Global prospective case series of ERCPs using a single-use duodenoscope.

BACKGROUND: The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. METHODS: 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). RESULTS: Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis. CONCLUSIONS: In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.

Multicenter retrospective cohort of EUS-guided anterograde pancreatic duct access.

Background and study aims Pancreatic duct (PD) cannulation may be difficult during conventional endoscopic retrograde cholangiopancreatography (ERCP) due to underlying pathology, anatomical variants or surgically altered anatomy. Pancreatic access in these cases previously necessitated percutaneous or surgical approaches. Endoscopic ultrasound (EUS) allows for an alternative and can be combined with ERCP for rendezvous during the same procedure, or for other salvage options. Patients and methods Patients with attempted EUS access of the PD from tertiary referral centers between 2009 and 2022 were included in the cohort. Demographic data, technical data, procedural outcomes and adverse events were collected. The primary outcome was rendezvous success. Secondary outcomes included rates of successful PD decompression and change in procedural success over time. Results The PD was accessed in 105 of 111 procedures (95 %), with successful subsequent ERCP in 45 of 95 attempts (47 %). Salvage direct PD stenting was performed in 5 of 14 attempts (36 %). Sixteen patients were scheduled for direct PD stenting (without rendezvous) with 100 % success rate. Thus 66 patients (59 %) had successful decompression. Success rates improved from 41 % in the first third of cases to 76 % in the final third. There were 13 complications (12 %), including post-procedure pancreatitis in seven patients (6 %). Conclusions EUS-guided anterograde pancreas access is a feasible salvage method if retrograde access fails. The duct can be cannulated, and drainage can be achieved in the majority of cases. Success rates improve over time. Future research may involve investigation into technical, patient and procedural factors contributing to rendezvous success.

Effect of Genotype and Environment on Food-Related Traits of Organic Winter Naked Barleys.

This study aimed to understand how genetics and environment influence organic winter naked barley composition and functionality, and to identify traits that might effectively categorize basic physicochemical functionality of food barley. Across three years, two locations, and 15 genotypes, genotype significantly influenced all 10 food-related traits and was the dominant influence for three. Location significantly influenced eight traits and was dominant for three. Year significantly influenced all traits but was dominant only for one. Of the interactions location * year was the most influential and was the dominant effect for two traits. For all interaction terms where genotype was a component, the effect sizes were either small or non-significant suggesting that even with low leverage traits there is the potential for genetic gain by observing trait rankings across environments. Principal component analysis identified six traits that could serve to categorize basic physicochemical functionality of food barley. These were grain protein content, beta-glucan content, flour-water batter flow, water solvent retention capacity, time to peak viscosity of cooked flour, and hardness of cooked intact grains.

Endoscopic full-thickness resection of polyps involving the appendiceal orifice: a multicenter international experience.

BACKGROUND: Endoscopic resection of lesions involving the appendiceal orifice remains a challenge. We aimed to report outcomes with the full-thickness resection device (FTRD) for the resection of appendiceal lesions and identify factors associated with the occurrence of appendicitis. METHODS: This was a retrospective study at 18 tertiary-care centers (USA 12, Canada 1, Europe 5) between November 2016 and August 2020. Consecutive patients who underwent resection of an appendiceal orifice lesion using the FTRD were included. The primary outcome was the rate of R0 resection in neoplastic lesions, defined as negative lateral and deep margins on post-resection histologic evaluation. Secondary outcomes included the rates of: technical success (en bloc resection), clinical success (technical success without need for further surgical intervention), post-resection appendicitis, and polyp recurrence. RESULTS: 66 patients (32 women; mean age 64) underwent resection of colonic lesions involving the appendiceal orifice (mean [standard deviation] size, 14.5 (6.2) mm), with 40 (61 %) being deep, extending into the appendiceal lumen. Technical success was achieved in 59/66 patients (89 %), of which, 56 were found to be neoplastic lesions on post-resection pathology. Clinical success was achieved in 53/66 (80 %). R0 resection was achieved in 52/56 (93 %). Of the 58 patients in whom EFTR was completed who had no prior history of appendectomy, appendicitis was reported in 10 (17 %), with six (60 %) requiring surgical appendectomy. Follow-up colonoscopy was completed in 41 patients, with evidence of recurrence in five (12 %). CONCLUSIONS: The FTRD is a promising non-surgical alternative for resecting appendiceal lesions, but appendicitis occurs in 1/6 cases.

Effect of polyphenols on mixing properties and solvent retention of wheat flour doughs.

BACKGROUND: The effect of polyphenol addition on dough mixing properties and flour functionality was examined using flours from different wheat varieties. RESULTS: Both the mixograph and farinograph experiments showed that polyphenol addition affected dough stability and optimum mixing time. These effects were most apparent in hard wheat flour with the addition of catechin. Water absorption was dependent on wheat variety (P < 0.0001) but not on the addition of polyphenols (P = 0.54). Except for the 5 g kg-1 sodium carbonate solvent retention capacity (SRC), SRC values of the flours were dependent on wheat variety but not on polyphenol addition. However, 5 g kg-1 sodium carbonate SRC was significantly increased by the addition of caffeic acid and catechin. Since sodium carbonate SRC is associated with damaged starch levels, further investigations are needed to see how polyphenols influence either the absorption of a sodium carbonate solution or the starch itself. CONCLUSION: Polyphenol addition affected dough stability and optimum mixing time. Addition of catechin to hard wheat flour was most effective. Water absorption and SRC values except for 5 g kg-1 sodium carbonate solvent were affected by the wheat variety, but not by polyphenol addition. © 2021 Society of Chemical Industry.

Effectiveness and Safety of Lumen-Apposing Metal Stents in Endoscopic Interventions for Off-Label Indications.

BACKGROUND: Although released only for drainage of pseudocyst and walled-off necrosis (WON) with ≤ 30% solid debris, the utilization of lumen-apposing metal stent (LAMS) in "real-world" practice has deviated from approved indications. We evaluated the contemporary use of LAMS and associated clinical, procedural outcomes in the setting of a tertiary referral center in the USA. METHODS: Data from 303 consecutive patients who underwent LAMS placement were analyzed. Outcomes included technical and clinical success rates and adverse events. RESULTS: Of 303 patients, 190 (62.7%) received LAMS for off-label indications. The latter included gallbladder drainage (n = 56, 18.5%), gastroenterostomy (n = 52, 17.2%), treatment of gastrointestinal strictures (n = 37, 12.2%), biliary drainage (n = 20, 6.6%), temporary gastric access for endoscopy (n = 13, 4.3%), symptomatic WON with > 30% solid debris (n = 8, 2.6%), and miscellaneous (n = 4, 1.3%). Technical success rates in the on- and off-label arm were 98.2% and 95.8%, respectively (P = .331; 95% CI 0.08 to 1.96). Clinical success rates in the on- and off-label arm were 89.4% and 83.2%, respectively (P = .137; 95% CI 0.28 to 1.19). The rate of adverse events was 20.5% (n = 39) in the off-label arm and 16.8% (n = 19) in the on-label arm (P = .242; 95% CI 0.69 to 2.34). CONCLUSION: Off-label use of LAMS out-numbered on-label use in our practice. The safety profile between the groups was similar and with the exception of refractory stricture treatment, efficacy was comparable.

Economic burden of enhanced practices of duodenoscopes reprocessing and surveillance: balancing risk and cost containment.

Background and study aims Recent outbreaks attributed to contaminated duodenoscopes have led to the development of enhanced surveillance and reprocessing techniques (enhanced-SRT) aimed at minimizing cross-contamination. Common enhanced-SRT include double high-level disinfection (HLD), ethylene oxide (EtO) gas sterilization, and culture-based monitoring of reprocessed scopes. Adoption of these methods adds to the operational costs and we aimed to assess its economic impact to an institution. Methods We compared the estimated costs of three enhanced-SRT versus single-HLD using data from two institutions. We examined the cost of capital measured as scope inventory and frequency of scope use per unit time, the constituent reprocessing costs required on a per-cycle basis, and labor & staffing needs. The economic impact attributable to enhanced-SRT was defined as the difference between the total cost of enhanced-SRT and single HLD. Results Compared to single HLD, adoption of double HLD increased the costs approximately by 47 % ($80 vs $118). Similarly, culture and quarantine and EtO sterilization increased costs by 160 % and 270 %, respectively ($80 vs $208 and $296). Enhanced-SRT introduced significant scope downtime due to prolonged techniques, necessitating a 3.4-fold increase in the number of scopes needed to maintain procedural volume. The additional annual budget required to implement enhanced-SRT approached $406,000 per year in high-volume centers. Conclusions While enhanced-SRT may reduce patient risk of exposure to contaminated duodenoscopes, it significantly increases the cost of performing ERCP. Future innovation should focus on approaches that can ensure patient safety while maintaining the ability to perform ERCP in a cost-effective manner.

The characterisation and provenance of crude oils stranded on the South Australian coastline. Part II: Potential parent petroleum systems.

In 2014-2016 more than 600 specimens of semi-solid crude oil were recovered from 30 ocean beaches along the coastline of South Australia, as part of the recently completed Great Australian Bight Research Program. All are believed to be products of submarine oil seepage. Their source-specific biomarker signatures provide the basis for their assignment to sixteen oil families, some previously unrecognised. Two of these families (asphaltite and asphaltic tar) likely originated from Cretaceous marine source rocks in the offshore Bight Basin. The others comprise waxy oils of lacustrine, fluvio-deltaic and marine source affinity. Their biomarker characteristics do not match those of any Australian crude oil. However, they are strikingly similar to those of oils found in Cenozoic and Mesozoic basins throughout the Indonesian Archipelago and elsewhere in Southeast Asia.

Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity.

BACKGROUND AND AIMS: Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience. METHODS: Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events. RESULTS: Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P = .131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P = .999), median ERCP completion time (25.0 vs 28.5 minutes, P = .130), mean cannulation attempts (2.8 vs 2.8, P = .954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P = .840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P < .001). Serious adverse events were reported in 13 patients (6.5%). CONCLUSIONS: In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.).

The characterisation and provenance of crude oils stranded on the South Australian coastline. Part I: Oil types and their weathering.

Semi-solid crude oil has been known to wash ashore along the South Australian coastline for over 120 years. The early reports pre-date offshore petroleum exploration and tanker shipping activities in Australian waters, suggesting that this stranded oil originates from natural offshore seepage. Three physically distinct varieties are represented: waxy bitumen, asphaltite and tar. In order to distinguish this natural "background" contamination of the coastline from any potential anthropogenic sources of petroleum, such as oil spills, whole-oil GC-MS analysis was employed to identify at least seven geochemically different types of stranded oil, based on a suite of 633 specimens collected from the coastline during three annual surveys of 30 ocean beaches between 2014 and 2016. The waxy bitumens, which in terms of their biomarker alkanes display an atypical pattern of alteration due to weathering in the marine environment, are more severely altered than similar specimens collected 25 years ago.

The natural hydrocarbon loading of the South Australian coastline.

Crude oil released from natural offshore seeps may strand in coastal environments. Understanding the different types of oil which accumulate on a given coastline, in addition to their spatial distribution and abundance, may be used to establish an environmental baseline for natural "background" petroleum contamination. Here we summarise the hydrocarbon loading of thirty beaches on Australia's southern margin based on three annual surveys in 2014-2016. Comparison with the results of surveys conducted in 1990 and 1991 reveals a marked reduction in hydrocarbon loading. Furthermore, modern samples of the most commonly encountered oil, attributed to a lacustrine petroleum system in the Indonesian Archipelago, are significantly more degraded than those of prior studies. We attribute this reduction in hydrocarbon loading to prolonged oil production in Southeast Asia, which in turn results in reduced reservoir pressures and the eventual cessation of formerly active offshore seepage.

Incidence and Significance of Biliary Stricture in Chronic Pancreatitis Patients Undergoing Extracorporeal Shock Wave Lithotripsy for Obstructing Pancreatic Duct Stones.

Background/Aims: This study assessed the significance of biliary stricture in symptomatic chronic pancreatitis patients requiring extracorporeal shock wave lithotripsy (ESWL) and endoscopic retrograde cholangiopancreatography (ERCP) to remove obstructing pancreatic calculi. Methods: A total of 97 patients underwent ESWL followed by ERCP to remove pancreatic calculi between October 2014 and October 2017 at Virginia Mason Medical Center. Significant biliary stricture (SBS) was defined as a stricture with upstream dilation on computed tomography scan or magnetic resonance cholangiopancreatography scans accompanied by cholestasis and/or cholangitis. SBS was initially managed by either a plastic stent or fully covered self-expandable metallic stent (fcSEMS). If the stricture did not resolve, the stent was replaced with either multiple plastic stents or another fcSEMS. Data were collected by retrospectively reviewing the medical records. Results: Biliary strictures were noted in approximately one-third of patients (34/97, 35%) undergoing ESWL for pancreatic calculi. Approximately one-third of the biliary strictures (11/34, 32%) were SBS. Pseudocysts were more frequently found in those with SBS (36% vs 8%, p=0.02), and all pseudocysts in the SBS group were located in the pancreatic head. The initial stricture resolution rates with fcSEMSs and plastic prostheses were 75% and 29%, respectively. The overall success rate for stricture resolution was 73% (8/11), and the recurrence rate after initial stricture resolution was 25% (2/8). Conclusions: Although periductal fibrosis is the main mechanism underlying biliary stricture development in chronic pancreatitis, inflammation induced by obstructing pancreatic calculi, including pseudocysts, is an important contributing factor to SBS formation during the acute phase.

Learning Predictive and Interpretable Timeseries Summaries from ICU Data.

Machine learning models that utilize patient data across time (rather than just the most recent measurements) have increased performance for many risk stratification tasks in the intensive care unit. However, many of these models and their learned representations are complex and therefore difficult for clinicians to interpret, creating challenges for validation. Our work proposes a new procedure to learn summaries of clinical timeseries that are both predictive and easily understood by humans. Specifically, our summaries consist of simple and intuitive functions of clinical data (e.g. "falling mean arterial pressure"). Our learned summaries outperform traditional interpretable model classes and achieve performance comparable to state-of-the-art deep learning models on an in-hospital mortality classification task.

Duodenoscope as a Vector for Transmission.

Elevator-based endoscope-related infections from patient cross-contamination is a multifactorial problem related to device design, maintenance, and function, with additional risk incurred from a high-level disinfection process that lacks quality controls. This article reviews the historical context for these outbreaks, technical aspects of scope design contributing to this risk, and innovations in endoscope technology that have the potential to overcome these shortcomings. Also reviewed are interim solutions and the data that support use of some of these interventions. Still needed are a validated manufacturer-recommended schedule for routine duodenoscope and echoendoscope maintenance with reprocessing protocols that can be implemented in endoscopy units.

Rectus Sheath Hematoma Causing Bladder Outlet Obstruction.

A 93-year-old woman on Coumadin with history of atrial fibrillation and chronic obstructive pulmonary disease (COPD) presented with urinary retention for one day. Computed tomography (CT) of abdomen and pelvis demonstrated grade 3 rectus sheath hematoma (RSH), with the hematoma dissecting between the transversalis fascia and muscle into the prevesical space. The large-sized hematoma caused compression at the bladder outflow tract causing urinary retention. In view of age and the patient being a poor surgical candidate, the patient was managed by percutaneous drain of the hematoma to reduce size to relieve urinary symptoms. The hematoma shrunk in size over the period of next few weeks and thereby avoided surgical intervention.

Long-Term Outcomes of Endoscopic Papillectomy for Ampullary Adenomas.

BACKGROUND AND AIMS: Endoscopic papillectomy is a safe and effective treatment for ampullary adenomas and has mostly replaced surgical local resection. Recent data have discussed the role of endoscopic removal of laterally spreading adenomas associated with ampullary adenomas. We evaluated our long-term results of endoscopic papillectomy for ampullary adenomas. METHODS: We retrospectively analyzed patients who underwent endoscopic papillectomy of biopsy-proven adenomas at our tertiary center between 1994 and 2017. Clinical success was defined as complete excision of an adenoma with no evidence of recurrence during follow-up, no evidence of cancer, and without the need for surgery. RESULTS: A total of 161 patients (73M/88F) with a mean age of 61 (range 19-93) were included. Mean adenoma size was 20 mm (range 5-70). In total, 114/161 patients continued endoscopic surveillance for a minimum of 6 months with a median follow-up of 30 months (range 6-283). Recurrent adenomas were diagnosed in 8 patients (7%) after a median of 36 months (range 12-138). Clinical success was 83%; 35 laterally spreading adenomas were treated, which were larger than adenomas confined to the papilla (mean size 38 mm vs 15 mm, P < 0.05) and required more piecemeal resections (77% vs 15%, P < 0.05). However, no difference was found in recurrence rates between the two groups (8% vs 4%, P = 0.26); 24/161 (15%) of patients had adverse events including bleeding (6%) and pancreatitis (7%). CONCLUSIONS: Endoscopic papillectomy is a safe and effective treatment for ampullary adenomas, including laterally spreading ones. Long-term surveillance demonstrates low recurrence rates at expert centers.

Novel single-use duodenoscope compared with 3 models of reusable duodenoscopes for ERCP: a randomized bench-model comparison.

BACKGROUND AND AIMS: Multidrug-resistant infectious outbreaks associated with duodenoscope reuse have been documented internationally. A single-use endoscope could eliminate exogenous patient-to-patient infection associated with ERCP. METHODS: We conducted a comparative bench simulation study of a new single-use and 3 models of reusable duodenoscopes on a synthetic anatomic bench model. Four ERCP tasks were performed: guidewire locking (single-use and 1 reusable duodenoscope only), plastic stent placement and removal, metal stent placement and removal, and basket sweeping. The study schedule included block randomization by 4 duodenoscopes, 4 tasks, and 2 anatomic model ERCP stations. Ability to complete tasks, task completion times, and subjective ratings of overall performance, navigation/pushability, tip control, and image quality on a scale of 1 (worst) to 10 (best) were compared among duodenoscopes. RESULTS: All 4 ERCP tasks (total 14 subtasks) were completed by 6 expert endoscopists using all 4 duodenoscopes, with similar task completion times (median, 1.5-8.0 minutes per task) and overall performance ratings by task (median, 8.0-10.0). Navigation/pushability ratings were lower for the single-use duodenoscope than for the 3 reusable duodenoscopes (median, 8.0, 10.0, 9.0, and 9.0, respectively; P < .01). Tip control ratings were similar among all the duodenoscopes (median, 9.0-10.0; P = .77). Image quality ratings were lower for 1 reusable duodenoscope compared with the single-use and other 2 reusable duodenoscopes (median, 8.0, 9.0, 9.0, and 9.0, respectively; P < .01). CONCLUSIONS: A new single-use duodenoscope was used to simulate 4 ERCP tasks in an anatomic model, with performance ratings and completion times comparable with 3 models of reusable duodenoscopes.

Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography.

BACKGROUND & AIMS: Disposable, single-use duodenoscopes might reduce outbreaks of infections associated with endoscope reuse. We tested the feasibility, preliminary safety, and performance of a new single-use duodenoscope in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). METHODS: We conducted a case-series study of the outcomes of ERCP with a single-use duodenoscope from April through May 2019 at 6 academic medical centers. We screened consecutive patients (18 years and older) without alterations in pancreaticobiliary anatomy and enrolled 73 patients into the study. Seven expert endoscopists performed roll-in maneuvers (duodenoscope navigation and visualization of duodenal papilla only) in 13 patients and then ERCPs in the 60 other patients. Outcomes analyzed included completion of ERCP for the intended clinical indication, crossover from a single-use duodenoscope to a reusable duodenoscope, endoscopist performance ratings of the device, and serious adverse events (assessed at 72 hours and 7 days). RESULTS: Thirteen (100%) roll-in maneuver cases were completed using the single-use duodenoscope. ERCPs were of American Society for Gastrointestinal Endoscopy procedural complexity grade 1 (least complex; 7 patients [11.7%]), grade 2 (26 patients [43.3%]), grade 3 (26 patients [43.3%]), and grade 4 (most complex; 1 patient [1.7%]). Fifty-eight ERCPs (96.7%) were completed using the single-use duodenoscope only and 2 ERCPs (3.3%) were completed using the single-use duodenoscope followed by crossover to a reusable duodenoscope. Median overall satisfaction was 9 out of 10. Three patients developed post-ERCP pancreatitis, 1 patient had post-sphincterotomy bleeding, and 1 patient had worsening of a preexisting infection and required rehospitalization. CONCLUSIONS: In a case-series study, we found that expert endoscopists can complete ERCPs of a wide range of complexity using a single-use duodenoscope for nearly all cases. This alternative might decrease ERCP-related risk of infection. Clinicaltrials.gov no: NCT03701958.

Complicated postoperative course secondary to kratom withdrawal: a case report.

We herein report a case of a 55-year-old female with an unusual case of post-operative kratom withdrawal. The patient's withdrawal symptoms subsequently contributed to complications and admission to the intensive care unit. Features of this case are discussed, alongside the management of kratom withdrawal and the implications of supplementation with unregulated herbal medications.