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.

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.

The association between microvascular and macrovascular diseases and diabetes remission after bariatric surgery.

BACKGROUND: Type-2 diabetes mellitus (T2DM) results in detrimental vascular complications including both microvascular and macrovascular diseases. Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are effective weight-loss therapies that enhance T2DM remission. However, limited data are present regarding the association between diabetes-associated diseases before RYGB and SG with T2DM remission. METHODS: This is a retrospective cohort study in patients with T2DM who underwent RYGB or SG. We collected data on preoperative microvascular (i.e., retinopathy, nephropathy, and neuropathy) and macrovascular (coronary artery disease, cerebrovascular accidents, and peripheral artery disease) diabetes-associated diseases. Our end points included assessment of association and cumulative effect of diabetes-associated diseases and disease remission. We also performed a multivariate logistic regression to evaluate the parameters associated with T2DM remission. RESULTS: A total of 536 patients (67% female, 94% White) were included in this study. Patients without diabetes-associated diseases had an OR of 2.72 (95% CI 1.92 to 3.88) to achieve T2DM remission compared to patients with diabetes-associated diseases (27.9% vs 59.4%; p < 0.001). Importantly, there was an additive effect of the number of diabetes-associated diseases on the T2DM remission (p < 0.001). We demonstrate a significant association between HbA1c (p < 0.001), number of diabetes medications (p < 0.001), T2DM duration (p < 0.001), surgery type (p = 0.009), and insulin use (p = 0.04) with T2DM remission. CONCLUSION: Patients with presurgical diabetes-associated diseases had a lower remission rate after RYGB and SG. Not only do these complications represent a more practical and consistent variable to predict T2DM remission, but also help planning a multidisciplinary management of patients with more severe T2DM.

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.

Diabetes Mellitus Remission in Patients with BMI > 50 kg/m2 after Bariatric Surgeries: A Real-World Multi-Centered Study.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a common comorbidity associated with obesity, particularly in patients with body mass index (BMI) ≥ 50 kg/m2. We aim to study real-world T2DM long-term remission in patients with BMI ≥ 50 kg/m2 following Roux-En-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). METHODS: This was a retrospective study of the electronic medical records of all patients with BMI ≥ 50 kg/m2, T2DM, and have undergone RYGB or SG at three tertiary referral centers in the United States. We assessed the change in T2DM outcomes after bariatric surgery using a matched paired t-test for continuous variables and Bowker and Pearson test for categorical variables. We performed a multivariate logistic regression to determine predictors of remission. RESULTS: A total of 279 patients with T2DM (65% females, mean age 51.0 ± 11.7 years, 89% white, BMI 56.6 ± 5.9 kg/m2) were analyzed. Long-term T2DM remission (≥ 5 years) was demonstrated in 47% of patients. The duration of T2DM (p < 0.0001), number of T2DM medications (p = 0.003) and weight loss (p = 0.048) were the only independent factors for long-term T2DM remission. CONCLUSIONS: In this cohort of patients with BMI ≥ 50 kg/m2, RYGB and SG demonstrated significant and similar long-term T2DM remission rates and weight loss outcomes.

Predictors of marginal ulcer after gastric bypass: a systematic review and meta-analysis.

INTRODUCTION: Marginal ulcer (MU) is a common complication following Roux-en-Y gastric bypass (RYGB) with an incidence rate of up to 25%. Several studies have evaluated different risk factors associated with MU with inconsistent findings. In this meta-analysis, we aimed to identify the predictors of MU after RYGB. METHODS: A comprehensive literature search of PubMed, Embase, and Web of Science databases was conducted through April 2022. All studies that used a multivariate model to assess risk factors for MU after RYGB were included. Pooled odds ratios (OR) with 95% confidence intervals (CI) for risk factors reported in ≥ 3 studies were obtained within a random-effects model. RESULTS: Fourteen studies with 344,829 patients who underwent RYGB were included. Eleven different risk factors were analyzed. Meta-analysis demonstrated that Helicobacter pylori (HP) infection (OR 4.97 [2.24-10.99]), smoking (OR 2.50 [1.76-3.54]), and diabetes mellitus (OR 1.80 [1.15-2.80]), were significant predictors of MU. Increased age, body mass index, female gender, obstructive sleep apnea, hypertension, and alcohol use were not predictors of MU. There was a trend of an increased risk of MU associated with nonsteroidal anti-inflammatory drugs (OR 2.43 [0.72-8.21]) and a lower risk of MU with proton pump inhibitors use (OR 0.44 [0.11-2.11]). CONCLUSIONS: Smoking cessation, optimizing glycemic control, and eradication of HP infection reduce the risk of MU following RYGB. Recognition of predictors of MU after RYGB will allow physicians to identify high-risk patients, improve surgical outcomes, and reduce the risk of MU.

Perioperative Interventions to Prevent Gastroesophageal Reflux Disease and Marginal Ulcers After Bariatric Surgery - an International Experts' Survey.

OBJECTIVE: This study aimed to survey international experts in metabolic and bariatric surgery (MBS) to improve and consolidate perioperative interventions to prevent gastroesophageal reflux disease (GERD) and marginal ulcers (MU) after MBS. BACKGROUND: Very important long-term complications after MBS include GERD, Barrett's esophagus, and MU. Prevention might be fundamental to reduce the incidence, severe complications, and the increasing number of revisional bariatric surgeries. METHODS: An international scientific team designed an online confidential questionnaire with 45 multiple-choice questions. The survey was sent to 110 invited experts and 96 of them (from 41 different countries) participated from 21 July 2022 to 4 September 2022. RESULTS: Most experts (≥ 90%) prescribe postoperative acid suppression agents after MBS. Life-long proton pump inhibitors prophylaxis in smokers with avoidance of non-steroidal anti-inflammatory drugs are recommended by most of the experts (66%, 73%) after any type of gastric bypass. Two-thirds of experts (69%) perform Helicobacter pylori eradication prior to MBS. Two-thirds of experts (68%) routinely perform EGD and biopsy before MBS. Follow-up esophagogastroduodenoscopy (EGD) and timing threshold for revisional and conversional MBS were variable among experts. CONCLUSION: This expert survey underlines important perioperative interventions that reached a two-thirds consensus among MBS international experts. Variability in follow-up EGD, approach to complication management, and thresholds for revisional and conversional MBS emphasize the need for further researches and consensus guidelines.

Transoral incisionless fundoplication for recurrent symptoms after laparoscopic fundoplication.

BACKGROUND: Revision of a failed laparoscopic fundoplication carries higher risk of complication and lower chance of success compared to the original surgery. Transoral incisionless fundoplication (TIF) may be an endoscopic alternative for select GERD patients without need of a moderate/large hiatal hernia repair. The aim of this study was to assess feasibility, efficacy, and safety of TIF 2.0 after failed laparoscopic Nissen or Toupet fundoplication (TIFFF). METHODS: This is a multicenter retrospective cohort study of patients who underwent TIFFF between September 2017 and December 2020 using TIF 2.0 technique (EsophyX Z/Z+) performed by gastroenterologists and surgeons. Patients were included if they had (1) recurrent GERD symptoms, (2) pathologic reflux based upon pH testing or Grade C/D esophagitis or Barrett's esophagus, and (3) hiatal hernia ≤ 2 cm. The primary outcome was improvement in GERD Health-Related Quality of Life (GERD-HRQL) post-TIFFF. The TIFFF cohort was also compared to a similar surgical re-operative cohort using propensity score matching. RESULTS: Twenty patients underwent TIFFF (median 4.1 years after prior fundoplication) and mean GERD-HRQL score improved from 24.3 ± 22.9 to 14.75 ± 21.6 (p = 0.014); mean Reflux Severity Index (RSI) score improved from 14.1 ± 14.6 to 9.1 ± 8.0 (p = 0.046) with 8/10 (80%) of patients with normal RSI (< 13) post-TIF. Esophagitis healed in 78% of patients. PPI use decreased from 85 to 55% with 8/20 (45%) patients off of PPI. Importantly, mean acid exposure time decreased from 12% ± 17.8 to 0.8% ± 1.1 (p = 0.028) with 9/9 (100%) of patients with normalized pH post-TIF. There were no statistically significant differences in clinical efficacy outcomes between TIFFF and surgical revision, but TIFFF had significantly fewer late adverse events. CONCLUSION: Endoscopic rescue with TIF is a safe and efficacious alternative to redo laparoscopic surgery in symptomatic patients with appropriate anatomy and objective evidence of persistent or recurrent reflux.

Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial.

OBJECTIVE: We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection. SUMMARY BACKGROUND DATA: Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON. DESIGN: We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events. RESULTS: Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths. CONCLUSIONS: Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808.

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.

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.

Safety and short-term effectiveness of endoscopic sleeve gastroplasty using overstitch: preliminary report from a multicenter study.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an option for patients with Class I and II obesity or patients who refuse to undergo a laparoscopic bariatric surgery. The aims of this study are as follows: (1) to demonstrate a short-term outcome after primary ESG and (2) to compare the effectiveness of weight loss between Class I and Class II obesity patients. METHODS: Patients undergoing ESG at four bariatric centers in Brazil between April 1, 2017 and December 31, 2018 were prospectively enrolled in the study (BMI 30.0-39.9 kg/m2). ESG was performed using Overstitch (Apollo Endosurgery, Austin, TX). Descriptive analysis, t test, Chi-square test, and Mann-Whitney test were used to present the results. RESULTS: A total of 233 patients underwent primary ESG. The mean age and BMI of the patients were 41.1 years and 34.7 kg/m2, respectively. Following ESG, the mean percentage of total weight loss (TWL) was 17.1% at 6 months and 19.7% at 12 months. Percentage of excess BMI loss (EBMIL) was 47.3% at 6 months and 54.8% at 12 months after ESG. The mean EBMIL was significantly greater among patients with Class I obesity than those with Class II obesity at 6 (51.1% vs. 43.7%) and 12 months (60.2% vs. 49.2%). One patient experienced bleeding during the procedure that was managed with sclerotherapy. CONCLUSION: Short-term results suggest that ESG is a safe and effective option for patients with Class I and II obesity.

Gastrojejunal anastomotic reduction for weight regain in roux-en-y gastric bypass patients: physiological, behavioral, and anatomical effects of endoscopic suturing and sclerotherapy.

BACKGROUND: Weight regain is common after Roux-en-Y gastric bypass. OBJECTIVES: To assess the mechanisms of weight loss after 2 gastrojejunal anastomotic reduction (GJAR) procedures to treat weight regain. SETTING: University hospital, United States. METHODS: Forty-three Roux-en-Y gastric bypass patients with weight regain were prospectively enrolled. Weight, ghrelin levels, responses to the 21-item three-factor eating questionnaire, and gastrojejunal anastomotic diameter were assessed. Nine patients underwent endoscopic suturing and 34 patients underwent sclerotherapy. At 3 months, weight, ghrelin levels, eating behavior, and outlet diameter were reassessed. RESULTS: Patients were aged 47±10 years and regained 43%±26% of maximal lost weight. Ghrelin levels were 123±106 ng/mL and outlet diameter was 21±6.3 mm. At 3 months, the entire cohort lost 4.1%±5.9% of total weight (TBW) and showed improvement in cognitive eating habits (P<.01). Endoscopic suturing and sclerotherapy patients lost 10.4%±2.2% TBW and 2.7%±5.5% TBW (P<.01), respectively. Suturing and sclerotherapy reduced the outlet diameter by 15.0±6.7 mm and 2.6±5.7 mm (P<.01). Ghrelin levels increased after suturing by 46±55 ng/mL and decreased by 37±110 ng/mL after sclerotherapy (P = .02). Suturing resulted in greater improvement in cognitive eating behavior than sclerotherapy (P = .03). Reduction in outlet size and changes in cognitive and emotional eating behaviors were predictors of weight loss after GJAR on a univariate analysis. On a multivariate analysis, the only predictor of weight loss was a reduction in outlet size (P< .01). CONCLUSIONS: Endoscopic suturing resulted in greater reduction in outlet size, improvement in eating behavior, and weight loss than sclerotherapy. Reduction of anastomosis size was a significant predictor of weight loss after GJAR.

Editorial: endoscopic stent placement as a bridge to surgery in malignant colorectal obstruction: a balance between study validity and real-world applicability.

The premise of self-expandable metal stent placement to restore luminal continuity in patients with acute left-sided malignant colonic obstruction is intuitively logical. However, the available body of literature addressing their benefit in this setting is contradictory. We sought to briefly critique the available literature and put the findings of Jiménez-Pérez et al. published in this current issue of the American Journal of Gastroenterology in perspective.