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PURPOSE: Changes in autonomic (ANS) and enteric nervous systems (ENS) may be involved in pathogenesis of obesity. We hypothesized that baseline autonomic and enteric parameters may predict outcomes of diverse obesity therapies. MATERIAL AND METHODS: We studied ANS and ENS physiology in 37 patients (8 male, 29 female, age 45 years, weight 129.7 kg) at 4 centers in patients undergoing medical (9: low-calorie diet) versus invasive (22: 16 sleeve, 6 bypass) and semi-invasive (6: 2 band, 2 high energy stimulation, 2 aspiration) weight loss therapies. Weight loss was reported as percent weight loss from baseline to latest values at 1 year and in some up to 5 years; classified as < or > /= 20% for each group. ANS testing included sympathetic adrenergic function by measuring reflex vasoconstriction and postural adjustment ratio. ENS was measured non-invasively using cutaneous low-resolution electrogastrogram. RESULTS: Percent weight loss was greater with the invasive (28.5%) than semi-invasive (9.1%) or non-invasive low-calorie diet (4.4%) (p < .001). Percent weight loss at 1 year (and up to 5 years) corresponded to the adrenergic measure of postural adjustment ratio (r = .42, p = .012), total pulse amplitude at rest (r = .56, p < .001), and electrogastrogram standing-to-rest difference (r = .33, p = .056). CONCLUSION: Baseline autonomic and enteric function measures correspond to percentage with loss in this pilot study using diverse weight loss methods. Autonomic and enteric profiling has potential clinical use for evaluation and treatment of obesity but needed larger controlled trials.
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This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥ 30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.
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Humanos , Cirurgia Bariátrica/normas , Metabolismo , Obesidade/cirurgia , Endoscopia GastrointestinalRESUMO
BACKGROUND AND AIMS: Gastric balloons and endoscopic sleeve gastroplasty appear to work by delaying gastric emptying. We hypothesized that pylorus-sparing antral myotomy would inhibit the antral pump, inducing gastric retention and similarly resulting in weight loss. METHODS: In this single-center pilot study, we assessed bariatric endoscopic antral myotomy (BEAM) using submucosal tunneling. The primary outcomes were feasibility, safety, and efficacy at 6 and 12 months, whereas the secondary outcomes were changes in the gastric-emptying rate and gastroparesis cardinal symptom index (GCSI) score. RESULTS: Six subjects underwent successful BEAM. One required needle decompression, and another developed pulmonary embolism, treated without sequela. At 6 and 12 months, patients achieved 9.1% ± 8.9% and 12.2% ± 7.1% total weight loss (P < .0005). The gastric-emptying rate was delayed by 36.6% in those with ≥10% total weight loss. The GCSI score increased significantly at 12 months, particularly regarding early satiety. CONCLUSIONS: This pilot study suggests BEAM is feasible and appears to induce delayed gastric emptying that is associated with significant weight loss, without symptoms of gastroparesis.
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BACKGROUND: The primary obesity surgery endoluminal (POSE) procedure is an innovative incision-less endoscopic bariatric procedure that is increasingly used. However, variable weight loss response and recurrence post-endoscopic bariatric procedures have at times necessitated laparoscopic bariatric conversion. The safety and approach of conversion to laparoscopic sleeve gastrectomy (LSG) or Roux-en-Y gastric bypass (RYGB), however, have been an active point of discussion within revisional bariatric surgery. METHODS: This retrospective review of four consecutive patients is the largest description of medium-term postoperative outcomes and technical highlights of a laparoscopic conversion of POSE to RYGB. Chart review was completed to evaluate patients' post-POSE clinical course and perioperative outcomes after surgical conversion. RESULTS: Early data suggests varied weight loss trajectory with POSE and marked improvement in weight response after surgical conversion. Qualitative review reveals successful single-staged conversions contrary to previous smaller case series describing staged conversions involving endoscopic removal of plications followed by RYGB. Review additionally reveals key perioperative considerations for successful conversions to include intraoperative endoscopy, upper gastrointestinal fluoroscopic studies, and at times computed tomography. The latter study and laparoscopic view of the post-POSE stomach challenge the prior notion that distal POSE allows for easy revision to LSG. CONCLUSIONS: Our case series underscores the complex multifactorial nature of metabolic disease and the increasing importance of a conscientious approach to conversion bariatric surgery as the adoption of POSE and the bariatric patient population continues to grow.
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Derivação Gástrica , Laparoscopia , Obesidade Mórbida , Reoperação , Redução de Peso , Humanos , Derivação Gástrica/métodos , Obesidade Mórbida/cirurgia , Estudos Retrospectivos , Feminino , Adulto , Laparoscopia/métodos , Resultado do Tratamento , Pessoa de Meia-Idade , Masculino , Gastroplastia/métodos , Gastrectomia/métodosRESUMO
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.
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Gastroplastia , Receptor do Peptídeo Semelhante ao Glucagon 1 , Peptídeos Semelhantes ao Glucagon , Humanos , Feminino , Masculino , Estudos Retrospectivos , Adulto , Gastroplastia/métodos , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Pessoa de Meia-Idade , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Peptídeos Semelhantes ao Glucagon/análogos & derivados , Obesidade Mórbida/cirurgia , Esvaziamento Gástrico/efeitos dos fármacos , Hipoglicemiantes/uso terapêutico , Liraglutida/uso terapêutico , Fragmentos Fc das Imunoglobulinas , Proteínas Recombinantes de FusãoRESUMO
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.
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Derivação Gástrica , Cirurgia Endoscópica por Orifício Natural , Humanos , Derivação Gástrica/métodos , Cirurgia Endoscópica por Orifício Natural/métodos , Obesidade Mórbida/cirurgia , Seleção de PacientesRESUMO
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.
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Técnica Delphi , Gastroplastia , Humanos , Gastroplastia/métodos , Consenso , Obesidade Mórbida/cirurgia , Gastroscopia/métodos , Gastroscopia/normasRESUMO
This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30âkg/m2, or with a BMI of 27.0-29.9âkg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.
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Cirurgia Bariátrica , Endoscopia Gastrointestinal , Obesidade , Humanos , Cirurgia Bariátrica/efeitos adversos , Endoscopia Gastrointestinal/normas , Endoscopia Gastrointestinal/métodos , Obesidade/complicações , Adulto , Balão Gástrico/efeitos adversosRESUMO
Importance: Obesity is a disease with a large socioeconomic burden. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric procedure with wide global adoption. More recently, new weight-loss medications, such as glucagon-like peptide-1 receptor agonists (eg, semaglutide), have attracted increased attention due to their efficacy. However, their cost-effectiveness over an extended period compared with ESG is a critical gap that needs to be better explored for informed health care decision-making. Objective: To assess the cost-effectiveness of semaglutide compared with ESG over 5 years for individuals with class II obesity. Design, Setting, and Participants: This economic evaluation study, conducted from September 1, 2022, to May 31, 2023, used a Markov cohort model to compare ESG and semaglutide, with a no-treatment baseline strategy. The study comprised adult patients in the US health care system with class II obesity (body mass index [BMI] of 35-39.9). The base case was a 45-year-old patient with class II obesity (BMI of 37). Patients undergoing ESG were subjected to risks of perioperative mortality and adverse events with resultant costs and decrement in quality of life. Interventions: Strategies included treatment with semaglutide and ESG. Main Outcomes and Measures: Costs (2022 US dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $100â¯000/QALY. A 5-year time horizon with a cycle length of 1 month with a 3% discount rate was used. Probabilities, costs, and quality-of-life estimates of the model were derived from published literature. One-way, 2-way, and probabilistic sensitivity analyses were also performed. Results: The model found that ESG was more cost-effective than semaglutide over a 5-year time horizon, with an ICER of -$595â¯532/QALY. Endoscopic sleeve gastroplasty added 0.06 QALYs and reduced total cost by $33â¯583 relative to semaglutide. The results remained robust on 1-way and probabilistic sensitivity analyses. Endoscopic sleeve gastroplasty sustained greater weight loss over 5 years vs semaglutide (BMI of 31.7 vs 33.0). To achieve nondominance, the annual price of semaglutide, currently $13â¯618, would need to be $3591. Conclusions and Relevance: This study suggests that ESG is cost saving compared with semaglutide in the treatment of class II obesity. On price threshold analyses, a 3-fold decrease in the price of semaglutide is needed to achieve nondominance.
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Gastroplastia , Peptídeos Semelhantes ao Glucagon , Adulto , Humanos , Pessoa de Meia-Idade , Obesidade/cirurgia , Qualidade de Vida , Redução de PesoRESUMO
This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥ 30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.
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Cirurgia Bariátrica , Endoscopia Gastrointestinal , Balão Gástrico , Obesidade , Humanos , Endoscopia Gastrointestinal/métodos , Obesidade/complicações , Adulto , Índice de Massa CorporalRESUMO
BACKGROUND AND AIMS: Endoscopic liver "palpation" can be performed by indenting the liver surface under EUS. Indentation depth is measured with the use of sonographic calipers. We hypothesized that fibrotic livers are more difficult to indent, and that indentation can accurately predict liver fibrosis staging. We compared EUS-guided liver palpation and conventional screening modalities in patients with suspected metabolic dysfunction-associated steatotic liver disease. METHODS: This was a cross-sectional pilot study. Consecutive patients at 3 hospitals from 2021 to 2023 underwent EUS-guided palpation with liver biopsy. Liver palpation was compared with fibrosis-4 index (FIB-4), aspartate transaminase to platelet ratio index (APRI), nonalcoholic fatty liver disease fibrosis score (NFS), and transient elastography in predicting fibrosis staging on histology. Area under the receiver operating characteristic curve analysis was performed. RESULTS: Seventy-three patients were included. Mean age was 49.1 years, and 71.2% were female. Mean body mass index was 41.1 kg/m.2 Indentation depth was negatively correlated with fibrosis stage (Kruskal-Willis test, P < .0001). EUS palpation demonstrated c-statistics of 0.79 and 0.95 in discriminating advanced fibrosis and cirrhosis, respectively. EUS liver palpation was superior to NFS in predicting advanced fibrosis (P = .0057) and superior to APRI and NFS in predicting cirrhosis (P = .0099 and P = .045, respectively). EUS palpation was not significantly different from FIB-4. EUS palpation was superior to transient elastography in predicting cirrhosis (P = .045). When optimal cutoffs were used, indentation measurement ≤3.5 mm yielded 100% predictive value for ruling in advanced fibrosis, and ≥4.0 mm yielded 100% predictive value for ruling out cirrhosis. CONCLUSIONS: EUS liver palpation is a novel, accurate, and easy-to-use screening tool for advanced fibrosis and cirrhosis in patients with metabolic dysfunction-associated steatotic liver disease.
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Técnicas de Imagem por Elasticidade , Endossonografia , Cirrose Hepática , Palpação , Humanos , Feminino , Projetos Piloto , Masculino , Pessoa de Meia-Idade , Cirrose Hepática/complicações , Cirrose Hepática/diagnóstico por imagem , Cirrose Hepática/patologia , Estudos Transversais , Técnicas de Imagem por Elasticidade/métodos , Adulto , Endossonografia/métodos , Hepatopatia Gordurosa não Alcoólica/diagnóstico por imagem , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/patologia , Curva ROC , Contagem de Plaquetas , Fígado/diagnóstico por imagem , Fígado/patologia , Biópsia , Aspartato Aminotransferases/sangue , Aspartato Aminotransferases/metabolismo , Índice de Gravidade de Doença , IdosoRESUMO
PURPOSE: The mainstay of treatment for metabolic dysfunction-associated steatotic liver disease (MASLD) is weight loss. Endoscopic gastric remodeling (EGR) and glucagon-like peptide-1 receptor agonist (GLP-1RA) are effective weight loss therapies. This study aims to assess the effect of combining EGR with GLP-1RA on liver-related outcomes and weight profile. MATERIALS AND METHODS: This is a retrospective study of a prospectively collected registry of patients with MASLD and compensated advanced chronic liver disease (cACLD) who underwent EGR. Patients were categorized as (1) monotherapy: EGR alone and (2) combination therapy: GLP-1RA prescribed within 6 months prior to or after EGR. Outcomes included changes in noninvasive tests of hepatic fibrosis, weight profile, and insulin resistance status at 12 months. RESULTS: Thirty patients (body mass index 40.7 ± 9.3 kg/m2) were included. Of these, 12 patients (40%) underwent EGR monotherapy, and 18 patients (60%) underwent EGR + GLP-1RA combination therapy. Combination therapy group experienced greater improvements in fibrosis compared to monotherapy group (alanine aminotransferase: reduction by 55 ± 23% vs 29 ± 22% (p = 0.008), NAFLD fibrosis score: reduction by 181 ± 182% vs 30 ± 83% (p = 0.04), liver stiffness measurement on transient elastography: reduction by 54 ± 12% vs 14 ± 45% (p = 0.05)). There were greater reductions in hemoglobin A1c and homeostatic model assessment for insulin resistance in combination therapy compared to monotherapy (p < 0.05). At 12 months, the combination therapy group experienced 18.2 ± 6.6% TWL, while monotherapy group experienced 9.6 ± 3.3% TWL (p = 0.004). CONCLUSIONS: In patients with MASLD and cACLD, combination of EGR with GLP-1RA is associated with greater improvements in hepatic fibrosis, weight profile, and insulin resistance compared to EGR alone.
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Diabetes Mellitus Tipo 2 , Resistência à Insulina , Hepatopatias , Doenças Metabólicas , Obesidade Mórbida , Humanos , Hipoglicemiantes , Diabetes Mellitus Tipo 2/metabolismo , Insulina , Estudos Retrospectivos , Obesidade Mórbida/cirurgia , Redução de Peso , Cirrose Hepática/tratamento farmacológico , FibroseRESUMO
BACKGROUND: Lifelong follow-up after metabolic and bariatric surgery (MBS) is necessary to monitor for patient outcomes and nutritional status. However, many patients do not routinely follow-up with their MBS team. We studied what prompted MBS patients to seek bariatric care after being lost to follow-up and the subsequent treatments they received. STUDY DESIGN: A retrospective cohort study of patients after MBS who had discontinued regular MBS follow-up but represented to the MBS clinic between July 2018 and December 2022 to re-establish care. Patients with a history of a sleeve gastrectomy (SG), Roux-En-Y gastric bypass (RYGB), and adjustable gastric banding (AGB) were included. RESULTS: We identified 400 patients (83.5% women, mean age 50.3 ± 12.2 years at the time of re-establishment of bariatric care), of whom 177 (44.3%) had RYGB, 154 (38.5%) had SG, and 69 (17.2%) had AGB. Overall, recurrent weight gain was the most common reason for presentation for all three procedures (81.2% in SG, 62.7% in RYGB, and 65.2% in AGB; p < 0.001). Patients who underwent SG were more likely to undergo a revision MBS compared with patients who underwent RYGB (16.9% vs 5.8%, p < 0.001), whereas patients who underwent RYGB were more likely to undergo an endoscopic intervention than patients who underwent SG (17.5% vs 7.8%, p < 0.001). The response to antiobesity medication agents, specifically glucagon-like peptide-1 receptor agonists drugs, was better in patients who underwent RYGB, than that in patients who underwent SG. CONCLUSIONS: This study highlights recurrent weight gain as the most common reason for patients after MBS seeking to re-establish care with the MBS team. SG had a higher rate of revision MBS than RYGB, whereas endoscopic interventions were performed more frequently in the RYGB group. Antiobesity medication agents, especially glucagon-like peptide-1 receptor agonists drugs, were more effective in patients who underwent RYGB.
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Cirurgia Bariátrica , Humanos , Feminino , Masculino , Estudos Retrospectivos , Pessoa de Meia-Idade , Cirurgia Bariátrica/métodos , Adulto , Obesidade Mórbida/cirurgia , Resultado do Tratamento , Aumento de Peso , Perda de SeguimentoRESUMO
BACKGROUND: The goals of therapy for patients with nonalcoholic fatty liver disease and compensated advanced chronic liver disease include weight loss and reduction of the portosystemic pressure gradient (PPG) to decrease the risk of hepatic decompensation. Endoscopic gastric plication (EGP) is an effective endoscopic weight loss procedure. This study aimed to assess the effect of EGP on PPG. METHODS: In this prospective pilot study, patients with nonalcoholic fatty liver disease and compensated advanced chronic liver disease underwent endoscopic ultrasound-guided PPG measurement prior to and at 6 months following EGP. Primary outcomes were the change in PPG and proportion of patients experiencing ≥â20â% reduction in PPG at 6 months. Secondary outcomes included percent total weight loss (TWL) and changes in noninvasive tests of fibrosis. RESULTS: 20 patients were included. Baseline median body mass index and liver stiffness measurement were 40.2âkg/m2 (range 30.1-56.7) and 14.7 kPa (range 8.2-36), respectively. At 6 months, median PPG decreased from 5.4âmmHg (range 0.7-19.6) to 1.8âmmHg (range 0.4-17.6) (Pâ=â0.002), with 79â% (11/14) experiencing ≥â20â% reduction. Patients experienced 12.5â% (6.5â%-26.1â%) TWL (Pâ<â0.001) at 6 months, with 89â% (17/19) achieving ≥â7â% and 68â% (13/19) achieving ≥â10â% TWL. There were significant improvements in noninvasive tests of fibrosis. CONCLUSION: EGP appeared to be effective at reducing PPG in patients with nonalcoholic fatty liver disease and compensated advanced chronic liver disease.
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Hepatopatia Gordurosa não Alcoólica , Humanos , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Hepatopatia Gordurosa não Alcoólica/cirurgia , Estudos Prospectivos , Projetos Piloto , Resultado do Tratamento , Fígado , Cirrose Hepática/complicações , Cirrose Hepática/patologia , Redução de PesoRESUMO
BACKGROUND AND AIMS: Endoscopic suturing is a complex skill with broad applications. The aim of this study was to develop and validate a novel endoscopic suturing simulator and scoring system for the purse-string suture pattern. METHODS: This was a prospective study of an endoscopic suturing simulator that consists of a circular opening representing a dilated gastrojejunal anastomosis of Roux-en-Y gastric bypass with 12 small target holes around its circumference. Purse-string suturing is performed in a counterclockwise fashion. Time allotted is 5 minutes, and each successful bite is awarded 10 points. Participants were divided into the novice, intermediate, and experienced groups. Validity evidence based on content, validity evidence based on other variables, and validity evidence based on consequences of testing were assessed. RESULTS: Seventeen subjects (3 novice, 7 intermediate, and 7 experienced) participated in the study. Validity evidence based on content: The content validity index for realism, relevance, and representativeness was 0.89, 1.00, and 1.00, respectively. Validity evidence based on other variables: The novice, intermediate, and experienced groups scored 30.0 ± 8.2, 57.1 ± 28.1, and 131.2 ± 51.7 (P = .001). Validity evidence based on consequences of testing: The simulator group required 5 ± 5 transoral outlet reduction cases before being able to independently complete an entire purse-string, whereas the non-simulator group required 38 ± 11 clinical cases (P < .0001). CONCLUSIONS: This novel endoscopic suturing simulator seems realistic, relevant, and representative of the clinical suturing experience. In addition, it seems effective at objectively assessing suturing skills and shortening the clinical learning curve.
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Derivação Gástrica , Laparoscopia , Humanos , Curva de Aprendizado , Estudos Prospectivos , Endoscopia , Reoperação , Técnicas de Sutura , Competência ClínicaRESUMO
Background and study aims Gastro-gastric fistulae (GGF) occur in 1.3â% to 6â% of Rouxy-en-Y gastric bypass (RYGB) patients and can be associated with abdominal pain, reflux, weight regain and onset of diabetes. Endoscopic and surgical treatments are available without prior comparisons. The study aim was to compare endoscopic and surgical treatment methods in RYGB patients with GGF. Patients and methods A retrospective matched cohort study of RYGB patients who underwent endoscopic closure (ENDO) or surgical revision (SURG) for GGF. One-to-one matching was performed based on age, sex, body mass index and weight regain. Patient demographics, GGF size, procedural details, symptoms and treatment-related adverse events (AEs) were collected. A comparison of symptom improvement and treatment-related AEs was performed. Fisher's Exact, t -test and Wilcoxon Rank Sum tests were performed. Results Ninety RYGB patients with GGF (45 ENDO, 45 matched SURG) were included. GGF symptoms included weight regain (80â%), gastroesophageal reflux disease (71â%) and abdominal pain (67â%). At 6 months, the ENDO and SURG groups experienced 0.59â% and 5.5â% total weight loss (TWL) ( P â=â0.0002). At 12 months, the ENDO and SURG groups experienced 1.9â% and 6.2â% TWL ( P â=â0.007). Abdominal pain improved in 12 (52.2â%) ENDO and 5 (15.2â%) SURG patients at 12 months ( P â=â0.007). Diabetes and reflux resolution rates were similar between groups. Treatment-related AEs occurred in four (8.9â%) ENDO and 16 (35.6â%) SURG patients ( P â=â0.005), of which none and eight (17.8%), respectively, were serious ( P â=â0.006). Conclusions Endoscopic GGF treatment produces greater improvement in abdominal pain and fewer overall and serious treatment-related AEs. However, surgical revision appears to yield greater weight loss.
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PURPOSE: Weight regain after Roux-en-Y gastric bypass (RYGB) is associated with worsening of liver outcomes. However, the effect of transoral outlet reduction (TORe) on liver fibrosis in RYGB patients with weight regain and possible advanced fibrosis remains unknown. MATERIALS AND METHODS: This was a retrospective analysis of prospectively collected data of RYGB patients who underwent TORe for weight regain. Only patients with possible advanced fibrosis were included. TORe was performed using either an endoscopic suturing device (S-TORe) or plication device (P-TORe) to reduce the gastrojejunal anastomosis (GJA) and pouch sizes. Primary outcomes included changes in non-invasive tests (NITs) for fibrosis at 6-12 months. Secondary outcomes included weight loss and changes in insulin resistance and lipid profile at 6-12 months. RESULTS: Fifty RYGB patients were included. Baseline age and BMI were 55 ± 11 years and 40.1 ± 7.3 kg/m2. Baseline GJA and pouch sizes were 20 ± 7 mm and 5 ± 2 cm, respectively. Thirty patients (60%) underwent S-TORe and 20 patients (40%) underwent P-TORe. At 12 months following TORe, there were statistically significant improvements in NITs for fibrosis, including ALT, AST and FIB-4. There was a trend towards significant improvement in liver stiffness measurement on transient elastography. Patients experienced 8.8 ± 11.2% total weight loss (TWL) (p < 0.0001), with 60% experiencing at least 10% TWL. Additionally, there was a significant improvement in HbA1c and a trend toward significant improvement in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), suggestive of improved insulin sensitivity. CONCLUSION: TORe is associated with an improvement in hepatic fibrosis in patients with NAFLD and possible advanced fibrosis.
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Derivação Gástrica , Resistência à Insulina , Hepatopatia Gordurosa não Alcoólica , Obesidade Mórbida , Humanos , Obesidade Mórbida/cirurgia , Hepatopatia Gordurosa não Alcoólica/cirurgia , Estudos Retrospectivos , Aumento de Peso , Resultado do Tratamento , Cirrose Hepática/cirurgia , Reoperação , Redução de PesoRESUMO
Video 1Demonstration of the steps of gastroplasty with endoscopic myotomy for the treatment of obesity.
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BACKGROUND AND AIMS: Transoral outlet reduction (TORe) and antiobesity medication (AOM) are effective treatments for weight regain after Roux-en-Y gastric bypass (RYGB). This study aims to assess the efficacy of combination therapy (TORe + AOM) for treating weight regain and to compare the safety and efficacy of combination therapy with AOM alone, TORe alone, and surgical revision of RYGB. METHODS: This was a retrospective study of RYGB patients with weight regain who underwent combination therapy, defined as initiation of at least 1 AOM within 6 months before or after TORe. Outcomes were weight loss after combination therapy and comparison of combination therapy with AOM alone, TORe alone, and surgical revision. RESULTS: One hundred forty-five RYGB patients underwent combination therapy. Most commonly prescribed AOMs were topiramate, phentermine/topiramate, phentermine, and liraglutide. At 12 months, patients experienced 15.2% ± 7.4% total weight loss (TWL). Ninety percent of patients achieved ≥5% TWL at 12 months. Combination therapy was associated with greater weight loss than AOM alone (15.2% ± 7.4% vs 6.8% ± 8.2% TWL, P < .0001) or TORe alone (15.2% ± 7.4% vs 8.7% ± 8.3% TWL, P < .0001), with similar serious adverse event rates (2.1% vs 4.7% vs .6% for combination therapy vs AOM alone vs TORe alone, P > .05). Combination therapy yielded similar weight loss to surgical revision (15.2% ± 7.4% vs 16.4% ± 13.1% TWL, P = .34), with a lower serious adverse event rate (2.1% vs 14.3%, P = .0004). CONCLUSIONS: Combination of TORe with AOM is superior to either therapy alone, providing similar efficacy to surgical revision with a better safety profile for the treatment of weight regain after RYGB.