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.

Cost analysis and outcomes of endoscopic, minimal access and open pancreatic necrosectomy.

OBJECTIVES: To assess both individual patient and institutional costs as well as outcomes in patients with pancreatic necrosis who underwent either endoscopic, minimal access or open pancreatic necrosectomy. These data can be used to evaluate clinical effectiveness with a view to informing local health care providers. SUMMARY BACKGROUND DATA: Intervention for infected pancreatic necrosis is associated with a high morbidity, mortality and long hospital stays. Minimal access surgical step-up approaches have been the gold standard of care, however endoscopic approaches are now offered preferentially. METHODS: All patients undergoing endoscopic (EN), minimal access retroperitoneal (MARPN) and open (OPN) necrosectomy at a single institution from April 2015-March 2017 were included. Patients were selected for intervention based on morphology and position of the necrosis and on clinical factors. Patient level costing systems were used to determine inpatient and outpatient costs. RESULTS: 86 patients were included: 38 underwent EN, 35 MARPN and 13 OPN. Pre-operative APACHEII was 6 vs 9 vs 9 (p=0.017) and CRP 107 vs 204 vs 278, (p=0.012), respectively. Post-operative stay was 19 days for EN vs. 41 for MARPN vs. 42 for OPN (p=0.007). Complications occurred in 68.4%, 68.6% and 46.2% (p=0.298) while mortality was 10.5%, 22.9% and 15.4% (p=0.379) respectively. Mean total cost was £31,364 for EN, £52,770 for MARPN (p=0.008) and £60,346 for OPN. Ward and critical care costs for EN were lower than for MARPN (ward: £9,430 vs. £14,033, p=0.024; critical care: £5,317 vs. £16,648, p=0.056).

A systematic review and meta-analysis of metal versus plastic stents for drainage of pancreatic fluid collections: metal stents are advantageous.

BACKGROUND: The use of fully covered metal stents (FCSEMS) and specifically designed lumen apposing metal stents for transmural drainage of pancreatic fluid collections has become widespread. A systematic review published in 2015 did not support the routine use of metal stents for drainage of pancreatic fluid collections. However, recent studies have shown conflicting data; therefore a systematic review and meta-analysis was performed. METHOD: We conducted a database search for original comparative studies between plastic and metal stents. The random effects model was used to calculate pooled risk ratios (RR) with 95% confidence intervals (CI). Outcomes analysed were clinical success, adverse events and requirement of further intervention. RESULTS: The search identified 936 studies, 7 studies with 681 (340 metal, 341 plastic) patients met inclusion criteria and were included in the meta-analysis. Clinical success was achieved in 93.8% versus 86.2% in the metal and plastic groups, respectively, RR 1.08 [95% CI 1.02-1.14]; p = 0.009. Adverse events were reduced for metal stents when compared with plastic (10.2% vs. 25.0%), RR 0.42 [95% CI 0.22-0.81]; p = 0.010. Metal stent usage reduced bleeding (2.8% vs. 7.9%), RR 0.37; [95% CI 0.18-0.75]; p = 0.006. Further intervention was required in 12.4% of patients in the metal stent group versus 26.7% for plastic stents, RR 0.54; [95% CI 0.22-1.29]; p = 0.165. CONCLUSIONS: The use of metal stents for drainage of pancreatic fluid collections is associated with improved clinical success, fewer adverse events and reduced bleeding compared to plastic stents.

The diagnostic value of Rosemont and Japanese diagnostic criteria for 'indeterminate', 'suggestive', 'possible' and 'early' chronic pancreatitis.

BACKGROUND: Longitudinal data are lacking to support consensus criteria for diagnosing early chronic pancreatitis. METHODS: Retrospective single centre study of the initial evidence for chronic pancreatitis (CP), with reassessment after follow-up (January 2003-November 2016). RESULTS: 807 patients were previously diagnosed with chronic pancreatitis. This diagnosis was rejected in 118 patients: 52 had another pathology altogether, the remaining 66 patients formed the study population. 38 patients with 'normal' imaging were reclassified as chronic abdominal pain syndrome (CAPS), and 28 patients had minimal change features of CP on EUS (MCEUS) but never progressed. Strict application of the Japanese diagnostic criteria would diagnose only two patients with early CP and eleven as possible CP. Patients were more likely to have MCEUS if the EUS was performed within 12 months of an attack of acute pancreatitis. 40 patients with MCEUS were identified, including an additional 12 who progressed to definite CP after a median of 30 (18.75-36.5) months. Those continuing to consume excess alcohol and/or continued smoking were significantly more likely to progress. Those who progressed were more likely to develop pancreatic exocrine insufficiency, require pancreatic surgery and had higher mortality. CONCLUSION: There needs to be more stringent application of the systems used for diagnosing chronic pancreatitis with revision of the current terminology 'indeterminate', 'suggestive', 'possible', and 'early' chronic pancreatitis. All patients with MCEUS features of CP require ongoing clinical follow up of at least 30 months and all patients with these features should be strongly counselled regarding smoking cessation and abstinence from alcohol.

Endoscopic ultrasonography-guided transmural drainage of walled-off pancreatic necrosis: Comparison between a specially designed fully covered bi-flanged metal stent and multiple plastic stents.

BACKGROUND AND AIM: Endoscopic ultrasonography (EUS)-guided drainage of walled-off necrosis (WON) may be carried out by placement of multiple plastic stents (MPS) or specially designed fully covered bi-flanged metal stents (BFMS). Comparative data on efficacy of these two stent types for WON drainage are limited. This retrospective study compares outcomes of WON drainage using BFMS and MPS. METHODS: During a 10-year period, 133 patients underwent EUS-guided WON drainage. MPS or BFMS were placed in a WON cavity through a single puncture, and direct endoscopic necrosectomy (DEN) was carried out whenever clinically necessary. Data in the two cohorts were retrospectively compared for primary outcomes - clinical success, adverse events and mortality; and secondary outcomes - DEN requirement, mean DEN sessions, need for salvage surgery and hospital stay. RESULTS: MPS were placed in 61 and BFMS in 72 patients. Patients undergoing BFMS drainage required fewer DEN sessions (mean 1.46 vs 2.74, P < 0.05), had fewer adverse events (5.6% vs 36.1%, P < 0.05), needed salvage surgery less often (2.7% vs 26.2%, P < 0.05), and had significantly shorter hospital stay (4.1 vs 8 days, P < 0.05) compared to those undergoing MPS drainage. There was no difference in DEN requirement (P = 0.217) and mortality (P = 0.5) in both groups. Overall clinical success with BFMS was superior to MPS (94% vs 73.7%, P < 0.05). CONCLUSION: BFMS appear to be superior to MPS for EUS-guided WON drainage in terms of clinical success, number of DEN sessions, adverse events, need for salvage surgery and hospital stay.

Performance characteristic of endoscopic ultrasound-guided fine needle aspiration is unaffected by pancreatic mass size.

BACKGROUND AND STUDY AIMS: Despite a well-established tool for diagnosis of pancreatic masses, endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) studies have shown suboptimal diagnostic performance at divergent mass sizes. Since the impact of gold standard follow-up and presence of on-site evaluation on this observation is unknown, we aimed to study the performance characteristics of EUS-FNA under these strict conditions. PATIENTS AND METHODS: EUS-FNA results from pancreatic mass lesions performed between July 2000 and March 2013 were evaluated. All patients with histological follow-up were then stratified into four groups: Group A ( ≤ 10 mm), Group B (11 - 20 mm), Group C (21 - 40 mm), and Group D (> 40 mm). Sensitivity and diagnostic accuracy were calculated for each group and compared. RESULTS: A total of 612 /3832 (16 %) patients with pancreatic masses who underwent EUS-FNA had histology confirmation. Of these, 81 were excluded due to unavailable lesion size, while the rest formed the study cohort. Mean age (SD) was 65.8 years (9.3) with 51.2 % female. The mean number of passes for the entire cohort was 2.9 (SD 1.9; range 1 - 12); patients in group D had a significantly higher number of passes for on-site diagnosis (P = 0.0124). There was no significant difference between the groups for sensitivity (P = 0.1134) or diagnostic accuracy (P = 0.2111). Proportional trend analysis revealed no significant correlation between size and sensitivity (P = 0.6192). The size of lesion measured by EUS was not associated with sensitivity or specificity after adjusting for age, sex, and pancreatic location. CONCLUSION: In the presence of rapid on-site cytopathology and when final histology is taken as the gold standard, pancreatic mass size does not affect the performance characteristics of EUS-FNA.

Endoscopic ultrasonography is not required for staging malignant esophageal strictures that preclude the passage of a diagnostic gastroscope.

BACKGROUND AND AIM: Endoscopic ultrasound (EUS) is considered the most sensitive modality for local staging of esophageal cancer (ECA) and current guidelines recommend EUS in all patients with non-metastatic disease. Our aim was to identify a subset of patients with stenotic, non-metastatic ECA who will not benefit from staging EUS. METHODS: This multicenter study evaluated consecutive patients with newly diagnosed non-metastatic ECA referred for local staging by EUS. All patients had endoscopic evaluation of malignant strictures with 9.8/9.9-mm diagnostic gastroscope prior to EUS. Main outcome measure was to evaluate the relationship between degree of malignant stenosis and tumor staging by EUS. RESULTS: Of 100 patients (median age, 65 years; male 81%), gastroscope could not be advanced past the stricture in 46, all of whom (100%) had locally advanced disease at EUS: T3N0/N+ in 39 and T4N0/N+ in seven. Echoendoscope could not traverse the stricture in any of these patients. Gastroscope could be advanced through the stricture in 54 patients in whom EUS staging was T1N0 in five, T2N0/N+ in eight and T3N0/N+ in 41; echoendoscope could not pass through the stricture in 24 of these 54 (44.4%) patients, all of whom had T3N0/N+ disease. On logistic regression analysis, inability to pass a gastroscope through the stricture was significantly associated with advanced (T3/4) tumor stage (OR = 28.7, 95% CI = 1.64-501.2; P = 0.021). CONCLUSION: Routine EUS examination may not be required in all patients with ECA as the inability to advance a diagnostic gastroscope past a malignant stricture correlates 100% with locally advanced disease on EUS.

Emerging Role of Endoscopic Ultrasound in the Diagnostic Evaluation of Idiopathic Pancreatitis.

BACKGROUND: "Idiopathic pancreatitis" is diagnosed when clinical, laboratory and conventional radiologic methods do not provide a clear etiology for the episode. Given its associated morbidity and mortality, it is important to determine the cause of pancreatitis to provide early treatment and prevent recurrence. METHODS: The aim of this systematic review was to evaluate the utility of endoscopic ultrasound (EUS) in determining an etiology in patients classified as having idiopathic pancreatitis and to assess how EUS performed compared with other modalities. A PubMed search for relevant articles (January 2000-November 2014) was performed using the search terms "(pancreatitis or idiopathic pancreatitis or unexplained pancreatitis) and (EUS or endoscopic ultrasound)." RESULTS: The search yielded a total of 963 articles, and 13 studies were included in the final review. In some studies, the yield of EUS was higher than magnetic resonance cholangiopancreatography in idiopathic pancreatitis. EUS more accurately detected biliary stones, whereas magnetic resonance cholangiopancreatography more often identified pancreatic duct abnormalities. The yield of EUS was lower in patients postcholecystectomy but was not influenced by gender, severity of pancreatitis, or recurrent disease. The most frequent diagnoses by EUS for those with idiopathic pancreatitis were biliary tract disease (41%). Overall, EUS identified additional diagnostic information in 61% of patients with idiopathic pancreatitis. CONCLUSIONS: Given the high incidence of microlithiasis and/or biliary sludge as a cause of idiopathic pancreatitis as well as the safety and high accuracy, EUS should be considered 1st for evaluation of idiopathic pancreatitis if conventional cross-sectional radiography fails to reveal a cause.

Endoscopic ultrasound-guided liver biopsy: a multicenter experience.

BACKGROUND AND AIMS: Endoscopic ultrasound-guided (EUS) liver biopsy (LB) is proposed as a newer method that offers several advantages over existing techniques for sampling liver tissue. This study evaluated the diagnostic yield of EUS-LB as the primary outcome measure. In addition, the safety of the technique in a large patient cohort was assessed. PATIENTS AND METHODS: Patients undergoing EUS for evaluation of elevated liver enzymes or hepatic disease were included in this prospective, non-randomized, multicenter study. EUS-LB was performed with EUS-fine needle aspiration (FNA; 19-gauge needle). Tissue was formalin-fixed and stained with hematoxylin and eosin, and trichrome. Using a microscope micrometer, specimen length was measured and the number of complete portal triads (CPTs) were counted. The main outcome measure was to assess the diagnostic yield of EUS-LB, and to monitor for any procedure-related complications. RESULTS: Patients (110; median age, 53 years; 62 women) underwent EUS-LB at eight centers. The indication was abnormal liver enzymes in 96 patients. LB specimens sufficient for pathological diagnosis were obtained in 108 of 110 patients (98 %). The overall tissue yield from 110 patients was a median aggregate length of 38 mm (range, 0 - 203), with median of 14 CPTs (range, 0 - 68). There was no statistical difference in the yield between bilobar, left lobe only, or right lobe only biopsies. There was one complication (0.9 %) where self-limited bleeding occurred in a coagulopathic and thrombocytopenic patient. This complication was managed conservatively. CONCLUSIONS: EUS-guided LB was a safe technique that yields tissue adequate for diagnosis among 98 % of patients evaluated.

Endoscopic extra-cavitary drainage of pancreatic necrosis with fully covered self-expanding metal stents (fcSEMS) and staged lavage with a high-flow water jet system.

AIM: To present a novel, less-invasive method of endoscopic drainage (ED) for walled-off pancreatic necrosis (WON).We describe the feasibility, success rate, and complications of combined ED extra-cavitary lavage and debridement of WON using a biliary catheter and high-flow water jet system (water pump). PATIENTS AND METHODS: Endoscopic ultrasound (EUS)-guided drainage was performed with insertion of two 7-Fr, 4-cm double pigtail stents. Subsequently a fully covered self-expanding metal stent (fcSEMS) was placed. The key aspect of the debridement was the insertion of a 5-Fr biliary catheter through or along the fcSEMS into the cavity, with ensuing saline lavage using a high-flow water jet system. The patients were then brought back for repeated, planned endoscopic lavages of the WON. No endoscopic intra-cavitary exploration was performed. RESULTS: A total of 17 patients (15 men, 2 women; mean age 52.6, range 24 - 69; mean American Society of Anesthesiologists [ASA] score of 3) underwent ED of WON with this new method. The mean initial WON diameter was 9.5 cm, range 8 to 26 cm. The total number of ED was 84, range 2 to 13. The mean stenting period was 42.5 days. The mean follow-up was 51 days, range 3 to 370. A resolution of the WON was achieved in 14 patients (82.3 %). There were no major complications associated with this method. CONCLUSION: ED of complex WON with fcSEMS followed by repeated endoscopic extra-cavitary lavage and debridement using a biliary catheter and high-flow water jet system is a minimally invasive, feasible method with high technical and clinical success and minimal complications.

ERCP-related perforations in the new millennium: A large tertiary referral center 10-year experience.

INTRODUCTION: Endoscopic retrograde cholangiopancreatography (ERCP) is an important diagnostic and therapeutic modality for pancreatic and biliary disorders. Perforation is one of the most dreaded complications of ERCP. Since it is uncommon, there has been little study of incidence, risk factors, and outcomes of management. OBJECTIVES: We aim to assess the incidence of ERCP-related perforations and outcomes at a large tertiary referral center. METHODS: We undertook a review of an ERCP database for all perforations from 2002 to December 2012. RESULTS: The cumulative incidence of ERCP-related perforations was 0.14% (12 out of 8264), and sphincterotomy-related perforations constituted the most common cause. The mean age of these 12 patients was 58.6 years and majority were female (83.3%). The most common indications for ERCP were: suspected sphincter of Oddi dysfunction (SOD) 41%, and common bile duct stones (CBD stones) 41%. Nine of the 12 patients (75%) had a leak and were managed medically, and four who had a perforation had surgical repair (25%). CONCLUSIONS: In our study, leaks were much more common than perforations and the majority of patients were successfully managed with conservative therapy alone. We report a very low perforation rate and most perforations can be managed conservatively with a good outcome.

Endoscopic management of peripancreatic fluid collections.

Peripancreatic fluid collections are a well-known complication of pancreatitis and can vary from fluid-filled collections to entirely necrotic collections. Although most of the fluid-filled pseudocysts tend to resolve spontaneously with conservative management, intervention is necessary in symptomatic patients. Open surgery has been the traditional treatment modality of choice though endoscopic, laparoscopic and transcutaneous techniques offer alternative drainage approaches. During the last decade, improvement in endoscopic ultrasound technology has enabled real-time access and drainage of fluid collections that were previously not amenable to blind transmural drainage. This has initiated a trend towards use of this modality for treatment of pseudocysts. In this review, we have summarised the existing evidence for endoscopic drainage of peripancreatic fluid collections from published studies.

Randomized Trial Comparing the Flexible 19G and 25G Needles for Endoscopic Ultrasound-Guided Fine Needle Aspiration of Solid Pancreatic Mass Lesions.

OBJECTIVES: Although a large gauge needle can procure more tissue at endoscopic ultrasound-guided fine needle aspiration (EUS-FNA), its advantage over smaller needles is unclear. This study compared flexible 19G and 25G needles for EUS-FNA of solid pancreatic masses. METHODS: This was a randomized trial of patients undergoing EUS-FNA of pancreatic masses using flexible 19G or 25G needle. Main outcome measure was to compare median number of passes for on-site diagnosis. Secondary measures were to compare specimen bloodiness, complications, technical failures, and histological core tissue procurement. RESULTS: One hundred patients were randomized to EUS-FNA using flexible 19G or 25G needle. Median of 1 pass was required to achieve on-site diagnosis of 96% and 92% (P = 0.68) in 19G and 25G cohorts. There was no significant difference in technical failure (0% vs 2%, P = 0.99) or adverse events (2% vs 0%, P = 0.99) between 19G and 25G cohorts. Although histological core tissue procurement was significantly better with flexible 19G needle (88% vs 44%, P < 0.001), specimens were bloodier (severe bloodiness, 36% vs 4%; P < 0.001). CONCLUSIONS: As there is no significant difference in the performance of flexible 19G and 25G needles, needle choice for sampling pancreatic masses should be based on endoscopist preference and need for histology.

Safety and yield of diagnostic ERCP in liver transplant patients with abnormal liver function tests.

Background. Abnormal liver enzymes postorthotopic liver transplant (OLT) may indicate significant biliary pathology or organ rejection. There is very little known in the literature regarding the current role of diagnostic ERCP in this scenario. Aim. To review the utility of diagnostic ERCP in patients presenting with abnormal liver function tests in the setting of OLT. Methods. A retrospective review of diagnostic ERCPs in patients with OLT from 2002 to 2013 from a prospectively maintained, IRB approved database. Results. Of the 474 ERCPs performed in OLT patients, 210 (44.3%; 95% CI 39.8-48.8) were performed for abnormal liver function tests during the study period. Majority of patients were Caucasian (83.8%), male (62.4%) with median age of 55 years (IQR 48-62 years). Biliary cannulation was successful in 99.6% of cases and findings included stricture in 45 (21.4 %); biliary stones/sludge in 23 (11%); biliary dilation alone in 31 (14.8%); and normal in 91 (43.3%). Three (1.4%) patients developed mild, self-limiting pancreatitis; one patient (0.5%) developed cholangitis and two (1%) had postsphincterotomy bleeding. Multivariate analyses showed significant association between dilated ducts on imaging with a therapeutic outcome. Conclusion. Diagnostic ERCP in OLT patients presenting with liver function test abnormalities is safe and frequently therapeutic.

Prevalence of normal liver tests in patients with choledocholithiasis undergoing endoscopic retrograde cholangiopancreatography.

BACKGROUND/AIMS: Abnormal liver chemistry tests are a hallmark of common bile duct (CBD) stones. There is little information, however, on the prevalence of and predictors for normal liver chemistry tests in such patients. METHODS: Over an 11-year period, all patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) at our Center were prospectively identified. Patients in this study were those with CBD stones found at ERCP and where the indication for ERCP was CBD stones seen on imaging studies or when CBD stones were highly suspected based upon clinical presentation and radiographic and laboratory findings. Liver chemistry tests were recorded from those taken at the time of initial presentation as well as the time closest to ERCP. RESULTS: Of a total of 5,133 patients undergoing ERCP during the study period, the indication was suspicion for CBD stones or for radiographically identified CBD stones in 476 and 593, respectively, with 115 patients having both indications. Of these 1184 patients, 765 had CBD stones of whom 541 had liver tests. Of these 541, 29 patients (5.4%) were found to consistently have normal liver chemistry tests. Multivariate analysis identified two factors predictive of normal liver tests including age >55 years and the presence of abdominal pain. CONCLUSIONS: Although rare, liver tests can be normal in patients with CBD stones. Patients most likely to have normal liver tests included older patients and those with abdominal pain.

Relationship between stent characteristics and treatment outcomes in endoscopic transmural drainage of uncomplicated pancreatic pseudocysts.

BACKGROUND: Transmural stents are placed at endoscopy to drain pancreatic fluid collections. This study evaluated the relationship between stent placement and treatment outcomes in patients undergoing endoscopic transmural drainage of uncomplicated pancreatic pseudocysts. METHODS: This is a retrospective study of all patients who underwent endoscopic drainage of uncomplicated pancreatic pseudocysts over a 10-year period. After dilating the transmural tracts in the range of 8-15 mm, single or multiple, 7 or 10Fr double-pigtail plastic stents were deployed. The main outcome measure was to evaluate the relationship between stent characteristics and the number of endoscopic interventions required to achieve resolution of the pancreatic pseudocyst (treatment success). RESULTS: Of 122 patients, 45 (36.9%) had 10Fr stents of which 30 patients (66.7%) had more than one stent; the remaining 77 (63.1%) patients had 7Fr stents of which 56 (72.7%) had more than one stent. The overall treatment success was 94.3%. Treatment was successful in 102 patients (83.6%) with one intervention; 13 patients (10.7%) required re-intervention for successful drainage and 7 patients (5.7%) failed endoscopic treatment. There was no significant difference in the number of interventions required for treatment success between patients with 7 or 10Fr stents (one intervention required in 87.7 vs. 90.5%, respectively; p = 0.766) and between patients with 1 or >1 stent (one intervention required in 88.9 vs. 88.6%, respectively; p = 0.999). On multiple logistic regression analysis, the stent size (OR 1.54; 95% CI 0.23-10.4) and number (OR 1.15; 95% CI 0.25-5.25) were not associated with the number of interventions required for treatment success when adjusted for pseudocyst size, location, drainage modality, the presence or absence of pancreatic duct stent and luminal compression. CONCLUSIONS: There appears to be no relationship between the number of interventions required for treatment success and stent characteristics in patients undergoing endoscopic transmural drainage of uncomplicated pancreatic pseudocysts.