Objective
The effects of intragastric balloon (IGB) therapy on gastric emptying (GE) and weight loss remain to be fully understood. The effects of IGB on GE were investigated in this study.
Methods
...This was a single‐center, randomized, controlled study in which subjects with obesity either underwent IGB placement or were matched controls. IGB was removed at 6 months. GE was measured at baseline and at weeks 0, 8, 16, 27, and 39. Percent total body weight loss (%TBWL) was measured at 6 and 12 months.
Results
Twenty‐nine subjects with obesity were enrolled; 15 were randomized to IGB placement and 14 to control. Two subjects had the IGB removed early. At baseline, 1‐ and 2‐h gastric retention values were comparable between the groups but increased in the IGB group at weeks 8 and 16 (during IGB treatment) and then returned to baseline levels at 27 and 39 weeks. A greater increase in gastric retention from baseline to 8 weeks was associated with higher %TBWL.
Conclusions
GE in subjects with IGB is delayed but returns to normal after IGB removal. Greater changes in increased gastric retention were associated with greater %TBWL. Altering gastric motility is a significant mechanism of action by which the IGB results in weight loss.
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.
Abstract In vivo real-time assessment of the histology of diminutive (≤5 mm) colorectal polyps detected at colonoscopy can be achieved by means of an “optical biopsy” by using currently available ...endoscopic technologies. This systematic review and meta-analysis was performed by the American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of these technologies have been met. We conducted direct meta-analyses calculating the pooled negative predictive value (NPV) for narrow-band imaging (NBI), i-SCAN, and Fujinon Intelligent Color Enhancement (FICE)–assisted optical biopsy for predicting adenomatous polyp histology of small/diminutive colorectal polyps. We also calculated the pooled percentage agreement with histopathology when assigning postpolypectomy surveillance intervals based on combining real-time optical biopsy of colorectal polyps 5 mm or smaller with histopathologic assessment of polyps larger than 5 mm. Random-effects meta-analysis models were used. Statistical heterogeneity was evaluated by means of I2 statistics. Our meta-analyses indicate that optical biopsy with NBI, exceeds the NPV threshold for adenomatous polyp histology, supporting a “diagnose-and-leave” strategy for diminutive predicted nonneoplastic polyps in the rectosigmoid colon. The pooled NPV of NBI for adenomatous polyp histology by using the random-effects model was 91% (95% confidence interval CI, 88–94). This finding was associated with a high degree of heterogeneity (I2 = 89%). Subgroup analysis indicated that the pooled NPV was greater than 90% for academic medical centers (91.8%; 95% CI, 89-94), for experts (93%; 95% CI, 91-96), and when the optical biopsy assessment was made with high confidence (93%; 95% CI, 90-96). Our meta-analyses also indicate that the agreement in assignment of postpolypectomy surveillance intervals based on optical biopsy with NBI of diminutive colorectal polyps is 90% or greater in academic settings (91%; 95% CI, 86-95), with experienced endoscopists (92%; 95% CI, 88-96) and when optical biopsy assessments are made with high confidence (91%; 95% CI, 88-95). Our systematic review and meta-analysis confirms that the thresholds established by the ASGE PIVI for real-time endoscopic assessment of the histology of diminutive polyps have been met, at least with NBI optical biopsy, with endoscopists who are expert in using this advanced imaging technology and when assessments are made with high confidence.
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.
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.
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.
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.
Apollo Endosurgery, Mayo Clinic.
The increasing global burden of obesity and its associated comorbidities has created an urgent need for additional treatment options to fight this pandemic. Endoscopic bariatric therapies (EBTs) ...provide an effective and minimally invasive treatment approach to obesity that would increase treatment options beyond surgery, medications, and lifestyle measures. This systematic review and meta-analysis were performed by the American Society for Gastrointestinal Endoscopy (ASGE) Bariatric Endoscopy Task Force comprising experts in the subject area and the ASGE Technology Committee Chair to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of available EBTs have been met. After conducting a comprehensive search of several English-language databases, we performed direct meta-analyses by using random-effects models to assess whether the Orbera intragastric balloon (IGB) (Apollo Endosurgery, Austin, Tex) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS) (GI Dynamics, Lexington, Mass) have met the PIVI thresholds. The meta-analyses results indicate that the Orbera IGB meets the PIVI thresholds for both primary and nonprimary bridge obesity therapy. Based on a meta-analysis of 17 studies including 1683 patients, the percentage of excess weight loss (%EWL) with the Orbera IGB at 12 months was 25.44% (95% confidence interval CI, 21.47%-29.41%) (random model) with a mean difference in %EWL over controls of 26.9% (95% CI, 15.66%-38.24%; P ≤ .01) in 3 randomized, controlled trials. Furthermore, the pooled percentage of total body weight loss (% TBWL) after Orbera IGB implantation was 12.3% (95% CI, 7.9%–16.73%), 13.16% (95% CI, 12.37%–13.95%), and 11.27% (95% CI, 8.17%–14.36%) at 3, 6, and 12 months after implantation, respectively, thus exceeding the PIVI threshold of 5% TBWL for nonprimary (bridge) obesity therapy. With the data available, the DJBS liner does appear to meet the %EWL PIVI threshold at 12 months, resulting in 35% EWL (95% CI, 24%-46%) but does not meet the 15% EWL over control required by the PIVI. We await review of the pivotal trial data on the efficacy and safety of this device. Data are insufficient to evaluate PIVI thresholds for any other EBT at this time. Both evaluated EBTs had ≤5% incidence of serious adverse events as set by the PIVI document to indicate acceptable safety profiles. Our task force consequently recognizes the Orbera IGB for meeting the PIVI criteria for the management of obesity. As additional data from the other EBTs become available, we will update our recommendations accordingly.
Background Obesity and its associated conditions, including type 2 diabetes and cardiovascular disease, have reached epidemic proportions. High-efficacy, high-risk surgical approaches are unlikely to ...meet the increasing burden of disease. Emerging endoscopic technologies have opened the door for endoscopic approaches to reproduce many of the benefits of GI weight loss surgery and thereby contribute to the effective treatment of obesity and its associated disorders. Objective To demonstrate the technical feasibility of transoral endoscopic gastric volume reduction with an endoscopic suturing device in a fashion similar to sleeve gastrectomy for the treatment of obesity. Design Single-center, pilot feasibility study. Patients Four human subjects with obesity. Interventions Transoral sleeve gastroplasty. Main Outcome Measurements Technical feasibility. Results We successfully used an endoscopic free-hand suturing system in 4 subjects, thus demonstrating the technical feasibility of a novel technique to mimic the anatomic manipulations created by surgical sleeve gastrectomy endoscopically. Limitations Pilot feasibility study with small number of subjects. Conclusions Endoscopic sleeve gastroplasty for treatment of obesity is feasible.
Background
Lumen apposing metal stent (LAMS) allows an easy access to peripancreatic fluid collections (PPFCs) and the possibility of performing direct endoscopic necrosectomy (DEN). The aim of our ...study was to evaluate the safety and efficacy of a new 20-mm LAMS in the management of PPFCs. This novel stent represents the largest diameter LAMS available on the market to date.
Methods
This is an international, multicenter retrospective study involving 20 centers. Consecutive patients who underwent EUS-guided PPFC drainage using a 20-mm LAMS were included. Primary outcomes were technical and clinical success. Secondary outcomes were rate and the severity of adverse events.
Results
A total 105 patients underwent PPFC drainage using the new 20-mm LAMS and 106 LAMS were placed. Technical success was 100% (106/106). 7/105 patients died due to causes not related to the stent. Clinical success was achieved in 92/98 patients (93.9%). Significant adverse events occurred in 8/98 patients (8.16%): 4 cases (4.08%) of bleeding, 3 cases (3.06%) of suprainfection, 1 case of gastric outlet obstruction.
Conclusions
This multicenter study demonstrated acceptable rates of technical and clinical success using a new 20-mm LAMS for PPFC, including walled-off pancreatic necrosis (WOPN). The results of our study suggest that a new 20-mm LAMS is non-inferior in terms of safety, efficacy, and adverse events as compared to smaller diameter LAMS in the management of PPFCs, including pancreatic psuedocysts (PP) and WOPN. Randomized controlled studies will be needed to determine the ideal size of LAMS need to achieve the greatest clinical benefit with the minimized risk exposure for this high-risk patient population.
Gastric emptying (GE) is involved in the regulation of appetite. We compared times of GE after different bariatric endoscopic and surgical interventions and associations with weight loss.
We ...performed a comprehensive search of publication databases, through September 14, 2018, for randomized and nonrandomized studies reporting outcomes of weight-loss surgeries. Two independent reviewers selected and appraised studies. The outcome of interest was GE T
(min), measured before and after the procedure. A random-effects model was used to pool the mean change in T
(min) after the intervention. We performed a meta-regression analysis to find associations between GE and weight loss. Heterogeneity was calculated using the I
statistic. Methodologic quality was assessed.
From 762 citations, the following studies were included in our analysis: 9 sleeve gastrectomies, 5 intragastric balloons, and 5 antral botulinum toxins. After sleeve gastrectomy, the pooled mean reduction in GE T
at 3 months was 29.2 minutes (95% CI, 40.9-17.5 min; I
= 91%). Fluid-filled balloons increased GE T
by 116 minutes (95% CI, 29.4-203.4 min; I
= 58.6%). Air-filled balloons did not produce a statistically significant difference in GE T
. Antral botulinum injections increased GE T
by 9.6 minutes (95% CI, 2.8-16.4 min; I
= 13.3%). Placebo interventions reduced GE T
by 6.3 minutes (95% CI, 10-2.6 min). Changes in GE were associated with weight loss after sleeve gastrectomy and intragastric balloons, but not botulinum toxin injections.
In a systematic review and meta-analysis, we found that sleeve gastrectomy reduced GE T
whereas fluid-filled balloons significantly increased GE T
. Air-filled balloons do not significantly change the time of GE, which could account for their low efficacy. Antral botulinum toxin injections produced small temporary increases in GE time, which were not associated with weight loss. Changes in GE time after surgical and endoscopic bariatric interventions correlated with weight loss and might be used to select interventions, based on patients' physiology.
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.
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.
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.
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.
Spatz Medical.
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