Per-oral cholangioscopy in patients with primary sclerosing cholangitis: a 12-month follow-up study.

Background and study aims Patients with primary sclerosing cholangitis (PSC) have a 9% to 20% lifetime incidence of cholangiocarcinoma (CCA). Per-oral cholangioscopy (POCS) added to endoscopic retrograde cholangiography (ERC) could potentially improve detection of CCA occurrence. We prospectively assessed POCS identification of 12-month CCA incidence in PSC patients undergoing ERC. Patients and methods Consecutive patients with PSC, an indication for ERC, and no prior liver transplantation were enrolled. During the index procedure, POCS preceded planned therapeutic maneuvers. The primary endpoint was ability for POCS visualization with POCS-guided biopsy to identify CCA during 12-month follow-up. Secondary endpoints included ability of ERC/cytology to identify CCA, repeat ERC, liver transplantation, and serious adverse events (SAEs). Results Of 42 patients enrolled, 36 with successful cholangioscope advancement were analyzed. Patients had a mean age 43.5±15.6 years and 61% were male. Three patients diagnosed with CCA had POCS visualization impressions of benign/suspicious/suspicious, and respective POCS-guided biopsy findings of suspicious/positive/suspicious for malignancy at the index procedure. The three CCA cases had ERC visualization impressions of benign/benign/suspicious, and respective cytology findings of atypical/atypical/suspicious for malignancy. No additional patients were diagnosed with CCA during median 11.5-month follow-up. Twenty-three repeat ERCs (5 including POCS) were performed in 14 patients. Five patients had liver transplantation, one after CCA diagnosis and four after benign cytology at the index procedure. Three patients (7.1%) had post-ERC pancreatitis. No SAEs were POCS-related. Conclusions In PSC patients, POCS visualization/biopsy and ERC/cytology each identified three cases of CCA. Some patients had a repeat procedure and none experienced POCS-related SAEs.

Post-ERCP cholecystitis: Incidence, characteristics, and outcomes from a prospective multicenter biliary endoscopy registry.

BACKGROUND AND AIMS: The incidence, risk factors, and outcomes of post-ERCP cholecystitis are poorly described. We aimed to describe cases of post-ERCP cholecystitis from a prospective multicenter registry with protocolized 30-day follow-up. METHODS: Patient- and procedure-related data from 7 centers were obtained. The primary outcome was post-ERCP cholecystitis, defined according to a Delphi-based criteria and causal attribution system. Risk factors and outcomes were described for all cases. RESULTS: Seventeen cases of post-ERCP cholecystitis were identified among 4428 patients with gallbladders undergoing ERCP between 2018 and 2023 (incidence, 0.38%; 95% confidence interval, 0.20-0.57). In ERCPs with covered metal stenting, 7 of 467 resulted in cholecystitis (incidence, 1.50%; 95% confidence interval, 0.40-2.60). Patients had symptoms at a median of 5 days (interquartile range, 5) after ERCP. Management strategies included cholecystectomy, percutaneous cholecystostomy, and endoscopic stent removal/exchange. CONCLUSIONS: Estimates of post-ERCP cholecystitis incidence can inform discussions around procedural risk.

Impact of splenectomy on circulating microparticles in patients with sickle cell anemia.

INTRODUCTION: Circulating microparticles (MP) are being described as potential biomarkers for disease activity in a variety of conditions including sickle cell anemia (SCA). However, relatively little is known about the influence of spleen status on MP levels in patients with SCA. METHODS: Using a prospective study design we characterize circulating MP in 144 patients with SCA in steady state by assessing their cellular origin and their relationships to spleen status defined by clinical and imaging findings. In addition, MP levels were studied according to demographic characteristics, clinical status, treatment modalities, and other hematological and biochemical parameters. Absolute plasma concentrations of MP were determined by flow cytometry. RESULTS: Patients with SCA displayed a 10-fold increase in levels of MP derived from red blood cell (RBC) and platelets (PLT) when compared to their healthy counterparts (p < 0.0001). Splenectomized patients with SCA have more pronounced levels of MPRBC and MPPLT, and remained elevated after several weeks of follow-up. Levels of MP were not significantly associated with spleen removal procedures, age, gender, clinical severity score, hydroxyurea therapy, hemoglobin F, and co-existence of glucose-6-phosphate dehydrogenase deficiency. CONCLUSION: Collectively, these results suggest that splenectomy affects circulating levels of MP regardless of the known SCA modifiers and correlates.

ERCP-related adverse events: incidence, mechanisms, risk factors, prevention, and management.

INTRODUCTION: Endoscopic retrograde cholangiopancreatography (ERCP) is a commonly performed procedure for pancreaticobiliary disease. While ERCP is highly effective, it is also associated with the highest adverse event (AE) rates of all commonly performed endoscopic procedures. Thus, it is critical that endoscopists and caregivers of patients undergoing ERCP have clear understandings of ERCP-related AEs. AREAS COVERED: This narrative review provides a comprehensive overview of the available evidence on ERCP-related AEs. For the purposes of this review, we subdivide the presentation of each ERCP-related AE according to the following clinically relevant domains: definitions and incidence, proposed mechanisms, risk factors, prevention, and recognition and management. The evidence informing this review was derived in part from a search of the electronic databases PubMed, Embase, and Cochrane, performed on 1 May 20231 May 2023. EXPERT OPINION: Knowledge of ERCP-related AEs is critical not only given potential improvements in peri-procedural quality and related care that can ensue but also given the importance of reviewing these considerations with patients during informed consent. The ERCP community and researchers should aim to apply standardized definitions of AEs. Evidence-based knowledge of ERCP risk factors should inform patient care decisions during training and beyond.

Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial).

BACKGROUND & AIMS: Endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is a promising modality for management of malignant distal biliary obstruction (MDBO) with potential for better stent patency. We compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M). METHODS: In this multicenter randomized controlled trial, we recruited patients with MDBO secondary to borderline resectable, locally advanced, or unresectable peri-ampullary cancers across 10 Canadian institutions and 1 French institution. This was a superiority trial with a noninferiority assessment of technical success. Patients were randomized to EUS-CDS or ERCP-M. The primary end point was the rate of stent dysfunction at 1 year, considering competing risks of death, clinical failure, and surgical resection. Analyses were performed according to intention-to-treat principles. RESULTS: From February 2019 to February 2022, 144 patients were recruited; 73 were randomized to EUS-CDS and 71 were randomized to ERCP-M. The mean (SD) procedure time was 14.0 (11.4) minutes for EUS-CDS and 23.1 (15.6) minutes for ERCP-M (P < .01); 40% of the former was performed without fluoroscopy. Technical success was achieved in 90.4% (95% CI, 81.5% to 95.3%) of EUS-CDS and 83.1% (95% CI, 72.7% to 90.1%) of ERCP-M with a risk difference of 7.3% (95% CI, -4.0% to 18.8%) indicating noninferiority. Stent dysfunction occurred in 9.6% vs 9.9% of EUS-CDS and ERCP-M cases, respectively (P = .96). No differences in adverse events, pancreaticoduodenectomy and oncologic outcomes, or quality of life were noted. CONCLUSIONS: Although not superior in stent function, EUS-CDS is an efficient and safe alternative to ERCP-M in patients with MDBO. These findings provide evidence for greater adoption of EUS-CDS in clinical practice as a complementary and exchangeable first-line modality to ERCP in patients with MDBO. CLINICALTRIALS: gov, Number: NCT03870386.

Extracorporeal shock wave lithotripsy for pancreatic duct stones in patients with chronic pancreatitis: Are we underutilizing a new technology?

The progressive inflammatory nature of chronic pancreatitis and its sparse therapeutic toolbox remain obstacles in offering patients durable solutions for their symptoms. Obstruction of the main pancreatic duct by either strictures or stones represents a scenario worthy of therapeutic focus, as nearly all patients with pancreatitis eventually have intraductal stones. A more recent option for removal of main duct stones is extracorporeal shock wave lithotripsy (ESWL). In an effort to explore the role of ESWL in a Canadian setting, we evaluated our initial experience over an 8-year period (2011-2019).

Incidence and Predictors of Incidental Biochemical and Radiologic Pancreatic Alterations Following Uncomplicated ERCP.

BACKGROUND: Despite post-ERCP pancreatitis (PEP) being a major focus of outcomes research in endoscopic retrograde cholangiopancreatography (ERCP), little is known regarding the frequency with which asymptomatic biochemical and/or radiologic pancreatic alterations occur in patients following ERCP. METHODS: Adult inpatients undergoing ERCP were identified from a prospective ERCP registry. Patients with any abdominal pain, confirmed PEP, or pancreatitis or abnormal pancreatic enzymes preceding ERCP were excluded. Primary outcomes were asymptomatic lipase elevation on bloodwork within 24 h of ERCP or asymptomatic cross-sectional imaging findings consistent with acute pancreatitis in the absence of clinical PEP within 14 days. Multinomial logistic regression and multiple logistic regression were used to examine associations between exposures and lipase levels and between PEP or imaging findings, respectively. RESULTS: In total, 646 and 187 patients were analyzed as part of the biochemical and radiologic cohorts, respectively. A total of 26.0% of patients had asymptomatic elevations in lipase above the upper limit of normal (ULN) within 24 h, and 9.4% had elevations >3× ULN. A total of 20.9% of patients had incidental findings of enlargement, inflammation/edema/fat stranding, peri-pancreatic fluid collections, and/or necrosis on cross-sectional imaging within 14 days. Pancreatic contrast injection was associated with higher odds of asymptomatic lipasemia (adjusted odds ratio, AOR, 7.22; 95% confidence intervals, CI, 1.13 to 46.02), as was the use of the double-wire technique (AOR 15.74; 95% 1.15 to 214.74) and placement of a common bile duct stent (AOR 4.19; 95% CI 1.37 to 12.77). Over 10 cannulation attempts were associated with the presence of one or more radiologic finding(s) (AOR 33.95; 95% CI 1.64, to 704.13). CONCLUSIONS: Significant rates of incidental biochemical and/or radiologic pancreatic abnormalities are present following ERCP. Clinicians should be aware of our findings to minimize misclassification and better direct healthcare utilization.

Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial.

Importance: Infection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level disinfection to completely eliminate microorganisms on the instrument. Objective: To determine (1) contamination rates after high-level disinfection and (2) technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs. Design, Setting, and Participants: In this parallel-arm multicenter randomized clinical trial at 2 tertiary ERCP centers in Canada, all patients 18 years and older and undergoing ERCP for any indication were eligible. Intervention: The intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design. Main Outcomes and Measures: Coprimary outcomes were persistent microbial contamination of the duodenoscope elevator or channel, defined as growth of at least 10 colony-forming units of any organism or any growth of gram-negative bacteria following high-level disinfection (superiority outcome), and technical success of ERCP according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers. Results: From December 2019 to February 2022, 518 patients were enrolled (259 disposable elevator cap duodenoscopes, 259 standard duodenoscopes). Patients had a mean (SD) age of 60.7 (17.0) years and 258 (49.8%) were female. No significant differences were observed between study groups, including in ERCP difficulty. Persistent microbial contamination was detected in 11.2% (24 of 214) of standard duodenoscopes and 3.8% (8 of 208) of disposable elevator cap duodenoscopes (P = .004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75) and number needed to treat of 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination. Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs 90.7%, P = .13). There were no differences between study groups in adverse events and other secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, disposable elevator cap duodenoscopes exhibited reduced contamination following high-level disinfection compared with standard scope designs, without affecting the technical performance and safety of ERCP. Trial Registration: ClinicalTrials.gov Identifier: NCT04040504.

Coexistence of sickle cell disease and systemic lupus erythematosus is associated with quantitative and qualitative impairments in circulating regulatory B cells.

The incidence of connective tissue diseases such as systemic lupus erythematous (SLE), in adult patients with sickle cell disease (SCD), appears to be increasing. The exact causes underlying this increased risk are still unknown, but a link with B regulatory (Breg) cells is possible as these cells suppress inflammatory responses, and maintain tolerance. Quantitative and qualitative analyses of circulating Breg cells were performed in a cohort of SCD patients with SLE, and their levels were correlated with key soluble mediators promoting autoreactive B cells. We demonstrated that levels of Breg cells were significantly decreased in SCD patients with SLE compared to patients with SCD only or healthy controls. Functional analysis of Breg cells from SCD patients with SLE revealed impairments in IL-10 production that correlated with lower levels of STAT3 phosphorylation, without abnormal expression of IL-10 receptor on Breg cells. On the other hand, BAFF levels were substantially elevated in SCD patients with SLE, but not significantly associated with Breg cell levels. Collectively, these results indicated numerical and functional deficits of Breg cells in SCD patients with SLE and their capacity to maintain tolerance and control inflammation is imbalanced, which leads to the development of autoimmune responses.

Learning curves in ERCP during advanced endoscopy training: a Canadian multicenter prospective study.

Background and study aims Growing emphasis on quality and patient safety has supported the shift toward competency-based medical education for advanced endoscopy trainees (AETs). In this study, we aimed to examine Canadian AETs learning curves and achievement of competence using an ERCP assessment tool with strong evidence of validity. Methods This prospective study was conducted at five institutions across Canada from 2017-2018. Data on every fifth procedure performed by trainees were collected using the United Kingdom Joint Advisory Joint Advisory Group of Gastrointestinal Endoscopy (JAG) ERCP Direct Observation of Procedural Skills (DOPS) tool, which includes a four-point rating scale for 27 items. Cumulative sum (CUSUM) analysis was used to create learning curves for overall supervision ratings and ERCP DOPS items by plotting scores for procedures performed during training. Results Eleven trainees who were evaluated for 261 procedures comprised our sample. The median number of evaluations by site was 49 (Interquartile range (IQR) 31-76) and by trainee was 15 (IQR 11-45). The overall cannulation rate by trainees was 82 % (241/261), and the native papilla cannulation rate was 78 % (149/191). All trainees achieved competence in the "overall supervision" domain of the ERCP DOPS by the end of their fellowship. Trainees achieved competency in all individual domains, except for tissue sampling and sphincteroplasty. Conclusions Canadian AETs are graduating from fellowship programs with acceptable levels of competence for overall ERCP performance and for the most specific tasks. Learning curves may help identify areas of deficiency that may require supplementary training, such as tissue sampling.

Test Performance Characteristics of Dynamic Liver Enzyme Trends in the Prediction of Choledocholithiasis.

(1) Background: Various methods to predict the presence or absence of choledocholithiasis (CDL) have been proposed. We aimed to assess the performance characteristics of dynamic liver enzyme trends in the prediction of CDL. (2) Methods: This was a single-center retrospective cohort study. All adult in-patients undergoing endoscopy for suspected CDL between 1 January 2012 and 7 October 2018 were identified, with patients with prior cholecystectomy, prior sphincterotomy, or indwelling biliary prostheses were excluded. Available laboratory parameters within 72 h preceding the procedure were recorded, allowing for the assessment of trends. Dynamic enzyme trends were defined as any increase or decrease by 30% and 50% within 72 h of the index procedure. (3) Results: A total of 878 patients were included. Mean age was 61.8 years, with 58.6% female. Increases in alkaline phosphatase (ALP) of at least 30% or 50% were both specific for the presence of CDL, with specificities of 82.7% (95% CI 69.7-91.8%) and 88.5% (95% CI 76.6-95.6%), respectively. Decreases in bilirubin or ALP of at least 50% were highly specific for the absence of CDL, with specificities of 91.7% (95% CI 85.7-95.8%) and 100.0% (97.2-100.0%), respectively. (4) Conclusions: Several liver enzyme trends appear to be specific for the absence or presence of stones; in particular, significant decreases in total bilirubin or ALP of at least 30-50% over the prior 72 h appear to be especially predictive of an absence of intraductal findings during endoscopy.

A Comparison of Two Scales to Determine Prevalence of Mood Disorders in Omani Patients Recently Diagnosed with Cancer.

OBJECTIVES: Studies on the prevalence rate of mood disorders in patients recently diagnosed with cancer from Middle East are scare in the literature. Therefore, this study assesses the prevalence rates of anxiety and depression, and their associations with socio-demographic factors, in recently diagnosed patients with cancer living in the Sultanate of Oman. METHODS: In this prospective study, adult patients were interviewed within the first three months of diagnosis of cancer using the Hospital Anxiety and Depression Scale (HADS), and the Centre for Epidemiological Studies Depression (CES-D) Scale. Associations were studied among symptoms of anxiety and depression, and the socio-demographic factors, along with levels of agreement between the two scales. RESULTS: Eighty-nine patients were interviewed, and 65% were females. Using the HADS tool, 41.6% of patients had anxiety, 28% had depression, whereas 5.6% displayed severe depression. Using the CES-D tool, 41.6% of patients had depression, and 11.2% had severe depression. A fair correlation between the CES-D and HADS tools was evidenced with a Cohen's Kappa coefficient value of 0.37 (P<0.001). The socio-demographic factors were not significantly associated with the presence of anxiety and depression (P >0.05). CONCLUSION: Collectively, these findings indicate high prevalence rates of anxiety and depression in Omani patients recently diagnosed with cancer along with a significant correlation between the two scales. These results support the implementation of screening tools early in the trajectory of cancer illness to improve the overall healthcare of these patients.

Particularities of urological complications in Crohn's disease: Report of two cases.

Urological complications of Crohn's disease are rare, often asymptomatic and present a diagnostic problem. These complications are dominated by fistulas. The renal prognosis may be involved. We report an observation of two clinical cases with urological complications of Crohn's disease. Case 1: Patient aged 26 years, followed for Crohn's disease. He presented with right iliac fossa pain related to a collection responsible for right uretero-hydronephrosis. Renal scintigraphy objectified that it was a dumb right kidney. Case 2: Patient was 37 years old, with no history; he consulted for pollakiuria and pneumaturia. Surgical exploration showed the presence of a vesico-colic fistula. Histological examination of the fistula path was related to Crohn's disease. Conclusion: Urological complications of Crohn's disease are rare but can become serious, their diagnosis is difficult, sometimes these complications can be inaugural.

Sleep pattern in the dromedary camel: a behavioral and polysomnography study.

STUDY OBJECTIVES: To investigate sleep patterns in the camel by combining behavioral and polysomnography (PSG) methods. METHODS: A noninvasive PSG study was conducted over four nights on four animals. Additionally, video recordings were used to monitor the sleep behaviors associated with different vigilance states. RESULTS: During the night, short periods of sporadic sleep-like behavior corresponding to a specific posture, sternal recumbency (SR) with the head lying down on the ground, were observed. The PSG results showed rapid shifts between five vigilance states, including wakefulness, drowsiness, rapid eye movement (REM) sleep, non-REM (NREM) sleep, and rumination. The camels typically slept only 1.7 hours per night, subdivided into 0.5 hours of REM sleep and 1.2 hours of NREM sleep. Camels spent most of the night being awake (2.3 hours), ruminating (2.4 hours), or drowsing (1.9 hours). Various combinations of transitions between the different vigilance states were observed, with a notable transition into REM sleep directly from drowsiness (9%) or wakefulness (4%). Behavioral postures were found to correlate with PSG vigilance states, thereby allowing a reliable prediction of the sleep stage based on SR and the head position (erected, motionless, or lying down on the ground). Notably, 100% of REM sleep occurred during the Head Lying Down-SR posture. CONCLUSIONS: The camel is a diurnal species with a polyphasic sleep pattern at night. The best correlation between PSG and ethogram data indicates that sleep duration can be predicted by the behavioral method, provided that drowsiness is considered a part of sleep.

A Surrogate Water Quality Index to assess groundwater using a unified DEA-OWA framework.

In this paper, we introduce a new approach, based on a unified framework incorporating Data Envelopment Analysis (DEA) and Ordered Weighted Averaging (OWA), for assessing water quality in contextual settings that involve a large number of hydrochemical parameters. In order to enhance discrimination among water sources, the DEA model is adopted with data-driven input variables, called "surrogate optimistic closeness values," computed through an aggregation procedure that includes the observed values of the hydrochemical parameters with OWA weights. The proposed DEA-OWA methodology has been employed to assess the quality of 51 water samples, collected from irrigation wells in Sereflikochisar Basin, Turkey, by means of 19 hydrochemical parameters. Using different subjectivity levels, the Surrogate Water Quality Indices (SWQIs) that are produced are proven effective in enhancing discrimination among the water sources while enabling a more robust water quality-based ranking. The k-means analysis has been used for clustering the water quality of the wells into Excellent, Good, Permissible, and Unsuitable rather than using pre-set boundaries. Only one water source has been identified as Excellent, whereas 17.65%, 45.10%, and 35.29% of the sampled wells, respectively, are categorized with Good, Permissible, and Unsuitable water quality. Inferred from wells' location, the results suggest that the groundwater might be drastically affected by saline water intrusion from Lake Tuz. The latter conclusion has been corroborated through a Tobit regression analysis.

Characteristics and Outcomes of ERCP at a Canadian Tertiary Centre: Initial Results from a Prospective High-Fidelity Biliary Endoscopy Registry.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure in the management of pancreatic and biliary disease. While its role is firmly established, further well-designed prospective ERCP research is required, as a large portion of previous work has employed retrospective or administrative methodologies, both prone to potential biases. The aim of the Calgary Registry for Advanced and Therapeutic Endoscopy (CReATE) is to be a high-fidelity prospective multicentre registry. METHODS: The study population consisted of consecutive adult ERCP patients from September 2018 to September 2019. Informed consent was acquired for each patient. All relevant preprocedural, procedural, peri-procedural and postprocedural data were captured in real time by a full-time third-party research assistant directly observing procedures. Outcomes were ascertained by comprehensive medical record review and patient phone interview 30 days after the index procedure. RESULTS: Five endoscopists performed 895 ERCP procedures, 90.1% of which were deemed successful. Suspected choledocholithiasis was the most common indication for ERCP, followed by suspected or confirmed stricture(s), at 61.0% and 29.5%, respectively. 61.0% of procedures were performed on ERCP-naive patients. Post-ERCP pancreatitis occurred following 4.9% of procedures, with clinically significant bleeding or perforation occurring following 1.8% and 0.1% of procedures, respectively. DISCUSSION: Through 12 months, CReATE captured 895 procedures prospectively, with each entry containing over 300 data fields. Active expansion to additional tertiary centres is underway, and this will enhance the existing data pool. CReATE has the potential to improve multiple facets of ERCP, including training, optimal procedural techniques, mitigation of adverse events and personalized patient care.

Endosonography-guided transmural drainage of pancreatic fluid collections: comparative outcomes by stent type.

BACKGROUND: Pancreatic fluid collections (PFCs), including walled-off necrosis (WON), are commonly described sequelae of pancreatitis. Endosonography-guided PFC drainage can be performed using plastic stents (PS), fully covered self-expanding metal stents (FCSEMS), or lumen-apposing metal stents (LAMS). We performed a retrospective study comparing clinical outcomes and adverse events by stent type. METHODS: In this historical cohort, patients undergoing endosonography-guided PFC drainage from 2010 to 2019 were divided into groups: those treated with (1) PS, (2) FCSEMS, and (3) LAMS. Clinical success, the primary outcome, was defined as complete resolution or size reduction of ≥ 50%, with resolution of symptoms and no reintervention required at 3 months following the index procedure. Adverse events (AEs) and procedure times were also evaluated. RESULTS: Fifty-eight patients were included. Procedure times were significantly shorter with LAMS (21.4 ± 10.8 min versus 53.0 ± 24.4 min for FCSEMS and 65.9 ± 23.4 min for PS, p < 0.001). Clinical success rates for WON were higher with LAMS compared with FCSEMS (95.7% vs 66.7%, respectively; p = 0.04). For all PFCs, treatment with LAMS trended towards higher clinical success rates compared with PS and FCSEMS (96.3% vs 81.8% vs 77.8%, respectively; p = 0.14). Early AEs (within 1 week) occurred at significantly lower rates in the LAMS group compared to PS and FCSEMS (0% vs 33.3% vs 10.6%, respectively; p = 0.006), as did late AEs (7.4% vs 44.5% vs 40%, respectively; p = 0.01). CONCLUSIONS: LAMS is superior in terms of WON clinical success, favorable in terms of lower adverse event profile, and shorter in terms of procedural time compared to FCSEMS and PS. LAMS can be considered as an initial approach for WON, given that clinical success in WON is lower when using PS or FCSEMS, though more high-quality data are needed.

Morphology of the major papilla predicts ERCP procedural outcomes and adverse events.

BACKGROUND: The morphology of the major papilla affects the difficulty of endoscopic retrograde cholangiopancreatography (ERCP), but no associations with adverse events have previously been established. We aimed to assess whether papillary morphology predicts ERCP adverse events. METHODS: A retrospective analysis was performed of a prospective registry of patients undergoing ERCP for biliary indications. The primary outcome was post-ERCP pancreatitis (PEP), with secondary outcomes including other adverse events and procedural outcomes such as inadvertent pancreatic duct cannulation, cannulation time, and attempts. Papillae were classified as normal (Type I), small or flat (Type II), bulging (Type IIIa), pendulous (Type IIIb), creased (Type IV), or peri-diverticular (Type D). Outcomes were ascertained prospectively at 30 days from index procedures. RESULTS: A total of 637 patients with native papillae were included. Compared to Type I papillae, Type II and Type IIIb papillae were associated with PEP, with adjusted odds ratios (AOR) of 7.28 (95% confidence intervals, CI, 1.84-28.74) and 4.25 (95% CI 1.26-14.32), respectively. Type II and IIIb papillae were associated with significantly longer cannulation times by 5.37 (95% CI 2.39-8.35) and 4.01 (95% CI 1.72-6.30) minutes, respectively. Type IIIb papillae were associated with lower deep cannulation success (AOR 0.17, 95% CI 0.06-0.48). CONCLUSION: Papillary morphology is an important factor influencing both ERCP success and outcomes. Understanding this is key for managing intraprocedural approaches and minimizing adverse events. PROSPECTIVE REGISTRY REGISTRATION: Clinicaltrials.gov identifier NCT04259580.