Storm, Andrew C

Abstract Background and Aims EUS-guided gastroenterostomy (EUS-GE) is an effective option to palliate symptoms of gastric outlet obstruction (GOO). While the jejunum is conventionally targeted (EUS-GJ), targeting the duodenum (EUS-GD) may offer clinical advantages. Outcomes were compared for EUS-GJ and EUS-GD. Methods Adult patients who underwent EUS-GE for GOO between 2020 and 2024 were included and categorized as an EUS-GD if the stent entered the transverse or ascending duodenum or an EUS-GJ if the stent entered more distally. The primary outcome was clinical success (soft diet tolerance at 7 days). Secondary outcomes included adverse events (AEs), stent misdeployment, and unplanned endoscopic reintervention. Baseline demographic variables and outcomes were compared with statistical significance at p < 0.05. Results Of the 139 included patients (median age 67 years (IQR 61–74); 41% female), 105 underwent EUS-GJ and 34 underwent EUS-GD. Clinical success was 98% for EUS-GJ and 94% for EUS-GD (p = 0.25). The misdeployment rate was 7% for EUS-GJ and 0% for EUS-GD (p = 0.19). The AE rate was 22% for EUS-GJ and 12% for EUS-GD (p = 0.23). There were no significant differences for stent obstruction (EUS-GJ 12% vs. EUS-GD 6%), bleeding (2% vs. 6%), perforation (4% vs. 0%), stent migration (1% vs. 0%), infection (3% vs. 0%), and unplanned reintervention (14% vs. 9%). Conclusion Both EUS-GJ and EUS-GD demonstrate high clinical success with no significant differences in adverse event rates. These data can support intraprocedural decision-making for endoscopists performing EUS-GE.

Background: Fluorescence in situ hybridization (FISH) is recommended as part of multimodality sampling in the evaluation of biliary strictures, but can be false negative in 40%–50% cases. The aim of this study was to comprehensively assess predictors of false-negative FISH in patients with biliary strictures. Methods: Patients undergoing tissue sampling for biliary strictures from October 20 to February 22 were prospectively enrolled (NCT04572711). Procedural factors such as sampling techniques, order, and utilization of combination sampling were recorded. Results of an optimized pancreatobiliary FISH panel with locus-specific probes for 1q21, 7p12, 8q24, and 9p21 were reported per guidelines. Statistical analyses were performed using BlueSky Statistics v.10.3.1, R package v8.81. Results: Of 327 patients, 93 (28.5%) were diagnosed with malignancy. A false-negative pancreatobiliary fluorescence in situ hybridization (PB-FISH) was reported in 40 (43.1%) patients. A history of primary sclerosing cholangitis was associated with lower odds of having a false-negative PB-FISH (aOR=0.38, 95% CI=0.16–0.82, p=0.02), whereas a hilar stricture was associated with a significantly higher false-negative PB-FISH in those with cholangiocarcinoma (aOR=3.2 [1.4–7.9], p=0.009). Dilation of biliary strictures prior to brushing was not associated with a lower rate of false-negative PB-FISH. Conclusions: In this prospective study, hilar strictures were more likely to have false-negative PB-FISH. Dilation of strictures did not affect PB-FISH performance. These results can help guide PB-FISH interpretation.

Abstract Clinicians struggle to accurately classify biliary strictures as benign or malignant. Current endoscopic retrograde cholangiopancreatography (ERCP)-based sampling modalities including brush cytology and forceps biopsy have poor sensitivity for pathologic confirmation of malignancy. Cholangioscopy allows for direct visualization and sampling of biliary pathology; however, this technology is also associated with inaccurate classification of biliary disease. Previously, an artificial intelligence (AI) system that analyzes cholangioscopy footage was found to be more accurate in diagnosing biliary malignancy than ERCP sampling techniques. The aim of this study was to validate this AI system on a new series of examinations. Three academic centers collected all available unedited cholangioscopy recordings. The videos were processed by the cholangioscopy AI system. After analyzing videos, the AI system provided predictions as to whether malignancy was present. AI performance in classifying strictures was compared with the performance of brush cytology and forceps biopsy. 112 cholangioscopy examinations (containing 4 817 081 images) were generated from 99 patients. Of those examinations, 61 (54.5%) were for investigation of biliary strictures (31 [50.8%] benign, 30 [49.2%] malignant). For the correct classification of strictures, the AI system was 80.0% sensitive and 90.3% specific. It was also significantly more accurate for stricture classification (85.2%) than brush cytology (52.5%; P<0.001), forceps biopsy (68.2%; P=0.04), and the combination of brush cytology and forceps biopsy (66.7%; P=0.02). A previously developed cholangioscopy AI system was found to continually outperform standard ERCP sampling modalities for accurate identification of malignancy, without additional retraining, in a multicenter validation cohort.

AbstractEndoscopic sleeve gastroplasty (ESG) is an effective treatment for obesity but typically is not covered by insurance. It is not known whether patients with financial investment in their endoscopic procedure are more likely to achieve and/or maintain weight loss as compared with those who have no financial buy-in. We aimed to compare treatment adherence and outcomes between patients paying out-of-pocket (OOP) and those who underwent ESG as part of any clinical trial where costs were covered by a study protocol (no payment; NP).Data were collected via retrospective chart review. One hundred sixty-four patients who had an ESG with at least 6 months of follow-up were included. Repeated measures with generalized linear model were used to evaluate weight loss at different time points after ESG and labs values at baseline and 1-year follow-up to assess for comorbidity improvement between cohorts. Compliance was evaluated by comparing exercise adherence rates.The pattern of weight loss and change in laboratory values was not different over time between the OOP group (n = 139) and NP group (n = 25). Patients lost an average of 14% (12.2–15.9) and 12.9% (9.3–16.5) of total body weight over all time points, respectively, in both groups (6, 12 and 24 months). Treatment adherence also did not differ between the groups.Having “skin in the game” by paying for ESG OOP does not correlate with better outcomes or treatment adherence, which further supports broad insurance coverage for this procedure.

AbstractEndoscopic ultrasound-guided gallbladder drainage (EUS-GBD) for symptomatic gallbladder disease has been shown to be safe and effective in patients with high surgical risk, but data are lacking for patients with cirrhosis. We investigated the safety and effectiveness of EUS-GBD in patients with and without cirrhosis.This retrospective review included patients who underwent EUS-GBD at four (three US and one Spanish) international tertiary care centers. Outcomes, including technical success, clinical success, and procedure-related adverse events, were compared between patients with and without cirrhosis.170 patients (47 with cirrhosis, 123 without cirrhosis) were included. There was no difference in age, sex, race, comorbidities, antiplatelet use, hemoglobin, or international normalized ratio between the two groups (P > 0.05 for all). The most common etiology of cirrhosis was alcohol (42.6%) with mean Model of End-stage Liver Disease-Sodium (MELD-Na) score of 16.2 (SD 8.8). Acute cholecystitis was more common in patients with cirrhosis (74.5% vs. 56.9%; P = 0.02). Technical (cirrhosis 97.9% vs. no cirrhosis 95.1%; P = 0.67) and clinical (93.6% vs. 94.9%; P = 0.71) success rates were similar in the two groups. Adverse events were infrequent and similar between groups, the most common being stent maldeployment (cirrhosis 4.3% vs. no cirrhosis 5.7%; P = 0.99). Survival rates were similar at the end of follow-up.EUS-GBD was safe and effective in patients with cirrhosis, with outcomes similar to patients without cirrhosis when performed by experienced echoendoscopists. Patients with cirrhosis and symptomatic gallbladder disease can be considered for EUS-GBD.

Abstract Cholecystectomy (CCY) is the standard treatment for acute cholecystitis. For non-surgical patients, percutaneous cholecystostomy tube (PT-GBD) is recommended but is associated with high readmission rates and poor quality of life. Endoscopic gallbladder decompression techniques, including endoscopic transpapillary gallbladder drainage (ET-GBD) and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), are alternatives. Studies comparing ET-GBD and EUS-GBD have shown EUS-GBD to have superior outcomes. However, these studies assessed ET-GBD mostly via single transcystic stent placement (SSET-GBD). This study aimed to compare outcomes of dual transcystic stents (DSET-GBD) and EUS-GBD in non-surgical candidates with acute cholecystitis. A multicenter analysis was conducted on patients who underwent ET-GBD or EUS-GBD between January 2019 and January 2023. Data were extracted from electronic medical records and outcomes including technical success, success, adverse events (AEs), and recurrence rates of cholecystitis were measured. Of 129 procedures (56 EUS-GBD; 73 ET-GBD), technical success was achieved in 87.5% of EUS-GBD and 86.3% of ET-GBD attempts. Immediate clinical success was achieved in 98.1% for EUS-GBD and 100% for DSET-GBD. AE rates were similar between the groups. Recurrent cholecystitis rates were 5.3% for EUS-GBD and 8.2% for DSET-GBD (P = 0.692). This study demonstrates that DSET-GBD has similarly low rates of recurrent acute cholecystitis compared with EUS-GBD. DSET-GBD should be considered as an alternative management strategy for management of acute cholecystitis in patients who are unable to undergo CCY.

Background and Aims: Early identification of malignant biliary strictures (MBSs) is challenging, with up to 20% classified as indeterminants after preliminary testing and tissue sampling with endoscopic retrograde cholangiopancreatography. We aimed to evaluate the use of methylated DNA markers (MDMs) from biliary brushings to enhance MBS detection in a prospective cohort. Approach: Candidate MDMs were evaluated for their utility in MBS diagnosis through a series of discovery and validation phases. DNA was extracted from biliary brushing samples, quantified, bisulfite-converted, and then subjected to methylation-specific droplet digital polymerase chain reaction. Patients were considered to have no malignancy if the sampling was negative and there was no evidence of malignancy after 1 year or definitive negative surgical histopathology. Results: Fourteen candidate MDMs were evaluated in the discovery phase, with top-performing and new markers evaluated in the technical validation phase. The top 4 MDMs were TWIST1, HOXA1, VSTM2B, and CLEC11A, which individually achieved AUC values of 0.82, 0.81, 0.83, and 0.78, respectively, with sensitivities of 59.4%, 53.1%, 62.5%, and 50.0%, respectively, at high specificities for malignancy of 95.2%–95.3% for the final biologic validation phase. When combined as a panel, the AUC was 0.86, achieving 73.4% sensitivity and 92.9% specificity, which outperformed cytology and fluorescence in situ hybridization (FISH). Conclusions: The selected MDMs demonstrated improved performance characteristics for the detection of MBS compared to cytology and FISH. Therefore, MDMs should be considered viable candidates for inclusion in diagnostic testing algorithms.

Abstract Background and study aims Endoscopic sleeve gastroplasty (ESG) is performed in clinical practice by gastroenterologists and bariatric surgeons. Given the increasing regulatory approval and global adoption, we aimed to evaluate real-world outcomes in multidisciplinary practices involving bariatric surgeons and gastroenterologists across the United States. Patients and methods We included adult patients with obesity who underwent ESG from January 2013 to August 2022 in seven academic and private centers in the United States. Patient and procedure characteristics, serious adverse events (SAEs), and weight loss outcomes up to 24 months were analyzed. SPSS (version 29.0) was used for all statistical analyses. Results A total of 1506 patients from seven sites included 235 (15.6%) treated by surgeons and 1271 (84.4%) treated by gastroenterologists. There were no baseline differences between groups. Gastroenterologists used argon plasma coagulation for marking significantly more often than surgeons (P<0.001). Surgeons placed sutures in the fundus in all instances whereas gastroenterologist placed them in the fundus in less than 1% of the cases (P<0.001>). Procedure times were significantly different between groups, with surgeons requiring approximately 20 minutes more during the procedure than gastroenterologists (P<0.001). Percent total body weight loss (%TBWL) and percent responders achieving >10 and >15% TBWL were similar between the two groups at 12, 18, and 24 months. Rates of SAEs were low and similar at 1.7% for surgeons and 2.7% for gastroenterologists (P>0.05). Conclusions Data from a large US cohort show significant and sustained weight loss with ESG and an excellent safety profile in both bariatric surgery and gastroenterology practices, supporting the scalability of the procedure across practices in a multidisciplinary setting.

Abstract Background and study aims Traditional transoral outlet reduction (TORe) is a minimally invasive endoscopic approach focused on reducing the aperture of the gastrojejunal (GJ) anastomosis, while the tubular transoral outlet reduction (tTORe) consists of tabularization of the distal pouch utilizing an O-shape gastroplasty suturing pattern. The primary aim of this study was to compare short-term weight loss between TORe and tTORe. Patients and methods Retrospective analysis of a prospectively maintained database was conducted at a tertiary care bariatric center of excellence. The study included patients with history of Roux-en-Y gastric bypass (RYGB) who had an endoscopic revision by TORe or tTORe and had follow-up data in their electronic medical record. The primary outcome was percent total body weight loss (%TBWL). Results A total of 128 patients were included (tTORe=85, TORe=43). At 3 and 6 months, the tTORe and TORe cohorts presented similar %TBWL (3 months: 8.5±4.9 vs. 7.3±6.0, P = 0.27 and 6 months: 8.1±7.4 vs. 6.8±5.6, P = 0.44). At 9 months, there was a trend toward greater weight loss in the tTORe cohort (9.7±8.6% vs. 5.1±6.8%, P = 0.053). At 12 months, the %TBWL was significantly higher in the tubularization group compared to the standard group (8.2±10.8 vs. 2.3±7.3%, P = 0.01). Procedure time was significantly different between both groups (60.5 vs. 53.4 minutes, P = 0.03). The adverse events rate was similar between groups (8.2% vs. 7.0% for tTORe and TORe, respectively, P = 0.61). Conclusions The tTORe enhances efficacy and durability of the standard procedure without adding significant procedure-related risks.

Background The primary obesity surgery endoluminal 2.0 (POSE 2.0) procedure involves full-thickness gastric body plications to narrow the stomach using durable suture anchor pairs. We evaluated POSE 2.0 as a treatment strategy for nonalcoholic fatty liver disease (NAFLD) in patients with obesity. Methods Adults with obesity and NAFLD were prospectively allocated based on their preference to undergo POSE 2.0 with lifestyle modification or lifestyle modification alone (control). Primary end points were improvement in controlled attenuation parameter (CAP) and resolution of hepatic steatosis at 12 months. Secondary end points included %total body weight loss (%TBWL), change in serum measures of hepatic steatosis and insulin resistance, and procedure safety. Results 42 adult patients were included (20 in the POSE 2.0 arm and 22 in the control arm). At 12 months, POSE 2.0 significantly improved CAP, whereas lifestyle modification alone did not (P < 0.001 for POSE 2.0; P = 0.24 for control). Similarly, both resolution of steatosis and %TBWL were significantly higher with POSE 2.0 than with control at 12 months. Compared with controls, POSE 2.0 significantly improved liver enzymes, hepatic steatosis index, and aspartate aminotransferase to platelet ratio at 12 months. There were no serious adverse events. Conclusion POSE 2.0 was effective for NAFLD in patients with obesity, with good durability and safety profile.