Utility of methylated DNA markers for the diagnosis of malignant biliary strictures.

BACKGROUND AND AIMS: Early identification of malignant biliary strictures (MBS) is challenging, with up to 20% classified as indeterminants after preliminary testing and tissue sampling with endoscopic retrograde cholangiopancreatography (ERCP). We aimed to evaluate the use of methylated DNA markers (MDM) from biliary brushings to enhance MBS detection in a prospective cohort. METHODS: 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 (ddPCR).  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 four 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 fluorescent in situ hybridization (FISH). CONCLUSIONS: The selected methylated DNA markers 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.​.

Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an effective, minimally invasive gastric remodeling procedure to treat mild and moderate obesity. Early adoption of ESG may be desirable to try to halt progression of obesity, but there are few data on its efficacy and safety for overweight patients. METHODS: This was a multicenter, international, analytical case series. Six U.S., 1 Brazilian, 1 Mexican, and 1 Indian center were included. Overweight patients according to local practice undergoing ESG were considered eligible for the study. The end points were percent total weight loss (%TWL), body mass index (BMI) reduction, rate of BMI normalization, and rate of adverse events. RESULTS: One hundred eighty-nine patients with a mean age of 42.6 ± 14.1 years and a mean BMI of 27.79 ± 1.17 kg/m2 were included. All procedures were successfully accomplished, and there were 3 intraprocedural adverse events (1.5%). The mean %TWL was 12.28% ± 3.21%, 15.03% ± 5.30%, 15.27% ± 5.28%, and 14.91% ± 5.62% at 6, 12, 24, and 36 months, respectively. At 12 and 24 months, 76% and 86% of patients achieved normal BMI, with a mean BMI reduction of 4.13 ± 1.46 kg/m2 and 4.25 ± 1.58 kg/m2. There was no difference in mean %TWL in the first quartile versus the fourth quartile of BMI in any of the time points. However, the BMI normalization rate was statistically higher in the first group at 6 and 12 months (6 months, 100% vs 48.5% [P < .01]; 12 months, 86.2% vs 50% [P < .01]; 24 months, 84.6% vs 76.1% [P = .47]; 36 months, 86.3% vs 66.6% [P = .26]). CONCLUSIONS: ESG is safe and effective in treating overweight patients with high BMI normalization rates. It could help halt or delay the progression to obesity.

Clinical predictors of significant findings on EUS for the evaluation of incidental common bile duct dilation.

BACKGROUND AND AIMS: Although EUS is highly accurate for the evaluation of common bile duct (CBD) dilation, the yield of EUS in patients with incidental CBD dilation is unclear. METHODS: Serial patients undergoing EUS for incidental, dilated CBD (per radiologist, minimum of >6 mm objectively) from 2 academic medical centers without active pancreaticobiliary disease or significantly elevated liver function test results were evaluated. Multivariable logistic regression identified predictors of EUS with significant findings and a novel prediction model was derived from one center, internally validated with bootstrapping, and externally validated at the second center. RESULTS: Of 375 patients evaluated, 31 (8.3%) had significant findings, including 26 choledocholithiasis, 1 ampullary adenoma, and 1 pancreatic mass. Predictors of significant findings with EUS included age of ≥70 years (odds ratio [OR], 3.7; 95% confidence interval [CI], 1.5-10.0), non-biliary-type abdominal pain without chronic pain (OR, 6.1; 95% CI, 2.3-17.3), CBD diameter of ≥15 mm or ≥17 mm with cholecystectomy (OR, 6.9; 95% CI, 2.7-18.7), and prior ERCP (OR, 6.8; 95% CI, 2.1-22.5). A point-based novel clinical prediction model was created: age of ≥70 years = 1, non-biliary-type abdominal pain without chronic pain = 2, prior ERCP = 2, and CBD dilation = 2. A score of <1 had 93% (development) and 100% (validation) sensitivity and predicted a <2% chance of having a significant finding in both cohorts while excluding the need for EUS in ∼30% of both cohorts. Conversely, a score of ≥4 was >90% specific for the presence of significant pathology. CONCLUSIONS: Less than 10% of patients undergoing EUS for incidental CBD dilation had pathologic findings. This novel, externally validated, clinical prediction model may reduce low-yield, invasive evaluation in nearly one-third of patients.

Safety of EUS latex balloon use in patients with a latex allergy.

BACKGROUND AND AIMS: Balloons are used in EUS to improve visualization. However, data on the safety of latex balloons in patients with latex allergies are limited, and nonlatex alternatives can be costly. We investigated the safety of latex balloon use during EUS. METHODS: A retrospective review was conducted at a tertiary center between 2019 and 2022. Patients with reported latex allergies who underwent linear EUS were included. Baseline demographics, EUS characteristics, and adverse events were collected. The primary outcome was the rate of adverse events. RESULTS: Eighty-seven procedures were performed on 57 unique patients (mean age, 65.3 ± 14.5 years). Latex balloons were used in 59 procedures (67.8%), with only 8 procedures (13.6%) using prophylactic medications. No adverse events occurred during or after procedures, regardless of medication use or history of anaphylaxis. CONCLUSIONS: The use of EUS latex balloons in patients with a latex allergy was associated with no adverse events.

Lumen-apposing metal stents with or without coaxial plastic stent placement for the management of pancreatic fluid collections.

BACKGROUND AND AIMS: Coaxial double-pigtail plastic stent (DPPS) placement is often performed within lumen-apposing metal stents (LAMSs) for drainage of pancreatic fluid collections (PFCs) to prevent adverse events (AEs) such as stent occlusion and bleeding. This study compares the safety and outcomes of LAMSs alone versus LAMSs with coaxial DPPSs for PFC management. METHODS: Patients undergoing drainage of a PFC with LAMSs were retrospectively identified and categorized as LAMS or LAMS/DPPS based on initial drainage strategy. The AE rate, AE type, and clinical success were extracted by chart review. RESULTS: One hundred eighty-five individuals (83 LAMS, 102 LAMS/DPPS) were identified. No significant differences were found in rates of clinical success (75.9% LAMS vs 69.6% LAMS/DDPS, P = .34) or overall AEs (15.7% LAMS vs 15.7% LAMS/DPPS, P = .825). CONCLUSIONS: In this comparative single-center study, placement of a coaxial DPPS for drainage of PFCs with LAMSs did not affect rates of AEs or clinical success.

Endoscopic Ultrasound-based Shear Wave Elastography for Detection of Advanced Liver Disease.

BACKGROUND AND AIMS: Endoscopic ultrasound shear wave elastography (EUS-SWE) is a novel modality for liver stiffness measurement. The aims of this study are to evaluate the performance and reliability of EUS-SWE for detecting advanced liver disease in a prospective cohort. METHODS: EUS-SWE measurements were prospectively obtained from patients undergoing EUS between August 2020 and March 2023. Liver stiffness measurements were compared between patients with and without advanced liver disease (ALD), defined as stage ≥3, to determine diagnostic accuracy for advanced fibrosis and portal hypertension. Logistic regression was performed to identify variables that impact the reliability of EUS-SWE readings. Select patients underwent paired magnetic resonance elastography (MRE) for liver fibrosis correlation. RESULTS: Patients with ALD demonstrated higher liver stiffness compared to healthy controls (left lobe: 17.6 vs. 12.7 kPa, P<0.001; median right lobe: 24.8 vs. 11.0 kPa, P<0.001). The area under the receiver operator characteristic (AUROC) for the detection of ALD was 0.73 and 0.80 for left and right lobe measurements, respectively. General anesthesia was associated with reliable EUS-SWE liver readings (odds ratio: 2.73, 95% CI: 1.07-7.39, P=0.040). Left lobe measurements correlated significantly with MRE with an increase of 0.11 kPa (95% CI: 0.05-0.17 kPA) for every 1 kPa increase on EUS-SWE. D. CONCLUSIONS: SWE is a promising technology that can readily be incorporated into standard EUS examinations for the assessment of ALD.

The impact of bariatric surgery on admissions for gastrointestinal complications and conditions associated with obesity: A nationwide study.

BACKGROUND: Obesity worsens various gastrointestinal pathologies. While bariatric surgery ameliorates obesity, it substantially modifies the gastrointestinal system depending on surgery type, with limited data on subsequent impact on obesity-related gastrointestinal admissions. METHODS: Using the 2012-2014 Nationwide Readmission Database, we included individuals with obesity who received vertical sleeve gastrectomy (VSG), Roux-en-Y gastric bypass (RYGB), or hernia repair (HR-control surgery). Our main focus was the adjusted odds ratio (aOR) for gastrointestinal inpatient admissions within 6 months following surgery compared to the 6 months preceding it, while controlling for several confounding factors. Gastrointestinal admissions were grouped into postoperative complications or obesity-associated gastrointestinal conditions. RESULTS: Our cohort included 140,103 adults with RYGB, 132,253 with VSG, and 12,436 HR controls. Postoperative gastrointestinal complications were most common after RYGB, prominently obstruction (aOR = 33.17, 95%CI: 18.01, 61.10), and Clostridium difficile infection (aOR: 12.52, 95%CI: 6.22, 25.19). VSG also saw significantly increased but less frequent similar conditions. Notably, for gastrointestinal conditions associated with obesity, acute pancreatitis risk was higher post-VSG (aOR = 6.26, 95%CI: 4.02, 9.73). Post-RYGB patients were most likely to be admitted for cholelithiasis with cholecystitis (aOR: 4.15, 95% CI: 3.24, 5.31), followed by chronic liver disease (aOR: 3.00, 95% CI: 2.33, 3.87). The risk of noninfectious colitis admissions was threefold higher after RYGB and VSG. No gastrointestinal conditions showed an increase after HR. CONCLUSION: Despite weight loss, bariatric surgery was associated with an increased risk of hepato-pancreatobiliary and colitis admissions related to obesity in the first six postoperative months, with considerable variations in rates of gastrointestinal conditions by surgery type.

A Matched Comparative Analysis of Type-2 Diabetes Mellitus Remission Between Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.

OBJECTIVE: Multiple scores validate long-term type-2 diabetes mellitus (T2DM) remission after metabolic and bariatric surgery (MBS). However, studies comparing Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) have not adequately controlled for certain parameters, which may influence procedure selection. METHODS: We conducted a multicenter retrospective review of patients with T2DM who underwent RYGB or SG between 2008 and 2017. Data on demographics, clinical, laboratory, and metabolic values were collected annually for up to 14 years. Each eligible RYGB patient was individually matched to an eligible SG patient based on diabetes severity, weight loss, and follow-up duration. RESULTS: Among 1149 T2DM patients, 467 were eligible for matching. We found 97 matched pairs who underwent RYGB or SG. RYGB showed significantly higher T2DM remission rates (46.4%) compared to SG (33.0%) after matching. SG patients had higher insulin usage (35.1%) than RYGB patients (20.6%). RYGB patients also experienced greater decreases in HbA1c levels and diabetes medication usage than SG patients. CONCLUSIONS: RYGB demonstrates higher efficacy for T2DM remission compared to SG, regardless of baseline characteristics, T2DM severity, weight loss, and follow-up duration. Further studies are needed to understand the long-term metabolic effects of MBS and the underlying pathophysiology of T2DM remission after MBS.

Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study.

OBJECTIVE: Endoscopic sleeve gastroplasty (ESG) has gained global adoption but our understanding of its mechanism(s) of action and durability of efficacy is limited. We sought to determine changes in gastric emptying (GE), gastric motility (GM), hormones and eating behaviours after ESG. DESIGN: A priori-designed single-centre substudy of a large US randomised clinical trial, adults with obesity were randomised to ESG or lifestyle interventions (LS) alone. We measured GE, hormones and weight loss and assessed eating behaviours. In a subset of ESG patients, we assessed GM. The primary outcome was the change in T1/2 (min) at 3 months, and secondary outcomes were changes in weight, GE, GM, hormones and eating behaviours. We used t-test analyses and regression to determine the association between GE and weight loss. RESULTS: 36 (ESG=18; LS=18) participated in this substudy. Baseline characteristics were similar between the two groups. At 3 months, T1/2 was delayed in the ESG group (n=17) compared with the LS group (n=17) (152.3±47.3 vs 89.1±27.9; p<0.001). At 12 months, T1/2 remained delayed in the ESG group (n=16) vs control group (n=14) (137±37.4 vs 90.1±23.4; p<0.001). Greater delays in GE at 3 months were associated with greater weight loss. GM was preserved and fasting ghrelin, glucagon-like peptide 1 and polypeptide YY significantly increased 18 months after ESG. CONCLUSION: ESG promotes weight loss through several key mechanistic pathways involving GE and hormones while preserving GM. These findings further support clinical adoption of this technique for the management of obesity. TRIAL REGISTRATION NUMBER: NCT03406975.

Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: Apollo Endosurgery, Mayo Clinic.

Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity.

BACKGROUND & AIMS: The Primary Obesity Surgery Endoluminal (POSE) 2.0 procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using durable suture anchor pairs. Our prospective, multicenter trial examined the safety, efficacy, durability, and physiologic effects of POSE 2.0 in adults with obesity. METHODS: Adults with obesity underwent POSE 2.0 at 3 centers. Primary outcomes were percent total body weight loss (%TBWL) and proportion of patients achieving >5% TBWL at 12 months. Secondary outcomes included change in obesity comorbidities, satiety, quality of life at 6 months, and durability of plications at 12 and 24 months. Subjects were followed for adverse events throughout the study duration. RESULTS: 44 patients (61% female; mean age, 45 ± 9.7 years; mean body mass index, 37 ± 2.1 kg/m2) were enrolled. This procedure used an average of 19 suture anchor pairs, with a mean duration of 37 ± 11 minutes, and was technically successful in all subjects. Mean %TBWL at 12 months was 15.7% ± 6.8%. At 12 months, %TBWL >5%, >10%, and >15% was achieved in 98%, 86%, and 58% of patients, respectively. Improvements in lipid profile, liver biochemistries, and hepatic steatosis were seen at 6 months. Improvements in hepatic steatosis persisted for 24 months in a subgroup of patients (P < .01). POSE 2.0 reduced maximum tolerated meal volume (P = .03) and was associated with increased fullness (P < .01) and improved eating behavior (P < .01) at 6 months. Impact of weight on quality-of-life questionnaire improved at 6 months (2.23 vs 1.23; P < .01). Repeat assessment at 24 months (n = 26) showed fully intact plications. No serious adverse events occurred. CONCLUSION: POSE 2.0 is an effective and durable endoscopic bariatric therapy which may influence physiologic pathways impacting satiety. Larger comparative studies are needed to further elucidate these initial findings. CLINICALTRIALS: gov Identifier: NCT03721731.

A Protocolized Management of Walled-Off Necrosis (WON) Reduces Time to WON Resolution and Improves Outcomes.

BACKGROUND AND AIMS: Patients with infected or symptomatic walled-off necrosis (WON) have high morbidity and health care utilization. Despite the recent adoption of nonsurgical treatment approaches, WON management remains nonalgorithmic. We investigated the impact of a protocolized early necrosectomy approach compared with a nonprotocolized, clinician-driven approach on important clinical outcomes. METHODS: Records were reviewed for consecutive patients with WON who underwent a protocolized endoscopic drainage with a lumen-apposing metal stent (cases), and for patients with WON treated with a lumen-apposing metal stent at the same tertiary referral center who were not managed according to the protocol (control subjects). The protocol required repeat cross-sectional imaging within 14 days after lumen-apposing metal stent placement, with regularly scheduled endoscopic necrosectomy if WON diameter reduction was <50%. Control patients were treated according to their clinician's preference without an a priori strategy. Inverse probability of treatment weighting-adjusted analysis was used to evaluate the influence of being in the protocolized group on time to resolution. RESULTS: A total of 24 cases and 47 control subjects were included. There were no significant differences in baseline characteristics. Although numbers of endoscopies and necrosectomies were similar, cases had lower adverse event rates, shorter intensive care unit stay, and required nutritional support for fewer days. On matched multivariate Cox regression, cases had earlier WON resolution (hazard ratio, 5.73; 95% confidence interval, 2.62-12.5). This was confirmed in the inverse probability of treatment weighting-adjusted analysis (hazard ratio, 3.4; 95% confidence interval, 1.92-6.01). CONCLUSIONS: A protocolized strategy resulted in faster WON resolution compared with a discretionary approach without the need for additional therapeutic interventions, and with a better safety profile and decreased health care utilization.

Identification of patients with malignant biliary strictures using a cholangioscopy-based deep learning artificial intelligence (with video).

BACKGROUND AND AIMS: Accurately diagnosing malignant biliary strictures (MBSs) as benign or malignant remains challenging. It has been suggested that direct visualization and interpretation of cholangioscopy images provide greater accuracy for stricture classification than current sampling techniques (ie, brush cytology and forceps biopsy sampling) using ERCP. We aimed to develop a convolutional neural network (CNN) model capable of accurate stricture classification and real-time evaluation based solely on cholangioscopy image analysis. METHODS: Consecutive patients with cholangioscopy examinations from 2012 to 2021 were reviewed. A CNN was developed and tested using cholangioscopy images with direct expert annotations. The CNN was then applied to a multicenter, reserved test set of cholangioscopy videos. CNN performance was then directly compared with that of ERCP sampling techniques. Occlusion block heatmap analyses were used to evaluate and rank cholangioscopy features associated with MBSs. RESULTS: One hundred fifty-four patients with available cholangioscopy examinations were included in the study. The final image database comprised 2,388,439 still images. The CNN demonstrated good performance when tasked with mimicking expert annotations of high-quality malignant images (area under the receiver-operating characteristic curve, .941). Overall accuracy of CNN-based video analysis (.906) was significantly greater than that of brush cytology (.625, P = .04) or forceps biopsy sampling (.609, P = .03). Occlusion block heatmap analysis demonstrated that the most frequent image feature for an MBS was the presence of frond-like mucosa/papillary projections. CONCLUSIONS: This study demonstrates that a CNN developed using cholangioscopy data alone has greater accuracy for biliary stricture classification than traditional ERCP-based sampling techniques.

Uncovered versus fully covered self-expandable metal stents for the management of distal malignant biliary obstruction.

BACKGROUND AND AIM: Self-expandable metal stents (SEMSs) are widely used for palliation of distal malignant biliary obstruction (dMBO). However, previous studies comparing the outcomes between uncovered SEMSs (UCSEMSs) and fully covered SEMSs (FCSEMSs) report conflicting results. This large cohort study aimed to compare the clinical outcomes between UCSEMSs and FCSEMSs for dMBO. METHODS: A retrospective cohort study was performed in patients with dMBO who underwent either UCSEMS or FCSEMS placement between May 2017 and May 2021. Primary outcomes were rates of clinical success, adverse events (AEs), and unplanned endoscopic reintervention. Secondary outcomes were types of AEs, intervention-free stent patency, and management and outcomes of stent occlusion. RESULTS: The cohort included 454 patients (364 in the UCSEMS group and 90 in the FCSEMS group). Median follow-up duration was 9.6 months and was similar between the 2 groups. Use of UCSEMSs and FCSEMSs had comparable clinical success (P = .250). However, use of UCSEMSs had significantly higher rates of AEs (33.5% vs 21.1%; P = .023) and unplanned endoscopic reintervention (27.0% vs 11.1%; P = .002). UCSEMSs had a higher rate of stent occlusion (26.9% vs 8.9%; P < .001) and shorter median time to stent occlusion (4.4 months vs 10.7 months; P = .002). Stent reintervention-free survival was higher in the FCSEMS group. FCSEMSs had a significantly higher rate of stent migration (7.8% vs 1.1%; P < .001), but patients in the FCSEMS group had similar rates of cholecystitis (.3% vs 1.1%; P = .872) and post-ERCP pancreatitis (6.3% vs 6.6%; P = .90). When UCSEMSs did occlude, placement of a coaxial plastic stent had a higher rate of stent reocclusion compared with coaxial SEMS placement (46.7% vs 19.7%; P = .007). CONCLUSION: FCSEMSs should be considered for the palliation of dMBO because of lower rates of AEs, longer patency rates, and lower rates of unplanned endoscopic intervention.

Novel classification system for walled-off necrosis: a step toward standardized nomenclature and risk-stratification framework.

BACKGROUND AND AIMS: The optimal therapeutic approach for walled-off necrosis (WON) is not fully understood, given the lack of a validated classification system. We propose a novel and robust classification system based on radiologic and clinical factors to standardize the nomenclature, provide a framework to guide comparative effectiveness trials, and inform the optimal WON interventional approach. METHODS: This was a retrospective analysis of patients who underwent endoscopic management of WON by lumen-apposing metal stent placement at a tertiary referral center. Patients were classified according to the proposed QNI classification system: quadrant ("Q"), represented an abdominal quadrant distribution; necrosis ("N"), denoted by the percentage of necrosis of WON; and infection ("I"), denoted as positive blood culture and/or systemic inflammatory response syndrome reaction with a positive WON culture. Two blinded reviewers classified all patients according to the QNI system. Patients were then divided into 2 groups: those with a lower QNI stratification (≤2 quadrants and ≤30% necrosis; group 1) and those with a higher stratification (≥3 quadrants, 2 quadrants with ≥30% necrosis, or 1 quadrant with >60% necrosis and infection; group 2). The primary outcome was mean time to WON resolution. Secondary procedural and clinical outcomes between the groups were compared. RESULTS: Seventy-one patients (75% men) were included and stratified by the QNI classification; group 1 comprised 17 patients and group 2, 54 patients. Patients in group 2 had a higher number of necrosectomies, longer hospital stays, and more readmissions. The mean time to resolution was longer in group 2 than in group 1 (79.6 ± 7.76 days vs 48.4 ± 9.22 days, P = .02). The mortality rate was higher in group 2 (15% vs 0%, P = .18). CONCLUSIONS: Despite the heterogeneous nature of WON in severe acute pancreatitis, a proposed QNI system may provide a standardized framework for WON classification to inform clinical trials, risk-stratify the disease course, and potentially inform an optimal management approach.

A novel blood-sensing capsule for rapid detection of upper GI bleeding: a prospective clinical trial.

BACKGROUND AND AIMS: Upper GI bleeding (UGIB) is a common medical emergency associated with high resource utilization, morbidity, and mortality. Timely EGD can be challenging from personnel, resource, and access perspectives. PillSense (EnteraSense Ltd, Galway, Ireland) is a novel swallowed bleeding sensor for the detection of UGIB, anticipated to aid in patient triage and guide clinical decision-making for individuals with suspected UGIB. METHODS: This prospective, open-label, single-arm comparative clinical trial of a novel bleeding sensor for patients with suspected UGIB was performed at a tertiary care center. The PillSense system consists of an optical sensor and an external receiver that processes and displays data from the capsule as "Blood Detected" or "No Blood Detected." Patients underwent EGD within 4 hours of capsule administration; participants were followed up for 21 days to confirm capsule passage. RESULTS: A total of 126 patients were accrued to the study (59.5% male; mean age, 62.4 ± 14.3 years). Sensitivity and specificity for detecting the presence of blood were 92.9% (P = .02) and 90.6% (P < .001), respectively. The capsule's positive and negative predictive values were 74.3% and 97.8%, and positive and negative likelihood ratios were 9.9 and .08. No adverse events or deaths occurred related to the PillSense system, and all capsules were excreted from patients on follow-up. CONCLUSIONS: The PillSense system is safe and effective for detecting the presence of blood in patients evaluated for UGIB before upper GI endoscopy. It is a rapidly deployed tool, with easy-to-interpret results that will affect the diagnosis and triage of patients with suspected UGIB. (Clinical trial registration number: NCT05385224.).

Improvements in hepatic steatosis, obesity, and insulin resistance in adults with nonalcoholic fatty liver disease after the primary obesity surgery endoluminal 2.0 procedure.

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.

Lumen-apposing metal stents for the treatment of benign gastrointestinal tract strictures: a single-center experience and proposed treatment algorithm.

BACKGROUND: Lumen-apposing metal stents (LAMS) are an alternative therapeutic option for benign gastrointestinal (GI) tract strictures. Our study aimed to evaluate the safety and efficacy of LAMS for the management of benign GI strictures. METHODS: Consecutive patients who underwent a LAMS placement for benign luminal GI strictures at a tertiary care center between January 2014 and July 2021 were reviewed. Primary outcomes included technical success, early clinical success, and adverse events (AEs). Other outcomes included rates of stent migration and re-intervention after LAMS removal. RESULTS: One hundred and nine patients who underwent 128 LAMS placements (67.9% female, mean age of 54.3 ± 14.2 years) were included, and 70.6% of the patients had failed prior endoscopic treatments. The majority of strictures (83.5%) were anastomotic, and the most common stricture site was the gastrojejunal anastomosis (65.9%). Technical success was achieved in 100% of procedures, while early clinical success was achieved in 98.4%. The overall stent-related AE rate was 25%. The migration rate was 27.3% (35/128). Of these, five stents were successfully repositioned endoscopically. The median stent dwell time was 119 days [interquartile range (IQR) 68-189 days], and the median follow-up duration was 668.5 days [IQR: 285.5-1441.5 days]. The re-intervention rate after LAMS removal was 58.3%. CONCLUSIONS: LAMS is an effective therapeutic option for benign GI strictures, offering high technical and early clinical success. However, the re-intervention rate after LAMS removal was high. In select cases, using LAMS placement as destination therapy with close surveillance is a reasonable option.

Utility of Urgent Endoscopic Retrograde Cholangiopancreatography in Patients with Predicted Mild Acute Pancreatitis and Cholestasis.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) within 72 h is suggested for patients presenting with acute biliary pancreatitis (ABP) and biliary obstruction without cholangitis. This study aimed to identify if urgent ERCP (within 24 h) improved outcomes compared to early ERCP (24-72 h) in patients admitted with predicted mild ABP. METHODS: Patients admitted for predicted mild ABP defined as a bedside index of severity in acute pancreatitis score < 3 and underwent ERCP for biliary obstruction within 72 h of presentation during the study period were included. Patients with prior biliary sphincterotomy or surgically altered anatomy preventing conventional ERCP were excluded. The primary outcome was the development of moderately severe or severe pancreatitis based on the revised Atlanta classification. Secondary outcomes were the length of hospital stay, the need for ICU admission, and ERCP-related adverse events (AEs). RESULTS: Of the identified 166 patients, baseline characteristics were similar between both the groups except for the WBC count (9.4 vs. 8.3/µL; p < 0.044) and serum bilirubin level (3.0 vs. 1.6 mg/dL; p < 0.0039). Biliary cannulation rate and technical success were both high in the overall cohort (98.8%). Urgent ERCP was not associated with increased development of moderately severe pancreatitis (10.4% vs. 15.7%; p = 0.3115). The urgent ERCP group had a significantly shorter length of hospital stay [median 3 (IQR 2-3) vs. 3 days (IQR 3-4), p < 0.01]. CONCLUSION: Urgent ERCP did not impact the rate of developing more severe pancreatitis in patients with predicted mild ABP but was associated with a shorter length of hospital stay and a lower rate of hospital readmission.

Novel Endoscopic Bariatric Therapies for the Management of Nonalcoholic Steatohepatitis.

Obesity is strongly associated with nonalcoholic fatty liver disease as well as advanced forms of the disease such as nonalcoholic steatohepatitis (NASH), cirrhosis, and hepatocellular carcinoma. While lifestyle and diet modifications have been the cornerstone of treatment for NASH thus far, they are only effective for less than half of the patients. New endoscopic bariatric therapies (EBTs) have already proved to be safe and effective for the treatment of obesity and type 2 diabetes mellitus, and may provide an intermediate, less invasive, cost-effective option for patients with NASH. In this review, we aim to describe the data and evidence as well as outline future areas of development for endobariatric therapies for the treatment of NASH. In conclusion, EBTs present an effective and safe therapeutic modality for use in the growing pandemic of obesity-related liver disease and should be investigated further with large-scale trials in this patient population.