Port-sharing techniques for laparoscopic cholecystectomy and sleeve gastrectomy.

In Japan, the number of bariatric surgeries performed has remained low. Thus, concomitant laparoscopic cholecystectomy (LC) with laparoscopic sleeve gastrectomy (LSG) is still relatively uncommon, but is increasing. We developed new port-sharing techniques for LC and LSG, which we performed on 26 obese Japanese patients with gall bladder (GB) diseases, using the LSG trocar arrangement and one additional trocar. We performed LC first, and after exchanging a port for a liver retractor in the epigastrium, we then completed LSG. One patient with an anomalous extrahepatic bile duct required one additional port. The mean LC time was 55 min, and the transition to LSG just after LC was smooth in all the patients. One patient suffered postoperative intraperitoneal hemorrhage, which was managed conservatively. Concomitant LC with LSG using port-sharing techniques is feasible and safe for obese Japanese patients with GB diseases.

Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB).

OBJECTIVE: The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS). SUMMARY BACKGROUND DATA: DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study. METHODS: We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed. RESULTS: A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%. CONCLUSIONS: The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.

Clinical follow-up on weight loss, glycemic control, and safety aspects of 24 months of duodenal-jejunal bypass liner implantation.

BACKGROUND: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device designed to induce weight loss and improve glycemic control. The liner is licensed for a maximum implant duration of 12 months. It might be hypothesized that extension of the dwelling time results in added value. The goals of our study were to determine weight change, change in glycemic control, and safety in patients with an intended 24 months of DJBL dwelling time. METHODS: Patients were initially selected for a 12-month implantation period. When no physical complaints or adverse events (AEs) occurred, motivated patients who responded well were selected for extension of dwelling time to 24 months. Patients underwent a control endoscopy 12 months after implantation and visited the out-patient clinic every 3 months up to explantation. Patients agreed to remove the DJBL when complaints or AEs occurred that could not be treated conservatively. RESULTS: Implantation was extended in 44 patients, and 24 (55%) patients completed the full 24 months. Twenty patients required early removal due to AEs. During dwelling time, body weight decreased significantly (15.9 kg; TBWL 14.6%). HbA1c decreased non-significantly (4.9 mmol/mol). The number of insulin users and daily dose of insulin both decreased significantly. At 24 months after removal, glycemic control had worsened, while body weight was still significantly lower compared to baseline. In total, 68% of the patients experienced at least one AE. Two patients developed a hepatic abscess. CONCLUSIONS: DJBL treatment results in significant weight loss and improves glycemic control during implantation. The largest beneficial effects occur during the first 9-12 months after implantation. Extension of dwelling time to 24 months results only in stabilization of body weight and glycemic control. After explantation, weight improvements are maintained, but glycemic control worsens. As the cumulative risk of AEs increases with time, a maximal dwelling time of 12 months is advisable.

Novel Trocar-Free Elastic Liver Retractor in Bariatric Surgery Patients: Comparison of a Standard Laparoscopic Retraction With the First Series Using the LiVac Sling System.

During upper gastrointestinal surgery, retraction of the liver plays an essential role in the visualization and creation of an optimal surgical field. Liver retraction may be problematic, particularly in obese patients. The use of conventional liver retractors requires additional skin incision and has the potential to cause pain as well as liver injuries. The present study is the first to evaluate the performance and safety of the LiVac Sling (Livac Pty Ltd, Melbourne, Australia) trocar-free retractor system in bariatric surgery patients. In this retrospective study, data from laparoscopic primary or revisional bariatric surgeries that were performed with the LiVac Sling system and a standard retractor between May 2017 and December 2017 were collected. Demographic data, body mass index, type of surgery, number and indication of LiVac Sling system used, surgery time, and complications were analyzed. In total, 51 procedures were included. Twenty Sling devices have been used in 17 patients (13 female; 75%). The distribution of baseline characteristics was similar between the standard retractor group and LiVac Sling retractor group. In the LiVac Sling group, the number of trocars used was significantly reduced over the study period. Within 30 days postoperatively, no complications could be identified, and no device-related adverse events were reported. In this bariatric population, the use of the LiVac Sling for liver retraction was safe. No device-related adverse events were registered, and compared with standard retraction, the number of trocars used could be reduced by one.

Evolution of Endoscopic Bariatric Devices: From Development to Practice.

OBJECTIVES: To familiarize medical providers with the Food and Drug Administration approval process for antiobesity devices and to provide a brief overview of current and promising endoscopy-based bariatric devices. METHODS: Literature review of published scholarly articles. RESULTS: There has been a rapid development of novel endoscopic bariatric therapies in recent years, resulting in the approval of multiple devices. Several promising endoscopic strategies are currently under investigation and review. The Food and Drug Administration has laid down an objective-tiered model to review antiobesity device applications. DISCUSSION: Endoscopic bariatric devices provide a new and promising paradigm in obesity management both as first-line therapy and as adjunctive treatment to medical and surgical strategies. Physicians who plan to offer endoscopic bariatric therapy in their practice need appropriate understanding of the regulatory processes involved in the development and approval of such devices.

Endoscopic techniques for weight loss and treating metabolic syndrome.

PURPOSE OF REVIEW: The endoscopic armamentarium against obesity and metabolic syndrome is rapidly growing and improving. Novel devices have been tested and recent data either support or reject their use. We aim to discuss current data on new endoscopic procedures addressing overweight, diabetes, and metabolic syndrome. RECENT FINDINGS: Four-year follow-up of the aspiration therapy have shown efficacy and safety at long term. A recent consensus on intragastric balloon gathered experience from more than 40 000 procedures and standardized most steps of the treatment. The TransPyloric Shuttle has been proven effective at short term but carries high rates of adverse events. The endoscopic sleeve gastroplasty promotes similar weight loss to laparoscopic sleeve gastrectomy in mildly obese patien. The endoluminal magnetic partial jejunal diversion promoted good weight loss and a significant reduction in glycated hemoglobin (HbA1c) but most cases required laparoscopic assistance to couple the magnets. One-year follow-up demonstrated that the duodenal mucosal resurfacing carried a 1.0% reduction in HbA1c. SUMMARY: Innovative endoscopic procedures focused on the treatment of overweight and related diseases are available and there is growing evidence supporting their use. Nonetheless, a multidisciplinary approach is mandatory. VIDEO ABSTRACT: http://links.lww.com/COG/A25.

Medical Devices in Obesity Treatment.

PURPOSE OF REVIEW: Obesity is increasing at an alarming rate and now poses a global threat to humankind. In recent years, we have seen the emergence of medical devices to combat the obesity epidemic. These therapeutic strategies are discussed in this review dividing them into gastric and duodenal therapies. RECENT FINDINGS: Traditionally, medical devices for obesity such as the intragastric balloon have focused on reducing gastric size, but more recently there has been a shift towards developing devices that modulate neural and hormonal responses to induce early satiety thus reducing oral intake. Medical devices for obesity treatment may have a role in those patients who are struggling to control their weight despite significant lifestyle modifications such as diet and exercise and who decline or are unfit for bariatric surgery. For the wider adoption and integration of these devices in the obesity treatment paradigm, more long-term efficacy and safety data from randomised controlled trials are required.

Advanced Endoscopic Procedures: An Update for Radiologists.

OBJECTIVE. The purposes of this article are to familiarize radiologists with endoscopic techniques currently in use and to improve identification of clinically relevant imaging findings and procedural complications related to common endoscopic interventions. CONCLUSION. The frequency of performance of therapeutic endoscopic ultrasound-guided procedures has risen precipitously in the last decade. These procedures are replacing surgical and percutaneous approaches to a variety of disease entities. Recent advances include endoscopic bariatric procedures, endoscopic myotomies, and endoscopic ultrasound-guided drainage procedures.

The fate of laparoscopic adjustable gastric band removal

Background: Long-term complications and lack of weight loss have caused a surge in laparoscopic adjustable gastric band (LAGB) removal. This study reviews the trend of LAGB removal and examines outcomes of patients undergoing subsequent revision bariatric surgery at a single tertiary care centre in Canada. Methods: All LAGB removals performed between January 2008 and December 2016 were reviewed. A subset of patients who underwent revision surgery was then analyzed for patient demographics, weight, body mass index and postoperative complications. Results: During the study period, 211 patients underwent LAGB removal (87.7% female). Most bands were inserted out of province. Reasons for band removal included dysphagia, band slip and weight recidivism. Fifty-nine patients (28%) underwent revision surgery at a mean of 12.8 ± 9.3 (range 0­55) months after LAGB removal. Mean age was 47 ± 9.7 (range 26­63) years, and mean pre-LAGB weight was 131.0 ± 30.0 kg. Following LAGB, the mean weight decreased to 120.5 ± 26.4 kg, but most regained weight after removal to a mean prerevision weight of 125.1 ± 27.0 kg. The lowest mean weight was achieved 12 months after revision surgery (98.7 ± 30.2 kg). The mean percent total weight loss was not significantly different after revision laparoscopic Roux-en-Y gastric bypass compared with revision laparoscopic sleeve gastrectomy (22.8 ± 9.6% v.17.5 ± 6.5%, p = 0.179). The overall revision surgery 30-day complication rate was 18.6% and increased to 23.7% long-term. No deaths occurred. Conclusion: The number of LAGB removals is increasing. Revision bariatric surgery leads to improved weight loss; however, revision surgery is associated with complications.

Contexte: Les complications à long terme et l'absence de perte de poids sont à l'origine de l'augmentation du nombre de retraits d'anneaux gastriques ajustables (AGA) installés par voie laparoscopique. Cette étude se penche sur la tendance aux retraits des AGA et sur les résultats chez les patients qui subissent une chirurgie bari atrique de révision par la suite dans un centre de soins tertiaire au Canada. Méthodes: Tous les retraits d'AGA effectués entre janvier 2008 et décembre 2016 ont été passés en revue. Un sous-groupe de patients ayant subi une chirurgie de révision a ensuite été analysé aux plans des caractéristiques démographiques, de la masse corporelle et des complications postopératoires. Résultats: Pendant la période de l'étude, 211 patients se sont fait retirer leur AGA (87,7 % de femmes). La plupart des anneaux avaient été insérés à l'extérieur de la province. Parmi les raisons invoquées pour les retraits, mentionnons dysphagie, glissement de l'anneau et reprise de poids. Cinquante-neuf patients (28 %) ont subi une chirurgie de révision en moyenne 12,8 ± 9,3 (éventail 0­55) mois après le retrait de l'AGA. L'âge moyen était de 47 ± 9,7 (éventail 26­63) ans et le poids moyen avant l'AGA était de 131,0 ± 30,0 kg. Après l'AGA, le poids moyen a diminué à 120,5 ± 26,4 kg, mais la plupart ont repris du poids après le retrait pour atteindre un poids moyen pré-révision de 125,1 ± 27,0 kg. Le plus bas poids moyen a été atteint 12 mois après la chirurgie de révision (98,7 ± 30,2 kg). La perte de poids totale moyenne en pourcentage n'était pas significativement différente après la dérivation de Roux-en-Y laparoscopique de révision, comparativement à la gastrectomie laparoscopique en manchon de révision (22,8 ± 9,6 % c. 17,5 ± 6,5 %, p = 0,179). Le taux global de complications des révisions chirurgicales à 30 jours a été de 18,6 % et est passé à 23,7 % à plus long terme. Aucun décès n'est survenu. Conclusion: Le nombre de retraits d'AGA est en hausse. La révision de la chirurgie bariatrique a amélioré la perte de poids, mais elle s'accompagne de complications.

Benefits of Robotic Camera Assistance in Minimally Invasive Bariatric Procedures: Prospective Clinical Trial Using a Joystick-Guided Camera-Holder.

BACKGROUND: While minimally invasive surgery is a growing sector in medicine, camera assistance remains a problem. Especially in bariatric surgery, the assistant holding the camera faces certain challenges. Furthermore, unless the surgeon controls the camera movement themselves, they will be challenged by an unstable image. The aim of this study was to investigate the benefits of a robotic camera assistant (SoloAssist®, AKTORmed™ GmbH, Barbing, Germany) in bariatric surgery. PATIENTS AND METHODS: Three hundred thirty one consecutive laparoscopic bariatric procedures were performed with the assistance of a camera robot, including Roux-en-Y gastric bypass, laparoscopic gastric banding, sleeve gastrectomy, and gastroplication. Failures and aborts were documented and 6 surgeons were interviewed regarding their experiences using a questionnaire. RESULTS: In 18 of 331 procedures, robotic assistance was aborted and the procedure was continued manually, mostly because of a need for frequent changes of position in narrow spaces and adverse angles. Two short circuits, 4 joystick faliures and one malfunction of the control unit were reported. All of the surgeons preferred robotic to human assistance, mostly because of a steady image and the capacity for self-control. DISCUSSION: The SoloAssist® is a reliable system for minimal invasive procedures, especially in bariatric surgery. It provides more comfortable conditions for the surgeon and their assistant by freeing one hand for other purposes. Even in narrow spaces (e.g., between a voluminous stomach and adipose liver), the robot guarantees a steady image. Slight movements of the camera can be precisely controlled, which leads to increased comfort for the surgeon.

Endoscopic Removal of Noneroded Nonadjustable Gastric Bands Using Induced Mucosal Erosion With a Stent, and Review of the Literature.

BACKGROUND: Laparoscopic removal of noneroded nonadjustable gastric bands (NAGBs) may lead to major life-threatening complications. A minimally invasive approach involving endoscopic removal by induced mucosal erosion with a stent (IMES) has been used in a few publications to remove NAGBs. OBJECTIVE: To examine a minimally invasive endoscopic approach to removal of a NAGB. SETTING: A large tertiary/quaternary referral hospital. METHODS: We report 4 patients that underwent IMES at our institution and present a literature review of published cases. The procedure includes using an endoscopically placed fully covered stent through the NAGB stricture to cause erosion of the mucosa where the stent is putting direct pressure. After a predetermined length of time, the stent is removed with the NAGB and without a laparoscopic or open procedure. Primary endpoint for our cohort was successful removal to the NAGB with IMES. Secondary endpoints included interval of time to retrieval of the stent, complications from IMES, presenting symptoms, and type of NAGB. These endpoints were then compared with previous publications indicating the use of IMES. RESULTS: Three of 4 patients were female with a mean age of 64.5 years. All patients had the NAGB successfully removed with IMES. The mean time for NAGB and stent removal after insertion was 17.5 days. No major complications were noted. Two patients had post-IMES strictures and were managed by balloon dilation. CONCLUSION: Endoscopic removal of NAGBs is a safe and feasible procedure for NAGB removal and can be used in place of laparoscopic surgery.

Endoscopic Bariatric and Metabolic Therapies: New and Emerging Technologies.

Endoscopic bariatric and metabolic therapies (EBMT) are a new addition to the treatment arsenal for obesity. These include devices that are placed or removed via flexible endoscopy, and procedures that utilize instruments that require flexible endoscopy for the indications of weight loss or treatment of glucose intolerance (from pre-diabetes to diabetes). The EBMTs are generally divided into gastric and small bowel categories, and although individual EBMTs may have unique mechanisms of action, similar themes in proposed mechanism of action are seen in the gastric and small bowel EBMTs, respectively. In this review we will describe the therapies approved for use in the United States or currently in the process of obtaining approval for use in the United States. We will discuss potential mechanisms of action and examine safety and efficacy data.

Endoscopic Interventions in the Treatment of Obesity and Diabetes.

Obesity is a global health problem which is on the rise and is strongly associated with the development of type 2 diabetes and other comorbidities. Bariatric surgery is now an established treatment for both these conditions, leading to impressive results in weight loss and glycemic control. More recently, we have seen the development of various endoscopic devices as potential alternatives or adjuncts to bariatric surgery. In this state-of-the-art review, we outline the current landscape of endoscopic treatments available for the management of both obesity and diabetes, including the clinical evidence supporting their use, efficacy, safety, and potential mechanisms of action.

Safety and efficacy of the endoscopic duodenal-jejunal bypass liner prototype in severe or morbidly obese subjects implanted for up to 3 years.

BACKGROUND: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device that mimics the duodenal-jejunal exclusion component of the Roux-en-Y gastric bypass. Previous studies assessing the efficacy of the DJBL have shown 10-40% excess weight loss (%EWL) and improvements in obesity-associated comorbidities. The aim of this study was to evaluate the safety and efficacy of a new DJBL prototype over a 3-year period. METHODS: Morbidly obese subjects were enrolled in a single-arm, open-label, prospective trial. The subjects were offered the opportunity to continue with the trial annually and signed a new consent form. The primary endpoint was safety. The secondary endpoints were changes in weight and biochemical parameters from baseline. RESULTS: The DJBL was implanted endoscopically in 80 subjects (age: 35±10 years; 69% female; weight: 109±17 kg; BMI: 42±5.4 kg/m2). Seventy-two severe adverse events (AEs) were observed in 55 patients (68%), of which nine subjects required a prolonged hospital stay and three subjects required major interventions. Overall, 23 subjects (29%) underwent early device removal due to AEs. Additionally, 95% of the patients experienced mild AEs that mainly consisted of abdominal pain. The severe AEs included a liver abscess (3), upper GI bleeding (4), cholangitis (1), and acute pancreatitis (1) and mostly occurred after 12 months of follow-up. Two patients presented a short esophageal perforation during explantation. These perforations were successfully managed with endoscopic closure in one subject and medical treatment in the other subject. In the completer population at 52 weeks (71 patients), 104 weeks (40 patients), and 156 weeks (11 patients), the mean %EWL were 44 ± 16, 40 ± 22, and 39 ± 20, respectively (p < 0.001). CONCLUSION: This study shows significant and sustained weight loss after 3 years of treatment with the new DJBL. However, the high frequency and severity of AEs preclude the use of this prototype for periods longer than 1 year.

In-and-Out Molecular Changes Linked to the Type 2 Diabetes Remission after Bariatric Surgery: An Influence of Gut Microbes on Mitochondria Metabolism.

Different kinds of gastrointestinal tract modulations known as "bariatric surgery" are actually the most effective treatment for obesity and associated co-morbidities, such as type 2 diabetes (T2DM). The potential causes of those effects have yet to be explained. In our study, we focused on molecular changes evoked by laparoscopic sleeve gastrectomy leading to T2DM remission. Two complementary metabolomics techniques, namely, liquid chromatography coupled with mass spectrometry (LC-MS) and gas chromatography mass spectrometry (GC-MS), were used to study those effects in a group of 20 obese patients with T2DM selected from a cohort of 372 obese individuals who underwent bariatric surgery and did not receive anti-diabetic treatment afterward. Modified levels of carnitines, lipids, amino acids (including BCAA) and α- and ß-hydroxybutyric acids were detected. Presented alterations suggest a major role of mitochondria activity in T2DM remission process. Moreover, some of the observed metabolites suggest that changes in gut microbiota composition may also correlate with the tempo of diabetes recovery. Additional analyses confirmed a relationship between biochemical and clinical parameters and the aforementioned metabolites, thereby, highlighting a role of mitochondria and microbes. Our data suggests that there is a previously undescribed relationship between mitochondria and gut microbiota, which changes after the bariatric surgery. More investigations are needed to confirm and explore the observed findings.

Safety and feasibility of an endoluminal-suturing device for endoscopic gastric reduction (with video).

BACKGROUND AND AIMS: Obesity is a major pandemic disease. Surgical therapy is highly effective, but its availability will likely be overwhelmed by the burden of the disease. Endoscopic technologies that could reproduce some of the clinical effects of surgery may become part of the treatment armamentarium. A simple transoral restrictive procedure could play a role in first-line surgical management. METHODS: We evaluated the safety and feasibility of transmural suturing using a simple triangulation platform for gastric volume reduction through the creation of multiple double plicatures. RESULTS: Between May and July 2015, 11 obese (body mass index 34.6 ± 2.1 kg/m2) patients (mean age, 36 ± 10 years) underwent gastroplasty through transmural endoscopic sutures (performed using a triangulation platform and an endoscopic stitcher). The median duration of the procedure was 2.00 hours (range, 1.15-3.15 hours) and dramatically decreased after the first 5 cases. No severe adverse events were observed. Mean (standard deviation) weight loss and percentage of excess weight loss were 5.8 kg (2.7%) and 21% (9%) at 1 month (n = 11), 8.8 kg (4.9%) and 33% (22%) at 3 months (n = 10), and 10.9 kg (7.3%) and 41% (33%) at 6 months (n = 10). CONCLUSIONS: Transoral endoscopic gastroplasty performed using a simple triangulation platform and a dedicated suturing device appears to be safe and effective at mid-term follow-up in creating gastric restriction and inducing weight loss in this first-in-humans experience. (Clinical trials registration number: NCT02534662.).

A multicentric prospective study evaluating the safety and efficacy of Kii® Fios® First Entry Trocar in laparoscopic bariatric surgery.

INTRODUCTION: Laparoscopic surgery has evolved as an important field of surgery due to its clear benefits when compared to open laparotomy surgery. However, specific complications of laparoscopic surgery have been reported, of which the majority are complications associated with first entry to the abdominal cavity. The emergence of bariatric surgery, combined with the special considerations of the abdominal wall and cavity of obese patients, leads to seeking new modalities of access to the abdominal cavity in this specific population.Kii Fios First Entry Bladeless Trocar (Applied) is a new device that may allow surgeons to facilitate the creation of pneumoperitoneum. This prospective multicenter nonrandomized trial aims to evaluate the safety and efficacy of Kii Fios First Entry Bladeless Trocar in laparoscopic bariatric surgery. METHODS: In the period between December 2013 and June 2014, 588 patients were included by 18 surgeons from several French hospitals to undergo laparoscopic surgery using Kii Fios First Entry Trocar as a first-entry trocar. The surgeons filled out a questionnaire assessing the safety and efficacy of the trocar for every patient. RESULTS: There were no mortality and no major complications. However, 11 cases (1.87%) of minor complications (liver and greater omentum injuries) were reported. The surgeons reported successful entry in less than 1 min for 70.58% of the cases. CONCLUSIONS: Kii Fios First Entry Trocar (Applied) is a safe and efficient method to establish first entry in laparoscopic bariatric surgery when all the recommendations are followed and respected.

Weight reduction and improvement in diabetes by the duodenal-jejunal bypass liner: a 198 patient cohort study.

BACKGROUND: The duodenal-jejunal bypass liner (DJBL) is an endoscopic treatment for patients with type 2 diabetes mellitus (T2DM) and (morbid) obesity. The aim of the current study was to determine its efficacy and safety profile. METHODS: Inclusion criteria for treatment with a DJBL were: age 18-70 years, BMI 28-45 kg/m2, and T2DM with a HbA1c > 48 mmol/mol. Primary outcomes were changes in HbA1c and body weight. Secondary outcomes included changes in blood pressure, lipids, and anti-diabetic medication. Predictive factors for success of treatment with the DJBL were determined. RESULTS: Between 2011 and 2014, 185 out of 198 patients successfully underwent a DJBL implantation procedure, with an intended implantation time of 12 months. In these 185 patients, body weight decreased by 12.8 ± 8.0 kg (total body weight loss of 11.9 ± 6.9 %, p < 0.001), HbA1c decreased from 67 to 61 mmol/mol (p < 0.001) despite a reduction in anti-diabetic medication, and blood pressure and serum lipid levels all decreased. In total, 57 (31 %) DJBLs were explanted early after a median duration of 33 weeks. Adverse events occurred in 17 % of patients. C-peptide ≥1.0 nmol/L and body weight ≥107 kg at screening were independent predictive factors for success. CONCLUSIONS: Treatment with the DJBL in T2DM patients with (morbid) obesity results in improvement in glucose control, a reduction in anti-diabetic medication, and significant weight loss. The largest changes are observed within the first 3-6 months. Initial C-peptide levels and body weight may help to select patients with the greatest chance of success.

Multicenter study on the safety of bariatric endoscopy.

INTRODUCTION: Bariatric endoscopy includes a series of specific techniques focused on the management of obese patients. As a quality criterion, safety as expressed by a minimal incidence of serious complications is required in addition to efficacy. METHODS: A descriptive, retrospective, multicenter review of the experience recorded at seven hospitals included in the Grupo Español de Endoscopia Bariátrica (GETTEMO) in order to document the incidence, cause, and resolution (including legal consequences) of serious complications reported for each bariatric technique, and according to endoscopist expertise. RESULTS: In all, 6,771 bariatric endoscopic procedures were collected, wherein 57 serious complications (0.84%) were identified. Balloons: Orbera®-Medsil®, 5/5,589; Spatz2® (older model): 44/225; Heliosphere®: 1/70; Obalon®: 0/107. Sutures: POSE®, 5/679; sleeve gastroplasty with Apollo® system: 0/55. Prostheses: Endobarrier®: 2/46. All complications were resolved with medical/endoscopic management except for five cases (0.07%) that required surgery. A single lawsuit occurred (esophageal perforation with Spatz2® balloon), which had a favorable outcome. There was no mortality, and apparently no differences were found according to endoscopist expertise level. CONCLUSIONS: In our multicenter experience, bariatric endoscopy may be considered as a safe procedure (0.84% of serious complications in all). However, some devices may induce a higher proportion of complications, such as 19.55% for Spatz2® balloons (already replaced) or 4.34% for Endobarrier® sleeves (at the upper limit of accepted safety), although our experience with the latter is limited. All complications were resolved with conservative medical management, and only exceptionally required surgery (0.07%). No technique-related mortality was seen, and only one lawsuit occurred. Further evolutionary studies are required on the novel endoscopic techniques presently emerging to authenticate our results.

Endoscopic treatment of obesity.

PURPOSE OF REVIEW: Obesity and its comorbid illnesses affect millions worldwide and are one of the major causes of preventable death in the world. Bariatric surgery is currently offered to individuals with a BMI greater than 40 kg/m or greater than 35 kg/m with obesity-related comorbidities such as hypertension or diabetes. Endoscopic bariatric therapies, with their reduced invasiveness and potential reversibility, may complement surgical approaches for achieving weight loss. RECENT FINDINGS: At the time of this writing, two endoscopically placed intragastric balloons and an endoscopically placed aspiration tube have been approved by the Food and Drug Administration for weight loss purposes. Some devices employ a suturing platform to create plications or to appose two surfaces. Other endoscopic strategies under investigation to treat obesity-related comorbidities such as diabetes include duodenal mucosal resurfacing and creation of a partial jejunoileal diversion using self-assembling magnets. SUMMARY: Current endoscopic methods for the treatment of obesity utilize various mechanisms, including occupying gastric volume, reducing gastric capacity, altering caloric absorption, or aspirating gastric contents. The long-term outcomes and cost-effectiveness of these strategies remain to be fully elucidated. The landscape of endoscopic bariatric therapies continues to evolve.