Type 1 Autoimmune Pancreatitis in Europe: Clinical Profile and Response to Treatment.

BACKGROUND & AIMS: Autoimmune pancreatitis (AIP) is an immune-mediated disease of the pancreas with distinct pathophysiology and manifestations. Our aims were to characterize type 1 AIP in a large pan-European cohort and study the effectiveness of current treatment regimens. METHODS: We retrospectively analyzed adults diagnosed since 2005 with type 1 or not-otherwise-specified AIP in 42 European university hospitals. Type 1 AIP was uniformly diagnosed using specific diagnostic criteria. Patients with type 2 AIP and those who had undergone pancreatic surgery were excluded. The primary end point was complete remission, defined as the absence of clinical symptoms and resolution of the index radiologic pancreatic abnormalities attributed to AIP. RESULTS: We included 735 individuals with AIP (69% male; median age, 57 years; 85% White). Steroid treatment was started in 634 patients, of whom 9 (1%) were lost to follow-up. The remaining 625 had a 79% (496/625) complete, 18% (111/625) partial, and 97% (607/625) cumulative remission rate, whereas 3% (18/625) did not achieve remission. No treatment was given in 95 patients, who had a 61% complete (58/95), 19% partial (18/95), and 80% cumulative (76/95) spontaneous remission rate. Higher (≥0.4 mg/kg/day) corticosteroid doses were no more effective than lower (<0.4 mg/kg/day) doses (odds ratio, 0.428; 95% confidence interval, 0.054-3.387) and neither was a starting dose duration >2 weeks (odds ratio, 0.908; 95% confidence interval, 0.818-1.009). Elevated IgG4 levels were independently associated with a decreased chance of complete remission (odds ratio, 0.639; 95% confidence interval, 0.427-0.955). Relapse occurred in 30% of patients. Relapses within 6 months of remission induction were independent of the steroid-tapering duration, induction treatment duration, and total cumulative dose. CONCLUSIONS: Patients with type 1 AIP and elevated IgG4 level may need closer monitoring. For remission induction, a starting dose of 0.4 mg/kg/day for 2 weeks followed by a short taper period seems effective. This study provides no evidence to support more aggressive regimens.

Endoscopic Ultrasound-Guided Gallbladder Drainage for Malignant Biliary Obstruction: A Systematic Review.

BACKGROUND: Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is a rescue technique for patients with malignant biliary obstruction who fail conventional treatment with ERCP or EUS-guided biliary drainage. The technique has been successfully employed in the management of acute cholecystitis in patients not fit for surgery. However, the evidence for its use in malignant obstruction is less robust. This review article aims to evaluate the data available at present to better understand the safety and efficacy of EUS-guided gallbladder drainage. METHODS: A detailed literature review was conducted and several databases were searched for any studies relating to EUS-GBD in malignant biliary obstruction. Pooled rates with 95% confidence intervals were calculated for clinical success and adverse events. RESULTS: Our search identified 298 studies related to EUS-GBD. The final analysis included 7 studies with 136 patients. The pooled rate of clinical success (95% CI) was 85% (78-90%, I2: 0%). The pooled rate of adverse events (95% CI) was 13% (7-19%, I2: 0%). Adverse events included: peritonitis, bleeding, bile leakage, stent migration, and stent occlusion. No deaths directly related to the procedure were reported; however, in some of the studies, deaths occurred due to disease progression. CONCLUSION: This review supports the use of EUS-guided gallbladder drainage as a rescue option for patients who have failed conventional measures.

Social deprivation does not impact on acute pancreatitis severity and mortality: a single-centre study.

BACKGROUND AND AIMS: The incidence of acute pancreatitis (AP) is increasing in the UK. Patients with severe AP require a significant amount of resources to support them during their admission. The ability to predict which patients will develop multiorgan dysfunction remains poor leading to a delay in the identification of these patients and a window of opportunity for early intervention is missed. Social deprivation has been linked with increased mortality across surgical specialties. Its role in predicting mortality in patients with AP remains unclear but would allow high-risk patients to be identified early and to focus resources on high-risk populations. METHODS: A prospectively collected single-centre database was analysed. English Index of Multiple Deprivation (IMD) was calculated based on postcode. Patients were grouped according to their English IMD quintile. Outcomes measured included all-cause mortality, Intestive care unit (ITU) admission, overall length of stay (LOS) and local pancreatitis-specific complications. RESULTS: 398 patients with AP between 2018 and 2021 were identified. There were significantly more patients with AP in Q1 (IMD 1-2) compared with Q5 (IMD 9-10) (156 vs 38, p<0.001). Patients who were resident in the most deprived areas were significantly younger (52.4 in Q1 vs 65.2 in Q5, p<0.001), and more often smokers (39.1% in Q1 vs 23.7% in Q5, p=0.044) with IHD (95.0% vs 92.1% in Q5, p<0.001). In multivariate modelling, there was no significance difference in pancreatitis-related complications, number of ITU visits, number of organs supported and overall, LOS by IMD quintile. CONCLUSIONS: Although there was a significantly higher number of patients admitted to our unit with AP from the most socially deprived quintiles, there was no correlation between social economic deprivation and mortality following AP.

Pancreaticobiliary versus head and neck presentation of immunoglobulin G4-related disease: different sides of the same coin?

BACKGROUND AND STUDY AIM: Immunoglobulin G4-related disease (IgG4-RD) is a rare immune mediated fibroinflammatory condition. Pancreaticobiliary (PB) and head and neck (HN) are two of the most commonly involved anatomical sites. It has been postulated that PB IgG4-RD and HN IgG4-RD have distinct clinical phenotypes. Whether the optimum treatment regimen or response to therapy differs between them is unknown. We aimed to assess differences between PB and HN IgG4-RD in a cohort of IgG4 disease managed by an IgG4-RD multispecialty team. METHODS: We performed a retrospective study of a prospectively maintained multidisciplinary IgG4-RD database to identify patients diagnosed with PB and HN IgG4-RD (based on initial presentation) between 2005 and 2019. The electronic patient records were reviewed. Use of immunosuppressive agents and clinical course was analysed. RESULTS: 60 patients with PB IgG4-RD and 14 with HN IgG4-RD were included in the study. PB IgG4-RD was associated with older age at diagnosis 64 versus 51 years (p<0.001), higher serum IgG4 level as a multiple of upper limit of normal median (IQR) 2 (1-3.75) vs 1 (1-2), (p=0.04) and greater proportion with more than one organ involved 68% vs 33% (p=0.03). HN IgG4-RD was more likely to receive second-line therapy 71% versus 36% (p=0.03). Persistent elevation of serum IgG4 after therapy was more common in PB IgG4-RD 84% versus 43% (p=0.03). CONCLUSION: These findings support the contention that PB IgG4-RD and HN IgG4-RD have different clinical profiles and represent distinct subtypes of IgG4-RD.

Impact of prior biliary stenting on diagnostic performance of endoscopic ultrasound for mesenteric vascular staging in patients with head of pancreas and periampullary malignancy.

OBJECTIVE: The diagnostic performance of endoscopic ultrasound (EUS) for stratification of head of pancreas and periampullary tumours into resectable, borderline resectable and locally advanced tumours is unclear as is the effect of endobiliary stents. The primary aim of the study was to assess the diagnostic performance of EUS for resectability according to stent status. DESIGN: A retrospective study was performed. All patients presenting with a solid head of pancreas mass who underwent EUS and surgery with curative intent during an 8-year period were included. Factors with possible impact on diagnostic performance of EUS were analysed using logistic regression. RESULTS: Ninety patients met inclusion criteria and formed the study group. A total of 49 (54%) patients had an indwelling biliary stent at the time of EUS, of which 36 were plastic and 13 were self-expanding metal stents (SEMS). Twenty patients underwent venous resection and reconstruction (VRR). Staging was successfully performed in 100% unstented cases, 97% plastic stent and 54% SEMS, p<0.0001. In successfully staged patients, sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) for classification of resectability were 70%, 70%, 70%, 42% and 88%. For vascular involvement (VI), sensitivity, specificity, accuracy, PPV and NPV were 80%, 68%, 69%, 26% and 96%. Increasing tumour size OR 0.53 (95% CI, 0.30 to 0.95) was associated with a decrease in accuracy of VI classification. CONCLUSIONS: EUS has modest diagnostic performance for stratification of staging. Staging was less likely to be completed when a SEMS was in situ. Staging EUS should ideally be performed before endoscopic retrograde cholangiopancreatography and biliary drainage.

Analgesia in the Initial Management of Acute Pancreatitis: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

BACKGROUND: The optimal analgesic strategy for patients with acute pancreatitis (AP) remains unknown. OBJECTIVE: The present systematic review and meta-analysis aims to compare the efficacy of different analgesic modalities trialled in AP. METHODS: A systematic search of PubMed, MEDLINE, EMBASE, CENTRAL, SCOPUS and Web of Science conducted up until June 2021, identified all randomised control trials (RCTs) comparing analgesic modalities in AP. A pooled analysis was undertaken of the improvement in pain scores as reported on visual analogue scale (VAS) on day 0, day 1 and day 2. RESULTS: Twelve RCTs were identified including 542 patients. Seven trial drugs were compared: opiates, non-steroidal anti-inflammatories (NSAIDs), metamizole, local anaesthetic, epidural, paracetamol, and placebo. Across all modalities, the pooled VAS scores showed global improvement from baseline to day 2. Epidural analgesia appears to provide the greatest improvement in VAS within the first 24 h but is equivalent to opiates by 48 h. Within 24 h, NSAIDs offered similar pain-relief to opiates, while placebo also showed equivalence to other modalities but then plateaued. Local anaesthetics demonstrated least overall efficacy. VAS scores for opiate and non-opiate analgesics were comparable at baseline and day 1. The identified RCTs demonstrated significant statistical and methodological heterogeneity in pain-relief reporting. CONCLUSIONS: There is remarkable paucity of level 1 evidence to guide pain management in AP with small datasets per study. Epidural administration appears effective within the first 24 h of AP although infrequently used and featured in only a single RCT. NSAIDs are an effective opiate sparing alternative during the first 24 h.

EUS-guided choledochoduodenostomy with electrocautery-enhanced lumen-apposing metal stents in patients with malignant distal biliary obstruction: multicenter collaboration from the United Kingdom and Ireland.

BACKGROUND AND AIMS: EUS-guided choledochoduodenostomy (EUS-CDD) with an electrocautery-enhanced lumen-apposing metal stent (EC-LAMS) has emerged as a viable method of establishing biliary drainage in patients with malignant distal biliary obstruction (MDBO). Our aim was to assess the efficacy, safety, and outcomes in patients with MDBO who underwent EUS-CDD with an EC-LAMS. METHODS: A retrospective review of consecutive patients with MDBO who underwent EUS-CDD with EC-LAMSs at 8 tertiary institutions across the United Kingdom and Ireland between September 2016 and November 2020 was undertaken. RESULTS: One hundred twenty patients (55% men) with a median age of 73 years (interquartile range, 17; range, 43-94) were included. The median follow-up period in 117 patients was 70 days (interquartile range, 169; range, 3-869), and 23 patients (19.2%) were alive at the end of the follow-up. Three patients were lost to follow-up. Technical success was achieved in 109 patients (90.8%). Clinical success (reduction of serum bilirubin to ≤50% of original value within 14 days) was achieved in 94.8% of patients (92/97). The adverse event rate was 17.5% (n = 21). Biliary reintervention after initial technical success was required in 9 patients (8.3%). CONCLUSIONS: EUS-CDD with EC-LAMSs at tertiary institutions within a regional hepatopancreatobiliary network for treatment of MDBO was effective in those where ERCP was not possible or was unsuccessful. When technical failures or adverse events occur, most patients can be managed with conservative or endoscopic therapy.

Diagnostic accuracy and interobserver agreement of digital single-operator cholangioscopy for indeterminate biliary strictures.

BACKGROUND AND AIMS: Digital single-operator cholangioscopy (d-SOC) with cholangioscopic biopsy sampling has shown promise in the evaluation of indeterminate biliary strictures. Some studies have suggested higher sensitivity for visual impression compared with biopsy sampling, although assessors were not blinded to previous investigations. We aimed to investigate the diagnostic accuracy and interobserver agreement (IOA) of d-SOC in the visual appraisal of biliary strictures when blinded to additional information. METHODS: A multicenter, international cohort study was performed. Cholangioscopic videos in patients with a known final diagnosis were systematically scored. Pseudonymized videos were reviewed by 19 experts in 2 steps: blinded for patient history and investigations and unblinded. RESULTS: Forty-four high-quality videos were reviewed of 19 benign and 25 malignant strictures. The sensitivity and specificity for the diagnosis of malignancy was 74.2% and 46.9% (blinded) and 72.7% and 62.5% (unblinded). Cholangioscopic certainty of a malignant diagnosis led to overdiagnosis (sensitivity, 90.6%; specificity, 33%), especially if no additional information was provided. The IOA for the presence of malignancy was fair for both assessments (Fleiss' κ = .245 [blinded] and κ = .321 [unblended]). For individual visual features, the IOA ranged from slight to moderate for both assessments (κ = .059-.400 vs κ = .031-.452). CONCLUSIONS: This study showed low sensitivity and specificity for blinded and unblinded d-SOC video appraisal of indeterminate biliary strictures, with considerable interobserver variation. Although reaching a consensus on the optical features of biliary strictures remains important, optimizing visually directed biopsy sampling may be the most important role of cholangioscopy in biliary stricture assessment.

Novel multidisciplinary hub-and-spoke tertiary service for the management of severe acute pancreatitis.

OBJECTIVE: Severe acute pancreatitis (SAP) is associated with high mortality (15%-30%). Current guidelines recommend these patients are best managed in a multidisciplinary team setting. This study reports experience in the management of SAP within the UK's first reported hub-and-spoke pancreatitis network. DESIGN: All patients with SAP referred to the remote care pancreatitis network between 2015 and 2017 were prospectively entered onto a database by a dedicated pancreatitis specialist nurse. Baseline characteristics, aetiology, intensive care unit (ICU) stay, interventions, complications, mortality and follow-up were analysed. RESULTS: 285 patients admitted with SAP to secondary care hospitals during the study period were discussed with the dedicated pancreatitis specialist nurse and referred to the regional service. 83/285 patients (29%; 37 male) were transferred to the specialist centre mainly for drainage of infected pancreatic fluid collections (PFC) in 95% (n=79) of patients. Among the patients transferred; 29 (35%) patients developed multiorgan failure with an inpatient mortality of 14% (n=12/83). The median follow-up was 18.2 months (IQR=11.25-35.51). Multivariate analysis showed that transferred patients had statistically significant longer overall hospital stay (p<0.001) but less ICU stay (p<0.012). CONCLUSION: This hub-and-spoke model facilitates the management of the majority of patients with SAP in secondary care setting. 29% warranted transfer to our tertiary centre, predominantly for endoscopic drainage of PFCs. An evidence-based approach with a low threshold for transfer to tertiary care centre can result in lower mortality for SAP and fewer days in ICU.

Effect of the SARS-CoV2 Pandemic on Endoscopy Provision - The Impact of Compliance with National Guidance.

Objective: There are limited data on the impact of the pandemic upon endoscopy service provision and quality indicators.Methods: Analysis of number and type of procedure, in-room time (minutes), key performance indicators, and list utilization was performed over three periods; pre-lockdown, lockdown, and early recovery and compared with the previous year.Results: Endoscopy activity reduced to 13.3% of the same period in 2019 with the largest drops in colonoscopy and flexible sigmoidoscopy numbers. In-room time increased significantly for gastroscopy (35 vs. 24, p < 0.0001), flexible sigmoidoscopy (20 vs. 15, p < 0.0001), endoscopic ultrasound (40 vs. 32, p = 0.0009), and ERCP (59 vs. 45, p = 0.0041). There was no increase for colonoscopy (35 vs 35, p = 0.129). There was a significant reduction in in-room time for gastroscopy alone (44.5 vs. 30.0, p = 0.0002) over the study period. There was no significant difference in cecal intubation rate, polyp detection rate, or biliary cannulation rate compared to the previous year.Conclusions: The pandemic has profoundly reduced the number of endoscopies performed with some recovery. In-room time has significantly increased but with the preservation of key performance indicators. List utilization remains a significant problem and resources need to be adequately aligned to improve this.

Utility of endoscopic ultrasound-guided fine-needle biopsy in the diagnosis of type 1 autoimmune pancreatitis.

Background and study aims Endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) performs poorly in the histological diagnosis of type 1 autoimmune pancreatitis (AIP). The aim of this study was to assess the performance of fine-needle biopsy (FNB) comparing reverse bevel (RB) and fork-tip (FT) needles. Patients and methods A retrospective study of prospectively maintained databases was performed. Patients with a final diagnosis of type 1 AIP who underwent EUS-FNB during diagnostic workup were included. Pathology reports were reviewed and classified as per international consensus diagnostic criteria (ICDC). The Primary outcome was EUS-FNB sensitivity in diagnosing type 1 AIP. Results Between March 2011 and December 2018, 24 patients with a final diagnosis of type 1 AIP underwent FNB. Six patients underwent biopsy with the RB needle and 18 with the FT needle. Mean age (±â€ŠSD) 62.2 (±â€Š11.4), 17 (70.8 %) male. No RB samples were diagnostic compared to 14 (78 %) FT; P  = 0.001; of which 13 (72 %) were level 1. In eight (44 %) of FT cases a diagnosis was not possible without histology. Initial biopsy was diagnostic in five (62.5 %) of these cases. Including repeat biopsy, seven (87 %) had a diagnosis made by FT needle. Obliterative phlebitis (44 %) was the least frequently identified pathological feature and immunoglobulin (IgG)4 + plasma cells > 10 per high power field (78 %) the most common. Conclusion The FT needle demonstrated good performance for diagnosing type 1 AIP. The results support the preferential use of this core biopsy needle for EUS pancreatic tissue sampling.

Fork-tip needle biopsy versus fine-needle aspiration in endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized crossover study.

BACKGROUND: A novel fork-tip fine-needle biopsy (FNB) needle has recently been introduced for endoscopic ultrasound (EUS)-guided sampling. The aim of this study was to compare the performance of fork-tip FNB histology and standard fine-needle aspiration (FNA) cytology in the diagnosis of solid pancreatic masses. METHODS: A randomized crossover study was performed in patients referred for EUS-guided sampling. Three passes were taken with each needle in a randomized order. Only samples reported as diagnostic of malignancy were considered positive. The primary end point was the sensitivity of diagnosis of malignancy. Secondary end points included the amount of sample obtained, ease of diagnosis, duration of tissue sampling, pathologist viewing time, and cost. RESULTS: 108 patients were recruited. Median age was 69 years (range 30 - 87) and 57 were male; 85.2 % had a final diagnosis of malignancy. There were statistically significant differences in sensitivity (82 % [95 % confidence interval (CI) 72 % to 89 %] vs. 71 % [95 %CI 60 % to 80 %]), accuracy (84 % [95 %CI 76 % to 91 %] vs. 75 % [95 %CI 66 % to 83 %]), proportion graded as a straightforward diagnosis (69 % [95 %CI 60 % to 78 %] vs. 51 % [95 %CI 41 % to 61 %]), and median pathology viewing time (188 vs. 332 seconds) (P < 0.001) between FNB and FNA needles, respectively. There was no significant difference in cost between an FNB or FNA strategy. CONCLUSION: The diagnostic performance of the fork-tip FNB needle was significantly better than that of FNA; it was associated with ease of diagnosis, shorter pathological viewing times, and was cost neutral.

Endoscopic ultrasound-guided fine-needle biopsy is superior to fine-needle aspiration in assessing pancreatic neuroendocrine tumors.

Background and study aims Pancreatic neuroendocrine tumors (PanNETs) outcomes are dependent upon grading by Ki67. This study compared endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) to fine-needle aspiration (FNA) in assessing PanNETs. Patients and methods All pancreatic histology for PanNET between January 2009 and June 2017 was included if EUS sampling was performed prior to surgical resection. Ki67 and grade from FNA and FNB samples was compared to surgical histology using correlation coefficient and kappa values. Subgroup analysis was performed for purely solid lesions, lesions < 2 cm and FNB needle type. Results One hundred sixity-four patients had PanNET of which 57 underwent surgical resection. Thirty-five lesions underwent FNA and 26 FNB (4 had both) confirming PanNET. 23/ of 35 FNA samples reported Ki67/grading compared to all 26 FNB samples ( P  = 0.0006). Compared to surgical histology, Ki67 on FNA correlated poorly overall (r = -0.08), in solid lesions (r = -0.102) and lesions < 2 cm (r = -0.149) whereas FNB correlated moderately overall (r = 0.65), in solid lesions (r = 0.64) and lesions < 2 cm (r = 0.61). Tumor grade showed poor agreement (kappa) with FNA overall (0.026), in solid lesions (0.044) and lesions < 2 cm (0.00) whereas FNB showed moderate-good agreement overall (0.474), in solid lesions (0.58) and lesions < 2 cm (0.745). Fork-tip FNB needles Ki67 showed strong correlation with surgical histology (r = 0.788) compared to reverse bevel FNB needles (r = 0.521). Both FNB needles showed moderate agreement with tumor grade. Conclusion FNB samples were significantly more likely than FNA to provide adequate material for Ki67/grading and showed a closer match to surgical histology. FNB needle types require prospective investigation.

Impact of metal and plastic stents on endoscopic ultrasound-guided aspiration cytology and core histology of head of pancreas masses.

BACKGROUND: Stents are frequently placed in patients with biliary obstruction due to a mass in the head of the pancreas. The impact of plastic or self-expandable metal stents (SEMSs) on endoscopic ultrasound (EUS)-guided tissue sampling is unclear. This study aimed to assess, using strict pathological criteria, whether stents impair fine-needle aspiration (FNA) or fine-needle biopsy (FNB). METHODS: All patients with a solid mass in the head of the pancreas who underwent EUS-guided tissue sampling between 2010 and 2016 at our unit were included. Factors with possible impact on diagnostic performance were analyzed using logistic regression. Analysis was performed using both strict (malignant only) and less strict (suspicious for malignancy) cutoffs. RESULTS: Of 631 individuals undergoing 698 procedures, 535 (84.8 %) had a final diagnosis of malignancy, 141 had SEMS, 149 had plastic stents, and 341 had no stent. Using strict criteria, SEMS were associated with an increased occurrence of incorrect diagnosis of EUS tissue sampling, with an odds ratio (OR) of 1.96 (95 % confidence interval [CI] 1.24 - 3.10). Increasing tumor size (OR 0.72, 95 %CI 0.59 - 0.87), increasing number of passes (OR 0.84, 95 %CI 0.72 - 0.99), and fork-tip biopsy needle (OR 0.52, 95 %CI 0.31 - 0.86) were independently associated with a decrease in incorrect diagnosis. Repeat tissue sampling was more common with SEMSs (10.2 %) than with plastic stents (2.9 %) or no stents (4.5 %) (P < 0.02). CONCLUSION: SEMS use had a negative impact on tissue diagnosis in pancreatic head masses, whereas use of a fork-tip biopsy needle and increasing number of passes were independently associated with improved accuracy.

Novel temperature-controlled RFA probe for treatment of blocked metal biliary stents in patients with pancreaticobiliary cancers: initial experience.

BACKGROUND AND STUDY AIMS: Radiofrequency ablation (RFA) is used to treat blocked biliary stents in patients with pancreaticobiliary (PB) tumors with varying results. We report our experience with a novel temperature-controlled probe for treatment of blocked metal stents. PATIENTS AND METHODS: Patients with histologically proven PB cancers and a blocked biliary stents were treated using ELRATM electrode (Taewoong Medical) under fluoroscopic guidance. Demographics, clinical outcome, stricture diameter improvements, complications and mortality at 30 days were prospectively recorded. RESULTS: Nine procedures were performed on seven patients (4 male, 3 female); mean age 65.33 (range 56 - 82 years). Mean stricture diameter prior to RFA was 1.13 mm (SD ±â€Š0.54) and 4.42 mm (SD ±â€Š1.54) following RFA ( P  < 0.0001). Five of seven patients (71 %) required additional stents to ensure optimal drainage. There were no procedure-related complications. Mean follow-up was 193.55 days (range 31 - 540) and three of nine patients (33 %) died due to terminal cancer. CONCLUSION: These are the first reported data on use of a temperature-controlled RFA catheter in humans to treat blocked metal biliary stents. The device is safe but further randomized trials are required to establish the efficacy and survival benefits of this probe.

A comparison of outcomes between a lumen-apposing metal stent with electrocautery-enhanced delivery system and a bi-flanged metal stent for drainage of walled-off pancreatic necrosis.

BACKGROUND AND STUDY AIMS: Bi-flanged metal stents (BFMS) have shown promise in the drainage of walled-off pancreatic necrosis (WON), but their placement requires multiple steps and the use of other devices. More recently, a novel device consisting of a combined lumen-apposing metal stent (LAMS) and electrocautery-enhanced delivery system has been introduced. The aim of this study was to compare the placement and outcomes of the two devices. PATIENTS AND METHODS: This was a retrospective review of consecutive patients undergoing endoscopic ultrasound-guided placement of BFMS or LAMS for drainage of symptomatic WON. Data from procedures between October 2012 and December 2016 were taken from a prospectively maintained database. We compared technical and clinical success, procedure time, costs, and composite end point of significant events (adverse events, stent migration, additional percutaneous drainage) between BFMS and LAMS. RESULTS: 72 consecutive patients underwent placement of BFMS (40 patients, 44 stents) or LAMS (32 patients, 33 stents). Technical success was 91 % for BFMS and 97 % for LAMS. Clinical success was 65 % vs. 78 %, respectively. Median in-room procedure time was significantly shorter in the LAMS group (45 minutes [range 30 - 80]) than in the BFMS group (62.5 minutes [range 35 - 135]; P  < 0.001) and fewer direct endoscopic necrosectomies (DEN) were performed (median 1 [0 - 2.0] vs. 2 [0 - 3.7], respectively; P  = 0.005). If only inpatients were considered (35 BFMS and 19 LAMS), there was no significant difference in DEN 2 (range 0 - 11) and 2 (range 0 - 8), respectively. The composite end point of 32 % vs. 24 % was not significantly different. Median procedural costs for all patients with successful stent placement for WON treatment was €4427 (range 1630 - 12 926) for BFMS vs. €3500 (range 2509 - 13 393) for LAMS ( P  = 0.10). CONCLUSION: LAMS was superior to BFMS in terms of procedure time, with comparable adverse events, success, and costs.

Therapeutic endoscopic ultrasound.

Endoscopic ultrasound (EUS) is now firmly established as one of the essential tools for diagnosis in most gastrointestinal MDTs across the UK. However, the ability to provide therapy with EUS has resulted in a significant impact on the management of the patients. These include drainage of peripancreatic collections, EUS-guided endoscopic retrograde cholangiopancreatogram, EUS-guided coeliac plexus blocks, etc. The rapid development of this area in endoscopy is a combination of newer tools and increasing expertise by endosonographers to push the boundaries of intervention with EUS. However, the indications are limited and we are at the start of the learning curve for these high-risk procedures. These therapies should, therefore, be confined to centres with a robust multidisciplinary team, including interventional endoscopists, radiologists and surgeons.

Comparison of the diagnostic performance of 2 core biopsy needles for EUS-guided tissue acquisition from solid pancreatic lesions.

BACKGROUND AND AIMS: A new core biopsy needle with a novel tip, opposing bevel, and sheath design has recently been introduced for EUS-guided fine-needle biopsy (FNB). The diagnostic utility of this needle for differentiating solid pancreatic masses is currently unknown. The aim of this study was to compare the diagnostic performance and yield for tissue acquisition from solid pancreatic lesions of the opposing bevel needle with those of a reverse bevel EUS-FNB needle. METHODS: Consecutive patients with solid pancreatic masses undergoing EUS-FNB using the opposing bevel (n = 101) and the reverse bevel (n = 100) core biopsy needles were included in the study. Final diagnosis was based on positive histology or at least 12 months of follow-up in cases with a negative biopsy. The primary outcome was the diagnostic performance of the 2 needles for malignant pancreatic masses. A secondary outcome was the diagnostic yield. RESULTS: Compared with the reverse bevel needle, using strict criteria the opposing bevel needle provided significantly higher sensitivity (71.1% vs 90.1%; P = .0006) and overall accuracy (74% vs 92%; I = 0.0006) for discriminating malignant from benign solid pancreatic masses. The proportion of samples classified as adequate for histologic analysis was 87% for the reverse bevel needle versus 99% for the opposing bevel needle (p = 0.002) Multivariate analysis controlling the needle gauge and site did not show any significant difference in accuracy and sensitivity between the 2 groups. There were no adverse events in either group. CONCLUSIONS: In this first, large, single-center preliminary cohort study, an EUS core biopsy needle with a novel tip, opposing bevel, and sheath design afforded substantially superior tissue yield and diagnostic performance compared with a reverse-bevel needle. If replicated by randomized controlled trials, our findings suggest that similarly designed needles could become the standard of care for EUS-guided tissue acquisition from solid pancreatic masses.

Endoscopic drainage of walled-off pancreatic necrosis using a novel self-expanding metal stent.

BACKGROUND AND STUDY AIMS: This report describes the use of a novel, fully covered, self-expanding metal stent (FCSEMS) for endoscopic ultrasound (EUS)-guided drainage of walled-off pancreatic necrosis (WON). PATIENTS AND METHODS: Patients with WON, as defined by the revised Atlanta Criteria, were included in this open-lable, two-center, observational study. The WON was punctured using a cystotome, and the FCSEMS was inserted under fluoroscopic guidance. Necrosectomy procedures were performed as necessary. RESULTS: A total of 19 patients were included. The median maximum collection size was 15 cm with a median of 50 % necrosis. A total of 14/19 patients underwent necrosectomy, requiring a median of 4 procedures. Resolution or reduction in the size of collection by at least 80 % was achieved in all patients. Percutaneous or surgical drainage was required in three patients. Five stents migrated or dislodged. One patient had abdominal pain post-procedure. Five patients died during follow-up (three from multi-organ failure, and two unrelated to pancreatitis). CONCLUSIONS: Use of this stent is feasible and safe for drainage of WON. However, stent displacement rates were high, and improvements to the stent design are required before it can be advocated for routine use in WON.