Endoscopic sleeve gastroplasty in class Ⅲ obesity:Efficacy, safety, and durability outcomes in 404 consecutive patients

BACKGROUND Endoscopic sleeve gastroplasty(ESG) is an effective therapy for class Ⅰ-Ⅱ obesity, but there are knowledge gaps in the published literature about its implementation in patients with class Ⅲ obesity [body mass index(BMI) ≥ 40 kg/m2].AIM To evaluate the safety, clinical efficacy, and durability of ESG in adults with class Ⅲ obesity.METHODS This was a retrospective cohort study that used prospectively collected data on adults with BMI ≥ 40 kg/m2who underwent ESG and longitudinal lifestyle counseling at two centers with expertise in endobariatric therapies from May 2018-March 2022. The primary outcome was total body weight loss(TBWL) at 12 mo. Secondary outcomes included changes in TBWL, excess weight loss(EWL) and BMI at various time points up to 36 mo, clinical responder rates at 12 and 24 mo, and comorbidity improvement. Safety outcomes were reported through the study duration. One-way ANOVA test was performed with multiple Tukey pairwise comparisons for TBWL, EWL, and BMI over the study duration.RESULTS 404 consecutive patients(78.5% female, mean age 42.9 years, mean BMI 44.8 ± 4.7 kg/m2) were enrolled. ESGs were performed using an average of 7 sutures, over 42 ± 9 min, and with 100% technical success. TBWL was 20.9 ± 6.2% at 12 mo, 20.5 ± 6.9% at 24 mo, and 20.3 ± 9.5% at 36 mo. EWL was 49.6 ± 15.1% at 12 mo, 49.4 ± 16.7% at 24 mo, and 47.1 ± 23.5% at 36 mo. There was no difference in TBWL at 12, 15, 24, and 36 mo from ESG. TBWL exceeding 10%, 15%, and 20% was achieved by 96.7%, 87.4%, and 55.6% of the cohort at 12 mo, respectively. Of the cohort with the relevant comorbidity at time of ESG, 66.1% had improvement in hypertension, 61.7% had improvement in type Ⅱ diabetes, and 45.1% had improvement in hyperlipidemia over study duration. There was one instance of dehydration requiring hospitalization(0.2% serious adverse event rate).CONCLUSION When combined with longitudinal nutritional support, ESG induces effective and durable weight loss in adults with class Ⅲ obesity, with improvement in comorbidities and an acceptable safety profile.

Gallbladder plication as a rare complication of endoscopic sleeve gastroplasty:A case report

Endoscopic sleeve gastroplasty(ESG)is a minimally invasive procedure used in the treatment of obesity,with a complication rate of less than 2%of cases.There have been only two reported cases worldwide of gallbladder injuries as a major complication of ESG.CASE SUMMARY We present the case of a 34-year-old patient who developed a complication after ESG.The patient experienced epigastric and right hypochondrium pain 12 h after the procedure,and a positive Murphy’s sign was identified on physical examination.Laboratory results showed a leukocyte count of 17×10^(3)/μL,and computed tomography indicated the presence of free fluid in the pelvic cavity and perihepatic recesses as well as a possible suture in the wall of the Hartmann’s pouch toward the anterior surface of the stomach.A diagnostic laparoscopy was performed,revealing plication of the Hartmann’s pouch wall to the anterior stomach wall.Laparoscopic cholecystectomy and lavage were carried out.The patient had a stable recovery and was discharged 72 h after surgery,tolerating oral intake.CONCLUSION Gallbladder plication should be suspected if signs and symptoms consistent with acute cholecystitis occur after ESG.

Current status of endoscopic sleeve gastroplasty: An opinion review

Bariatric surgeries have been demonstrated to be safe and effective treatment options for morbid obesity patients, but operative risks and high health care costs limit their clinical application. Endoscopic bariatric therapies are emerging as valuable alternatives for patients with doubts about bariatric surgery or ineligible for it. Endoscopic sleeve gastroplasty(ESG), a relatively novel technique of endoscopic bariatric therapies, has gained standing in the past few years. The safety, feasibility, repeatability, and potential for reversibility of ESG have been proven by multicenter studies. Compared to other weight loss strategies, current evidence demonstrates that ESG offers satisfactory efficacy in weight loss. Even though it is inferior to laparoscopic sleeve gastrectomy, it has lower risks of adverse events than surgical interventions and intragastric balloon within oneyear follow-up. Furthermore, ESG may be the ideal weight control strategy for patients who have poor adherence to behavioral interventions. Even so, trends in decreased weight loss effect over time, post-procedure weight regain, postprocedure gut hormone alteration, and possible effects of race and ethnicity on ESG still remain undetermined due to very limited reports and very short followups. Further clinical trials are required to validate and answer these questions.

Endoscopic sleeve gastroplasty: From whence we came and where we are going

The most effective and durable treatment for obesity is bariatric surgery.However,less than 2% of eligible patients who fulfill the criteria for bariatric surgery undergo the procedure. As a result,there is a drive to develop less invasive therapies to combat obesity. Endoscopic bariatric therapies(EBT) for weight loss are important since they are more effective than pharmacological treatments and lifestyle changes and present lower adverse event rates compared to bariatric surgery. Endoscopic sleeve gastroplasty(ESG) is a minimally invasive EBT that involves remodeling of the greater curvature. ESG demonstrated favorable outcomes in several centers,with up to 20.9% total body weight loss and 60.4% excess weight loss(EWL) on 2-year follow-up,with a low rate of severe adverse events(SAE). As such,it could be considered safe and effective in light of ASGE/ASMBS thresholds of > 25% EWL and ≤ 5% SAE,although there are no comparative trials to support this. Additionally,ESG showed improvement in diabetes mellitus type 2,hypertension,and other obesity-related comorbidities. As this procedure continues to develop there are several areas that can be addressed to improve outcomes,including device improvements,technique standardization,patient selection,personalized medicine,combination therapies,and training standardization. In this editorial we discuss the origins of the ESG,current data,and future developments.

Long-term results after revisions of failed primary vertical banded gastroplasty

AIM: To compare the results after revision of primary vertical banded gastroplasty(Re-VBG) and conversion to sleeve gastrectomy(cS G) or gastric bypass(cR YGB).METHODS: In this retrospective single-center study, all patients with a failed VBG who underwent revisional surgery were included. Medical charts were reviewed and additional postal questionnaires were sent to update follow-up. Weight loss, postoperative complications and long-term outcome were assessed. RESULTS: A total 152 patients were included in this study, of which 21 underwent Re-VBG, 16 underwent c SG and 115 patients underwent c RYGB. Sixteen patients necessitated a second revisional procedure. No patients were lost-to-follow-up. Two patients deceased during the follow-up period, 23 patients did not return the questionnaire. Main reasons for revision were dysphagia/vomiting, weight regain and insufficient weight loss. Excess weight loss(%EWL) after Re-VBG, cS G and cR YGB was, respectively, 45%, 57% and 72%. Eighteen patients(11.8%) reported postoperative complications and 27% reported long-term complaints. CONCLUSION: In terms of additional weight loss, postoperative complaints and reintervention rate, Rouxen-Y gastric bypass seems feasible as a revision for a failed VBG.

Gastric Bezoar after Vertical Banded Gastroplasty: A Case Report and Review of the Literature

Gastric bezoars are uncommon in the bariatric surgery population. Though popular in earlier decades, the Vertical Banded Gastroplasty (VBG) is no longer a staple procedure in the United States. It has been supplanted by the Roux-en-Y gastric bypass (RYGBP) and the laparoscopic adjustable gastric band (LAGB) as the most commonly performed bariatric procedures. However, there are many patients who have previously undergone VBGs, and may present with associated complications. We present a case of a gastric obstruction caused by a bezoar in a patient who had a VBG fifteen years prior to presentation.

Endoscopic treatment of staple line disruption in patient with vertical banded gastroplasty using the over-the-scope-clip system (with video)

Background: scope-clip (OTSC;Ovesco Endoscopy GmbH, Tuebingen, Germany) system is a newly designed method for the mechanical compression of large areas in the gastrointestinal tract. So far, indications for OTSC application are hemostasis of pri-mary or post-interventional bleeding, closure of iatrogenic full-thickness or covered perforations. Recently closure of gastrointestinal tract fistulas using this device has been described. Objective: In this case, we describe the successful endoscopic closure, using the OTSC system, of a gastrogastric fistula due to staple line disruption in patient with vertical banded gastroplasty. Conclusion: Endoscopic application of the OTSC device is safe and effective for the treatment of a staple line disruption.

How to establish an endoscopic bariatric practice

Obesity is a chronic,progressive,and relapsing disease of excess adiposity that contributes to more than two hundred medical conditions and is projected to affect more than half the adult population of the United States by the year 2030.Given the limited penetrance of traditional bariatric surgery,as well as the cost and adherence barriers to anti-obesity medications,there is growing interest in the rapidly evolving field of endoscopic bariatric therapies(EBTs).EBTs are minimally invasive,same-day,per-oral endoscopic procedures and include endoscopic sleeve gastroplasty,intragastric balloons,and endoscopic bariatric revisional procedures.This field represents an exciting and innovative subspe-cialty within gastroenterology.However,building a successful endoscopic bariatric practice requires intentional,coordinated,and sustained efforts to overcome the numerous obstacles to entry.Common barriers include acquisition of the technical and cognitive skillset,practice limitations including the availability of nutrition counseling,facility capabilities,direct-to-consumer marketing,and financial pressures such as facility and anesthesia fees.As the highest-volume center for metabolic and bariatric endoscopy in the United States,we provide insights into successfully establishing an endoscopic bariatric program.

Hybrid Duodenal Transit Bipartition: An Endoscopic and Laparoscopic Metabolic Procedure

Obesity has been increasing significantly in Brazil and worldwide, becoming a major public health issue. Traditional prevention and treatment strategies, including behavioral interventions, nutritional modifications, physical activity, pharmacotherapy, and metabolic/bariatric procedures, have proven insufficient to reverse this trend. Bariatric surgery is recognized as the most effective treatment for obesity and its comorbidities, but it carries potential long-term risks. Hybrid Duodenal Transit Bipartition is proposed as a minimally invasive “endobariatric” procedure combining endoscopic sleeve gastroplasty (ESG) with laparoscopic duodenoileal or distal duodenojejunal anastomosis. The main objective of this study is to demonstrate the importance of the intestinal metabolic component of hybrid duodenal transit bipartition. This intestinal component is responsible for optimizing and attempting to maintain weight loss and control comorbidities from an ESG through the incretin stimulus generated by the early arrival of food in the ileum or distal jejunum (duodenoileal or distal duodenojejunal anastomosis). Additionally, it is a minimally invasive procedure that preserves the entire digestive system and does not involve gastrointestinal exclusion, allowing for endoscopic and nutritional access. To date, only one patient has undergone the hybrid duodenal bipartition procedure, with satisfactory early postoperative results at 60 days and weight loss exceeding the scientific literature on patients who underwent isolated endoscopic sleeve gastroplasty. Further studies are needed to validate these results and assess the long-term metabolic benefits of this new approach.

Effects on physiologic measures of appetite from intragastric balloon and endoscopic sleeve gastroplasty: results of a prospective study

Background: Endoscopic bariatric therapies can help address widening management gaps in obesity. Their ability to facilitate weight loss is largely tied to influences on appetite through perturbations of gastric emptying and accommodation. As these tools gain traction in obesity therapy, their physiologic underpinnings require exploration, which may enhance efficacy, tolerance, and patient-tailored care.Methods: We prospectively assessed consecutive subjects with fluid-filled intragastric balloons (IGBs) (n = 18) placed between October 2016 and June 2017 or underwent endoscopic sleeve gastroplasty (ESG) (n = 23) from March 2018 to June 2018. Patients underwent physiologic appraisal at 3 months with13C-spirulina-based gastric emptying breath test to determine time to half emptying (T50), as well as maximum tolerated volume (MTV) of a standard nutrient drink test. Changes in T50 and MTV at 3 months were compared with percent total body weight loss (%TBWL) at 3 and 6 months using best-fit linear regression.Results: The change in T50 at 3 months correlated with %TBWL at 3 months for IGB (P = 0.01) and ESG (P = 0.01) but with greater impact on %TBWL in IGB compared to ESG (R2 = 0.42vs. 0.26). Change in T50 at 3 months was predictive of weight loss at 6 months for IGB (P = 0.01) but not ESG (P = 0.11). ESG was associated with greater decrease in MTV compared to IGB (340.25 ± 297.97 mLvs. 183.00 ± 217.13 mL,P = 0.08), indicting an enhanced effect on satiation through decreased gastric accommodation. Changes in MTV at 3 months did not correlate with %TBWL for either IGB (P = 0.26) or ESG (P = 0.49) but trended toward significance for predicting %TBWL at 6 months for ESG (P = 0.06) but not IGB (P = 0.19).Conclusion: IGB and ESG both induce weight loss but likely through distinct gastric motor function phenotypes, and gastric emptying may predict future weight loss in patients with IGB.

Endoscopic foregut surgery and interventions:The future is now.The state-of-the-art and my personal journey

In this paper, I reviewed the emerging field of endoscopic surgery and present data supporting the contention that endoscopy can now be used to treat many foregut diseases that have been traditionally treated surgically. Within each topic,the content will progress as follows: "lessons learned", "technical considerations"and "future opportunities". Lessons learned will provide a brief background and update on the most current literature. Technical considerations will include my personal experience, including tips and tricks that I have learned over the years.Finally, future opportunities will address current unmet needs and potential new areas of development. The foregut is defined as "the upper part of the embryonic alimentary canal from which the pharynx, esophagus, lung, stomach, liver,pancreas, and part of the duodenum develop". Foregut surgery is well established in treating conditions such as gastroesophageal reflux disease(GERD), achalasia, esophageal diverticula, Barrett's esophagus(BE) and esophageal cancer, stomach cancer, gastric-outlet obstruction, and obesity. Over the past decade, remarkable progress in interventional endoscopy has culminated in the conceptualization and practice of endoscopic foregut surgery for various clinical conditions summarized in this paper. Regarding GERD, there are now several technologies available to effectively treat it and potentially eliminate symptoms, and the need for long-term treatment with proton pump inhibitors.For the first time, fundoplication can be performed without the need for open or laparoscopic surgery. Long-term data going out 5-10 years are now emerging showing extended durability. In respect to achalasia, per-oral endoscopic myotomy(POEM) which was developed in Japan, has become an alternative to the traditional Heller's myotomy. Recent meta-analysis show that POEM may have better results than Heller, but the issue of post-POEM GERD still needs to be addressed. There is now a resurgence of endoscopic treatment of Zenker's diverticula with improved technique(Z-POEM) and equipment; thus, patients are choosing flexible endoscopic treatment as opposed to open or rigid endoscopy options. In regard to BE, endoscopic submucosal dissection(ESD)which is well established in Asia, is now becoming more mainstream in the West for the treatment of BE with high grade dysplasia, as well as early esophageal cancer. In combination with all the ablation technologies(radiofrequency ablation, cryotherapy, hybrid argon plasma coagulation), the entire spectrum of Barrett's and related dysplasia and early cancer can be managed predominantly by endoscopy.Importantly, in regard to early gastric cancer and submucosal tumors(SMTs) of the stomach, ESD and full thickness resection(FTR) can excise these lesions enbloc and endoscopic suturing is now used to close large defects and perforations.For treatment of patients with malignant gastric outlet obstruction(GOO),endoscopic gastro-jejunostomy is now showing better results than enteral stenting. G-POEM is also emerging as a treatment option for patients with gastroparesis. Obesity has become an epidemic in many western countries and is becoming also prevalent in Asia. Endoscopic sleeve gastroplasty(ESG) is now becoming an established treatment option, especially for obese patients with body mass index between 30 and 35. Data show an average weight loss of 16 kg after ESG with long-term data confirming sustainability. Finally, in respect to endo-hepatology, there are many new endoscopic interventions that have been developed for patients with liver disease. Endoscopic ultrasound(EUS)-guided liver biopsy and EUS-guided portal pressure measurement are exciting new frontiers for the endo-hepatologists.

Esophagogastric anastomosis with invagination into stomach:New technique to reduce fistula formation

AIM: To present a new technique of cervical esophagogastric anastomosis to reduce the frequency of fistula formation. METHODS: A group of 31 patients with thoracic and abdominal esophageal cancer underwent cervical esophagogastric anastomosis with invagination of the proximal esophageal stump into the stomach tube. In the region elected for anastomosis, a transverse myotomy of the esophagus was carried out around the entire circumference of the esophagus. Afterwards, a 4-cm long segment of esophagus was invaginated into the stomach and anastomosed to the anterior and the posterior walls. RESULTS: Postoperative minor complications occurred in 22 (70.9%) patients. Four (12.9%) patients had serious complications that led to death. The discharge of saliva was at a lower region, while attempting to leave the anastomosis site out of the alimentary transit. Three (9.7%) patients had fistula at the esophagogastric anastomosis, with minimal leakage of air or saliva and with mild clinical repercussions. No patients had esophago- gastric fistula with intense saliva leakage from either the cervical incision or the thoracic drain. Fibrotic stenosis of anastomoses occurred in seven (22.6%) patients. All these patients obtained relief from their dysphagia with endoscopic dilatation of the anastomosis.CONCLUSION: Cervical esophagogastric anastomosis with invagination of the proximal esophageal stump into the stomach tube presented a low rate of esophagogastric fistula with mild clinical repercussions.

Organization of future training in bariatric gastroenterology

A world-wide rise in the prevalence of obesity continues. This rise increases the occurrence of, risks of, and costs of treating obesity-related medical conditions. Diet and activity programs are largely inadequate for the long-term treatment of medically-complicated obesity. Physicians who deliver gastrointestinal care after completing traditional training programs, including gastroenterologists and general surgeons, are not uniformly trained in or familiar with available bariatric care. It is certain that gastrointestinal physicians will incorporate new endoscopic methods into their practice for the treatment of individuals with medically-complicated obesity, although the longterm impact of these endoscopic techniques remains under investigation. It is presently unclear whether gastrointestinal physicians will be able to provide or coordinate important allied services in bariatric surgery, endocrinology, nutrition, psychological evaluation and support, and social work. Obtaining longitudinal results examining the effectiveness of this ad hoc approach will likely be difficult, based on prior experience with other endoscopic measures, such as the adenoma detection rates from screening colonoscopy. As a longterm approach, development of a specific curriculum incorporating one year of subspecialty training in bariatrics to the present training of gastrointestinal fellows needs to be reconsidered. This approach should be facilitated by gastrointestinal trainees' prior residency training in subspecialties that provide care for individuals with medical complications of obesity, including endocrinology, cardiology, nephrology, and neurology. Such training could incorporate additional rotations with collaborating providers in bariatric surgery, nutrition, and psychiatry. Since such training would be provided in accredited programs, longitudinal studies could be developed to examine the potential impact on accepted measures of care, such as complication rates, outcomes, and costs, in individuals with medically-complicated obesity.

New Era: Endoscopic treatment options in obesity–a paradigm shift

The prevalence of obesity continues to rise,and along with it comes a multitude of health-related consequences.The healthcare community has consistently struggled with providing treatment options to obese patients,in part due to the reluctance of patients in pursuing the more effective(yet invasive)surgical approaches such as sleeve gastrectomy and Rou-en-Y gastric bypass.On the other hand,the less invasive approach such as lifestyle/behavioral interventions and pharmacotherapy(Orlistat,Phenteramine,Phentermine/Topiramate,Locaserin,Naltrexon/Buproprion,and Liraglutide)have very limited efficacy,especially in the morbidly obese patients.Despite our best efforts,the epidemic of obesity continues to rise and pose enormous costs on our healthcare system and society.Bariatric endoscopy is an evolving field generated to combat this epidemic through minimally invasive techniques.These procedures can be performed in an ambulatory setting,are potentially reversible,repeatable,and pose less complications than their invasive surgical counterparts.These modalities are designed to alter gut metabolism by means of space occupation,malabsorption,or restriction.In this review we will discuss different bariatric endoscopic options(such as intragastric balloons,endoscopic sleeve gastroplasty,endoscopic aspiration therapies and gastrointestinal bypass sleeves),their advantages and disadvantages,and suggest a new paradigm where providers may start incorporating this modality in their treatment approach for obese patients.

Endoscopic therapy of weight regain after bariatric surgery

Weight regain following primary bariatric surgery occurs in a significant proportion of patients and is attributed to epidemiological,anatomical and metabolic factors.Surgical revision of these patients has significant risks and limited benefits.Endoscopic revisions that reduce gastric pouch size and diameter of the gastrojejunal anastomosis may offer an effective,safe,less invasive and even reproducible treatment.We herein discuss the indication,selection and feasibility of different endoscopic techniques that could be used in the management of weight regain following primary bariatric surgery.Future research could optimize a personalized approach not only in the endoscopic management but also in combination with other therapeutic modalities for weight regain after bariatric surgery.

Weight loss endoscopy: Development, applications, and current status

Obesity and its comorbidities- including diabetes and obstructive sleep apnea- have taken a large and increasing toll on the United States and the rest of the world. The availability of commercial, clinical, and operative therapies for weight management have not been effective at a societal level. Endoscopic bariatric therapy is gaining acceptance as more effective than diet and lifestyle measures, and less invasive than bariatric surgery. Various endoscopic therapies are analogues of the restrictive or bypass components of bariatric surgery, utilizing gastric remodeling or intestinal anastomosis to achieve proven weight loss and metabolic benefits. Others, such as aspiration therapy, employnovel mechanisms of action. Intragastric balloons have recently been approved by the United States Food and Drug Administration, and a number of other technologies have completed large multicenter trials(such as AspireA ssist aspiration therapy and Primary Obesity Surgery Endolumenal). Endoscopic sleeve gastroplasty and transoral outlet reduction for endoscopic revision of gastric bypass have proven safe and effective in a number of studies. As devices are approved for use, data will continue to accumulate for safety, effectiveness, and cost effectiveness. Bariatric endoscopists should be prepared to appropriately target and apply various endoscopic bariatric therapies in the context of a comprehensive long-term weight management program.

Advances in endobariatrics:past,present,and future

The obesity epidemic in the USA and worldwide is well documented and continues to grow.Endoscopic metabolic and bariatric therapies may offer a less invasive approach than surgical intervention.This article will review advances in endobariatrics over the last several decades,addressing the past and current state of bariatric and metabolic endoscopy.Food and Drug Administration-cleared devices and interventions currently under investigation are described including gastric devices,gastric remodeling procedures,small-bowel devices,duodenal ablation,as well as procedures to address weight regain after bariatric surgery.Future studies evaluating gastric and duodenal combination therapy,adjunctive pharmacotherapy,as well as individualized precision-health algorithms are underway.