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

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

Bariatric endoscopic antral myotomy: a pilot study assessing technical feasibility, physiologic changes, and preliminary efficacy.

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.

Development of a novel endoscopic suturing simulator: validation and impact on clinical learning curve (with video).

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.

EUS-guided liver palpation as a screening tool for advanced fibrosis and cirrhosis in patients with suspected metabolic dysfunction-associated steatotic liver disease: a pilot study.

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.

American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

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.

The effect of endoscopic gastric plication on portosystemic pressure gradient in patients with nonalcoholic fatty liver disease and compensated advanced chronic liver disease.

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 ≥ 20 % 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 40.2 kg/m2 (range 30.1-56.7) and 14.7 kPa (range 8.2-36), respectively. At 6 months, median PPG decreased from 5.4 mmHg (range 0.7-19.6) to 1.8 mmHg (range 0.4-17.6) (P = 0.002), with 79 % (11/14) experiencing ≥ 20 % reduction. Patients experienced 12.5 % (6.5 %-26.1 %) TWL (P < 0.001) at 6 months, with 89 % (17/19) achieving ≥ 7 % and 68 % (13/19) achieving ≥ 10 % 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.

American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

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.

Regression of Hepatic Fibrosis After Endoscopic Gastric Plication in Nonalcoholic Fatty Liver Disease.

INTRODUCTION: Fibrosis stage is the strongest predictor of mortality in patients with nonalcoholic fatty liver disease (NAFLD). There is currently no approved therapy that specifically targets fibrosis. This study aims to assess the effect of endoscopic gastric plication on hepatic fibrosis in patients with underlying NAFLD. METHODS: This is a retrospective analysis of prospectively collected registry of patients with obesity and NAFLD with clinically significant hepatic fibrosis (≥F2) who underwent endoscopic gastric plication. Full-thickness plications were placed in the gastric body using a commercially available platform to reduce the gastric volume. The primary outcome included various noninvasive tests (NITs) of hepatic fibrosis based on clinical chemistry and/or imaging. The secondary outcomes included NITs of hepatic steatosis, other metabolic outcomes, including hemoglobin A1c, insulin resistance, and total weight loss (TWL), and adverse events. RESULTS: Forty-five patients (age 51 ± 13 years and body mass index 40.7 ± 6.9 kg/m 2 ) were included. All patients underwent endoscopic gastric plication successfully. At 6-12 months, there were significant reductions in biochemistries (alanine aminotransferase: 49.7 ± 36.8 U/L to 24.2 ± 12.0 U/L [ P < 0.0001], aspartate aminotransferase: 39.1 ± 24.1 U/L to 24.1 ± 10.0 U/L [ P < 0.0001]), composite fibrosis score (NAFLD fibrosis score: 0.48 ± 1.51 to -1.18 ± 1.56 [ P < 0.0001], fibrosis-4 index: 1.4 ± 1.2 to 1.2 ± 0.7 [ P = 0.03]), and imaging-based markers of fibrosis (vibration-controlled transient elastography: 13.9 ± 7.5 kPa to 8.9 ± 4.8 kPa ( P < 0.0001) and Agile 3+: 0.53 ± 0.28 to 0.37 ± 0.28 [ P = 0.001]). There were significant reductions in controlled attenuation parameter, Homeostatic Model Assessment for Insulin Resistance, and hemoglobin A1c ( P < 0.05 for all). At 12 months, patients experienced 15.5% ± 7.9% TWL, with 63% reaching at least 10% TWL. DISCUSSION: Endoscopic gastric plication seems effective at treating NAFLD, with significant reduction in NITs of hepatic fibrosis even in patients with cirrhosis.

Combining transoral outlet reduction with pharmacotherapy yields similar 1-year efficacy with improved safety compared with surgical revision for weight regain after Roux-en-Y gastric bypass (with videos).

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.

Short-term outcomes after peroral endoscopic myotomy, Heller myotomy, and pneumatic dilation in patients with achalasia: a nationwide analysis.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM), laparoscopic Heller myotomy (LHM), and pneumatic dilation (PD) are the most common modalities for management of achalasia. Our study aimed to directly compare their short-term outcomes and safety profile in a hospitalized cohort in the United States. METHODS: The National Readmission Database (2016-2019) was queried using International Classification of Diseases, Tenth Revision, Clinical Modification codes to identify a cohort of inpatient admissions who underwent POEM, LHM, or PD. Baseline demographic variables, resource utilization, periprocedural outcomes, and 30-day readmissions were analyzed. A univariate and multivariate logistic regression model was used to compare odds of readmission with POEM as a reference. RESULTS: LHM was the most performed procedure (n = 9710) as compared with PD (n = 2453) and POEM (n = 1911). Patients undergoing PD were older with a higher Charlson Comorbidity Index. The 30-day readmission rate was 4.3%, 3.9%, and 12.6% for POEM, LHM, and PD, respectively. Compared with POEM, the adjusted odds of readmission for PD was 2.42 (95% confidence interval, 1.56-3.75). There was no statistically significant difference in odds of readmission for LHM (.91; 95% confidence interval, .62-1.33) compared with POEM. Within the 30-day readmitted population, 13.1% of PD and 3.4% of LHM patients required achalasia-related procedural intervention. The rate of bleeding (4.3%), blood transfusion (2.3%), and mortality were higher (1.1%) in PD as compared with POEM and LHM. CONCLUSIONS: In the United States, the risk of readmission and resource utilization are higher in patients with achalasia undergoing PD. The outcomes are comparable between POEM and LHM, but there is a significant difference between the utilization of these myotomy procedures.