American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥ 30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

Intravenous Hemin, a potential heme oxygenase-1 activator, does not protect from post-ERCP acute pancreatitis in humans: Results of a randomized multicentric multinational placebo-controlled trial.

OBJECTIVE: Hemin, a heme oxygenase 1 activator has shown efficacy in the prevention and treatment of acute pancreatitis in mouse models. We conducted a randomized controlled trial (RCT) to assess the protective effect of Hemin administration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in patients at risk. METHODS: In this multicenter, multinational, placebo-controlled, double-blind RCT, we assigned patients at risk for PEP to receive a single intravenous dose of Hemin (4 mg/kg) or placebo immediately after ERCP. Patients were considered to be at risk on the basis of validated patient- and/or procedure-related risk factors. Neither rectal NSAIDs nor pancreatic stent insertion were allowed in randomized patients. The primary outcome was the incidence of PEP. Secondary outcomes included lipase elevation, mortality, safety, and length of stay. RESULTS: A total of 282 of the 294 randomized patients had complete follow-up. Groups were similar in terms of clinical, laboratory, and technical risk factors for PEP. PEP occurred in 16 of 142 patients (11.3%) in the Hemin group and in 20 of 140 patients (14.3%) in the placebo group (p = 0.48). Incidence of severe PEP reached 0.7% and 4.3% in the Hemin and placebo groups, respectively (p = 0.07). Significant lipase elevation after ERCP did not differ between groups. Length of hospital stay, mortality and severe adverse events rates were similar between groups. CONCLUSION: We failed to detect large improvements in PEP rate among participants at risk for PEP who received IV hemin immediately after the procedure compared to placebo. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov number, NCT01855841).

Pilot study of an endoluminal-suturing device as a treatment for patients with gastroesophageal reflux disease.

Background and study aims Endoscopic therapy is a promising option for patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess safety and feasibility of the Endomina suturing platform as a treatment for GERD. Patients and methods This was a two-center study of patients with chronic GERD symptoms that responded at least partially to proton pump inhibitors (PPIs). Primary endpoints were to assess the safety of the procedure and persistence of the sutures. Secondary endpoints were to assess esophageal pH-impedance and manometry parameters changes at 6 months, as well as GERD symptoms and PPI use up to 12 months of follow-up. Results Fourteen patients were treated (13 males, mean of 43±12 years), with a mean number of three plications per patient. Thirteen, 10, and nine patients were analyzed at 3, 6, and 12 months of follow-up, respectively. One device-related adverse event occurred (loss of needle tip requiring endoscopic retrieval 1 week later). A mean of two plications persisted at 3 and 12 months. A decrease in median acid exposure time and reflux episodes was observed after the procedure. Mean Reflux Symptom Index and GERD-Health-Related Quality of Life scores decreased during follow-up visits and 90% of the patients discontinued PPI use at 1 year. Conclusions Endoscopic full-thickness suturing of the esophagogastric junction with the Endomina suturing platform is feasible, allowing persistence of two-thirds of the plications, with promising results for decreasing reflux and improving GERD symptoms.

Portal cavernography during endoscopic retrograde cholangiopancreatography: from bilhemia to hemobilia.

Portobiliary fistulas are rare but may lead to life-threatening complications. Biliary plastic stent-induced portobiliary fistulas during endoscopic retrograde cholangiopancreatography have been described. Herein, we present a case of portal cavernography and recurrent hemobilia after endoscopic retrograde cholangiopancreatography in which a portobiliary fistula was detected in a patient with portal biliopathy. This likely indicates a change in clinical presentation (from bilhemia to hemobilia) after biliary drainage that was successfully treated by placement of a fully covered, self-expandable metallic stent.

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.

Weight loss after endoscopic sleeve gastroplasty is independent of suture pattern: results from a randomized controlled trial.

Background and study aims This was a single-blind, single-center, prospective randomized controlled trial aimed at comparing the efficacy of three different suture patterns for endoscopic sleeve gastroplasty using Endomina (E-ESG). Patients and methods The suture patterns aimed to modify gastric accommodation by increasing the fundus distention ability (Group A), to reduce gastric volume (Group B) or to interrupt gastric emptying (Group C). Patients were randomized 1:1:1 and underwent clinical follow-up, gastric emptying scintigraphy, and satiety tests at baseline and 6 and 12 months post-procedure. The primary outcome was total body weight loss (TBWL) and excess weight loss (EWL) at 12 months post-procedure. Secondary outcomes included the impact of the suture patterns on gastric emptying and satiety. Results Overall, 48 patients (40 [83.3 %] female, aged 41.9 ±â€Š9.5 years, body mass indexI 33.8 ±â€Š2.7 kg/m 2 ) were randomized (16 in each group). In the entire cohort, mean (95 % confidence interval [CI]) TBWL and EWL at the end of the follow-up were 10.11 % (7.1-13.12) and 42.56 (28.23-56.9), respectively. There was no difference among the three study groups in terms of TBWL (95 %CI) (9.13 % [2.16-16.11] vs. 11.29 % [5.79-16.80] vs. 9.96 % [4.58-15.35]; P  = 0.589) and EWL (95 %CI) (34.54 % [6.09-62.99] vs. 44.75 % [23.63-65.88] vs. 46.94 % [16.72-77.15]; P  = 0.888) at 12 months post-procedure. The three groups did not differ in terms of mean gastric emptying time or in terms of satiety tests at the end of the follow-up. No serious adverse events occurred. Conclusions Three different suture patterns during E-ESG demonstrated comparable efficacy in terms of weight loss, with an overall EWL of > 25 % and TBWL of > 10 % at 12 months.

Nutritional consequences of endoluminal gastroplasty in the treatment of morbidly obese patients.

BACKGROUND: The Endoscopic sleeve gastroplasty (ESG) is one of the new advanced restrictive techniques of bariatric endoscopy. The principle of this bariatric technique is the reduction of stomach volume through endoscopic plication. The long-term efficacy and metabolic effects of this procedure are the subject of this study. METHODS: 20 patients were enrolled; four men, sixteen women. Then they were followed for 24 months in terms of glycemic control, body composition, vitamin, and nutritional status. Observed parameters included glucose, triacylglycerols, high- and low-density lipoprotein cholesterol, micro and macro nutrients, fat mass, and lean body mass. RESULTS: We observed significant weight loss and a decrease body composition resulted from procedure vs. baseline, with levels of blood glucose also showing statistically significant reductions. The most notable decline in measured values was observed in period six months after the procedure. No significant changes were observed in measurement of micronutrients. CONCLUSIONS: Good restriction results were obtained following ESG, which might be mediated via altered glucose metabolism. The ESG method has shown a positive effect on fat and muscle mass. Unlike surgical methods, there were no deficits or deficiencies, especially in terms of essential vitamin levels.

Endoscopic Dilation of Post-Sleeve Gastrectomy Stenosis: Long-Term Efficacy and Safety Results.

INTRODUCTION: Post-sleeve gastrectomy (SG) stenoses occur in about 5% of cases. Hydrostatic dilation (HD) and pneumatic dilation (PD) have been proposed as treatments, but efficacy data remain scarce. Objective is to describe long-term efficacy and safety of HD and PD. METHODS: This retrospective study in a referral endoscopy center included patients with symptomatic post-SG stenosis treated with endoscopic balloon dilation (EBD). Stenosis was defined as "organic" if luminal narrowing was evident, "functional" for a deformation, or "combined." Endoscopic treatment consisted of ≥ 1 HD (15-20 mm) and/or ≥ 1 PD (30-35 mm). Initial success was defined as improvement of stenosis-related symptoms at 1 month and long-term success as persistence of improvement at last follow-up. RESULTS: Forty-four patients (73% women; mean age 45.5 ± 11 years; mean follow-up 26 ± 23 months) underwent EBD between 2013 and 2019. HD and PD were used in 15 (34%) and 29 (66%) patients, respectively, (mean dilation number: 1.8 ± 1.1). Post-SG stenoses were considered organic in 10 (23%), functional in 21 (48%), and combined in 13 (29%) patients. Initial success was achieved in 42 (96%) patients, while 35 (80%) patients had no symptom recurrence at last follow-up. Perforation occurred in one patient. HD was more frequently used in organic stenoses (8/10), while PD in functional and combined stenoses (18/21 and 9/13, respectively; p < 0.001). Rates of success did not differ by type of stenosis. CONCLUSION: Endoscopic dilation is an effective treatment for post-SG stenoses, providing long-term symptom relief. PD should be preferred in cases of functional stenoses, and HD used for organic stenoses.

Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial.

OBJECTIVE: Endoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium). DESIGN: Eligible patients (body mass index 30-40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG. RESULTS: Of the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%. CONCLUSIONS: This study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment. TRIAL REGISTRATION NUMBER: NCT03255005.

Metabolic endoscopy: Today's science-tomorrow's treatment.

Obesity, type 2 diabetes mellitus (T2DM) and nonalcoholic steatohepatitis are increasing pandemic metabolic disorders. Lifestyle intervention (LSI) is the cornerstone treatment for these but is successful as standard care alone in only a few patients, given the modest weight loss at mid and long term. Conversely, bariatric surgery is the only proven effective treatment for these metabolic disorders, albeit offered only in a small percentage of cases because of its invasiveness and cost. The so-called endoscopic bariatric and metabolic therapies (EBMTs) include new, less-invasive technologies such as intragastric balloons, aspiration therapy, endoscopic sleeve gastroplasty, diversion devices, and duodenal mucosal resurfacing, currently at various stages of development. EBMTs, as an add-on to LSI, might represent an effective treatment filling the gap between medical and surgical management, taking into account, however, that obesity and its associated comorbidities constitute a chronic disease that needs lifelong therapy. In this review we describe the current scientific evidence surrounding EBMTs as well as future opportunities for such treatments in managing obesity and metabolic disorders.

Endoscopic full-thickness resection using an endoluminal-suturing device: a proof-of-concept study.

Background and study aims Endoscopic full-thickness resection (EFTR) is used to achieve R0 resection in difficult situations and as a way to overcome the limitations of endoscopic submucosal dissection. Multiple techniques have been described but adequate tools are still under evaluation. In this study, we evaluated the safety and feasibility of non-exposed endoscopic full-thickness resection using a novel endoscopic suturing device. Materials and methods Full-thickness resections of gastric predetermined lesions were performed on five pigs using the Endomina platform. After creating virtual lesion > 20 mm, sutures were placed around it using this triangulation platform. After tightening the knots, the bulging lesion, internalized into the gastric lumen, was cut with a needle knife. Results R0 resections of large lesions (42 to 60 mm) were achieved in all cases. One perforation occurred and prompted us to improve the procedure by shortening the sutures for more maneuverability and reinforcing the suture line before section. Procedure duration dropped by 50 % between the first case and the fourth case. Histological analysis confirmed successful full-thickness resection of all resected specimens. Conclusion EFTR using this triangulation platform seems feasible for lesions > 20 mm. Additional possible improvements were identified to simplify the procedure before moving to human trials.

Endoscopic gastric reduction with an endoluminal suturing device: a multicenter prospective trial with 1-year follow-up.

BACKGROUND: Obesity is the pandemic disease of this century. Surgery is the only effective treatment but cannot be offered to every patient. Endoscopic sutured gastroplasty is a minimally invasive technique that may potentially fill the gap between surgery and behavioral therapy. In this study, we prospectively investigated the efficacy and safety of a novel suturing device. METHODS: After a pre-bariatric multidisciplinary work-up, class 1 and 2 obese patients were included. Using a simple triangulation platform, transmural sutures with serosa-to-serosa apposition were performed in the gastric cavity. Patients were followed according to the same routines as those performed for bariatric procedures. RESULTS: Between November 2015 and December 2016, 51 patients were included across three European Centers. Mean body mass index at baseline was 35.1 kg/m2 (SD 3.0). Excess weight loss and total body weight loss at 1 year were 29 % (SD 28) and 7.4 % (SD 7), respectively, for the whole cohort (45 patients). At follow-up gastroscopy, 88 % of sutures were still in place (30 patients). No severe adverse events were observed. CONCLUSIONS: Endoscopic sutured gastroplasty using this novel device is safe and achieved weight loss results in line with criteria expected for these endoluminal techniques. Further prospective studies vs. placebo or nutritional support are needed.

Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes.

Type 2 diabetes is a pandemic disease with an incidence that has risen steadily over recent decades. Experimental evidence in animals has demonstrated that intestinal bypass surgery of the upper small intestine, particularly the duodenum, has an important role in glucose homoeostasis. Furthermore, Roux-en-Y bypass performed as bariatric surgery has shown to correct hyperglycaemia from the first postoperative days in obese diabetic patients. Therefore, on the basis of these considerations, duodenal mucosal resurfacing was studied in type 2 diabetes patients as a minimally invasive procedure that could offer an alternative treatment for these patients. Further studies, and particularly large controlled trials, are needed to determine the place of this procedure in the treatment of type 2 diabetes as well as other metabolic diseases such as non-alcoholic fatty liver disease/non-alcoholic steatohepatitis.

In Vivo Validation of a Less Invasive Gastrostimulator.

Gastrointestinal stimulator implants have recently shown promising results in helping obese patients lose weight. However, to place the implant, the patient currently needs to undergo an invasive surgical procedure. We report a less invasive procedure to stimulate the stomach with a gastrostimulator. After attempting fully endoscopic implantation, we more recently focused on a single incision percutaneous procedure. In both cases, the challenges in electronic design of the implant are largely similar. This article covers the work achieved to meet these and details the in vivo validation of a gastrostimulator aimed to be endoscopically placed and anchored to the stomach.

Use of cis-atracurium to maintain moderate neuromuscular blockade in experimental pigs.

OBJECTIVE: To determine the dose of cis-atracurium needed to produce a moderate neuromuscular blockade (NMB) in pigs. STUDY DESIGN: Prospective experimental study. ANIMALS: Seven pigs [five females and two males; median (range) body weight: 47 (36-64) kg]. METHODS: Pigs were premedicated with intramuscular midazolam (0.3 mg kg-1) and ketamine (7 mg kg-1). Anaesthesia was induced with intravenous (IV) propofol 3 (1-4) mg kg-1 and maintained with isoflurane in oxygen. Based on a preliminary study, the subjects were administered 0.3 mg kg-1 cis-atracurium followed by 0.48 mg kg-1 hour-1 constant rate infusion (CRI) IV. A moderate NMB was defined as a train-of-four (TOF) count of ≤2 by acceleromyography. When the TOF count was >2, 0.1 mg kg-1 cis-atracurium was administered and the CRI was increased. The cis-atracurium CRI was decreased when the TOF count was under 2 for more than 15 minutes. The total dose of cis-atracurium required to maintain a moderate NMB was calculated as the total amount of cis-atracurium used (both CRI and supplementary boluses) divided by the administration time. RESULTS: The cis-atracurium CRI lasted for 87 (76-151) minutes. To induce and maintain a moderate neuromuscular blockade, the initial dose of cis-atracurium was 0.3 (0.3- 0.5) mg kg-1 and the CRI was 0.71 (0.37-0.98) mg kg-1 hour-1. CONCLUSIONS AND CLINICAL RELEVANCE: The doses described in our study may help researchers obtain a moderate NMB using cis-atracurium in pigs.