Endoscopic Ultrasound 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 endoscopic ultrasound (EUS). Indentation depth is measured with sonographic calipers. We hypothesize that fibrotic livers are more difficult to indent, and indentation can accurately predict liver fibrosis staging. We compared EUS-guided liver palpation to conventional screening modalities in patients with suspected metabolic dysfunction-associated steatotic liver disease (MASLD). METHODS: This was a cross-sectional pilot study. Consecutive patients at three hospitals between 2021-2023 underwent EUS-guided palpation with liver biopsy. Liver palpation was compared to Fibrosis-4 index (FIB-4), AST to Platelet Ratio Index (APRI), NAFLD Fibrosis Score (NFS), and transient elastography in predicting fibrosis staging on histology. Area under the receiver operator characteristic (AUROC) curve analysis was performed. RESULTS: 73 patients were included. Mean age was 49.1 and 71.2% were female. Mean body mass index was 41.1. Indentation depth was negatively correlated with fibrosis stage (Kruskal-Willis test, p<0.0001). EUS palpation demonstrated c-statistic of 0.79 and 0.95 discriminating advanced fibrosis and cirrhosis respectively. EUS-liver palpation was superior to NFS in predicting advanced fibrosis (p=0.0057) and superior to APRI and NFS predicting cirrhosis (p=0.0099 and 0.045 respectively). EUS palpation was not significantly different versus FIB-4. EUS palpation was superior to transient elastography in predicting cirrhosis (p=0.045). Using optimal cut-offs, indentation measurement ≤3.5mm yielded 100% predictive value ruling in advanced fibrosis, and ≥4.0mm yielded 100% predictive value 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 MASLD.

Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial.

BACKGROUND/AIMS: Upper gastrointestinal bleeding (UGIB) is the most common GI condition requiring hospitalization, and can be diagnosed by direct visualization. The present study aimed to evaluate the safety and feasibility of using the PillSense system (EnteraSense Ltd.), a novel diagnostic tool designed for the rapid in vivo detection of UGIB, in human volunteers. METHODS: In the present study, 10 volunteers swallowed a PillSense capsule, followed by 2 servings of an autologous blood preparation. Participants were monitored for capsule passage, overall tolerability of the procedure, and adverse events. RESULTS: The procedure was completed per the protocol established in the present study in 9/10 cases. In 9 of the subjects, after capsule ingestion, the device indicated the absence of blood with sensor output values of 1. After the ingestion of the first blood mixture, the sensor outputs of all devices increased from 2.8 to 4, indicating that each camera detected blood. The sensor output remained within that range after the ingestion of the second mixture; however, in one case, the baseline capsule signal was positive, because of a preexisting condition. The passage of the capsule was verified in all patients, and no adverse events were reported. CONCLUSION: The first trial of the PillSense system in human subjects demonstrated the feasibility, safety, and tolerability of utilizing this product as a novel, noninvasive, and easy-to-use triage tool for the diagnosis of patients suspected of having UGIB.

Preclinical study of a novel ingestible bleeding sensor for upper gastrointestinal bleeding.

BACKGROUND/AIMS: Upper gastrointestinal bleeding (UGIB) is a life-threatening condition that necessitates early identification and intervention and is associated with substantial morbidity, mortality, and socioeconomic burden. However, several diagnostic challenges remain regarding risk stratification and the optimal timing of endoscopy. The PillSense System is a noninvasive device developed to detect blood in patients with UGIB in real time. This study aimed to assess the safety and performance characteristics of PillSense using a simulated bleeding model. METHODS: A preclinical study was performed using an in vivo porcine model (14 animals). Fourteen PillSense capsules were endoscopically placed in the stomach and blood was injected into the stomach to simulate bleeding. The safety and sensitivity of blood detection and pill excretion were also investigated. RESULTS: All the sensors successfully detected the presence or absence of blood. The minimum threshold was 9% blood concentration, with additional detection of increasing concentrations of up to 22.5% blood. All the sensors passed naturally through the gastrointestinal tract. CONCLUSION: This study demonstrated the ability of the PillSense System sensor to detect UGIB across a wide range of blood concentrations. This ingestible device detects UGIB in real time and has the potential to be an effective tool to supplement the current standard of care. These favorable results will be further investigated in future clinical studies.

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.

EUS-guided coil injection therapy in the management of gastric varices: the first U.S. multicenter experience (with video).

BACKGROUND AND AIMS: Despite the significant morbidity associated with gastric variceal bleeding, there is a paucity of high-quality data regarding optimal management. EUS-guided coil injection therapy (EUS-COIL) has recently emerged as a promising endoscopic modality for the treatment of gastric varices (GV), particularly compared with traditional direct endoscopic glue injection. Although there are data on the feasibility and safety of EUS-COIL in the management of GV, these have been limited to select centers with particular expertise. The aim of this study was to report the first U.S. multicenter experience of EUS-COIL for the management of GV. METHODS: This retrospective analysis included patients with bleeding GV or GV at risk of bleeding who underwent EUS-COIL at 10 U.S. tertiary care centers between 2018 and 2022. Baseline patient and procedure-related information was obtained. EUS-COIL entailed the injection of .018 inch or .035 inch hemostatic coils using a 22-gauge or 19-gauge FNA needle. Primary outcomes were technical success (defined as successful deployment of coil into varix under EUS guidance with diminution of Doppler flow), clinical success (defined as cessation of bleeding if present and/or absence of bleeding at 30 days' postintervention), and intraprocedural and postprocedural adverse events. RESULTS: A total of 106 patients were included (mean age 60.4 ± 12.8 years; 41.5% female). The most common etiology of GV was cirrhosis (71.7%), with alcohol being the most common cause (43.4%). Overall, 71.7% presented with acute GV bleeding requiring intensive care unit stay and/or blood transfusion. The most common GV encountered were isolated GV type 1 (60.4%). A mean of 3.8 ± 3 coils were injected with a total mean length of 44.7 ± 46.1 cm. Adjunctive glue or absorbable gelatin sponge was injected in 82% of patients. Technical success and clinical success were 100% and 88.7%, respectively. Intraprocedural adverse events (pulmonary embolism and GV bleeding from FNA needle access) occurred in 2 patients (1.8%), and postprocedural adverse events occurred in 5 (4.7%), of which 3 were mild. Recurrent bleeding was observed in 15 patients (14.1%) at a mean of 32 days. Eighty percent of patients with recurrent bleeding were successfully re-treated with repeat EUS-COIL. No significant differences were observed in outcomes between high-volume (>15 cases) and low-volume (<7 cases) centers. CONCLUSIONS: This U.S. multicenter experience on EUS-COIL for GV confirms high technical and clinical success with low adverse events. No significant differences were seen between high- and low-volume centers. Repeat EUS-COIL seems to be an effective rescue option for patients with recurrent bleeding GV. Further prospective studies should compare this modality versus other interventions commonly used for GV.

A Unique Management Strategy for Migrated Biliary Stent Causing Duodenal Perforation.

Distal stent migration leading to duodenal perforation is an uncommon complication of endoscopic biliary plastic stent placement. We present a case in which a patient with a migrated biliary plastic stent that perforated through the duodenum was managed expectantly until a duodenocolic fistula formed prior to endoscopic removal.

Gastric varices.

PURPOSE OF REVIEW: Gastric varices are a rare cause of gastrointestinal bleeding in patients with portal hypertension. There have been significantly advances within endoscopic ultrasound for treatment of gastric varices over the past 5 years in addition to the conventional endoscopic and endovascular therapies. In this review, we will review the latest literature on gastric varices with emphasis on changes to the conventional classification systems and comparisons among the different treatment options for gastric varices in terms of efficacy and safety. RECENT FINDINGS: There have been new guidelines proposed by the American Gastrointestinal Association on a simpler classification system compared to the conventional Sarin classification. In addition, endoscopic ultrasound guided coil embolization, a novel treatment pioneered over the past 5 years for gastric varices, has shown increased efficacy and reduced adverse event profile compared to cyanoacrylate glue, the more traditional therapy for gastric variceal bleeding. Options for endovascular therapy overall have not significantly changed over the recent years. SUMMARY: Based on our literature review, we recommend a step-up approach with initial medical and endoscopic management with consideration of endovascular therapies when initial therapies fail.

Closure of refractory gastrocutaneous fistula with endoscopically guided percutaneous suturing with the use of miniature biopsy forceps.

Video 1Closure of a refractory gastrocutaneous fistula with endoscopically guided percutaneous suturing with the use of miniature biopsy forceps.

AGA Clinical Practice Update on Interventional EUS for Vascular Investigation and Therapy: Commentary.

DESCRIPTION: The purpose of this AGA Institute Clinical Practice Update is to review the available evidence supporting and examine opportunities for future research in endoscopic ultrasound-guided vascular investigation and therapies. METHODS: This Clinical Practice Update was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Clinical Gastroenterology and Hepatology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors who are advanced endoscopists with expertise in endoscopic ultrasound-guided vascular investigation and therapy.

Defining the optimal technique for endoscopic ultrasound shear wave elastography: a combined benchtop and animal model study with comparison to transabdominal shear wave elastography.

BACKGROUND/AIMS: Shear wave elastography (SWE) is used for liver fibrosis staging based on stiffness measurements. It can be performed using endoscopic ultrasound (EUS) or a transabdominal approach. Transabdominal accuracy can be limited in patients with obesity because of the thick abdomen. Theoretically, EUS-SWE overcomes this limitation by internally assessing the liver. We aimed to define the optimal technique for EUS-SWE for future research and clinical use and compare its accuracy with that of transabdominal SWE. METHODS: Benchtop study: A standardized phantom model was used. The compared variables included the region of interest (ROI) size, depth, and orientation and transducer pressure. Porcine study: Phantom models with varying stiffness values were surgically implanted between the hepatic lobes. RESULTS: For EUS-SWE, a larger ROI size of 1.5 cm and a smaller ROI depth of 1 cm demonstrated a significantly higher accuracy. For transabdominal SWE, the ROI size was nonadjustable, and the optimal ROI depth ranged from 2 to 4 cm. The transducer pressure and ROI orientation did not significantly affect the accuracy. There were no significant differences in the accuracy between transabdominal SWE and EUS-SWE in the animal model. The variability among the operators was more pronounced for the higher stiffness values. Small lesion measurements were accurate only when the ROI was entirely situated within the lesion. CONCLUSION: We defined the optimal viewing windows for EUS-SWE and transabdominal SWE. The accuracy was comparable in the non-obese porcine model. EUS-SWE may have a higher utility for evaluating small lesions than transabdominal SWE.

Endoscopic submucosal dissection with ductotomy for the resection of a gastric duplication cyst with a communicating duct.

Video 1The endoscopic submucosal dissection of the gastric duplication cyst with ductotomy of an incidental communicating duct.

Predicting success of direct endoscopic necrosectomy with lumen-apposing metal stents for pancreatic walled-off necrosis.

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) with lumen-apposing metal stents (LAMSs) is increasingly used in the management of pancreatic walled-off necrosis (WON). However, it still remains unknown which patients will fail to respond to DEN with LAMSs and require additional surgical intervention. Therefore, the aim of our study was to explore predictors of successful DEN with LAMSs for pancreatic WON. METHODS: This is a retrospective analysis of a prospectively collected database. All consecutive patients who underwent DEN with LAMSs for pancreatic WON were included. Collected data were demographics, disease severity, morphologic features, and procedure characteristics. Potential factors affecting DEN outcome were predefined and analyzed. RESULTS: One hundred one consecutive patients undergoing DEN with LAMSs for WON were identified, among whom 4 patients were excluded for technical failure (n = 1) and previous debridement without LAMSs (n = 3). In the 97 included patients, clinical success was achieved in 79 patients (81.4%). In logistic multivariable regression, 3 independent factors were negatively associated with success of DEN with LAMSs: increasing Acute Physiology and Chronic Health Evaluation II score (odds ratio [OR], .70; 95% confidence interval [CI], .55-.90; P = .005), >50% pancreatic necrosis (OR, .16; 95% CI, .03-.77; P = .022), and paracolic gutter extension (OR, .08; 95% CI, .02-.42; P = .003). A receiver-operating characteristic curve of the prediction model with these 3 factors demonstrated an area under the curve of .926. CONCLUSIONS: Paracolic gutter extension, increasing Acute Physiology and Chronic Health Evaluation II score, and >50% gland necrosis are negative predictors for success of DEN with LAMSs in WON. This prediction model with nomogram may be helpful in clinical decision-making and prognostication.

Variceal Bleeding: Beyond Banding.

Despite advances in the management of complications of portal hypertension, variceal bleeding continues to be associated with significant morbidity and mortality. While endoscopic variceal band ligation remains first line therapy for treating bleeding and high-risk non-bleeding esophageal varices, alternate therapies have been explored, particularly in cases of refractory bleeding. The therapies being explored include stent placement, hemostatic powder use, over-the-scope clips and others. For gastric variceal bleeding, endoscopic ultrasound-guided therapies have recently emerged as promising interventions for hemostasis. The aim of this article is to highlight these alternative therapies and their potential role in the management of gastric and esophageal variceal bleeding.

Evaluation of sutureless anastomosis after ileostomy takedown using the self-forming magnet anastomosis system in a porcine model.

BACKGROUND: Current standard of care for creation of small bowel anastomoses after a loop ileostomy reversal includes the use of stapler devices and sutures. Compression anastomosis devices have been used for decades, aimed toward improved outcomes with a "staple free" & "suture free" anastomosis. The self-forming magnet (SFM) device is a type of compression anastomosis device used to safely and effectively create an end-to-end small bowel anastomosis without the localized inflammatory response seen with sutures or staples, as no foreign bodies are left behind. METHODS: A Good Laboratory Practice preclinical study using a porcine model to evaluate creating an in vivo anastomosis via magnetic compression between two segments of small bowel (jejunum or ileum) was performed. Magnetic anastomoses were compared to stapled and handsewn anastomoses. Six animals were used for the magnetic anastomosis and eight for the two control groups for a total of 14 subjects. RESULTS: Mean creation times were 17.1 min (SD 6.06) for the SFM group, 10.3 min (SD 6.55, CI 95%) for the stapled anastomosis group, and 28.3 min (SD 2.63, CI 95%) for the suture anastomosis group, with a statistically significant difference among groups (p < 0.0021). All evaluated SFM anastomosis, stapled anastomosis, and handsewn anastomosis underwent a burst test with a pressure of 1.3 PSI. All six magnets used for anastomoses were naturally expelled. The range of days to expel magnets was 10-17 days. Intestinal anastomoses using magnets had considerably less residual scarring and intestinal distortion than anastomoses done with either suture or staples. CONCLUSION: This preclinical study documents the safety and efficacy of creating end-to-end small bowel anastomoses after ileostomy takedown using a magnetic compression device. The result is an anastomosis free of foreign objects with less inflammation, scarring, distortion, and mural thickening than seen in sutured or stapled anastomoses.

Endoscopic ultrasound-guided biliary drainage in benign biliary pathology with normal foregut anatomy: a multicenter study.

BACKGROUND AND AIMS: Biliary drainage using endoscopic ultrasound (EUS-BD) has been developed as a novel technique to obtain biliary access and drainage when ERCP fails. Numerous studies have demonstrated its safety and efficacy specifically pertaining to those with malignant distal biliary obstruction or altered foregut anatomy. The aim of this study is to evaluate the safety and efficacy of EUS-BD in benign indications in patients with normal foregut anatomy. METHODS: We performed a retrospective comparative study from 5 academic medical centers (2008-2018) involving patients with benign biliary obstruction and native foregut anatomy who had an initial failed ERCP with subsequent attempt at biliary decompression via EUS-BD or by repeating ERCP. RESULTS: 36 patients (mean age 61.6 ± 2.2, 38.9% female) who underwent attempted EUS-BD following initial failed ERCP were compared to 50 patients (mean age 62.7 ± 2.3, 73.5% female) who underwent repeat ERCP following an initial failed cannulation. EUS-BD was technically successful in 28 (77.8%) patients with rendezvous being the most common approach (86.1%). A higher level of pre-procedural bilirubin was found to be associated with technical success of EUS-BD (3.65 ± 0.63 versus 1.1 ± 0.4, p value 0.04). Success of repeat ERCP following failed cannulation was 86%. Adverse events were significantly more frequent in the EUS-BD cohort when compared to the repeat ERCP (10 (27.8%) versus 4 (8.0%), p = 0.02, OR 4.32. CONCLUSIONS: EUS-BD remains a viable therapeutic option in the setting of benign biliary disease, with success rates of 77.8%. Adverse events were significantly more common with EUS-BD vs. repeat ERCP, emphasizing the need to perform in expert centers with appropriate multidisciplinary support and to strongly consider the urgency of biliary decompression before considering same session EUS-BD after failed initial biliary access.

Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial.

BACKGROUND: Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity. METHODS: In this prospective, multicentre, open-label, randomised clinical trial done at seven US sites, adults aged 22-65 years with obesity were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks. Balloon volume could be increased to facilitate weight loss or decreased for tolerability. Coprimary endpoints included mean percentage total bodyweight loss and responder rate (≥5% total bodyweight loss) at 32 weeks. We used a multiple imputed intention-to-treat population analysis. This study was registered with ClinicalTrials.gov, NCT02812160. FINDINGS: Between Aug 9, 2016, and Dec 7, 2018, we randomly assigned 288 patients to aIGB (n=187 [65%]) or control (n=101 [35%]) groups. Mean total bodyweight loss at 32 weeks was 15·0% (95% CI 13·9-16·1) in the aIGB group versus 3·3% (2·0-4·6) in the control group (p<0·0001). Clinical response was observed in 171 (92%) patients in the aIGB group. Adjustments to the aIGB occurred in 145 (80%) patients for weight loss plateau or intolerance. Upward volume adjustment facilitated an additional mean 5·2% (4·5-5·8) total bodyweight loss. Downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy. Intolerance caused early removal of the device in 31 (17%) patients. No micronutrient deficiencies were observed in the aIGB cohort. Device-related serious adverse events were observed in seven (4%) patients, without any deaths. INTERPRETATION: When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualised therapy, maximising weight loss and tolerance. FUNDING: Spatz Medical.

Effects of endoscopic gastric plication on portal pressure gradient in a patient with nonalcoholic steatohepatitis cirrhosis.

Video 1Endoscopic gastric plication (EGP) to treat obesity and nonalcoholic steatohepatitis (NASH) in a patient with compensated cirrhosis, as well as the application of EUS-guided portal pressure gradient (EUS-PPG) measurement to monitor changes in PPG after EGP.

Lower EUS-guided ganglion impar blockade.

Video 1.

Endoscopic simulators: training the next generation.

PURPOSE OF REVIEW: To provide a review of current evidence evaluating endoscopic simulators as teaching platforms in gastroenterology training, with emphasis on upper gastrointestinal anatomy. RECENT FINDINGS: Endoscopic simulators have leveraged mechanical, virtual reality and ex-vivo or live animal platforms to deliver training in both general and therapeutic endoscopy. Simulators have demonstrated their greatest utility in training novice endoscopists. Intermediate and expert endoscopists may additionally benefit from simulator exposure when learning advanced therapeutic techniques including large tissue resection or natural orifice transluminal endoscopic surgery. SUMMARY: Simulator-based learning offers promise to complement conventional endoscopic training modalities for novice trainees. Nevertheless, additional evidence demonstrating a clear benefit is required for simulators to become an integral part of gastroenterology training. As novel advanced endoscopic therapies are developed, endoscopic simulators may assume a larger role in training prior to clinical practice.