Outcomes of concomitant antiobesity medication use with endoscopic sleeve gastroplasty in clinical US settings.

Background: To evaluate the weight loss outcomes of the large US cohort of patients undergoing endoscopic sleeve gastroplasty (ESG) with or without concomitant anti-obesity (AOM) use. Methods: We performed a retrospective analysis of adult patients who underwent ESG from seven different sites, from January 1, 2020 to November 30, 2022. Percent total body weight loss (%TBWL) and %excess weight loss (%EWL) were calculated based on baseline weight at the procedure. Medication use was considered if the subject received a prescribed AOM during the study period. SPSS (version 29.0) was used for statistical analyses. Results: A total of 1506 patients were included (1359 (90.2 %) no AOM use and 147 (9.8 %) AOM use). Patients who were on an active AOM at the time of the procedure had a significantly lower TBWL% as compared to patients not on AOMs at 6 months. At the 24-month visit, patients who were prescribed AOMs after the 12-month visit had a significantly higher TBWL% and EWL% as compared to patients who were on active AOM at the time of the procedure. There was no significant difference between classes of medications at any time point, however, patients on a GLP-1RA had a trend towards improved weight loss at 18 and 24 months. Conclusion: In this large, real-world cohort of patients from the United States, data signal that with the use of pharmacotherapy at the appropriate time, patients can achieve optimal results.

Safe Continuation of Glucagon-like Peptide 1 Receptor Agonists at Endoscopy: A Case Series of 57 Adults Undergoing Endoscopic Sleeve Gastroplasty.

PURPOSE: Glucagon-like receptor agonists (GLP1-RAs) have raised peri-procedural concerns due to their potential to delay gastric emptying. The American Association of Anesthesiologists has advised pausing a single dose before elective endoscopy. However, a subsequent directive from multiple gastroenterology societies underscored the need for further assessment to substantiate this practice. We aimed to evaluate the frequency of serious adverse events and retained gastric products during endoscopic sleeve gastroplasty (ESG) with uninterrupted GLP1-RA use. MATERIALS AND METHODS: We conducted a retrospective evaluation of all patients undergoing ESG while on GLP1-RAs at three centers from August 2022 to February 2024. Per standard protocol, all patients had refrained from solid foods for at least 24 h and maintained nil per os for 12 h preceding their ESG. Records were reviewed for patient characteristics and medication type and doses. Primary outcomes included serious adverse events and retained gastric products based on patient records, procedure reports, and procedural videos. RESULTS: Fifty-seven consecutive adults (89.5% women, mean age of 44 ± 9 years, mean BMI of 40.1 ± 8.1 kg/m2, 35.1% with T2DM, and 26.3% with pre-T2DM) underwent ESG without stopping GLP1-RAs, which included semaglutide (45.6%), liraglutide (19.3%), dulaglutide (22.8%), and tirzepatide (12.3%). During intubation, endoscopy, and recovery, there were no instances of retained gastric solids, pulmonary aspiration, gastroesophageal regurgitation, or hypoxia. CONCLUSION: A ≥ 24-h pre-endoscopy liquid-only diet with ≥ 12-h pre-endoscopy fast may negate the need for GLP1-RA interruption for routine upper endoscopy in adults with native gastric anatomy.

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 subspecialty 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.

Celiac artery mesenteric fat measurement with endosonography (CAMEUS) reliably correlates with obesity and related comorbidities.

Background: Visceral fat represents a metabolically active entity linked to adverse metabolic sequelae of obesity. We aimed to determine if celiac artery mesenteric fat thickness can be reliably measured during endoscopic ultrasound (EUS), and if these measurements correlate with metabolic disease burden. Methods: This was a retrospective analysis of patients who underwent celiac artery mesenteric fat measurement with endosonography (CAMEUS) measurement at a tertiary referral center, and a validation prospective trial of patients with obesity and nonalcoholic steatohepatitis who received paired EUS exams with CAMEUS measurement before and after six months of treatment with an intragastric balloon. Results: CAMEUS was measured in 154 patients [56.5% females, mean age 56.5 ± 18.0 years, body mass index (BMI) 29.8 ± 8.0 kg/m2] and was estimated at 14.7 ± 6.5 mm. CAMEUS better correlated with the presence of non-alcoholic fatty liver disease (NAFLD) (R2 = 0.248, P < 0.001) than BMI (R2 = 0.153, P < 0.001), and significantly correlated with metabolic parameters and diseases. After six months of intragastric balloon placement, the prospective cohort experienced 11.7% total body weight loss, 1.3 points improvement in hemoglobin A1c (P = 0.001), and a 29.4% average decrease in CAMEUS (-6.4 ± 5.2 mm, P < 0.001). CAMEUS correlated with improvements in weight (R2 = 0.368), aspartate aminotransferase to platelet ratio index (R2 = 0.138), and NAFLD activity score (R2 = 0.156) (all P < 0.05). Conclusions: CAMEUS is a novel measure that is significantly correlated with critical metabolic indices and can be easily captured during routine EUS to risk-stratify susceptible patients. This station could allow for EUS access to sampling and therapeutics of this metabolic region.

Endoscopic sleeve gastroplasty: the identification of the key procedural steps through a modified Delphi method.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an innovative, minimally invasive bariatric procedure with an excellent safety and efficacy profile in adults with obesity. The purpose of the procedure is to shorten and tubularize the stomach along its greater curvature. Nevertheless, there are some heterogeneities in the approach to ESG, which will be important to address as the procedure sees increasingly widespread clinical adoption. Here, an expert consensus on standardized ESG techniques is presented. METHODS: The modified Delphi method was used to establish the key procedural steps of an ESG. A panel of 8 experts was selected, of which 6 participated. The panel was selected based on their experience with performing the procedure and consisted of 1 bariatric surgeon and 5 interventional gastroenterologists. A neutral facilitator was designated and produced a skeletonized initial version of the key steps that was sent to each expert. Each survey began with the experts rating the given steps on a Likert scale of 1 to 5, with 1 being the most inaccurate and 5 being the most accurate. Furthermore, the final product was rated. The survey continued with open-ended questions designed to revise and polish the key steps. Areas of discrepancy were addressed using binary questions and a majority vote. The respondents were given 10 days to complete each survey. At the end of each round, the survey was redistributed with updated key steps and questions. This process was continued for a predesignated 3 rounds. RESULTS: Of the 8 experts who were queried, 6/8, 5/8, and 5/8 replied to each round. The given ratings for the accuracy of the steps in each round were 4.2, 4.6, and 4.4. The final rating was 4.8. Although expert opinion varied around smaller portions of the procedure, such as the placement of an overtube and the shape of each suture line, there was consensus on the need for full-thickness bites and appropriate swirling of the tissue with the helix device. Whether or not to include the fundus in the gastroplasty was an additional area of discrepancy. Of note, 4 of 5 experts agreed that the fundus should remain intact. The final protocol consisted of 21 steps curated from the summarized responses of the experts. CONCLUSION: Using the modified Delphi method, 21 key steps have been described for a safe and effective ESG. This rubric will be standardized across institutions and practitioners. Furthermore, these findings allow for the generation of educational assessment tools to facilitate training and increase the adoption of ESG by endoscopists.

Transoral Outlet Reduction: Expert Tips, Tricks, and Troubleshooting.

Transoral outlet reduction (TORe) is an incisionless, endoscopic procedure to address weight recurrence after Roux-en-Y gastric bypass. Given the chronic, progressive nature of obesity and the minimally invasive, anatomy preserving technique of TORe, the procedure is expected to be met with high patient acceptance and widening clinical adoption. Nevertheless, the approach to TORe has been heterogeneous. As endoscopic bariatric therapies are increasingly incorporated into the multidisciplinary management of obesity, it is crucial to have a standardized, evidence-based framework for their implementation. In this review, based on the available literature and the authors' combined experience of over 1,000 TORe procedures, we present our approach to patient selection, procedural technique, troubleshooting, and patient aftercare unique to TORe.

Outcomes of Endoscopic Sleeve Gastroplasty Following Laparoscopic Adjustable Gastric Band: A Propensity Score-matched Analysis.

BACKGROUND: The performance of endoscopic sleeve gastroplasty (ESG) in patients with prior laparoscopic adjustable gastric band (LAGB) has not been characterized. MATERIALS AND METHODS: This is a retrospective propensity score-matched study of ESG after LAGB at 2 centers with expertise in bariatric endoscopy. The primary outcome was total weight loss (TWL) at 12 months. Secondary outcomes included TWL at 3 and 6 months, 12-month excess weight loss (EWL), procedural characteristics, predictors of TWL, and serious adverse events. RESULTS: Twenty-six adults (88.5% female, age 50.8 y, BMI 36.5 kg/m 2 ) with prior LAGB (median duration 8 y) underwent ESG at a median of 3 years after LAGB removal. A 2:1 age-matched, sex-matched, and BMI-matched comparator group was created, comprising ESG patients from the same organization and time frame but without prior LAGB. TWL for the LAGB-to-ESG cohort versus the ESG-only cohort was 10.1±5.5% versus 13.0±4.4% at 3 months ( P =0.0256), 12.4±7.2% versus 16.0±5.4% at 6 months ( P =0.0375), and 12.7±8.2% versus 18.4±6.5% at 12 months ( P =0.0149). At 12 months, the LAGB-to-ESG cohort had an EWL of 52.5±50.0%, and 75% achieved TWL ≥10%. There was no association between TWL at 3, 6, or 12 months and the following traits: age or BMI at the time of ESG, patient sex, and time from LAGB removal to ESG. No serious adverse events occurred in either cohort. CONCLUSION: ESG after LAGB facilitates safe and clinically meaningful weight loss but is attenuated compared to primary ESG.

Practice patterns and outcomes of endoscopic sleeve gastroplasty based on provider specialty.

Background and study aims Endoscopic sleeve gastroplasty (ESG) is performed in clinical practice by gastroenterologists and bariatric surgeons. Given the increasing regulatory approval and global adoption, we aimed to evaluate real-world outcomes in multidisciplinary practices involving bariatric surgeons and gastroenterologists across the United States. Patients and methods We included adult patients with obesity who underwent ESG from January 2013 to August 2022 in seven academic and private centers in the United States. Patient and procedure characteristics, serious adverse events (SAEs), and weight loss outcomes up to 24 months were analyzed. SPSS (version 29.0) was used for all statistical analyses. Results A total of 1506 patients from seven sites included 235 (15.6%) treated by surgeons and 1271 (84.4%) treated by gastroenterologists. There were no baseline differences between groups. Gastroenterologists used argon plasma coagulation for marking significantly more often than surgeons ( P <0.001). Surgeons placed sutures in the fundus in all instances whereas gastroenterologist placed them in the fundus in less than 1% of the cases ( P <0.001>). Procedure times were significantly different between groups, with surgeons requiring approximately 20 minutes more during the procedure than gastroenterologists ( P <0.001). Percent total body weight loss (%TBWL) and percent responders achieving >10 and >15% TBWL were similar between the two groups at 12, 18, and 24 months. Rates of SAEs were low and similar at 1.7% for surgeons and 2.7% for gastroenterologists ( P >0.05). Conclusions Data from a large US cohort show significant and sustained weight loss with ESG and an excellent safety profile in both bariatric surgery and gastroenterology practices, supporting the scalability of the procedure across practices in a multidisciplinary setting.

Performance of Endoscopic Sleeve Gastroplasty by Obesity Class in the United States Clinical Setting.

INTRODUCTION: Endoscopic sleeve gastroplasty (ESG) has gained popularity over the past decade and has been adopted in both academic and private institutions globally. We present outcomes of the largest cohort of patients from the United States undergoing ESG and evaluate these according to obesity class. METHODS: We performed a retrospective analysis of adult patients who underwent ESG. Medical information was abstracted from the electronic record with weight records up to 2 years after ESG. Percent total body weight loss (%TBWL) at 6, 12, 18, and 24 months was calculated based on baseline weight at the procedure. SPSS (version 29.0) was used for all statistical analyses. RESULTS: A total of 1,506 patients from 7 sites were included (501 Class I obesity, 546 Class II, and 459 Class III). Baseline demographics differed according to obesity class due to differences in age, body mass index (BMI), height, sex distribution, and race. As early as 6 months post-ESG, mean BMI for each class dropped to the next lower class and remained there through 2 years. %TWBL achieved in the Class III group was significantly greater when compared with other classes at all time points. At 12 months, 83.2% and 60.9% of patients had ≥10% and ≥15% TBWL for all classes. There were no differences in adverse events between classes. DISCUSSION: Real-world data from a large cohort of patients of all BMI classes across the United States shows significant and sustained weight loss with ESG. ESG is safe to perform in a higher obesity class with acceptable midterm efficacy.

Endoscopic revision of one-anastomosis gastric bypass (ER-OAGB) for weight recurrence: a case series of 17 adults.

Weight recurrence after one-anastomosis gastric bypass (OAGB), the third most common metabolic and bariatric surgery performed worldwide, is observed in a subset of patients due to the chronic, progressive nature of obesity. Endoscopic revision of the OAGB (ER-OAGB) through full-thickness suturing to reduce the gastrojejunal anastomosis and gastric pouch is a potential alternative to surgical revision. Here, we present a case series of ER-OAGB and long-term nutritional support at two international centers with expertise in bariatric endoscopy. Data were retrospectively evaluated from a prospectively maintained database. The primary outcome was total body weight loss (TBWL) at 12 months. Secondary outcomes included TBWL at 3, 6, and 15 months; excess weight loss (EWL) at 3, 6, 12, and 15 months; frequency of new/worsening symptoms of gastroesophageal reflux disease (GERD); and the frequency of serious adverse events. In this series, 17 adults (70.6% female, mean age 46.8 years, mean BMI 39.1 kg/m2) successfully underwent ER-OAGB an average of 8 years (range 2-21 years) after OAGB for a mean weight recurrence of 43.2% (range 10.9-86.9%). TBWL from ER-OAGB was 9.7 ± 1.8% at 3 months, 13.4 ± 3.5% at 6 months, 18.5 ± 2.1% at 12 months, and 18.1 ± 2.2% at 15 months. EWL from ER-OAGB was 30.5 ± 14.7% at 3 months, 42.6 ± 16.2% at 6 months, 54.2 ± 11.3% at 12 months, and 54.2 ± 11.7% at 15 months. There were no instances of new/worsening GERD symptoms or serious adverse events. In this small series of adults who experienced weight recurrence after OAGB, ER-OAGB facilitated safe and clinically meaningful weight loss, without new or worsening GERD symptoms, when performed by experienced bariatric endoscopists in concert with longitudinal nutritional support.

Endoscopic revision of one-anastomosis gastric bypass for weight recurrence The one-anastomosis gastric bypass (OAGB) is now the third most commonly performed metabolic and bariatric surgery worldwide. As with other weight loss surgeries, the OAGB is associated with weight recurrence over time that prompts patients to seek further treatment; however, revisional surgeries are known to carry increased risk. The endoscopic revision of the OAGB (ER-OAGB) is an incisionless technique that reduces the gastrojejunal anastomosis and gastric pouch to facilitate weight loss after weight recurrence in OAGB. Here, we showed in a series of 17 adults that the ER-OAGB safely helped patients lose over 18% of their body weight within the year following their revision.

Endoscopic removal of a weight-loss device with stoma closure using a tack-and-suture device.

Video 1.

Transoral outlet reduction: Outcomes of endoscopic Roux-en-Y gastric bypass revision in 284 patients at a community practice.

BACKGROUND: Transoral outlet reduction (TORe) is a minimally invasive endoscopic revision of Roux-en-Y gastric bypass (RYGB) for weight recurrence; however, little has been published on its clinical implementation in the community setting. AIM: To characterize the safety and efficacy of TORe in the community setting for adults with weight recurrence after RYGB. METHODS: This is a retrospective cohort study of argon plasma coagulation and purse-string suturing for gastric outlet reduction in consecutive adults with weight recurrence after RYGB at a single community center from September 2020 to September 2022. Patients were provided longitudinal nutritional support via virtual visits. The primary outcome was total body weight loss (TBWL) at twelve months from TORe. Secondary outcomes included TBWL at three months and six months; excess weight loss (EWL) at three, six, and twelve months; twelve-month TBWL by obesity class; predictors of twelve-month TBWL; rates of post-TORe stenosis; and serious adverse events (SAE). Outcomes were reported with descriptive statistics. RESULTS: Two hundred eighty-four adults (91.9% female, age 51.3 years, body mass index 39.3 kg/m2) underwent TORe an average of 13.3 years after RYGB. Median pre- and post-TORe outlet diameter was 35 mm and 8 mm, respectively. TBWL was 11.7% ± 4.6% at three months, 14.3% ± 6.3% at six months, and 17.3% ± 7.9% at twelve months. EWL was 38.4% ± 28.2% at three months, 46.5% ± 35.4% at six months, and 53.5% ± 39.2% at twelve months. The number of follow-up visits attended was the strongest predictor of TBWL at twelve months (R2 = 0.0139, P = 0.0005). Outlet stenosis occurred in 11 patients (3.9%) and was successfully managed with endoscopic dilation. There was one instance of post-procedural nausea requiring overnight observation (SAE rate 0.4%). CONCLUSION: When performed by an experienced endoscopist and combined with longitudinal nutritional support, purse-string TORe is safe and effective in the community setting for adults with weight recurrence after RYGB.

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/m2 who 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.

Performance Characteristics of Endoscopic Sleeve Gastroplasty in Patients with Prior Intragastric Balloon: Results of a Propensity Score Matched Study.

INTRODUCTION: The performance characteristics of endoscopic sleeve gastroplasty (ESG) for weight recurrence after intragastric balloon (IGB) are unknown. METHODS: This is a retrospective propensity score matched study of ESG after IGB (IGB-to-ESG) vs ESG without prior IGB (ESG-only). The primary outcome was total weight loss (TWL) at 12 months. Secondary outcomes included TWL at 3 and 6 months, 12-month excess weight loss (EWL), procedural characteristics, and safety. RESULTS: Thirty-nine adults underwent ESG from August 2020 to September 2022 after IGB explantation a median of 24 months (range 2-56 months) prior and a median post-IGB nadir weight increase of 100.0% (range 0 to 3200%). An ESG-only 2:1 age- sex- and BMI- propensity score matched cohort was derived from 649 patients (Pearson's goodness-of-fit: 0.86). TWL for IGB-to-ESG vs. ESG-only was 12.3 ± 13.5% vs. 12.4 ± 3.7% at 3 months (p = 0.97), 10.1 ± 7.1% vs. 15.4 ± 4.6% at 6 months (p < 0.001), and 8.7 ± 7.7% vs. 17.1 ± 5.7% at 12 months (p < 0.001). Twelve-month EWL for IGB-to-ESG vs ESG-only was 27.8 ± 46.9% vs 62.0 ± 21.0% (p < 0.001). There was no difference in mean procedural duration of ESG; however, more sutures were used with IGB-to-ESG vs. ESG-only (7 vs. 6, p < 0.0002). There were no serious adverse events in either cohort. CONCLUSION: ESG after IGB produces safe, acceptable weight loss but with an attenuated effect compared to ESG alone. Further study is required to understand the factors driving this discrepancy.

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.

A Protocolized Management of Walled-Off Necrosis (WON) Reduces Time to WON Resolution and Improves Outcomes.

BACKGROUND AND AIMS: Patients with infected or symptomatic walled-off necrosis (WON) have high morbidity and health care utilization. Despite the recent adoption of nonsurgical treatment approaches, WON management remains nonalgorithmic. We investigated the impact of a protocolized early necrosectomy approach compared with a nonprotocolized, clinician-driven approach on important clinical outcomes. METHODS: Records were reviewed for consecutive patients with WON who underwent a protocolized endoscopic drainage with a lumen-apposing metal stent (cases), and for patients with WON treated with a lumen-apposing metal stent at the same tertiary referral center who were not managed according to the protocol (control subjects). The protocol required repeat cross-sectional imaging within 14 days after lumen-apposing metal stent placement, with regularly scheduled endoscopic necrosectomy if WON diameter reduction was <50%. Control patients were treated according to their clinician's preference without an a priori strategy. Inverse probability of treatment weighting-adjusted analysis was used to evaluate the influence of being in the protocolized group on time to resolution. RESULTS: A total of 24 cases and 47 control subjects were included. There were no significant differences in baseline characteristics. Although numbers of endoscopies and necrosectomies were similar, cases had lower adverse event rates, shorter intensive care unit stay, and required nutritional support for fewer days. On matched multivariate Cox regression, cases had earlier WON resolution (hazard ratio, 5.73; 95% confidence interval, 2.62-12.5). This was confirmed in the inverse probability of treatment weighting-adjusted analysis (hazard ratio, 3.4; 95% confidence interval, 1.92-6.01). CONCLUSIONS: A protocolized strategy resulted in faster WON resolution compared with a discretionary approach without the need for additional therapeutic interventions, and with a better safety profile and decreased health care utilization.

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.

Comparison of biochemical, microbial and mucosal mRNA expression in bile acid diarrhoea and irritable bowel syndrome with diarrhoea.

OBJECTIVE: There are altered mucosal functions in irritable bowel syndrome with diarrhoea (IBS-D); ~30% of patients with IBS-D have abnormal bile acid (BA) metabolism (ABAM) and diarrhoea (summarised as BAD). AIM: To compare biochemical parameters, gastrointestinal and colonic transit, rectal sensation and pathobiological mechanisms in IBS-D without ABAM and in BAD (serum 7C4>52 ng/mL). DESIGN: In patients with Rome III criteria of IBS-D, we compared biochemical features, colonic transit, rectal sensation, deep genotype of five BA-related genes, ileal and colonic mucosal mRNA (differential expression (DE) analysis) and stool dysbiosis (including functional analysis of microbiome). Results in BAD were compared with IBS-D without ABAM. RESULTS: Compared with 161 patients with IBS-D without ABAM, 44 patients with BAD had significantly faster colonic transit, lower microbial alpha diversity, different compositional profile (beta diversity) and higher Firmicutes to Bacteroidetes ratio with evidence of decreased expression of bile acid thiol ligase (involved in transformation of primary to secondary BAs) and decreased sulfatases. In BAD (compared with IBS-D without ABAM), terminal ileal biopsies showed downregulation of SLC44A5 (a BA transporter), and ascending colon biopsies showed upregulation in barrier-weakening genes (CLDN2), serine protease inhibitors, immune activation, cellular differentiation and a cellular transporter (FABP6; BA binding). No DE of genes was documented in descending colon biopsies. The two groups had similar rectal sensation. CONCLUSION: Though sharing clinical symptoms with IBS-D, BAD is associated with biological differences and mechanisms that have potential to enhance diagnosis and treatment targeting barrier dysfunction, inflammatory and microbial changes.

Novel classification system for walled-off necrosis: a step toward standardized nomenclature and risk-stratification framework.

BACKGROUND AND AIMS: The optimal therapeutic approach for walled-off necrosis (WON) is not fully understood, given the lack of a validated classification system. We propose a novel and robust classification system based on radiologic and clinical factors to standardize the nomenclature, provide a framework to guide comparative effectiveness trials, and inform the optimal WON interventional approach. METHODS: This was a retrospective analysis of patients who underwent endoscopic management of WON by lumen-apposing metal stent placement at a tertiary referral center. Patients were classified according to the proposed QNI classification system: quadrant ("Q"), represented an abdominal quadrant distribution; necrosis ("N"), denoted by the percentage of necrosis of WON; and infection ("I"), denoted as positive blood culture and/or systemic inflammatory response syndrome reaction with a positive WON culture. Two blinded reviewers classified all patients according to the QNI system. Patients were then divided into 2 groups: those with a lower QNI stratification (≤2 quadrants and ≤30% necrosis; group 1) and those with a higher stratification (≥3 quadrants, 2 quadrants with ≥30% necrosis, or 1 quadrant with >60% necrosis and infection; group 2). The primary outcome was mean time to WON resolution. Secondary procedural and clinical outcomes between the groups were compared. RESULTS: Seventy-one patients (75% men) were included and stratified by the QNI classification; group 1 comprised 17 patients and group 2, 54 patients. Patients in group 2 had a higher number of necrosectomies, longer hospital stays, and more readmissions. The mean time to resolution was longer in group 2 than in group 1 (79.6 ± 7.76 days vs 48.4 ± 9.22 days, P = .02). The mortality rate was higher in group 2 (15% vs 0%, P = .18). CONCLUSIONS: Despite the heterogeneous nature of WON in severe acute pancreatitis, a proposed QNI system may provide a standardized framework for WON classification to inform clinical trials, risk-stratify the disease course, and potentially inform an optimal management approach.