UK and Ireland Joint Advisory Group (JAG) consensus statements for training and certification in diagnostic endoscopic ultrasound (EUS).

BACKGROUND AND AIMS: International endoscopy societies vary in their approach for credentialing individuals in endoscopic ultrasound (EUS) to enable independent practice; however, there is no consensus in this or its implementation. In 2019, the Joint Advisory Group on GI Endoscopy (JAG) commissioned a working group to examine the evidence relating to this process for EUS. The aim of this was to develop evidence-based recommendations for EUS training and certification in the UK. METHODS: Under the oversight of the JAG quality assurance team, a modified Delphi process was conducted which included major stakeholders from the UK and Ireland. A formal literature review was made, initial questions for study were proposed and recommendations for training and certification in EUS were formulated after a rigorous assessment using the Grading of Recommendation Assessment, Development and Evaluation tool and subjected to electronic voting to identify accepted statements. These were peer reviewed by JAG and relevant stakeholder societies before consensus on the final EUS certification pathway was achieved. RESULTS: 39 initial questions were proposed of which 33 were deemed worthy of assessment and finally formed the key recommendations. The statements covered four key domains, such as: definition of competence (13 statements), acquisition of competence (10), assessment of competence (5) and postcertification mentorship (5). Key recommendations include: (1) minimum of 250 hands-on cases before an assessment for competency can be made, (2) attendance at the JAG basic EUS course, (3) completing a minimum of one formative direct observation of procedural skills (DOPS) every 10 cases to allow the learning curve in EUS training to be adequately studied, (4) competent performance in summative DOPS assessments and (5) a period of mentorship over a 12-month period is recommended as minimum to support and mentor new service providers. CONCLUSIONS: An evidence-based certification pathway has been commissioned by JAG to support and quality assure EUS training. This will form the basis to improve quality of training and safety standards in EUS in the UK and Ireland.

Appendixoscopy to evaluate a suspected mucinous appendiceal lesion.

Video 1Colonoscopy with "appendixoscopy" using a single-operator digital cholangioscope to exclude a mucinous lesion of the appendix.

Factors predictive of persistent fistulas in EUS-directed transgastric ERCP: a multicenter matched case-control study.

BACKGROUND AND AIMS: EUS-directed transgastric ERCP (EDGE) is an established method for managing pancreaticobiliary pathology in Roux-en-Y gastric bypass patients, with high rates of technical success and low rates of serious adverse events (AEs). However, widespread adoption of the technique has been limited because of concerns about the development of persistent gastrogastric or jejunogastric fistulas. Gastrogastric and jejunogastric fistulas have been reported in up to 20% of cases in some series, but predictive risk factors and long-term management and outcomes are lacking. Therefore, our aims were to assess factors associated with the development of persistent fistulas and the technical success of endoscopic fistula closure. METHODS: This is a case-control study involving 9 centers (8 USA, 1 Europe) from February 2015 to September 2021. Cases of persistent fistulas were defined as endoscopic or imaging evidence of fistula more than 8 weeks after lumen-apposing metal stent (LAMS) removal. Control subjects were defined as endoscopic or imaging confirmation of no fistula more than 8 weeks after LAMS removal. AEs were defined and graded according to the American Society for Gastrointestinal Endoscopy lexicon. RESULTS: Twenty-five patients identified to have evidence of a persistent fistula on follow-up surveillance (cases) were matched with 50 patients with no evidence of a persistent fistula on follow-up surveillance (control subjects) based on age and sex. Mean LAMS dwell time was 74.7 ± 106.2 days. After LAMS removal, argon plasma coagulation (APC) ablation of the fistula was performed in 46 patients (61.3%). Primary closure of the fistula was performed in 26.7% of patients (20: endoscopic suturing in 17, endoscopic tacking in 2, and over-the-scope clips + endoscopic suturing in 1). When comparing cases with control subjects, there was no difference in baseline demographics, fistula site, LAMS size, or primary closure frequency between the 2 groups (P > .05). However, in the persistent fistula group, the mean LAMS dwell time was significantly longer (127 vs 48 days, P = .02) and more patients had ≥5% total body weight gain (33.3% vs 10.3%, P = .03). LAMS dwell time was a significant predictor of persistent fistula (odds ratio, 4.5 after >40 days in situ, P = .01). The odds of developing a persistent fistula increased by 9.5% for every 7 days the LAMS was left in situ. In patients with a persistent fistula, endoscopic closure was attempted in 19 (76%) with successful resolution in 14 (73.7%). CONCLUSIONS: Longer LAMS dwell time was found to be associated with a higher risk of persistent fistulas in EDGE patients. APC or primary closure of the fistula on LAMS removal was not found to be protective against developing a persistent fistula, which, if present, can be effectively managed through endoscopic closure in most cases.

Suturing a 20-mm lumen-apposing metal stent allows for safe same-session EUS-directed transgastric intervention in patients with Roux-en-Y gastric bypass anatomy: a multicenter study (with video).

BACKGROUND AND AIMS: EUS-directed transgastric intervention (EDGI) is an established technique for the management of pancreaticobiliary pathology in Roux-en-Y gastric bypass (RYGB) patients. There is an inherent risk of intraprocedural stent dislodgement, leading to perforation. The procedure is therefore often performed in 2 stages, 2 to 4 weeks apart, to allow for fistula maturation to mitigate the risk of lumen-apposing metal stent (LAMS) dislodgment. However, some clinical indications such as cholangitis require more urgent intervention, rendering this approach impractical. The aim of this study was to evaluate the safety and efficacy of same-session (SS)-EDGI with fixation of a 20-mm LAMS using endoscopic suturing. METHODS: This was a 2-center, retrospective study of consecutive RYGB patients who underwent SS-EDGI using a sutured 20-mm LAMS between February 2018 and May 2020. Patient demographics, procedural details, and clinical outcomes were recorded. RESULTS: Thirty-seven patients (mean age, 58.1 years; 86.5% women) underwent SS-EDGI with a median follow-up of 31.8 months. The procedural intervention was ERCP in 33 patients (89.2%) and ERCP with EUS in 4 patients (10.8%). Technical success was 100%. Access was achieved through the gastrogastric fistula in 26 patients (70.3%) and the jejunogastric fistula in 11 (29.7%). The LAMS was anchored with 2 endoscopic sutures in 33 patients (89.2%) and 1 suture in 4 (10.8%). Adverse events occurred in 4 patients (10.8%; 3 postprocedural bleeding, 1 cholangitis). There were no episodes of stent dislodgement or delayed stent migration. A persistent fistula was diagnosed in 7 patients (18.9%) who underwent objective testing (n = 28, 75.7%), of which 6 were successfully closed endoscopically. CONCLUSIONS: Single-stage EDGI using a sutured 20-mm LAMS was associated with a high rate of technical success, low rates of adverse events, and no episodes of stent migration. Persistent fistulas, although common, were amenable to endoscopic management.

Excess diabetes mellitus-related deaths during the COVID-19 pandemic in the United States.

Background: Diabetes mellitus (DM) is a critical risk factor for severe SARS-CoV-2 infection, and SARS-CoV-2 infection contributes to worsening glycemic control. The COVID-19 pandemic profoundly disrupted the delivery of care for patients with diabetes. We aimed to determine the trend of DM-related deaths during the pandemic. Methods: In this serial population-based study between January 1, 2006 and December 31, 2021, mortality data of decedents aged ≥25 years from the National Vital Statistics System dataset was analyzed. Decedents with DM as the underlying or contributing cause of death on the death certificate were defined as DM-related deaths. Excess deaths were estimated by comparing observed versus expected age-standardized mortality rates derived from mortality during 2006-2019 with linear and polynomial regression models. The trends of mortality were quantified with joinpoint regression analysis. Subgroup analyses were performed by age, sex, race/ethnicity, and state. Findings: Among 4·25 million DM-related deaths during 2006-2021, there was a significant surge of more than 30% in mortality during the pandemic, from 106·8 (per 100,000 persons) in 2019 to 144·1 in 2020 and 148·3 in 2021. Adults aged 25-44 years had the most pronounced rise in mortality. Widened racial/ethnic disparity was observed, with Hispanics demonstrating the highest excess deaths (67·5%; 95% CI 60·9-74·7%), almost three times that of non-Hispanic whites (23·9%; 95% CI 21·2-26·7%). Interpretation: The United States saw an increase in DM-related mortality during the pandemic. The disproportionate rise in young adults and the widened racial/ethnic disparity warrant urgent preventative interventions from diverse stakeholders. Funding: National Natural Science Foundation of China.

Erratum: UK Joint Advisory Group consensus statements for training and certification in endoscopic retrograde cholangiopancreatography.

[This corrects the article DOI: 10.1055/a-1629-7540.].

Cholangioscopy-guided double-guidewire technique for complex malignant hilar obstruction.

Video 1Cholangioscopy-guided double-guidewire technique for the management of complex malignant hilar obstruction.

UK Joint Advisory Group consensus statements for training and certification in endoscopic retrograde cholangiopancreatography.

Background and study aims Despite the high-risk nature of endoscopic retrograde cholangiopancreatography (ERCP), a robust and standardized credentialing process to ensure competency before independent practice is lacking worldwide. On behalf of the Joint Advisory Group (JAG), we aimed to develop evidence-based recommendations to form the framework of ERCP training and certification in the UK. Methods Under the oversight of the JAG, a modified Delphi process was conducted with stakeholder representation from the British Society of Gastroenterology, Association of Upper Gastrointestinal Surgeons, trainees and trainers. Recommendations on ERCP training and certification were formulated after formal literature review and appraised using the GRADE tool. These were subjected to electronic voting to achieve consensus. Accepted statements were peer-reviewed by JAG and relevant Specialist Advisory Committees before incorporation into the ERCP certification pathway. Results In total, 27 recommendation statements were generated for the following domains: definition of competence (9 statements), acquisition of competence (8 statements), assessment of competence (6 statements) and post-certification support (4 statements). The consensus process led to the following criteria for ERCP certification: 1) performing ≥ 300 hands-on procedures; 2) attending a JAG-accredited ERCP skills course; 3) in modified Schutz 1-2 procedures: achieving native papilla cannulation rate ≥80%, complete bile duct clearance ≥ 70 %, successful stenting of distal biliary strictures ≥ 75 %, physically unassisted in ≥ 80 % of cases; 4) 30-day post-ERCP pancreatitis rates ≤5 %; and 5) satisfactory performance in formative and summative direct observation of procedural skills (DOPS) assessments. Conclusions JAG certification in ERCP has been developed following evidence-based consensus to quality assure training and to ultimately improve future standards of ERCP practice.

Voice-Assisted Image Labeling for Endoscopic Ultrasound Classification Using Neural Networks.

Ultrasound imaging is a commonly used technology for visualising patient anatomy in real-time during diagnostic and therapeutic procedures. High operator dependency and low reproducibility make ultrasound imaging and interpretation challenging with a steep learning curve. Automatic image classification using deep learning has the potential to overcome some of these challenges by supporting ultrasound training in novices, as well as aiding ultrasound image interpretation in patient with complex pathology for more experienced practitioners. However, the use of deep learning methods requires a large amount of data in order to provide accurate results. Labelling large ultrasound datasets is a challenging task because labels are retrospectively assigned to 2D images without the 3D spatial context available in vivo or that would be inferred while visually tracking structures between frames during the procedure. In this work, we propose a multi-modal convolutional neural network (CNN) architecture that labels endoscopic ultrasound (EUS) images from raw verbal comments provided by a clinician during the procedure. We use a CNN composed of two branches, one for voice data and another for image data, which are joined to predict image labels from the spoken names of anatomical landmarks. The network was trained using recorded verbal comments from expert operators. Our results show a prediction accuracy of 76% at image level on a dataset with 5 different labels. We conclude that the addition of spoken commentaries can increase the performance of ultrasound image classification, and eliminate the burden of manually labelling large EUS datasets necessary for deep learning applications.

Prophylactic appendiceal retrograde intraluminal stent placement (PARIS).

Video 1Video of the prophylactic appendiceal retrograde intraluminal stent placement technique.

A Review of the Diagnosis and Management of Premalignant Pancreatic Cystic Lesions.

Pancreatic cystic lesions are an increasingly common clinical finding. They represent a heterogeneous group of lesions that include two of the three known precursors of pancreatic cancer, intraductal papillary mucinous neoplasms (IPMN) and mucinous cystic neoplasms (MCN). Given that approximately 8% of pancreatic cancers arise from these lesions, careful surveillance and timely surgery offers an opportunity for early curative resection in a disease with a dismal prognosis. This review summarizes the current evidence and guidelines for the diagnosis and management of IPMN/MCN. Current pre-operative diagnostic tests in pancreatic cysts are imperfect and a proportion of patients continue to undergo unnecessary surgical resection annually. Balancing cancer prevention while preventing surgical overtreatment, continues to be challenging when managing pancreatic cysts. Cyst fluid molecular markers, such as KRAS, GNAS, VHL, PIK3CA, SMAD4 and TP53, as well as emerging endoscopic technologies such as needle-based confocal laser endomicroscopy and through the needle microbiopsy forceps demonstrate improved diagnostic accuracy. Differences in management and areas of uncertainty between the guidelines are also discussed, including indications for surgery, surveillance protocols and if and when surveillance can be discontinued.

Diagnosis and management of benign biliary strictures post liver transplantation in adults.

Benign biliary strictures after liver transplantation are common and can lead to graft dysfunction and decreased patient survival. Post-transplant strictures are classified as anastomotic or non-anastomotic which differ in response to therapy. Risk factors for biliary strictures following transplantation include impaired blood supply, surgical factors, and biliary anomalies. Patients can present with biliary obstruction but most will be asymptomatic, with only abnormal graft function. MRCP is the most sensitive noninvasive tool for diagnosing biliary complications. In most centres worldwide endoscopy is used first-line in the management of anastomotic strictures, although there is significant variation in endoscopic technique employed; including dilation, placing a single or multiple plastic stents, a fully covered metal stent and most recently using intra-ductal fully covered metal stents. With the introduction of fully covered metal stents the number of interventions patients require has reduced and overall the clinical success of the endoscopic approach has steadily improved. Percutaneous and surgical treatments are now reserved for patients in whom endoscopic management fails or who have had Roux-en-Y anastomoses. However even in these cases, combined procedures with interventional radiology, or implementation of enteroscopy and EUS-guided approaches now means very few patients ultimately require surgical revision.

Assessment of the learning curve for EUS-guided gastroenterostomy for a single operator.

BACKGROUND AND AIMS: EUS-guided gastroenterostomy (EUS-GE) is increasingly used as an alternative to surgery and enteral stent placement to manage gastric outlet obstruction (GOO). However, no data are available on the learning curve (LC) for EUS-GE. Defining the LC is necessary to create adequate subspecialty training programs and quality assurance. METHODS: This study is a retrospective analysis of a prospectively maintained dataset of patients who underwent EUS-GE at 1 tertiary referral center. Primary outcome was the LC for EUS-GE defined by the number of cases needed to achieve proficiency and mastery using cumulative sum (CUSUM) analysis. Moving average graphs and sequential time-block analysis were also performed to assess procedural time. Secondary outcomes included efficacy and safety of EUS-GE. RESULTS: Eighty-seven consecutive patients underwent EUS-GE, mostly for malignant GOO. For consistency, 14 patients were excluded from analysis (noncautery-assisted EUS-GE, 11; surgical anatomy, 3). The same endoscopist performed all procedures using the same freehand technique. Technical success was achieved in 68 of 73 patients (93%). Immediate adverse events occurred in 4 patients (5.5%), whereas late adverse events occurred only in 1 patient (1%), all managed conservatively or endoscopically. All immediate adverse events occurred during the first 39 cases. Clinical success (defined as resuming at least an oral liquid diet within a week) was achieved in 97% of patients. The mean procedural time was 36 minutes (standard deviation, 24). Evaluation of the CUSUM curve revealed that 25 cases were needed to achieve proficiency and 40 cases to achieve mastery. These results were confirmed with the average moving curve and sequential time-block analysis. CONCLUSIONS: We report, for the first time, data on the LC for EUS-GE. About 25 procedures can be considered as the threshold to achieve proficiency and about 40 cases are needed to reach mastery of the technique.

Clinical and radiological features that predict malignant transformation in cystic lesions of the pancreas: a retrospective case note review.

Background: Pancreatic cystic lesions (PCL) are being detected with increasing frequency. Current methods of stratifying risk of malignant transformation are imperfect. This study aimed to determine the frequency of pancreatic malignancy in patients with PCL and define clinical and radiological features that predict malignant transformation in patients managed by surgery and/or surveillance. Methods: A retrospective cohort of adults who were evaluated in a tertiary hepatopancreaticobiliary centre between January 2000 - December 2013 with a confirmed PCL and followed up for at least 5 years. All cystic lesions were discussed at a weekly multidisciplinary meeting. Results: Of the 1,090 patients diagnosed with a PCL, 768 patients were included in the study: 141 patients were referred for immediate pancreatic resection, 570 entered surveillance while 57 had a malignant PCL which was unresectable at diagnosis (n=47) or were unfit for surgery (n=10). In those who were resected following presentation, malignancy was present in 38%. During follow-up 2% of those entering a surveillance programme underwent malignant transformation. Clinical and radiological features associated with a high-risk PCL included older age, symptoms, associated solid component or dilated main pancreatic duct. In intraductal papillary mucinous neoplasms, larger size was not a feature of malignant transformation (benign vs. malignant 30mm vs. 23mm; P= 0.012). Conclusion: The sensitivity of standard diagnostic tests leading to immediate surgery for high-risk PCL (malignant or mucinous) was 92% but with a specificity of just 5%. Surveillance of PCL without high-risk features within a multidisciplinary meeting was associated with a low incidence of cancer development, supporting the use of worrisome clinical and radiological features in the initial stratification of PCL.

Early detection of pancreatic cancer.

Pancreatic ductal adenocarcinoma is most frequently detected at an advanced stage. Such late detection restricts treatment options and contributes to a dismal 5-year survival rate of 3-15%. Pancreatic ductal adenocarcinoma is relatively uncommon and screening of the asymptomatic adult population is not feasible or recommended with current modalities. However, screening of individuals in high-risk groups is recommended. Here, we review groups at high risk for pancreatic ductal adenocarcinoma, including individuals with inherited predisposition and patients with pancreatic cystic lesions. We discuss studies aimed at finding ways of identifying pancreatic ductal adenocarcinoma in high-risk groups, such as among individuals with new-onset diabetes mellitus and people attending primary and secondary care practices with symptoms that suggest this cancer. We review early detection biomarkers, explore the potential of using social media for detection, appraise prediction models developed using electronic health records and research data, and examine the application of artificial intelligence to medical imaging for the purposes of early detection.

A prospective trial of CONfocal endomicroscopy in CYSTic lesions of the pancreas: CONCYST-01.

Background and study aims Pancreatic cystic lesions (PCL) are common. While some harbor malignant potential, accurate preoperative diagnosis remains challenging. Needle-based confocal laser endomicroscopy (nCLE) via a 19G FNA needle enables real-time imaging of the cyst wall. This study evaluated the safety and utility of nCLE in patients with an indeterminate PCL undergoing EUS-FNA. Patients and methods The CONCYST study prospectively recruited patients with indeterminate PCL attending three hepatopancreaticobiliary (HPB) referral centers in the UK, with indeterminate PCL, who required EUS-FNA between July 2014 and October 2016. Following the procedure, all patients were followed up in telephone clinic for at least 12 months. Ethical approval for the study was granted by the National Research Ethics Service (14/LO/0040). Results Sixty-seven patient were recruited, 11 excluded and 56 included in the final analysis: 35 male, 21 female; median age 68 (range 28 - 80). Recognizable confocal images were obtained in 48 of 56 cases. Median nCLE scanning time was 5 minutes and did not exceed 10 minutes in any case. EUS-nCLE findings correlated with final diagnosis (based on imaging, cytology and multidisciplinary team review) in 43/56 (77 %) of cases, compared with 37/56 (66 %) for cytology alone ( P  = 0.12). One patient experienced mild pruritus following the procedure and another developed an infected pseudocyst, which resolved with antibiotics. Conclusions EUS-nCLE under conscious sedation in the day case setting is safe and provides additional information to standard EUS-FNA for diagnosing indeterminate PCL.