Tubularization of the gastric pouch helps sustain weight loss after transoral outlet reduction for post-Roux-en-Y gastric bypass weight recurrence.

Background and study aims Traditional transoral outlet reduction (TORe) is a minimally invasive endoscopic approach focused on reducing the aperture of the gastrojejunal (GJ) anastomosis, while the tubular transoral outlet reduction (tTORe) consists of tabularization of the distal pouch utilizing an O-shape gastroplasty suturing pattern. The primary aim of this study was to compare short-term weight loss between TORe and tTORe. Patients and methods Retrospective analysis of a prospectively maintained database was conducted at a tertiary care bariatric center of excellence. The study included patients with history of Roux-en-Y gastric bypass (RYGB) who had an endoscopic revision by TORe or tTORe and had follow-up data in their electronic medical record. The primary outcome was percent total body weight loss (%TBWL). Results A total of 128 patients were included (tTORe=85, TORe=43). At 3 and 6 months, the tTORe and TORe cohorts presented similar %TBWL (3 months: 8.5±4.9 vs. 7.3±6.0, P = 0.27 and 6 months: 8.1±7.4 vs. 6.8±5.6, P = 0.44). At 9 months, there was a trend toward greater weight loss in the tTORe cohort (9.7±8.6% vs. 5.1±6.8%, P = 0.053). At 12 months, the %TBWL was significantly higher in the tubularization group compared to the standard group (8.2±10.8 vs. 2.3±7.3%, P = 0.01). Procedure time was significantly different between both groups (60.5 vs. 53.4 minutes, P = 0.03). The adverse events rate was similar between groups (8.2% vs. 7.0% for tTORe and TORe, respectively, P = 0.61). Conclusions The tTORe enhances efficacy and durability of the standard procedure without adding significant procedure-related risks.

Pitfalls of EUS-guided gastrojejunostomy in a patient with history of Roux-en-Y gastric bypass and a frozen abdomen.

Video 1Case of EUS-guided gastrojejunostomy in a patient with a history of Roux-en-Y gastric bypass and a frozen abdomen.

Improvements in hepatic steatosis, obesity, and insulin resistance in adults with nonalcoholic fatty liver disease after the primary obesity surgery endoluminal 2.0 procedure.

BACKGROUND: The primary obesity surgery endoluminal 2.0 (POSE 2.0) procedure involves full-thickness gastric body plications to narrow the stomach using durable suture anchor pairs. We evaluated POSE 2.0 as a treatment strategy for nonalcoholic fatty liver disease (NAFLD) in patients with obesity. METHODS: Adults with obesity and NAFLD were prospectively allocated based on their preference to undergo POSE 2.0 with lifestyle modification or lifestyle modification alone (control). Primary end points were improvement in controlled attenuation parameter (CAP) and resolution of hepatic steatosis at 12 months. Secondary end points included %total body weight loss (%TBWL), change in serum measures of hepatic steatosis and insulin resistance, and procedure safety. RESULTS: 42 adult patients were included (20 in the POSE 2.0 arm and 22 in the control arm). At 12 months, POSE 2.0 significantly improved CAP, whereas lifestyle modification alone did not (P < 0.001 for POSE 2.0; P = 0.24 for control). Similarly, both resolution of steatosis and %TBWL were significantly higher with POSE 2.0 than with control at 12 months. Compared with controls, POSE 2.0 significantly improved liver enzymes, hepatic steatosis index, and aspartate aminotransferase to platelet ratio at 12 months. There were no serious adverse events. CONCLUSION : POSE 2.0 was effective for NAFLD in patients with obesity, with good durability and safety profile.

Endoscopic ultrasound-guided gastroenterostomy for the management of gastric outlet obstruction: A large comparative study with long-term follow-up.

Background and study aims Gastric outlet obstruction (GOO) is traditionally managed with surgical gastroenterostomy (surgical-GE) and enteral stenting (ES). Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is now a third option. Large studies assessing their relative risks and benefits with adequate follow-up are lacking. We conducted a comparative analysis of patients who underwent EUS-GE, ES, or surgical-GE for GOO. Patients and methods In this retrospective comparative cohort study, consecutive patients presenting with GOO who underwent EUS-GE, ES, or surgical-GE at two academic institutions were reviewed and independently cross-edited to ensure accurate reporting. The primary outcome was need for reintervention. Secondary outcomes were technical and clinical success, length of hospital stay (LOS), and adverse events (AEs). Results A total of 436 patients (232 EUS-GE, 131 ES, 73 surgical-GE) were included. The median duration of follow-up of the entire cohort was 185.5 days (interquartile range 55.25-454.25 days). The rate of reintervention in the EUS-GE group was lower than in the ES and surgical-GE groups (0.9 %, 12.2 %, and 13.7 %, P  < 0.0001). Technical success was achieved in 98.3 %, 99.2 %, and 100 % ( P  = 0.58), and clinical success was achieved in 98.3 %, 91.6 %, and 90.4 % ( P  < 0.0001) in the EUS-GE, ES, and surgical-GE groups, respectively. The EUS-GE group had a shorter LOS (2 days vs. 3 days vs. 5 days, P  < 0.0001) and a lower AE rate than the ES and surgical-GE groups (8.6 % vs. 38.9 % vs. 27.4 %, P  < 0.0001). Conclusion This large cohort study demonstrates the safety and palliation durability of EUS-GE as an alternative strategy for GOO palliation in select patients.

Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity.

BACKGROUND & AIMS: The Primary Obesity Surgery Endoluminal (POSE) 2.0 procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using durable suture anchor pairs. Our prospective, multicenter trial examined the safety, efficacy, durability, and physiologic effects of POSE 2.0 in adults with obesity. METHODS: Adults with obesity underwent POSE 2.0 at 3 centers. Primary outcomes were percent total body weight loss (%TBWL) and proportion of patients achieving >5% TBWL at 12 months. Secondary outcomes included change in obesity comorbidities, satiety, quality of life at 6 months, and durability of plications at 12 and 24 months. Subjects were followed for adverse events throughout the study duration. RESULTS: 44 patients (61% female; mean age, 45 ± 9.7 years; mean body mass index, 37 ± 2.1 kg/m2) were enrolled. This procedure used an average of 19 suture anchor pairs, with a mean duration of 37 ± 11 minutes, and was technically successful in all subjects. Mean %TBWL at 12 months was 15.7% ± 6.8%. At 12 months, %TBWL >5%, >10%, and >15% was achieved in 98%, 86%, and 58% of patients, respectively. Improvements in lipid profile, liver biochemistries, and hepatic steatosis were seen at 6 months. Improvements in hepatic steatosis persisted for 24 months in a subgroup of patients (P < .01). POSE 2.0 reduced maximum tolerated meal volume (P = .03) and was associated with increased fullness (P < .01) and improved eating behavior (P < .01) at 6 months. Impact of weight on quality-of-life questionnaire improved at 6 months (2.23 vs 1.23; P < .01). Repeat assessment at 24 months (n = 26) showed fully intact plications. No serious adverse events occurred. CONCLUSION: POSE 2.0 is an effective and durable endoscopic bariatric therapy which may influence physiologic pathways impacting satiety. Larger comparative studies are needed to further elucidate these initial findings. CLINICALTRIALS: gov Identifier: NCT03721731.

Use of an intragastric trocar to perform a novel stapling procedure for reflux disease.

Background and study aims A percutaneous intragastric trocar (PIT) enables intraluminal use of laparoscopic tools and helps overcome traditional limitations of endoscopy. The aim of this study was to determine the efficacy of using a PIT to perform an anti-reflux stapling procedure. Materials and methods Trocars were placed in four animals and an articulating stapler was used to perform fundoplication under endoscopic guidance. Animals were monitored for 14 days post-procedure. Functional lumen imaging of the esophagogastric junction (EGJ) was performed at baseline, immediately post-intervention, and at 14 days. Results The procedure was successful in all animals who survived to day 14 without distress or significant adverse events. Baseline EGJ distensibility was 5.0 ±â€Š1.2 mm 2 /mmHg, 2.7 ±â€Š0.7 mm 2 /mmHg post-procedurally, and 3.0 ±â€Š0.8mm 2 /mmHg on day 14. Average change in distensibility pre- and post-procedure was -2.3 ±â€Š1.8 mm 2 /mmHg (95 % confidence interval [CI] -0.5 to 5.1, P  = 0.08) while change in pre- and day 14 distensibility was -2.0 ±â€Š1.4 mm 2 /mmHg (95 % CI -0.1 to 4.2, P  = 0.06). Conclusions An intragastric trocar allows for use of large-diameter laparoscopic instruments to safely and effectively perform endoluminal fundoplication with anti-reflux properties that persist for at least 14 days.

Comparative Effectiveness and Safety Between Endoscopic Sleeve Gastroplasty and Laparoscopic Sleeve Gastrectomy: a Meta-analysis of 6775 Individuals with Obesity.

INTRODUCTION: Endoscopic sleeve gastroplasty (ESG) is a novel endoscopic bariatric therapy that complements current medical and surgical therapeutic offerings for weight management and fills an unmet need. Few meta-analyses compared ESG to laparoscopic sleeve gastrectomy (LSG). However, these studies relied on indirect evidence derived from non-comparative studies. Comparative effectiveness data derived from direct comparative studies is needed. We performed a meta-analysis of studies that directly compared ESG with LSG. METHODS: A comprehensive search of PubMed, Embase, and Cochrane databases was conducted. Single-arm studies were excluded. Pooled mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CIs) were obtained within a random-effect model. RESULTS: Seven studies with 6,775 patients (3,413 with ESG vs. 3,362 with LSG) were included. There were significant differences in 6-month (MD - 7.48; 95% CI - 10.44, - 4.52; P < 0.00001), 12-month (MD - 9.90; 95% CI - 10.59, - 9.22; P < 0.00001), and 24-month (MD - 7.63; 95% CI - 11.31, - 3.94; P < 0.0001) TBWL% favoring LSG over ESG. There was a trend toward lower incidence of adverse events with ESG compared to LSG but did not reach statistical significance (RR 0.51, 95% CI 0.23-1.11, P = 0.09). The incidence of new-onset gastroesophageal reflux disease (GERD) was significantly lower after ESG compared to LSG, 1.3% vs. 17.9%, respectively (RR 0.10, 95% CI 0.02-0.53, P = 0.006). CONCLUSIONS: ESG achieved clinically adequate but lower short- and mid-term weight loss when compared to LSG, with fewer adverse events, including GERD. Given the stomach-sparing nature of ESG and acceptable safety profile, it provides an acceptable alternative to LSG for patients with mild-to-moderate obesity.

Novel Endoscopic Bariatric Therapies for the Management of Nonalcoholic Steatohepatitis.

Obesity is strongly associated with nonalcoholic fatty liver disease as well as advanced forms of the disease such as nonalcoholic steatohepatitis (NASH), cirrhosis, and hepatocellular carcinoma. While lifestyle and diet modifications have been the cornerstone of treatment for NASH thus far, they are only effective for less than half of the patients. New endoscopic bariatric therapies (EBTs) have already proved to be safe and effective for the treatment of obesity and type 2 diabetes mellitus, and may provide an intermediate, less invasive, cost-effective option for patients with NASH. In this review, we aim to describe the data and evidence as well as outline future areas of development for endobariatric therapies for the treatment of NASH. In conclusion, EBTs present an effective and safe therapeutic modality for use in the growing pandemic of obesity-related liver disease and should be investigated further with large-scale trials in this patient population.

Endoscopic Management of Weight Recurrence Following Bariatric Surgery.

Metabolic and bariatric surgery is the most effective therapy for weight loss and improving obesity-related comorbidities, comprising the Roux-en-Y gastric bypass (RYGB), gastric banding, sleeve gastrectomy (SG), and biliopancreatic diversion with duodenal switch. While the effectiveness of weight loss surgery is well-rooted in existing literature, weight recurrence (WR) following bariatric surgery is a concern. Endoscopic bariatric therapy presents an anatomy-preserving and minimally invasive option for managing WR in select cases. In this review article, we will highlight the endoscopic management techniques for WR for the most commonly performed bariatric surgeries in the United States -RYGB and SG. For each endoscopic technique, we will review weight loss outcomes in the short and mid-terms and discuss safety and known adverse events. While there are multiple endoscopic options to help address anatomical issues, patients should be managed in a multidisciplinary approach to address anatomical, nutritional, psychological, and social factors contributing to WR.

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 with 13 C-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  = 0.42 vs . 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 ±â€Š297.97 mL vs. 183.00 ±â€Š217.13 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.

Use of the Molecular Adsorbent Recirculating System in Acute Liver Failure: Results of a Multicenter Propensity Score-Matched Study.

OBJECTIVES: The molecular adsorbent recirculating system removes water-soluble and albumin-bound toxins and may be beneficial for acute liver failure patients. We compared the rates of 21-day transplant-free survival in acute liver failure patients receiving molecular adsorbent recirculating system therapy and patients receiving standard medical therapy. DESIGN: Propensity score-matched retrospective cohort analysis. SETTING: Tertiary North American liver transplant centers. PATIENTS: Acute liver failure patients receiving molecular adsorbent recirculating system at three transplantation centers (n = 104; January 2009-2019) and controls from the U.S. Acute Liver Failure Study Group registry. INTERVENTIONS: Molecular adsorbent recirculating system treatment versus standard medical therapy (control). MEASUREMENTS AND MAIN RESULTS: One-hundred four molecular adsorbent recirculating system patients were propensity score-matched (4:1) to 416 controls. Using multivariable conditional logistic regression adjusting for acute liver failure etiology (acetaminophen: n = 248; vs nonacetaminophen: n = 272), age, vasopressor support, international normalized ratio, King's College Criteria, and propensity score (main model), molecular adsorbent recirculating system was significantly associated with increased 21-day transplant-free survival (odds ratio, 1.90; 95% CI, 1.07-3.39; p = 0.030). This association remained significant in several sensitivity analyses, including adjustment for acute liver failure etiology and propensity score alone ("model 2"; molecular adsorbent recirculating system odds ratio, 1.86; 95% CI, 1.05-3.31; p = 0.033), and further adjustment of the "main model" for mechanical ventilation, and grade 3/4 hepatic encephalopathy ("model 3"; molecular adsorbent recirculating system odds ratio, 1.91; 95% CI, 1.07-3.41; p = 0.029). In acetaminophen-acute liver failure (n = 51), molecular adsorbent recirculating system was associated with significant improvements (post vs pre) in mean arterial pressure (92.0 vs 78.0 mm Hg), creatinine (77.0 vs 128.2 µmol/L), lactate (2.3 vs 4.3 mmol/L), and ammonia (98.0 vs 136.0 µmol/L; p ≤ 0.002 for all). In nonacetaminophen acute liver failure (n = 53), molecular adsorbent recirculating system was associated with significant improvements in bilirubin (205.2 vs 251.4 µmol/L), creatinine (83.1 vs 133.5 µmol/L), and ammonia (111.5 vs 140.0 µmol/L; p ≤ 0.022 for all). CONCLUSIONS: Treatment with molecular adsorbent recirculating system is associated with increased 21-day transplant-free survival in acute liver failure and improves biochemical variables and hemodynamics, particularly in acetaminophen-acute liver failure.

Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial.

BACKGROUND: Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity. METHODS: In this prospective, multicentre, open-label, randomised clinical trial done at seven US sites, adults aged 22-65 years with obesity were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks. Balloon volume could be increased to facilitate weight loss or decreased for tolerability. Coprimary endpoints included mean percentage total bodyweight loss and responder rate (≥5% total bodyweight loss) at 32 weeks. We used a multiple imputed intention-to-treat population analysis. This study was registered with ClinicalTrials.gov, NCT02812160. FINDINGS: Between Aug 9, 2016, and Dec 7, 2018, we randomly assigned 288 patients to aIGB (n=187 [65%]) or control (n=101 [35%]) groups. Mean total bodyweight loss at 32 weeks was 15·0% (95% CI 13·9-16·1) in the aIGB group versus 3·3% (2·0-4·6) in the control group (p<0·0001). Clinical response was observed in 171 (92%) patients in the aIGB group. Adjustments to the aIGB occurred in 145 (80%) patients for weight loss plateau or intolerance. Upward volume adjustment facilitated an additional mean 5·2% (4·5-5·8) total bodyweight loss. Downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy. Intolerance caused early removal of the device in 31 (17%) patients. No micronutrient deficiencies were observed in the aIGB cohort. Device-related serious adverse events were observed in seven (4%) patients, without any deaths. INTERPRETATION: When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualised therapy, maximising weight loss and tolerance. FUNDING: Spatz Medical.