Slivka, Adam

INTRODUCTION: Prophylactic pancreatic stent placement (PSP) is effective for preventing pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk cases, but the optimal technical approach to this intervention remains uncertain. METHODS: In this secondary analysis of 787 clinical trial patients who underwent successful stent placement, we studied the impact of (i) whether pancreatic wire access was achieved for the sole purpose of PSP or naturally during the conduct of the case, (ii) the amount of effort expended on PSP, (iii) stent length, (iv) stent diameter, and (v) guidewire caliber. We used logistic regression models to examine the adjusted association between each technical factor and post-ERCP pancreatitis (PEP). RESULTS: Ninety-one of the 787 patients experienced PEP. There was no clear association between PEP and whether pancreatic wire access was achieved for the sole purpose of PSP (vs occurring naturally; odds ratio [OR] 0.82, 95% confidence interval [CI] 0.37–1.84), whether substantial effort expended on stent placement (vs nonsubstantial effort; OR 1.58, 95% CI 0.73–3.45), stent length (>5 vs ≤5 cm; OR 1.01, 95% CI 0.63–1.61), stent diameter (≥5 vs <5 Fr; OR 1.13, 95% CI 0.65–1.96), or guidewire caliber (0.035 vs 0.025 in; 0.83, 95% CI 0.49–1.41). DISCUSSION: The 5 modifiable technical factors studied in this secondary analysis of large-scale randomized trial data did not appear to have a strong impact on the benefit of prophylactic PSP in preventing PEP after high-risk ERCP. Within the limitations of post hoc subgroup analysis, these findings may have important implications in procedural decision making and suggest that the benefit of PSP is robust to variations in technical approach.

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.

Objective: We report the development and validation of a combined DNA/RNA next-generation sequencing (NGS) platform to improve the evaluation of pancreatic cysts. Background and Aims: Despite a multidisciplinary approach, pancreatic cyst classification, such as a cystic precursor neoplasm, and the detection of high-grade dysplasia and early adenocarcinoma (advanced neoplasia) can be challenging. NGS of preoperative pancreatic cyst fluid improves the clinical evaluation of pancreatic cysts, but the recent identification of novel genomic alterations necessitates the creation of a comprehensive panel and the development of a genomic classifier to integrate the complex molecular results. Methods: An updated and unique 74-gene DNA/RNA-targeted NGS panel (PancreaSeq Genomic Classifier) was created to evaluate 5 classes of genomic alterations to include gene mutations (e.g., KRAS, GNAS, etc.), gene fusions and gene expression. Further, CEA mRNA (CEACAM5) was integrated into the assay using RT-qPCR. Separate multi-institutional cohorts for training (n=108) and validation (n=77) were tested, and diagnostic performance was compared to clinical, imaging, cytopathologic, and guideline data. Results: Upon creation of a genomic classifier system, PancreaSeq GC yielded a 95% sensitivity and 100% specificity for a cystic precursor neoplasm, and the sensitivity and specificity for advanced neoplasia were 82% and 100%, respectively. Associated symptoms, cyst size, duct dilatation, a mural nodule, increasing cyst size, and malignant cytopathology had lower sensitivities (41–59%) and lower specificities (56–96%) for advanced neoplasia. This test also increased the sensitivity of current pancreatic cyst guidelines (IAP/Fukuoka and AGA) by >10% and maintained their inherent specificity. Conclusions: PancreaSeq GC was not only accurate in predicting pancreatic cyst type and advanced neoplasia but also improved the sensitivity of current pancreatic cyst guidelines.

Objective The aim of the study was to report the prevalence and predictors of abdominal pain and disability 1 year after an acute pancreatitis (AP) attack. Methods Patients were prospectively enrolled between December 2012 and April 2016. Enrolled subjects were contacted at a median of 13 months after enrollment. Multivariable regression models were used to determine factors independently associated with abdominal pain at follow-up. Results Response rate was 71% (110/155). Of respondents, median age was 51 years, 58% were female, and 14% had severe AP. At follow-up, 24% of patients reported abdominal pain (65% intermittent, 35% constant), 10% used analgesics regularly, and 6% had regular opioids use. Furthermore, 41% of patients experienced pain-related interference with work or daily activities, and 8% developed disability. On regression analysis, idiopathic etiology (odds ratio [OR], 3.8; 95% confidence interval [CI], 1.1–13.6) failure (OR, 3.3; 95% CI, 1.1–7.9), and recurrent AP (OR, 2.9; 95% CI, 1.1–10.6) were independently associated with abdominal pain at follow-up. Disability at follow-up was associated with younger age, current smoking, and intensive care unit admission (all P < 0.05). Conclusions Abdominal pain and disability are potential long-term sequelae of AP. Certain pre-existing factors and pancreatitis features are associated with these outcomes at one-year follow-up of AP.

INTRODUCTION: Exogenous transmission of infection via duodenoscope cross-contamination after failed disinfection is a preventable risk. Inadequate reprocessing of reusable duodenoscopes can occur. Given this possibility, a new single-use duodenoscope was recently developed. It had comparable performance to reusable duodenoscopes when tested by expert endoscopists in a comparative bench model for endoscopic retrograde cholangiopancreatography (ERCP). We subsequently aimed to assess the performance of this disposable duodenoscope in a series of human cases. METHODS: Six academic medical centers enrolled consecutive adults 18 years or older without altered pancreaticobiliary anatomy scheduled for an ERCP. Seven ERCP experts rated the new EXALT single-use Model D duodenoscope (Boston Scientific, Marlborough, MA; ClinicalTrials.gov NCT03701958) in ERCP procedures for Overall Satisfaction on a scale of 1 (unsatisfied) to 10 (very satisfied), “Not preferred/Neutral/Preferred” compared to reusable duodenoscopes on 23 ERCP maneuvers, and Qualitative Comparison of 17 performance characteristics on a scale of 1 (not preferred) to 5 (comparable to reusable duodenoscopes). RESULTS: Sixty consecutive patients had an ERCP using the first-generation single-use duodenoscope in April and May 2019. Thirty-seven (61.7%) were male, mean age was 64.4 years, and 44 (73.3%) had a prior ERCP at baseline. All 60 ERCP procedures were successfully performed, 58 (96.7%) with the single-use duodenoscope alone and 2 (3.3%) with crossover to a reusable duodenoscope. Median overall satisfaction with the single-use duodenoscope was rated 9.0 (range 1-10). The overall satisfaction rating was ≥ 7 in 56 (93.3%) ERCPs. All three ratings were at or above midpoint (Overall satisfaction ≥ 5, Comparative ERCP maneuver “Neutral/Preferred,” Qualitative Comparative rating of performance characteristic 3-5) in 47 (78.3%) cases. Four ERCPs had low (≤4) overall satisfaction ratings attributed to inadequate pushability of instruments due to suboptimal positioning of the duodenoscope in front of the papilla; these ERCPs were a subset in which biliary or pancreatic duct strictures were dilated and/or stented. CONCLUSION: Expert endoscopists reported good overall performance of a new single-use duodenoscope in a broad array of cases. Low ratings occurred rarely and were associated with particular ERCP maneuvers. Detailed design improvements to the single-use duodenoscope are underway.

Background Probe‐based confocal laser endomicroscopy (pCLE) provides microscopic imaging during an endoscopic procedure. Its introduction as a standard modality in gastroenterology has brought significant progress in management strategies, affecting many aspects of clinical care and requiring standardisation of practice and training. Objective This study aimed to provide guidance on the standardisation of its practice and training in Barrett's oesophagus, biliary strictures, colorectal lesions and inflammatory bowel diseases. Methods Initial statements were developed by five group leaders, based on the available clinical evidence. These statements were then voted and edited by the 26 participants, using a modified Delphi approach. After two rounds of votes, statements were validated if the threshold of agreement was higher than 75%. Results Twenty‐six experts participated and, among a total of 77 statements, 61 were adopted (79%) and 16 were rejected (21%). The adoption of each statement was justified by the grade of evidence. Conclusion pCLE should be used to enhance the diagnostic arsenal in the evaluation of these indications, by providing microscopic information which improves the diagnostic performance of the physician. In order actually to implement this technology in the clinical routine, and to ensure good practice, standardised initial and continuing institutional training programmes should be established.

Background. The SpyGlass Direct Visualization System (Boston Scientific, Natick, MA) is routinely used during single operator choledochoscopy (SOC) to identify biliary lesions or strictures with a diagnostic accuracy up to 88%. The objective of this study was to determine the interobserver agreement (IOA) of modified scoring criteria for diagnosing biliary lesions/strictures. Methods. 27 SPY SOC video clips were reviewed and scored by 9 interventional endoscopists based on published criteria that included the presence and severity of surface structure, vasculature visualization, lesions, and findings. Results. Overall IOA was “slight” for all variables. The K statistics are as follows: surface (K=0.12, SE = 0.02); vessels (K=0.14, SE = 0.02); lesions (K=0.11, SE = 0.02); findings (K=0.08, SE = 0.03); and final diagnosis (K=0.08, SE = 0.02). The IOA for “findings” and “final diagnosis” was also only “slight.” The final diagnosis was malignant (11), benign (11), and indeterminate (5). Conclusion. IOA using the modified criteria of SOC images was slight to almost poor. The average accuracy was less than 50%. These findings reaffirm that imaging criteria for benign and malignant biliary pathology need to be formally established and validated.