Semaglutide vs Endoscopic Sleeve Gastroplasty for Weight Loss.

Importance: Obesity is a disease with a large socioeconomic burden. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric procedure with wide global adoption. More recently, new weight-loss medications, such as glucagon-like peptide-1 receptor agonists (eg, semaglutide), have attracted increased attention due to their efficacy. However, their cost-effectiveness over an extended period compared with ESG is a critical gap that needs to be better explored for informed health care decision-making. Objective: To assess the cost-effectiveness of semaglutide compared with ESG over 5 years for individuals with class II obesity. Design, Setting, and Participants: This economic evaluation study, conducted from September 1, 2022, to May 31, 2023, used a Markov cohort model to compare ESG and semaglutide, with a no-treatment baseline strategy. The study comprised adult patients in the US health care system with class II obesity (body mass index [BMI] of 35-39.9). The base case was a 45-year-old patient with class II obesity (BMI of 37). Patients undergoing ESG were subjected to risks of perioperative mortality and adverse events with resultant costs and decrement in quality of life. Interventions: Strategies included treatment with semaglutide and ESG. Main Outcomes and Measures: Costs (2022 US dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $100 000/QALY. A 5-year time horizon with a cycle length of 1 month with a 3% discount rate was used. Probabilities, costs, and quality-of-life estimates of the model were derived from published literature. One-way, 2-way, and probabilistic sensitivity analyses were also performed. Results: The model found that ESG was more cost-effective than semaglutide over a 5-year time horizon, with an ICER of -$595 532/QALY. Endoscopic sleeve gastroplasty added 0.06 QALYs and reduced total cost by $33 583 relative to semaglutide. The results remained robust on 1-way and probabilistic sensitivity analyses. Endoscopic sleeve gastroplasty sustained greater weight loss over 5 years vs semaglutide (BMI of 31.7 vs 33.0). To achieve nondominance, the annual price of semaglutide, currently $13 618, would need to be $3591. Conclusions and Relevance: This study suggests that ESG is cost saving compared with semaglutide in the treatment of class II obesity. On price threshold analyses, a 3-fold decrease in the price of semaglutide is needed to achieve nondominance.

Multi-centre evaluation of variation in cumulative dose assessment in reirradiation scenarios.

BACKGROUND AND PURPOSE: Safe reirradiation relies on assessment of cumulative doses to organs at risk (OARs) across multiple treatments. Different clinical pathways can result in inconsistent estimates. Here, we quantified the consistency of cumulative dose to OARs across multi-centre clinical pathways. MATERIAL AND METHODS: We provided DICOM planning CT, structures and doses for two reirradiation cases: head & neck (HN) and lung. Participants followed their standard pathway to assess the cumulative physical and EQD2 doses (with provided α/ß values), and submitted DVH metrics and a description of their pathways. Participants could also submit physical dose distributions from Course 1 mapped onto the CT of Course 2 using their best available tools. To assess isolated impact of image registrations, a single observer accumulated each submitted spatially mapped physical dose for every participating centre. RESULTS: Cumulative dose assessment was performed by 24 participants. Pathways included rigid (n = 15), or deformable (n = 5) image registration-based 3D dose summation, visual inspection of isodose line contours (n = 1), or summation of dose metrics extracted from each course (n = 3). Largest variations were observed in near-maximum cumulative doses (25.4 - 41.8 Gy for HN, 2.4 - 33.8 Gy for lung OARs), with lower variations in volume/dose metrics to large organs. A standardised process involving spatial mapping of the first course dose to the second course CT followed by summation improved consistency for most near-maximum dose metrics in both cases. CONCLUSION: Large variations highlight the uncertainty in reporting cumulative doses in reirradiation scenarios, with implications for outcome analysis and understanding of published doses. Using a standardised workflow potentially including spatially mapped doses improves consistency in determination of accumulated dose in reirradiation scenarios.

Transoral incisionless fundoplication is cost-effective for treatment of gastroesophageal reflux disease.

Background and study aims Given the sizable number of patients with symptomatic gastroesophageal reflux disease (GERD) despite proton pump inhibitor (PPI) therapy, non-pharmacologic treatment has become increasingly utilized. The aim of this study was to analyze the cost-effectiveness of medical, endoscopic, and surgical treatment of GERD. Patients and methods A deterministic Markov cohort model was constructed from the US healthcare payer's perspective to evaluate the cost-effectiveness of three competing strategies: 1) omeprazole 20 mg twice daily; 2) transoral incisionless fundoplication (TIF 2.0); and 3) laparoscopic Nissen fundoplication [LNF]. Cost was reported in US dollars with health outcomes recorded in quality-adjusted life years (QALYs). Ten-year and lifetime time horizons were utilized with 3 % discount rate and half-cycle corrections applied. The main outcome was incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $ 100,000 per QALY. Probabilistic sensitivity analyses were also performed. Results In our base-case analysis, the average cost of TIF 2.0 was $ 13,978.63 versus $ 17,658.47 for LNF and $ 10,931.49 for PPI. Compared to the PPI strategy, TIF 2.0 was cost-effective with an incremental cost of $ 3,047 and incremental effectiveness of 0.29 QALYs, resulting in an ICER of $ 10,423.17 /QALY gained. LNF was strongly dominated by TIF 2.0. Over a lifetime horizon, TIF 2.0 remained the cost-effective strategy for patients with symptoms despite twice-daily 20-mg omeprazole. TIF 2.0 remained cost-effective after varying parameter inputs in deterministic and probabilistic sensitivity analyses and for scenario analyses in multiple age groups. Conclusions Based upon this study, TIF 2.0 was cost-effective for patients with symptomatic GERD despite low-dose, twice-daily PPI.

Optimizing outcomes for EUS-guided gastroenterostomy: results of a Standardized Clinical Assessment and Management Plan (with video).

BACKGROUND AND AIMS: EUS-guided gastroenterostomy (EUS-GE) has emerged as an option for managing malignant gastric outlet obstruction (GOO). However, there is currently no standardized technique, and outcomes are variable with inconsistencies both within and across centers. The present study aims to develop and assess outcomes of a Standardized Clinical and Assessment Management Plan (SCAMP) for EUS-GE. METHODS: A SCAMP was created by a multidisciplinary team to develop and optimize a systematic approach for EUS-GE. This is a single-center, prospective cohort study on patients undergoing EUS-GE for GOO, using the developed SCAMP. Baseline demographics, cancer diagnosis and stage, Eastern Cooperative Oncology Group (ECOG) performance score, clinical and technical success, adverse events (AEs), and obstruction recurrence were collected. Primary outcomes included technical and clinical success. Obstruction-free and overall survival were calculated and compared with Kaplan-Meier analysis. RESULTS: Fifty patients underwent EUS-GE in accordance with the SCAMP. Mean age was 67 years, 54% were women, and pancreatic cancer represented the largest cancer type (51%). Technical success was 100% and clinical success 92%. AEs occurred in 2 patients (4%). Recurrent obstruction occurred in 16%, related to distal small-bowel obstruction from carcinomatosis. Estimated mean obstruction-free survival was 217 days. Median overall survival was 230 days among patients with ECOG scores 0 to 2 and 82 days for ECOG scores ≥3 (P = .008). CONCLUSIONS: The standardized technique used was associated with high technical and clinical success and low rates of AEs, morbidity and procedure-related mortality. Adopting a similar uniform systematic approach may improve procedural outcomes and dissemination.

Evaluation of socioeconomic and healthcare disparities on same admission cholecystectomy after endoscopic retrograde cholangiopancreatography among patients with acute gallstone pancreatitis.

BACKGROUND: Despite literature and guidelines recommending same admission cholecystectomy (CCY) after endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute gallstone pancreatitis, clinical practice remains variable. The aim of this study was to investigate the role of clinical and socio-demographic factors in the management of acute gallstone pancreatitis. METHODS: Patients with acute gallstone pancreatitis who underwent ERCP during hospitalization were reviewed from the U.S. Nationwide Inpatient Sample database between 2008 and 2014. Patients were classified by treatment strategy: ERCP + same admission CCY (ERCP + CCY) versus ERCP alone. Measured variables including age, race/ethnicity, Charlson Comorbidity Index (CCI), hospital type/region, insurance payer, household income, length of hospital stay (LOS), hospitalization cost, and in-hospital mortality were compared between cohorts using χ2 and ANOVA. Multivariable logistic regression was performed to identify specific predictors of same admission CCY. RESULTS: A total of 205,012 patients (ERCP + CCY: n = 118,318 versus ERCP alone: n = 86,694) were analyzed. A majority (53.4%) of patients that did not receive same admission CCY were at urban-teaching hospitals. LOS was longer with higher associated costs for patients with same admission CCY [(6.8 ± 5.6 versus 6.4 ± 6.5 days; P < 0.001) and ($69,135 ± 65,913 versus $52,739 ± 66,681; P < 0.001)]. Mortality was decreased significantly for patients who underwent ERCP + CCY versus ERCP alone (0.4% vs 1.1%; P < 0.001). Multivariable regression demonstrated female gender, Black race, higher CCI, Medicare payer status, urban-teaching hospital location, and household income decreased the odds of undergoing same admission CCY + ERCP (all P < 0.001). CONCLUSION: Based upon this analysis, multiple socioeconomic and healthcare-related disparities influenced the surgical management of acute gallstone pancreatitis. Further studies to investigate these disparities are indicated.

Cost-effective modified endoscopic vacuum therapy for the treatment of gastrointestinal transmural defects: step-by-step process of manufacturing and its advantages.

Video 1Cost-effective modified endoscopic vacuum therapy for GI transmural defects. Step-by-step process of manufacturing and potential advantages.1.Cut half gauze to the ideal size to cover only the fenestrated portion of the nasogastric tube (NGT).2.Wrap the gauze around the fenestrated portion of the NGT. The assistance of another person is important in this process.3.Cut the antimicrobial incise drape to match the size of the fenestrated portion of the NGT. Note that the incise drape is a very strong adhesive; therefore, 3 people are usually required to assemble it properly.4.Next, the suture is used to fix the gauze and drape to the NGT. Perform fixation of the modified sponge in 3 places. The first knot is in the proximal portion, just below the last fenestra of the NGT, as a marker of where the vacuum system starts. The second knot is at the distal end, to avoid migration of the modified sponge. The third knot is in the middle of the modified sponge, which is essential to serve as a guide during endoscopic placement. For example, in cases of defects without collection in which the sponge will be placed in an intraluminal position, it is ideal to place the vacuum system in the middle of the defect; in cases of intracavitary placement, it will work as a guide to how much of the modified sponge will be inside the collection.5.Finally, use a needle to make innumerable punctures in the modified sponge system to obtain adequate aspiration. An 18G needle is recommended because, in addition to having an adequate diameter, it is very sharp, which facilitates perforation of the modified sponge system.6.After creation of the modified endoscopic vacuum therapy, the functionality test is performed. Turn on the wall suction system, connect the distal end of the NGT to the tube of the canister connected on the wall, and place the NGT inside a bowl with a liquid solution. The aspiration of a large amount of liquid indicates proper functioning of the modified endoscopic vacuum therapy system.7.The device is then ready to be positioned endoscopically in the patient. After proper positioning, connect the NGT to the suction tube to avoid migration of the device upon removal of the scope.8.In addition to the cost-effective device as described, in our practice we also use wall suction to reduce costs associated with the use of the vacuum machine.9.Use the antimicrobial incise drape to seal the connection between the NGT and the suction tube to avoid leakage within the connection.10.Last, owing to instability of the negative wall pressure, a 20F intravenous catheter is connected to the tube to maintain a negative pressure between -75 and -150 mmHg, as confirmed by laboratory studies performed by our group.

Estimates of persistent inward currents in tibialis anterior motor units during standing ramped contraction tasks in humans.

Persistent inward currents (PICs) play an essential role in setting motor neuron gain and shaping motor unit firing patterns. Estimates of PICs in humans can be made using the paired motor unit analysis technique, which quantifies the difference in discharge rate of a lower threshold motor unit at the recruitment onset and offset of a higher threshold motor unit (ΔF). Because PICs are highly dependent on the level of neuromodulatory drive, ΔF represents an estimate of level of neuromodulation at the level of the spinal cord. Most of the estimates of ΔF are performed under constrained, isometric, seated conditions. In the present study, we used high-density surface EMG arrays to discriminate motor unit firing patterns during isometric seated conditions with torque or EMG visual feedback and during unconstrained standing anterior-to-posterior movements with root mean square EMG visual feedback. We were able to apply the paired motor unit analysis technique to the decomposed motor units in each of the three conditions. We hypothesized that ΔF would be higher during unconstrained standing anterior-to-posterior movements compared with the seated conditions, reflecting an increase in the synaptic input to motoneurons drive while standing. In agreement with previous work, we found that there was no evidence of a difference in ΔF between the seated and standing postures, although slight differences in the initial and peak discharge rates were observed. Taken together, our results suggest that both the standing and seated postures are likely not sufficiently different, both being "upright" postures, to result in large changes in neuromodulatory drive.NEW & NOTEWORTHY In the present study, we show that the discharge rate of a lower threshold motor unit at the recruitment onset and offset of a higher threshold motor unit (ΔF) is similar between standing and seated conditions in human tibialis anterior motor units, suggesting that at least for these two upright postures neuromodulatory drive is similar. We also highlight a proposed technological development in using high-density EMG arrays for real-time muscle activity feedback to accomplish standing ramped contraction tasks and demonstrate the validity of the paired motor unit analysis technique during these conditions.

Gender disparities in advanced endoscopy fellowship.

Background and study aims Women remain underrepresented in gastroenterology, especially advanced endoscopy. Women represent 30 % of general gastroenterology fellows; yet in 2019, only 12.8 % of fellows who matched into advanced endoscopy fellowship (AEF) programs were women. Methods We administered a web-based survey to the program directors (PDs) of AEF programs that participated in the 2018-2019 American Society for Gastroenterology (ASGE) match. We assessed PD and program characteristics, in addition to perceived barriers and facilitators (scale 1-5, 5 = most important) influencing women pursuing AEF training. Results We received 38 (59.3 %) responses from 64 PDs. 15.8 % (6/38) of AEF PDs and 13.2 % (5/38) of endoscopy chiefs were women. By program, women represented 14.8 % (mean) ± 17.0 % (SD) of AEF faculty and 12.0 % (mean) ± 11.1 % (SD) of AEF trainees over the past 10 years. 47.4 % (18/38) programs reported no female advanced endoscopy faculty and 31.6 % (12/38) of programs have never had a female fellow. Percentage of female fellows was strongly associated with percentage of female AEF faculty (ß = 0.43, P  < 0.001). Inflexible hours and call (mean rank 3.3 ±â€Š1.1), exposure to fluoroscopy (2.9 ±â€Š1.1), lack of women endoscopists at national conferences/courses (2.9 ±â€Š1.1) and lack of female mentorship (2.9 ±â€Š1.0) were cited as the most important barriers to recruitment. Conclusion We utilized a survey of AEF PDs participating in the ASGE match to determine program characteristics and identify contributors to gender disparity. Women represent a minority of AEF PDs, endoscopy chiefs, advanced endoscopy faculty and AEF trainees. Our study highlights perceived barriers and facilitators to recruitment, and emphasizes the importance of having female representation in faculty, and leadership positions in endoscopy.

Healthcare Disparities in the Management of Acute Cholecystitis: Impact of Race, Gender, and Socioeconomic Factors on Cholecystectomy vs Percutaneous Cholecystostomy.

BACKGROUND: While percutaneous cholecystostomy (PC) is a recommended treatment strategy in lieu of cholecystectomy (CCY) for acute cholecystitis among patients who may not be considered good surgical candidates, reports on disparities in treatment utilization remain limited. The aim of this study was to investigate the role of demographic, clinical, and socioeconomic factors in treatment of acute cholecystitis. METHODS: Patients with a diagnosis of acute cholecystitis who underwent CCY versus PC were reviewed from the U.S. Nationwide Inpatient Sample (NIS) database between 2008-2014. Measured variables including age, race/ethnicity, Charlson comorbidity index (CCI), hospital type/region, insurance payer, household income, length of stay (LOS), hospital cost, and mortality were compared using chi-square and ANOVA. Multivariable logistic regression was performed to identify specific predictors of cholecystitis treatment. RESULTS: A total of 1,492,877 patients (CCY:n=1,435,255 versus PC:n=57,622) were analyzed. The majority of patients that received PC were at urban teaching hospitals (65.2%). LOS was significantly longer with higher associated costs for PC [(11.1±11.0 versus 4.5±5.3 days; P<0.001) and ($99577±138850 versus $48399±58330; P<0.001)]. Mortality was also increased for patients that received PC compared to CCY (8.8% versus 0.6%; P<0.001). Multivariable regression demonstrated multiple socioeconomic and healthcare-related factors influencing the utilization of PC including male gender, Black or Asian race/ethnicity, Medicare payer status, urban hospital location, and household income (all P<0.001). CONCLUSION: Although patients receiving PC had higher CCI scores, multiple socioeconomic and healthcare related factors appeared to also influence this treatment decision. Additional studies to investigate these disparities are indicated to improve outcomes for all individuals with this condition.

A comparison of clinical outcomes and cost utility among laparoscopy, enteroscopy, and temporary gastric access-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy.

BACKGROUND AND AIMS: Gastric Access Temporary for Endoscopy (GATE), also known as EUS-Directed Trangastric ERCP (EDGE), has demonstrated advantages over device-assisted enteroscopy (DAE) and laparoscopic-assisted ERCP (LA-ERCP) for patients with Roux-en-Y gastric bypass (RYGB) anatomy. We aimed to directly compare clinical outcomes and cost utility among the three ERCP modalities. METHODS: Patients with RYGB anatomy who had DAE, LA-ERCP, or GATE from 2009 to 2019 at 2 tertiary centers were included in our review. We measured outcomes in three areas: success rate, post-procedural adverse events (AEs) and hospitalization, and cost utility per Medicare/Medicaid insurance payments. RESULTS: Cohort Total 130 patients (70 underwent DAE, 42 LA-ERCP, and 18 GATE). Success rate DAE was successful in 59% of patients, compared to success rates of 98 and 100% for LA-ERCP and GATE, respectively (p < 0.001). For DAE, 62% of unsuccessful cases required rescue therapy. Adverse events and hospitalization Patients who underwent GATE had the lowest rate of hospitalization post procedure (44% vs. 77% and 100% for DAE and LA-ERCP, respectively, p < 0.01) and spent the least amount of time hospitalized (median time 0 days vs 2 and 3 days for DAE and LA-ERCP, respectively, p < 0.0001). GATE had lower AE rates than LA-ERCP (6 vs 31%, p = 0.046), and both had similar rates to DAE. Cost utility LA-ERCP carried the highest total procedural and hospitalization cost per Medicare/ Medicaid insurance payments (median payment difference of $9.7 K vs GATE and $7.9 K vs DAE, p < 0.01 for both). Procedural and hospitalization costs were similar between GATE and DAE (p = 0.76). CONCLUSIONS: GATE is a safe modality for ERCP with high success rates in RYGB patients and exhibits the lowest hospitalization time and rate of adverse events when compared to DAE and LA-ERCP. GATE is similar to DAE from a cost utility approach, and both are less costly than LA-ERCP.

Development and clinical outcomes of an endoscopic submucosal dissection fellowship program: early united states experience.

BACKGROUND/AIMS: Adoption of endoscopic submucosal dissection (ESD) in the USA is challenging due to limited training opportunities. We describe the development of an ESD fellowship program in the USA and evaluate outcomes of ESD performed during this experience. METHODS: A 1-year ESD fellowship was implemented under close supervision from a recognized ESD expert. The curriculum was tailored to the trainee based on their background and prior endoscopic training. Under the expert's discretion, the trainee started by assisting cases and was gradually allowed to begin performing portions of ESD, with increasing difficulty as determined by technical progress, until complete procedures could be performed. Technical characteristics, outcomes, and adverse events were recorded. RESULTS: A total of 72 consecutive ESD cases were performed during the training period, in which the trainee assisted/observed 19 cases, partially performed 18 cases, and mainly performed 26 cases. Mean lesion diameter was 44.5 mm, with 79.2% colorectal cases. The trainee more frequently performed procedures with lower degree of fibrosis (p = 0.016). En bloc, complete, and curative resection was achieved in 84.7, 81.2, and 76.8% of cases, with no significant differences in resection outcomes or adverse events from trainee involvement. CONCLUSIONS: ESD can be safely and effectively taught within a 1-year advanced endoscopy fellowship. This was possible in the USA, even with limited gastric lesions, due to a progression focusing on easier portions of complex ESD procedures and advancing as technical progress allowed. Importantly, there was no increase in adverse event rate with trainee involvement in complex ESD cases.

A Seat at the Table.

Organized medicine and psychiatry have a long tradition of governmental advocacy and public engagement. The American Academy of Psychiatry and the Law (AAPL), since its founding 50 years ago, has made some forays into these fields. However, its involvement has been less substantial than other similarly situated professional organizations. With its increasing membership and expertise, AAPL now possesses the capacity to dedicate some of its organizational attention, energy, and resources to educating policymakers and the public on current and future topics related to forensic mental health. In addition, an increasing number and type of professional activities related to this discipline are affected by governmental regulation and public opinion. Therefore, the need to become involved in shaping policy is more urgent, particularly in light of the fact that other forensic mental health organizations have been actively involved in governmental advocacy for decades. Finally, as a field and in the near future, we likely will deal with life-changing technological innovations related to the practice of forensic psychiatry. AAPL and its members are perhaps uniquely qualified and have a responsibility to help ensure that these innovations are developed, implemented, and utilized appropriately. This can only be accomplished by having a proverbial seat at the table in the process.

Assessment of the July effect in post-endoscopic retrograde cholangiopancreatography pancreatitis: Nationwide Inpatient Sample.

AIM: To assess incidence of post-endoscopic retrograde cholangiopancreatography (post-ERCP) pancreatitis in the early (July/August/September) vs the late (April/May/June) academic year and evaluate in-hospital mortality, length of stay (LOS), and total hospitalization charge between these time periods. METHODS: This was a retrospective cohort study using the 2012 Nationwide Inpatient Sample (NIS). Patients with International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM) procedure codes for ERCP were included. Patients were excluded from the study if they had an ICD-9 CM code for a principal diagnosis of acute pancreatitis, if the ERCP was performed before or on the day of admission or if they were admitted to non-teaching hospitals. Post-ERCP pancreatitis was defined as an ICD-9 CM code for a secondary diagnosis of acute pancreatitis in patients who received an ERCP as delineated above. ERCPs performed during the months of July, August and September was compared to those performed in April, May and June in academic hospitals. ERCPs performed at academic hospitals during the early vs late year were compared. Primary outcome was incidence of post-ERCP pancreatitis. Secondary outcomes included in-hospital mortality, length of stay (LOS), and total hospitalization charge. Proportions were compared using fisher's exact test and continuous variables using student t-test. Multivariable regression was performed. RESULTS: From the 36480032 hospitalizations in 2012 in the United States, 6248 were included in the study (3065 in July/August/September and 3183 in April/May/June) in the 2012 academic year. Compared with patients admitted in July/August/September, patients admitted in April/May/June had no statistical difference in all variables including mean age, percent female, Charleston comorbidity index, race, median income, and hospital characteristics including region, bed size, and location. Incidence of post-ERCP pancreatitis in early vs late academic year were not statistically significant (OR = 1.03, 95%CI: 0.71-1.51, P = 0.415). Similarly, the adjusted odds ratio of mortality, LOS, and total hospitalization charge in early compared to late academic year were not statistically significant. CONCLUSION: Incidence of post-ERCP pancreatitis does not differ at academic institutions depending on the time of year. Similarly, mortality, LOS, and total hospital charge do not demonstrate the existence of a temporal effect, suggesting that trainee level of experience does not impact clinical outcomes in patients undergoing ERCP.

Preclinical endoscopic training using a part-task simulator: learning curve assessment and determination of threshold score for advancement to clinical endoscopy.

BACKGROUND: Preclinical simulator training has the potential to decrease endoscopic procedure time and patient discomfort. This study aims to characterize the learning curve of endoscopic novices in a part-task simulator and propose a threshold score for advancement to initial clinical cases. METHODS: Twenty novices with no prior endoscopic experience underwent repeated endoscopic simulator sessions using the part-task simulator. Simulator scores were collected; their inverse was averaged and fit to an exponential curve. The incremental improvement after each session was calculated. Plateau was defined as the session after which incremental improvement in simulator score model was less than 5%. Additionally, all participants filled out questionnaires regarding simulator experience after sessions 1, 5, 10, 15, and 20. A visual analog scale and NASA task load index were used to assess levels of comfort and demand. RESULTS: Twenty novices underwent 400 simulator sessions. Mean simulator scores at sessions 1, 5, 10, 15, and 20 were 78.5 ± 5.95, 176.5 ± 17.7, 275.55 ± 23.56, 347 ± 26.49, and 441.11 ± 38.14. The best fit exponential model was [time/score] = 26.1 × [session #]-0.615; r 2 = 0.99. This corresponded to an incremental improvement in score of 35% after the first session, 22% after the second, 16% after the third and so on. Incremental improvement dropped below 5% after the 12th session corresponding to the predicted score of 265. Simulator training was related to higher comfort maneuvering an endoscope and increased readiness for supervised clinical endoscopy, both plateauing between sessions 10 and 15. Mental demand, physical demand, and frustration levels decreased with increased simulator training. CONCLUSION: Preclinical training using an endoscopic part-task simulator appears to increase comfort level and decrease mental and physical demand associated with endoscopy. Based on a rigorous model, we recommend that novices complete a minimum of 12 training sessions and obtain a simulator score of at least 265 to be best prepared for clinical endoscopy.

Optimizing EUS-guided liver biopsy sampling: comprehensive assessment of needle types and tissue acquisition techniques.

BACKGROUND AND AIMS: EUS-guided liver biopsy sampling using FNA and, more recently, fine-needle biopsy (FNB) needles has been reported with discrepant diagnostic accuracy, in part due to differences in methodology. We aimed to compare liver histologic yields of 4 EUS-based needles and 2 percutaneous needles to identify optimal number of needle passes and suction. METHODS: Six needle types were tested on human cadaveric tissue: one 19G FNA needle, one existing 19G FNB needle, one novel 19G FNB needle, one 22G FNB needle, and two 18G percutaneous needles (18G1 and 18G2). Two needle excursion patterns (1 vs 3 fanning passes) were performed on all EUS needles. Primary outcome was number of portal tracts. Secondary outcomes were degree of fragmentation and specimen adequacy. Pairwise comparisons were performed using t tests, with a 2-sided P < .05 considered to be significant. Multivariable regression analysis was performed. RESULTS: In total, 288 liver biopsy samplings (48 per needle type) were performed. The novel 19G FNB needle had significantly increased mean portal tracts compared with all needle types. The 22G FNB needle had significantly increased portal tracts compared with the 18G1 needle (3.8 vs 2.5, P < .001) and was not statistically different from the 18G2 needle (3.8 vs 3.5, P = .68). FNB needles (P < .001) and 3 fanning passes (P ≤ .001) were independent predictors of the number of portal tracts. CONCLUSIONS: A novel 19G EUS-guided liver biopsy needle provides superior histologic yield compared with 18G percutaneous needles and existing 19G FNA and core needles. Moreover, the 22G FNB needle may be adequate for liver biopsy sampling. Investigations are underway to determine whether these results can be replicated in a clinical setting.