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. Conclusions 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.

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. Conclusions 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.

Treating gastrointestinal (GI) fistulas endoscopically is challenging owing to an established epithelial tract. The variety of endoscopic approaches is transforming endoscopy into a first-line therapy. However, many sessions are often required, with variable success rates. Owing to these limitations, the off-label use of cardiac septal occluders (CSOs) has been reported.
We searched for articles related to CSOs in the MEDLINE, EMBASE, Cochrane Library, and LILACS databases and gray literature. The primary outcomes included technical success, clinical success, and safety of CSOs in GI fistula management.
A total of 25,574 records were identified, and 19 studies ultimately satisfied the inclusion criteria. Technical success was achieved in all cases. Of the 22 fistulas, 77.27% had successful closure, with a mean follow-up period of 32.02 weeks. The adverse event rate was 22.72%, with no associated mortality. Univariable and multivariable regression analyses showed no significant difference in the success of closure and adverse events in relation to several variables among the subgroups.
The use of CSOs appeared to be technically feasible, effective, and safe in the treatment of GI fistulas. The satisfactory results derived from this sparse literature suggest that it can be an option in the management of GI fistulas.

Background/Aims: Peroral endoscopic myotomy (POEM) has recently come to the forefront in the management of achalasia. We aimed to analyze the efficacy and safety of the use of electrocautery enhanced scissors (EES) for POEM. Methods: This retrospective cohort study prospectively collected the data of all adult patients (aged ≥18 years) with normal foregut anatomy who underwent POEM using EES. The patients’ baseline characteristics and procedure details (time, tunnel length, myotomy length, depth, and location) were recorded. The primary outcome was clinical success (3-month post-procedure Eckardt score of ≤3). The secondary outcomes were technical success and adverse events. A paired Student’s t-test was performed. Results: Fifteen patients were included in this study. The technical success rate of myotomy using EES was 100%. Fellows participated in the myotomy in all cases. The clinical success rate was 93.3% (14/15). The mean pre-Eckardt score was 5.4±2.5, while the mean post-Eckardt score was 1.3±1.3, which indicated a significant improvement (p≤0.0001). The most common treatment-related adverse events were post-procedure pain (4, 26.7%) and symptomatic reflux disease (4, 26.7%). Conclusions In the largest series to date on the use of EES in POEM, we demonstrated that this technique has both technical and clinical efficacy as well as an excellent safety profile.

Background/Aims: The diagnosis of biliary strictures can be challenging. There are no systematic reviews studying same-session endoscopic retrograde cholangiopancreatography (ERCP)-based tissue sampling and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for the diagnosis of biliary strictures. Methods: A systematic review was conducted on studies analyzing same-session EUS and ERCP for tissue diagnosis of suspected malignant biliary strictures. The primary outcome was the accuracy of each method individually compared to the two methods combined. The secondary outcome was the accuracy of each method in pancreatic and biliary etiologies. In the meta-analysis, we used Forest plots, summary receiver operating characteristic curves, and estimates of the area under the curve for intention-to-treat analysis. Results: Of the 12,132 articles identified, six were included, resulting in a total of 497 patients analyzed. The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and accuracy of the association between the two methods were: 86%, 98%, 12.50, 0.17, and 96.5%, respectively. For the individual analysis, the sensitivity, specificity and accuracy of EUS-FNA were 76%, 100%, and 94.5%, respectively; for ERCP-based tissue sampling, the sensitivity, specificity, and accuracy were 58%, 98%, and 78.1%, respectively. For pancreatic lesions, EUS-FNA was superior to ERCP-based tissue sampling. However, for biliary lesions, both methods had similar sensitivities. Conclusions Same-session EUS-FNA and ERCP-based tissue sampling is superior to either method alone in the diagnosis of suspected malignant biliary strictures. Considering these results, combination sampling should be performed when possible.

Background/Aims: Endoscopic retrograde cholangiopancreatography (ERCP) requires a unique skill set. Currently, there is no objective methodology to assess and train a professional to perform ERCP. This study aimed to develop and validate a novel ERCP simulator. Methods: The simulator consists of papillae presenting different anatomy and positioned in varied locations. Deep cannulation of the pancreatic duct, followed by the bile duct, was performed. The time allotted was 5 minutes. The content validity indexes (CVIs) for realism, relevance, and representativeness were calculated. Correlation between ERCP experience and simulator score was determined. Results: Twenty-three participants completed the simulation. The CVIs for realism were orientation of duodenoscope to papilla (1.00), angulation of papillotome to achieve cannulation (0.71), and haptic feedback during cannulation (0.80). The CVIs for relevance were use of elevator (1.00), wheels to achieve en face orientation (1.00), and papillotome for selective cannulation (1.00). Regarding CVI for representativeness, the results were as follows: basic cannulation (0.83), papilla locations (0.83), and papilla anatomies (0.80). The novice, intermediate, and experienced groups scored 6.7±8.7, 30.0±16.3, and 74.4±43.9, respectively (p<0.0001). There was a strong correlation between the ERCP experience level and the individual’s simulator score (Pearson value of 0.77, R2 of 0.60). Conclusions This simulator appears to be realistic, relevant, and representative of ERCP cannulation techniques. Additionally, it is effective at objectively assessing basic ERCP skills by differentiating scores based on clinical experience.

Background/Aims: Aspiration therapy (AT) involves endoscopic placement of a gastrostomy tube with an external device that allows patients to drain 30% of ingested calories after meals. Its efficacy for inducing weight loss has been shown. This study aimed to assess the effect of AT on obesity-related comorbidities. Methods: A meta-analysis of studies that assessed AT outcomes was conducted through December 2018. Primary outcomes were changes in comorbidities at 1 year following AT. Secondary outcomes were the amount of weight loss at up to 4 years and pooled serious adverse events (SAEs). Results: Five studies with 590 patients were included. At 1 year, there were improvements in metabolic conditions: mean difference (MD) in systolic blood pressure: -7.8 (-10.7 – -4.9) mm Hg; MD in diastolic blood pressure: -5.1 (-7.0 – 3.2) mm Hg; MD in triglycerides: -15.8 (-24.0 – -7.6) mg/dL; MD in high-density lipoprotein: 3.6 (0.7–6.6) mg/dL; MD in hemoglobin A1c (HbA1c): -1.3 (-1.8 – -0.8) %; MD in aspartate transaminase: -2.7 (-4.1 – -1.3) U/L; MD in alanine transaminase: -7.5 (-9.8 – -5.2) U/L. At 1 (n=218), 2 (n=125), 3 (n=46), and 4 (n=27) years, the patients experienced 17.8%, 18.3%, 19.1%, and 18.6% total weight loss (TWL), corresponding to 46.3%, 46.2%, 48.0%, and 48.7% excess weight loss (EWL) (p<0.0001 for all). Subgroup analysis of 2 randomized controlled trials (n=225) showed that AT patients lost more weight than did controls by 11.6 (6.5–16.7) %TWL and 25.6 (16.0–35.3) %EWL and experienced greater improvement in HbA1c and alanine transaminase by 1.3 (0.8–1.8) % and 9.0 (3.9–14.0) U/L. The pooled SAE rate was 4.1%. Conclusions Obesity-related comorbidities significantly improved at 1 year following AT. Additionally, a subgroup of patients who continued to use AT appeared to experience significant weight loss that persisted up to at least 4 years.

Background/Aims: Endoscopic ultrasound fine-needle aspiration (EUS-FNA) is preferred for sampling of lymph nodes (LNs) adjacent to the gastrointestinal wall; however, fine-needle biopsy (FNB) may provide improved diagnostic outcomes. This study aimed to evaluate the comparative efficacy and safety of FNA versus FNB for LN sampling. Methods: This was a multicenter retrospective study of prospectively collected data to evaluate outcomes of EUS-FNA and EUS-FNB for LN sampling. Characteristics analyzed included sensitivity, specificity, accuracy, the number of needle passes, diagnostic adequacy of rapid on-site evaluation (ROSE), cell-block analysis, and adverse events. Results: A total of 209 patients underwent EUS-guided LN sampling. The mean lesion size was 16.22±8.03 mm, with similar sensitivity and accuracy between FNA and FNB ([67.21% vs. 75.00%, respectively, p=0.216] and [78.80% vs. 83.17%, respectively, p=0.423]). The specificity of FNB was better than that of FNA (100.00% vs. 93.62%, p=0.01). The number of passes required for diagnosis was not different. Abdominal and peri-hepatic LN location demonstrated FNB to have a higher sensitivity (81.08% vs. 64.71%, p=0.031 and 80.95% vs. 58.33%, p=0.023) and accuracy (88.14% vs. 75.29%, p=0.053 and 88.89% vs. 70.49%, p=0.038), respectively. ROSE was a significant predictor for accuracy (odds ratio, 5.16; 95% confidence interval, 1.15–23.08; p=0.032). No adverse events were reported in either cohort. Conclusions Both EUS-FNA and EUS-FNB are safe for the diagnosis of LNs. EUS-FNB is preferred for abdominal LN sampling. EUSFNA+ ROSE was similar to EUS-FNB alone, showing better diagnosis for EUS-FNB than traditional FNA. While ROSE remained a significant predictor for accuracy, due to its poor availability in most centers, its use may be limited to cases with previous inconclusive diagnoses.

No abstract available.
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