnancy on Weight Loss After Endoscopic Sleeve Gastroplasty.

PURPOSE: Obesity and pregnancy are strictly related: on the one hand, obesity-one of the most common comorbidities in women of reproductive age-contributes to infertility and obesity-related pregnancy complications, whereas pregnancy is a condition in which, physiologically, the pregnant woman undergoes weight gain. Endoscopic sleeve gastroplasty (ESG) may be used for the treatment of obesity in women of childbearing age. MATERIALS AND METHODS: A retrospective analysis was conducted to evaluate weight trajectories, the evolution of obesity-related comorbidities, and lifestyle modification in women who became pregnant after ESG. A comparison was made between childbearing-age women who became pregnant after ESG and non-pregnant women. RESULTS: A total of 150 childbearing-age women underwent ESG at a large tertiary medical center. Of these, 11 patients (33.4 ± 6.2 years) became pregnant after the procedure, following a mean time interval of 5.5 ± 3.9 months. Three women (two affected by polycystic ovary syndrome) reported difficulty getting pregnant before undergoing ESG. The mean preconception BMI was 31.9±4.0 kg/m2 (-7.24 ± 4.0 kg/m2 after ESG). Total body weight loss (TBWL, %) was 18.08 ± 8.00, 11.00 ± 11.08, and 12.08 ± 8.49, at the beginning of pregnancy, at the delivery, and at the first follow-up (19.6 ± 7.8 months after ESG). TBWL of at least 5% was achieved before pregnancy in all patients (73% reached a TBWL ≥ 10%). No significant differences in weight loss and QoL were found between the pregnancy and non-pregnancy groups up to 24 months after ESG. CONCLUSIONS: Endoscopic sleeve gastroplasty allows for adequate weight loss before and after pregnancy in patients with obesity.

Weight Recidivism and Dumping Syndrome after Roux-En-Y Gastric Bypass: Exploring the Therapeutic Role of Transoral Outlet Reduction.

Obesity is a chronic, relapsing disease representing a global epidemic. To date, bariatric surgery is the most effective treatment for morbid obesity in the long-term. Roux-en-Y gastric bypass (RYGB) is one of the most performed bariatric interventions, with excellent long-term outcomes. However, about one-third of patients may experience weight regain over time, as well as dumping syndrome. Both these conditions are challenging to manage and require a multidisciplinary and personalized approach. The dilation of the gastro-jejunal anastomosis is a recognized etiological factor for both weight regain and dumping syndrome. Dietary modifications, behavioral interventions, and medications represent the first therapeutic step. Revisional surgery is the traditional approach when non-invasive treatments fail. However, re-interventions may be technically difficult and are associated with increased morbidity and mortality. Transoral outlet reduction (TORe) is an endoscopic procedure aimed at reducing the size of the anastomosis and is proposed as a minimally invasive treatment of weight regain and/or dumping syndrome refractory to conservative therapies. This review is aimed at providing a narrative overview of the role of TORe as part of the multidisciplinary therapeutic toolkit nowadays available to approach weight regain and dumping syndrome after RYGB.

Outcomes of Endoscopic Sleeve Gastroplasty in the Elder Population.

PURPOSE: With the aging of the population and the epidemic spread of obesity, the frequency of older individuals with obesity is steadily growing. To date, no data evaluating the use of endoscopic sleeve gastroplasty (ESG) in the elderly have been published. In this case series, we evaluate the short- and medium-term outcomes of ESG in patients with obesity aged 65 years and older. MATERIALS AND METHODS: A retrospective analysis was done on a prospective database; patients aged 65 years and older were included in our analysis. EWL%, TBWL%, the Bariatric Analysis and Reporting Outcome System (BAROS) questionnaire, and the presence of comorbidities were assessed. RESULTS: Eighteen patients aged 65 years and older underwent ESG between November 2017 and July 2021. The median age was 67 years and the mean baseline BMI was 41.2 kg/m2. After ESG, the median TBWL% was 15.1%, 15.5%, and 15.5% at 6, 12, and 24 months, while the median %EWL was 39%, 37%, and 41% at 6, 12, and 24 months, respectively. The median BAROS score was 3.0, 3.4, and 2.5 at 6, 12, and 24 months, respectively. Six out of twelve patients with hypertension and 3/4 diabetic patients reduced or removed their medications within 12 months following ESG. Two out of six patients with OSA stopped therapy with CPAP. No adverse events were recorded. CONCLUSION: According to our experience, ESG is a promising therapeutic option for elder individuals with obesity who fail non-invasive methods, and who refuse or are deemed not suitable for bariatric surgery because of age and comorbidities.