Revisional Bariatric Surgery After Roux-en-Y Gastric Bypass for Bile Reflux: a Single-Center Long-Term Cohort Study.

PURPOSE: Revisional bariatric surgery (RBS) after primary Roux-en-Y gastric bypass (RYGB) is indicated for the efficient management of specific complications such as bile reflux. Published literature on this topic remains scarce as we aim to evaluate the long-term outcomes (10 years) of RBS for bile reflux after RYGB. MATERIAL AND METHODS: We conducted a single-center retrospective study of patients who underwent primary RYGB complicated by bile reflux and had RBS between 2008 and 2023. Our cohort was divided into two groups based on the etiology of bile reflux. Long-term surgical outcomes and nutritional status were reported and compared between the groups. RESULTS: A total of 41 patients (100% primary RYGB; 90.2% female, 97.6% white) were included. 56.1% (n = 23) of patients underwent Roux limb lengthening and the remaining 43.9% (n = 18) had a gastrogastric fistula takedown, with no significant differences in terms of intraoperative complications, estimated blood loss (p = 0.616), length of hospital stay (p = 0.099), and postoperative complications between the two groups. Long-term resolution of obesity-related medical conditions was demonstrated for all the evaluated comorbidities. Lastly, there was no reported mortality, bile reflux recurrence, or micro- and macro-nutrient deficiencies over the total follow-up period of 10 years. CONCLUSION: In our cohort, RBS after a primary RYGB for bile reflux management demonstrated safe and efficient short- and long-term surgical outcomes without any reported bile reflux recurrence or mortality. Adequate supplementation and close patient follow-up remain essential to decrease the morbidity and mortality associated with RBS as further studies are required to support our findings.

Applicability of individualized metabolic surgery score for prediction of diabetes remission after endoscopic sleeve gastroplasty.

Background: Endoscopic sleeve gastroplasty (ESG) is a safe and effective obesity treatment. The individualized metabolic score (IMS) is a validated score that uses preoperative variables predicting T2D remission (DR) in bariatric surgery. Objectives: We evaluated the applicability of using the IMS score to predict DR in patients after ESG. Design/Methods: We performed a retrospective review of patients with obesity and T2D who underwent ESG. We calculated DR, IMS score, and severity, and divided patients based on IMS category. Results: The cohort comprised 20 patients: 25% (5) mild, 55% (11) moderate, and 20% (4) severe IMS stages. DR was achieved in 60%, 45.5%, and 0% of patients with mild, moderate, and severe IMS scores (p = 0.08), respectively. IMS score was significantly associated with DR (p = 0.03), with the area under the curve of the receiver operating characteristic for predicting DR 0.85. Conclusion: These pilot data demonstrate that the IMS score appears to be useful in predicting DR after ESG.

Use of individualized metabolic surgery score in endoscopic sleeve gastroplasty Why was the study done? Endoscopic sleeve gastroplasty (ESG) is effective and safe as a treatment for obesity and has also shown improvement in diabetes in previous studies. However, there is no data showing the rates of diabetes remission after this procedure and no measures to predict this outcome. This study uses the individualized metabolic score (IMS) to predict diabetes remission after ESG. What did the researchers do? They analyzed a sample of patients who had undergone ESG, and evaluated the change in their diabetes parameters at 1 year compared to baseline, and then correlated this with their calculated baseline IMS score. What did the researchers find? Patients with a higher IMS score, representing more severe disease, were less likely to have an improvement in their diabetes after ESG. What do the findings mean? ESG can be an effective treatment option for patients with obesity and early-stage diabetes.

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.

Effect of Glucagon-Like Peptide-1 Receptor Agonists on Bowel Preparation for Colonoscopy.

INTRODUCTION: Inadequate bowel preparation can result in decreased diagnostic accuracy and therapeutic safety of colonoscopy for colon cancer screening. The Boston Bowel Preparation Scale (BBPS) has been used to assess the quality of bowel preparation. Glucagon-like peptide-1 receptor agonists (GLP-1RA) are commonly used medications for diabetes mellitus and obesity that are known to delay gastrointestinal motility. We hypothesized that the use of GLP-1RA would be associated with decreased quality of bowel preparation. METHODS: We performed a retrospective cohort study of patients who underwent screening or surveillance colonoscopy at a large academic medical center between December 2021 and December 2022. We included patients taking any GLP-1RA for diabetes or obesity during colonoscopy defined as our cases, and patients who were prescribed GLP-1RA at one point but not within 3 months of colonoscopy defined as our controls. We excluded patients on any promotility or antimotility agents and those without BBPS recorded on their procedure report. Independent t test assessed statistical differences in the case and control groups to compare the quality of bowel preparation for continuous variables, and the χ 2 test was used for categorical variables. Multivariate linear regression including diabetes as a covariate was also performed for continuous variables, and multivariate logistic regression was performed for categorical variables. RESULTS: A total of 446 patients were included in the study, comprising 265 (59%) cases and 181 controls (41%). There were no statistically significant differences between groups at baseline except for the diagnosis of diabetes ( P = 0.001) with a higher proportion of patients with diabetes in the cases. The mean BBPS was significantly higher in controls (7.0 ± 1.9 vs 7.5 ± 2.4, P = 0.046) when controlling for diabetes. The percentage of patients with a total BBPS score of <5 was significantly higher in cases (15.5% vs 6.6%, P = 0.01). The proportion of patients who required a repeat colonoscopy due to poor bowel preparation was also significantly higher in cases (18.9% vs 11.1%, P = 0.041). DISCUSSION: The use of GLP-1RA was associated with a statistically significantly lower quality of bowel preparation, with additional clinical significance given a notable difference in the need for a repeat colonoscopy. It will be essential to understand the cumulative effect of medications that may delay gastric emptying on the quality of bowel preparation to better understand the appropriate measures and counseling that need to be taken before undergoing outpatient colonoscopies.

Endoscopic retrograde cholangiopancreatography (ERCP) approach for patients with Roux-en-Y gastric bypass: a comparative study between four ERCP techniques with proposed management algorithm.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is technically challenging in patients with Roux-en-Y gastric bypass (RYGB) due to altered anatomy. OBJECTIVE: To compare the procedural and clinical outcomes of 4 different ERCP techniques in RYGB patients. SETTING: Academic tertiary referral center in the United States. METHODS: A retrospective cohort study including patients with RYGB anatomy who underwent an ERCP between January 2015 and September 2020. We compared procedural success and adverse events (AEs) rates of balloon-assisted enteroscopy (BAE), gastrostomy-assisted ERCP (GAE), endoscopic ultrasound (EUS)-directed transgastric ERCP (EDGE), and rendezvous guidewire-assisted ERCP (RGA). RESULTS: Seventy-eight RYGB patients underwent a total of 132 ERCPs. The mean age was 60 ± 11.8 years, with female predominance (85.7%). The ERCP procedures performed were BAE (n = 64; 48.5%), GAE (n = 18; 13.7%), EDGE (n = 25; 18.9%), and RGA (n = 25; 18.9%), with overall procedure success rates of 64.1%, 100%, 89.5%, and 91.7%, respectively. All approaches were superior to BAE (GAE versus BAE, P = .003; EDGE versus BAE, P = .034; RGA versus BAE, P = .011). The overall AE rates were 10.9%, 11.1%, 15.8 %, and 25.0%, respectively. There was no statistical difference in AEs. There were also no differences in bleeding, post-ERCP pancreatitis, and perforation rates between the 4 approaches. CONCLUSION: Procedure success was similar between GAE, RGA, and EDGE, but superior to BAE. AE rates were similar between approaches.

Correlation Between Gastrojejunal Anastomosis Diameter, Distensibility Index, and Weight Regain After Roux-en-Y Gastric Bypass.

INTRODUCTION: Gastrojejunal anastomosis (GJA) dilation is an independent predictor of weight regain (WR) after Roux-en-Y gastric bypass (RYGB). However, the role of planimetric measurements in this context remains unknown. METHODS: This is a retrospective cohort study including adult RYGB patients who underwent a diagnostic endoscopy with Endoflip assessment of the GJA. We excluded patients in the early postoperative period and those with abnormal endoscopic findings (marginal ulcers and gastro-gastric fistulas). RESULTS: Thirty-four patients were initially included. Endoscopic GJA diameter had a moderate positive correlation with WR (r=+0.438, p=0.011). However, after excluding the 7 patients with GJA> 30 mm, there was no significant correlation. There was a moderate agreement between the EndoFLIP-GJA diameter at 60mL and endoscopic diameter (ICC=0.576, p=0.049). The distensibility index (DI) showed a consistent moderate negative correlation with WR. Considering the maximum DI at 40 ml, we found a cutoff of DI = 7 mm2/mmHg that split the sample in two significantly different populations in terms of WR (67.4% vs. 43.2%, p=0.04). CONCLUSION: Visual estimation of the GJA diameter correlates with EndoFLIP at 60mL. In the subset of patients with GJA ≤ 30 mm, more distensible GJAs are associated with lower rates of WR. Larger studies are needed to confirm this correlation and to validate its utility for clinical management.

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.

Structured training program on confocal laser endomicroscopy for pancreatic cystic lesions: a multicenter prospective study among early-career endosonographers (with video).

BACKGROUND AND AIMS: Data on how to teach endosonographers needle-based confocal laser endomicroscopy (nCLE)-guided histologic diagnosis of pancreatic cystic lesions (PCLs) are limited. Hence, we developed and tested a structured educational program to train early-career endosonographers in nCLE-guided diagnosis of PCLs. METHODS: Twenty-one early-career nCLE-naïve endosonographers watched a teaching module outlining nCLE criteria for diagnosing PCLs. Participants then reviewed 80 high-yield nCLE videos, recorded diagnoses, and received expert feedback (phase 1). Observers were then randomized to a refresher feedback session or self-learning at 4 weeks. Eight weeks after training, participants independently assessed the same 80 nCLE videos without feedback and provided histologic predictions (phase 2). Diagnostic performance of nCLE to differentiate mucinous versus nonmucinous PCLs and to diagnose specific subtypes were analyzed using histopathology as the criterion standard. Learning curves were determined using cumulative sum analysis. RESULTS: Accuracy and diagnostic confidence for differentiating mucinous versus nonmucinous PCLs improved as endosonographers progressed through nCLE videos in phase 1 (P < .001). Similar trends were observed with the diagnosis of PCL subtypes. Most participants achieved competency interpreting nCLE, requiring a median of 38 assessments (range, 9-67). During phase 2, participants independently differentiated PCLs with high accuracy (89%), high confidence (83%), and substantial interobserver agreement (κ = .63). Accuracy for nCLE-guided PCL subtype diagnoses ranged from 82% to 96%. The learned nCLE skills did not deteriorate at 8 weeks and were not impacted by a refresher session. CONCLUSIONS: We developed a practical, effective, and durable educational intervention to train early-career endosonographers in nCLE-guided diagnosis of PCLs.

Endoscopic ultrasound-guided versus percutaneous drainage for the management of post-operative fluid collections after distal pancreatectomy.

BACKGROUND: Post-operative pancreatic fluid collections (POPFCs) can be drained using percutaneous or endoscopic approaches. The primary aim of this study was to compare rates of clinical success between endoscopic ultrasound-guided drainage (EUSD) with percutaneous drainage (PTD) in the management of symptomatic POPFCs after distal pancreatectomy. Secondary outcomes included technical success, total number of interventions, time to resolution, rates of adverse events (AEs), and POPFC recurrence. METHODS: Adults who underwent distal pancreatectomy from January 2012 to August 2021 and developed symptomatic POPFC in the resection bed were retrospectively identified from a single academic center database. Demographic data, procedural data, and clinical outcomes were abstracted. Clinical success was defined as symptomatic improvement and radiographic resolution without requiring an alternate drainage modality. Quantitative variables were compared using a two-tailed t-test and categorical data were compared using Chi-squared or Fisher's exact tests. RESULTS: Of 1046 patients that underwent distal pancreatectomy, 217 met study inclusion criteria (median age 60 years, 51.2% female), of whom 106 underwent EUSD and 111 PTD. There were no significant differences in baseline pathology and POPFC size. PTD was generally performed earlier after surgery (10 vs. 27 days; p < 0.001) and more commonly in the inpatient setting (82.9% vs. 49.1%; p < 0.001). EUSD was associated with a significantly higher rate of clinical success (92.5% vs. 76.6%; p = 0.001), fewer median number of interventions (2 vs. 4; p < 0.001), and lower rate of POPFC recurrence (7.6% vs. 20.7%; p = 0.007). AEs were similar between EUSD (10.4%) and PTD (6.3%, p = 0.28), with approximately one-third of EUSD AEs due to stent migration. CONCLUSION: In patients with POPFCs after distal pancreatectomy, delayed drainage with EUSD was associated with higher rates of clinical success, fewer interventions, and lower rates of recurrence than earlier drainage with PTD.

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.

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.

Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study.

OBJECTIVE: Endoscopic sleeve gastroplasty (ESG) has gained global adoption but our understanding of its mechanism(s) of action and durability of efficacy is limited. We sought to determine changes in gastric emptying (GE), gastric motility (GM), hormones and eating behaviours after ESG. DESIGN: A priori-designed single-centre substudy of a large US randomised clinical trial, adults with obesity were randomised to ESG or lifestyle interventions (LS) alone. We measured GE, hormones and weight loss and assessed eating behaviours. In a subset of ESG patients, we assessed GM. The primary outcome was the change in T1/2 (min) at 3 months, and secondary outcomes were changes in weight, GE, GM, hormones and eating behaviours. We used t-test analyses and regression to determine the association between GE and weight loss. RESULTS: 36 (ESG=18; LS=18) participated in this substudy. Baseline characteristics were similar between the two groups. At 3 months, T1/2 was delayed in the ESG group (n=17) compared with the LS group (n=17) (152.3±47.3 vs 89.1±27.9; p<0.001). At 12 months, T1/2 remained delayed in the ESG group (n=16) vs control group (n=14) (137±37.4 vs 90.1±23.4; p<0.001). Greater delays in GE at 3 months were associated with greater weight loss. GM was preserved and fasting ghrelin, glucagon-like peptide 1 and polypeptide YY significantly increased 18 months after ESG. CONCLUSION: ESG promotes weight loss through several key mechanistic pathways involving GE and hormones while preserving GM. These findings further support clinical adoption of this technique for the management of obesity. TRIAL REGISTRATION NUMBER: NCT03406975.

Identification of patients with malignant biliary strictures using a cholangioscopy-based deep learning artificial intelligence (with video).

BACKGROUND AND AIMS: Accurately diagnosing malignant biliary strictures (MBSs) as benign or malignant remains challenging. It has been suggested that direct visualization and interpretation of cholangioscopy images provide greater accuracy for stricture classification than current sampling techniques (ie, brush cytology and forceps biopsy sampling) using ERCP. We aimed to develop a convolutional neural network (CNN) model capable of accurate stricture classification and real-time evaluation based solely on cholangioscopy image analysis. METHODS: Consecutive patients with cholangioscopy examinations from 2012 to 2021 were reviewed. A CNN was developed and tested using cholangioscopy images with direct expert annotations. The CNN was then applied to a multicenter, reserved test set of cholangioscopy videos. CNN performance was then directly compared with that of ERCP sampling techniques. Occlusion block heatmap analyses were used to evaluate and rank cholangioscopy features associated with MBSs. RESULTS: One hundred fifty-four patients with available cholangioscopy examinations were included in the study. The final image database comprised 2,388,439 still images. The CNN demonstrated good performance when tasked with mimicking expert annotations of high-quality malignant images (area under the receiver-operating characteristic curve, .941). Overall accuracy of CNN-based video analysis (.906) was significantly greater than that of brush cytology (.625, P = .04) or forceps biopsy sampling (.609, P = .03). Occlusion block heatmap analysis demonstrated that the most frequent image feature for an MBS was the presence of frond-like mucosa/papillary projections. CONCLUSIONS: This study demonstrates that a CNN developed using cholangioscopy data alone has greater accuracy for biliary stricture classification than traditional ERCP-based sampling techniques.

Histological assessment of new cholangioscopy-guided forceps in ERCP biliary stricture sampling: a blinded comparative study.

Background and study aims Obtaining quality tissue during ERCP biliary stricture sampling is of paramount importance for a timely diagnosis. While single-operator cholangioscopy (SOC)-guided biopsies have been suggested to be the superior biliary tissue acquisition modality given direct tissue visualization, less is known about the specimen histological quality. We aimed to analyze the specimen quality of SOC biopsies and compare the new generation forceps with prior "legacy" forceps. Patients and methods Patients who underwent SOC from January 2017-August 2021 for biliary sampling were reviewed. In February 2020, the SOC-guided biopsy forceps were changed from legacy SpyBite to the SpyBite Max forceps (max). Specimens were assessed by blinded pathologists for crush artifact (none, mild, or severe) and gross size (greatest dimension in mm). Crush artifact and gross size were compared between the two groups. The diagnostic performance characteristics for cholangiocarcinoma (CCA), were assessed in an exploratory fashion. Results Eighty-one patients (max = 27, legacy = 54) with similar baseline characteristics were included in this study. On blinded pathological assessment, 58 % had crush artifact, without significant differences between the two groups (Max 63 % vs. Legacy 56 %; P  = 0.64). A similar mean specimen size was found (max 3 mm vs. legacy 3.2 mm; P  = 0.24). The overall prevalence of CCA was 40 %. The sensitivity, specificity, positive predictive value, and negative predictive value of the entire cohort using a combination of cytology, fluorescence in situ hybridization, and SOC-guided biopsies were 78.1 %, 91.8 %, 86.2 %, and 86.5 %, respectively. No difference between legacy or max groups was found. Conclusions A high rate of crush artifact was found in SOC-guided biopsy specimens. Further investigation regarding proper biopsy technique and handling is necessary to increase the diagnostic yield with SOC-guided biopsies.

Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone. METHODS: We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21-65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m2. Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks. FINDINGS: Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery. INTERPRETATION: ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975. FUNDING: Apollo Endosurgery, Mayo Clinic.

Efficacy and safety of endoscopic ultrasound-guided gastrojejunostomy in patients with malignant gastric outlet obstruction and ascites.

Background and study aims Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is an endoscopic procedure for treating gastric outlet obstruction (GOO). Limited data exist regarding the safety and efficacy of EUS-GJ in patients with malignant GOO with ascites. Thus, we aimed to study the outcomes and safety of EUS-GJ in GOO patients with vs. without ascites. Patients and methods This is a retrospective cohort study of patients with malignant GOO who underwent successful EUS-GJ at a tertiary care academic center. Primary outcomes included the efficacy and safety of EUS-GJ. Secondary outcomes included 30-day readmission, reintervention, and survival utilizing Kaplan-Meier analysis. Results A total of 55 patients (mean age of 67.0 ±â€Š11.3 years, 40.0 % female) who underwent EUS-GJ, of whom 24 had ascites (small in 22, large in 2) were included. Clinical success was achieved in 91.7 % and 93.5 % ( P =  1.00) of patients with and without ascites, respectively. A higher rate of adverse events (AEs) was noted in patients with ascites but this was not statistically significant (37.5 % vs. 19.4 %, P =  0.13). Four patients in the ascites group (16.6 %) developed clinical evidence of peritonitis or sepsis post-EUS-GJ. Eight patients with ascites developed worsening ascites within a month of EUS-GJ. In contrast, only one patient without ascites developed evidence of new ascites. The median survival of patients was not significantly different between the two groups (patients with ascites: 129 days vs. patients without ascites: 180 days, ( P =  0.12). Conclusions The efficacy EUS-GJ in the presence of ascites is promising; however, the safety profile remains concerning given the high rate of AEs, specifically peritonitis and sepsis.

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.

Contamination of single fluid-filled intragastric balloons with orogastric fluid is not associated with hyperinflation: an ex-vivo study and systematic review of literature.

BACKGROUND: Spontaneous hyperinflation is reported to the Food and Drug Administration as a complication of intragastric balloons. It is postulated that orogastric contamination of the intragastric balloon may cause this phenomenon. We sought to investigate the effects of intentional balloon contamination with gastric contents on intragastric balloon perimeter and contents, whether methylene blue plays a role in preventing spontaneous hyperinflation, and review the available literature on spontaneous hyperinflation. METHODS: Four pairs of balloons with different combinations of sterile saline, orogastric contaminants, and methylene blue were incubated in a 37 °C water bath for six months to simulate physiological conditions with serial measurements of balloon perimeter. Our findings were compared against a systematic review across multiple databases to summarize the available literature. RESULTS: Balloon mean perimeter decreased from 33.5 cm ± 0.53 cm to 28.5 cm ± 0.46 cm (p < 0.0001). No significant differences were seen with the methylene blue group. Only 11 cases were found reported in the literature. CONCLUSIONS: Despite contaminating intragastric balloons with gastric aspirates, hyperinflation did not occur, and other factors may be in play to account for this phenomenon, when observed. Rates of hyperinflation remain under-reported in the literature. Further controlled experiments are needed.

Indications and Outcomes of Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass: a Systematic Review and a Meta-analysis.

PURPOSE: Sleeve gastrectomy (SG) is the most performed bariatric procedure. Conversion to Roux-en-Y gastric bypass (RYGB) for SG-related complications such as gastroesophageal reflux disease (GERD), insufficient weight loss (ISWL), and weight regain (WR) is increasing. Our aim was to investigate the safety, efficacy, and outcomes of conversion from SG to RYGB. METHODS: A literature search was performed from database inception to May 2020. Eligible studies must report indications for conversion, %total body weight loss (%TWL), and/or complications. The pooled mean or proportion were analyzed using a random-effects model. RESULTS: Seventeen unique studies (n = 556, 68.7% female, average age at time of conversion 42.6 ± 10.29 years) were included. The pooled conversion rate due to GERD was 30.4% (95% CI 23.5, 38.3%; I2 = 63.9%), compared to 52.0% (95% CI 37.0, 66.6%; I2 = 85.89%) due to ISWL/WR. The pooled baseline BMI at conversion was 38.5 kg/m2 (95% CI 36.49, 40.6 kg/m2; I2 = 92.1%) and after 1 year was 32.1 kg/m2 (95% CI 25.50, 38.7 kg/m2; I2 = 94.53%). The pooled %TWL after 1 year was 22.8% (95% CI 13.5, 32.1%; I2 = 98.05%). Complication rate within 30 days was 16.4% (95% CI 11.1, 23.6%; I2 = 57.17%), and after 30 days was 11.4% (95% CI 7.7, 16.7%; I2 = 0%). CONCLUSION: This meta-analysis showed that conversion from SG to RYGB is an option for conversion at a bariatric care center that produces sufficient weight loss outcomes, and potential resolution of symptoms of GERD. Further indication-based studies are required to obtain a clearer consensus on the surgical management of patients seeking RYGB following SG.