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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.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.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 after40 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%).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.

Gallstone disease is a recognized complication of bariatric surgery. Subsequent management of choledocholithiasis may be challenging due to altered anatomy which may include Roux-en-Y gastric bypass (RYGB). We conducted a retrospective service evaluation study to assess the safety and efficacy of endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) in patients with RYGB anatomy.All the patients who underwent EDGE for endoscopic retrograde cholangiopancreatography after RYGB at two tertiary care centers in the United Kingdom between January 2020 and October 2021 were included in the study. Clinical and demographic details were recorded for all patients. The primary outcome measures were technical and clinical success. Adverse events were recorded. Hot Axios lumen apposing metal stents measuring 20 mm in diameter and 10 mm in length were used in all the patients for creation of a gastro-gastric or gastro-jejunal fistula.A total of 14 patients underwent EDGE during the study period. The majority of the patients were female (85.7%) and the mean age of patients was 65.8 ± 9.8 years. Technical success was achieved in all but one patient at the first attempt (92.8%) and clinical success was achieved in 100% of the patients. Complications arose in 3 patients with 1 patient experiencing persistent fistula and weight gain.In patients with RYGB anatomy, EDGE facilitated biliary access has a high rate of clinical success with an acceptable safety profile. Adverse events are uncommon and can be managed endoscopically.

Background Endoscopic ultrasound guided gastrojejunostomy (EUS-GJ) with lumen apposing metal stents has recently emerged as a viable option, as an alternative to surgical gastrojejunostomy and endoscopic enteral stenting, for managing gastric outlet obstruction (GOO). We aim to perform a retrospective analysis of the efficacy, safety and outcomes of EUS-GJ performed at three tertiary institutions in the United Kingdom. Methods Consecutive patients who underwent EUS-GJ between August 2018 and March 2021 were identified from a prospectively maintained database. Data were obtained from interrogation of electronic health records. Results Twenty five patients (15 males) with a median age of 63 years old (range 29–80) were included for analysis. 88% (22/25) of patients had GOO due to underlying malignant disease. All patients were deemed surgically inoperable or at high surgical risk. Both technical and clinical success were achieved in 92% (23/25) of patients. There was an improvement in the mean Gastric Outlet Obstruction Scoring System scores following a technically successful EUS-GJ (2.52 vs 0.68, p Conclusion EUS-GJ in carefully selected patients is an effective and safe procedure when performed by experienced endoscopists.

Background Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) is an alternative to enteroscopy- and laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Although short-term results are promising, the long-term outcomes are not known. The aims of this study were: (1) to determine the rates of long-term adverse events after EDGE, with a focus on rates of persistent gastrogastric or jejunogastric fistula; (2) to identify predictors of persistent fistula; (3) to assess the outcomes of endoscopic closure when persistent fistula is encountered. Methods This was a multicenter retrospective study involving 13 centers between February 2015 and March 2019. Adverse events were defined according to the ASGE lexicon. Persistent fistula was defined as an upper gastrointestinal series or esophagogastroduodenoscopy showing evidence of fistula. Results 178 patients (mean age 58 years, 79 % women) underwent EDGE. Technical success was achieved in 98 % of cases (175/178), with a mean procedure time of 92 minutes. Periprocedural adverse events occurred in 28 patients (15.7 %; mild 10.1 %, moderate 3.4 %, severe 2.2 %). The four severe adverse events were managed laparoscopically. Persistent fistula was diagnosed in 10 % of those sent for objective testing (9/90). Following identification of a fistula, 5 /9 patients underwent endoscopic closure procedures, which were successful in all cases. Conclusions The EDGE procedure is associated with high clinical success rates and an acceptable risk profile. Persistent fistulas after lumen-apposing stent removal are uncommon, but objective testing is recommended to identify their presence. When persistent fistulas are identified, endoscopic treatment is warranted, and should be successful in closing the fistula.

Placement of a lumen-apposing metal stent (LAMS) between the gastric pouch and the excluded stomach allows for EUS-guided transgastric interventions (EDGIs) in patients with Roux-en-Y gastric bypass (RYGB). Although EUS-guided transgastric ERCP (EDGE) outcomes have been reported, data are scant on other endoscopic interventions. We aimed to evaluate the outcomes and safety of EDGIs.This retrospective study involved 9 centers (United States, 8; Europe, 1) and included patients with RYGB who underwent EDGIs between June 2015 and September 2021. The primary outcome was the technical success of EDGIs. Secondary outcomes were adverse events (AEs), length of hospital stay, and fistula follow-up and management.Fifty-four EDGI procedures were performed in 47 patients (mean age, 61 years; 72% women), most commonly for the evaluation of a pancreatic mass (n = 16) and management of pancreatic fluid collections (n = 10). A 20-mm LAMS was used in 26 patients and a 15-mm LAMS in 21, creating a gastrogastrostomy in 37 patients and jejunogastrostomy in 10. Most patients (n = 30, 64%) underwent a dual-session EDGI, with a median interval of 17 days between the 2 procedures. Single-session EDGI was performed in 17 patients, of whom 10 (59%) had anchoring of the LAMS. The most common interventions were diagnostic EUS (with or without FNA or fine-needle biopsy sampling; n = 28) and EUS-guided cystgastrostomy (n = 8). The mean procedural time was 97.6 ± 78.9 minutes. Technical success was achieved in 52 patients (96%). AEs occurred in 5 patients (10.6%), of which only 1 AE (2.1%) was graded as severe. Intraprocedural LAMS migration was the most common AE, occurring in 3 patients (6.4%), whereas delayed spontaneous LAMS migration occurred in 2 (4.3%). Four of the 5 LAMS migration events were managed endoscopically, and 1 required surgical repair. LAMS anchoring was found to be protective against LAMS migration (P = .001). The median duration of hospital stay was 2.1 ± 3.7 days. Of the 17 patients who underwent objective fistula assessment endoscopically or radiologically after LAMS removal, 2 (11.7%) were found to have persistent fistulas. In 1 case the fistula was intentionally left open to assist with weight gain. The other fistula was successfully closed endoscopically.EDGI is effective and safe for the diagnosis and management of pancreaticobiliary and foregut disorders in RYGB patients. It is associated with high rates of technical success and low rates of severe AEs. LAMS migration is the most common AE with evidence that anchoring can be protective against its occurrence. Persistent fistulas may occur, but endoscopic closure seems to be effective.

Background and Aims Stent misdeployment (SM) has hindered the dissemination of EUS-guided gastroenterostomy (EUS-GE) for gastric outlet obstruction (GOO) management. We aimed to provide a classification system for SM during EUS-GE and study clinical outcomes and management accordingly. Methods This is a retrospective study involving 16 tertiary care centers (8 in the United States, 8 in Europe) from March 2015 to December 2020. Patients who developed SM during EUS-GE for GOO were included. We propose classifying SM into 4 types. The primary outcome was rate and severity of SM (per American Society for Gastrointestinal Endoscopy lexicon), whereas secondary outcomes were clinical outcomes and management of dislodgement according to the SM classification type, in addition to salvage management of GOO after SM. Results From 467 EUS-GEs performed for GOO during the study period, SM occurred in 46 patients (9.85%). Most SMs (73.2%) occurred during the first 13 EUS-GE cases by the performing operators. SM was graded as mild (n = 28, 60.9%), moderate (n = 11, 23.9%), severe (n = 6, 13.0%), or fatal (n = 1, 2.2%), with 5 patients (10.9%) requiring surgical intervention. Type I SM was the most common (n = 29, 63.1%), followed by type II (n = 14, 30.4%), type IV (n = 2, 4.3%), and type III (n = 1, 2.2%). Type I SM was more frequently rated as mild compared with type II SM (75.9% vs 42.9%, P = .04) despite an equivalent rate of surgical repair (10.3% vs 7.1%, P = .7). Overall, 4 patients (8.7%) required an intensive care unit stay (median, 2.5 days). The median length of stay was 4 days after SM. Conclusions Although SM is not infrequent during EUS-GE, most are type I, mild/moderate in severity, and can be managed endoscopically with a surgical intervention rate of approximately 11%.

Background Choledocholithiasis is common, with patients usually treated with ERCP and subsequent cholecystectomy to remove the presumed source of common bile duct (CBD) stones. However, previous investigations into the management of patients following ERCP have focussed on recurrent CBD stones, negating the risks of cholecystectomy. Methods Patients undergoing ERCP and CBD clearance for choledocholithiasis at St James’s University Hospital January 2015 - December 2018 were included. Patients were divided into those who received cholecystectomy and those managed non-operatively. Readmissions, operative morbidity, mortality and treatment costs were investigated. Results 844 patients received ERCP and CBD clearance with 3.9 years follow up. 209 patients underwent cholecystectomy with 15% requiring complex surgery. 373 patients were non-operatively managed. Unplanned readmissions occurred in 15% following ERCP, mostly within two years. There was no difference in readmissions between the two groups. Accounting for the entire patient pathway, non-operative management was less expensive. Conclusions The majority of patients do not require readmission following ERCP for CBD stones and cholecystectomy did not reduce the risk of readmission. Few patients have recurrent CBD stones, but difficult biliary surgery is frequently required. Routine cholecystectomy following ERCP needs to be re-evaluated and a more stratified approach to future risk developed.

This review outlines the current classification of pancreatic cystic lesions, with a particular emphasis on pancreatic cystic neoplasms (PCNs). It will describe the diagnostic approach to PCNs, with reference to clinicopathological features, cross-sectional radiology and endoscopic ultrasound. This review will conclude with an evidence-based discussion of the management of PCNs focused on recent clinical guidelines.

Background and Aims Endoscopic ultrasound-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 MDBO. Our aim was to assess the efficacy, safety, and outcomes in patients with malignant distal biliary obstruction (MDBO), who underwent EUS-CDD with EC-LAMS. Methods A retrospective review of consecutive patients with MDBO who underwent EUS-CDD with EC-LAMS at 8 tertiary institutions across the United Kingdom and Ireland between September 2016 to November 2020 was undertaken. Results One hundred twenty patients (55% male) with a median age of 73 years (IQR 17, range 43 – 94) were included. The median follow-up period in 117 patients was 70 days (IQR 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% (92/97 patients). The adverse event (AE) rate was 17.5% (n=21). Biliary reintervention after initial technical success was required in 9 patients (8.3%). Conclusion EUS-CDD with EC-LAMS at tertiary institutions within a regional HPB network for treatment of MDBO is effective in those where ERCP was not possible or unsuccessful. When technical failures or adverse events occur, the majority can be managed with conservative or endoscopic therapy

Biliary drainage with ERCP is successful in only 80% to 90% of cases of extrahepatic cholangiocarcinoma and pancreatic cancer. We present the results of a multicenter prospective study assessing the safety, feasibility, and quality of life of patients after EUS-guided biliary drainage (EUS-BD) with lumen-apposing metal stents after failed ERCP.All consecutive adults with a dilated common bile duct (CBD) ≥14 mm secondary to inoperable malignant distal CBD stricture and failed ERCP biliary drainage were screened and recruited from 3 tertiary UK centers. Technical success of EUS-BD using lumen-apposing metal stents was the primary endpoint. Improvement in serum bilirubin level, 30-day mortality, procedure-related adverse events, and quality of life were secondary endpoints. Improvement in quality of life was measured using a validated questionnaire (EORTC QLQ-BIL21).Twenty patients were included in the analysis. EUS-BD was technically successful in all patients and the clinical success rate was 95% (19 of 20) at day 7 (50% reduction in bilirubin level) and 92.3% (12 of 13) at day 30 (bilirubin 50 μmol/L). There were significant improvements in overall quality of life score (49 vs 42, P = .03) at day 30. All-cause 30-day mortality was 20% and the moderate adverse event rate was 10% (1 cholangitis and 1 stent migration).EUS-BD has acceptable technical success and safety as a second-line palliative treatment for inoperable malignant distal CBD strictures. Randomized controlled studies comparing EUS-BD with percutaneous transhepatic biliary drainage are needed to determine their effectiveness in clinical practice. (ISCRTN registration number: ISRCTN13196704.).

ObjectiveThere is a paucity of studies in the literature body evaluating short term outcomes following endoscopic retrograde cholangiopancreatography (ERCP) in patients with inoperable malignant hilar biliary obstruction (MHBO). We aimed to primarily evaluate 30-day mortality in these patients and secondarily, conduct a systematic review of studies reporting 30-day mortality.DesignWe conducted a retrospective analysis of all patients with inoperable MHBO who underwent ERCP at Leeds Teaching Hospitals NHS Trust between February 2015 and September 2020. Logistic regression models constructed from baseline patient data, the modified Glasgow Prognostic Score (mGPS) and Charlson Comorbidity Index (CCI) were evaluated as predictors of 30-day mortality.ResultsEighty-seven patients (49 males) with a mean age of 70.4 years (SD ±12.3) were included. Cholangiocarcinoma was the most common aetiology of MHBO affecting 35/87 (40.2%). Technical success was achieved in 72/87 (82.8%). The 30-day mortality rate was 25.3% (22/87), of which 16 were due to progression of underlying malignant disease. On multivariate analysis, only leucocytosis (OR 4.12, 95% CI 2.70 to 7.41, p=0.02) was an independent predictor of 30-day mortality. Neither mGPS (p=0.47) nor CCI with a cut-off value of ≥7 (p=0.06) were significant predictors of 30-day mortality.ConclusionWe demonstrated that 30-day mortality following ERCP for inoperable MHBO remains high despite technical success. Further studies are warranted to identify patients most appropriate for intervention.

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.

The diagnosis of biliary strictures can be challenging. Endoscopy has an established role in the diagnosis and therapy of biliary strictures. However, the diagnostic yield from conventional endoscopic retrograde cholangiopancreatography tissue sampling is modest. Improvements in existing technologies as well as the implementation of novel technologies and techniques have the potential to improve the diagnostic performance of endoscopy and expand its therapeutic role. Recent studies have enabled greater clarity about the role of preoperative biliary drainage and the choice of stents in this setting as well as the utility of metal stents in benign and malignant disease.

Introduction Endoscopic ultrasound (EUS) fine needle aspiration (FNA) has poor performance in diagnosing autoimmune pancreatitis (AIP) due to small sample size and lack of preserved tissue architecture. In mass forming disease non-diagnostic EUS-FNA may result in a presumptive diagnosis of malignancy and unnecessary surgery. A core biopsy needle with a novel fork-tip design (SharkCore™) has been introduced with the aim of improving yield and maintaining tissue architecture. Literature on its performance in the diagnosis of AIP is limited to a few case reports. Aim To assess the diagnostic performance of EUS tissue sampling with a fork-tip needle in the diagnosis of type 1 AIP. Methods Retrospective review of a prospectively maintained AIP database in a tertiary center to identify patients with a final diagnosis of type 1 AIP who underwent EUS-TS during diagnostic workup. Pathology reports were reviewed and classified as per International Consensus Diagnostic Criteria (ICDC); Level 1 (highly suggestive) requires the presence of 3 or all 4 histological features and level 2 (probable) requires 2 features. Results Between March 2006 and November 2018, 35 procedures were performed on 28 individuals (29 lesions) with a final diagnosis of Type 1 AIP. Mean age ( ± SD) 63 (±11.4), 21 male. 29 procedures were for a mass lesion and or biliary obstruction. 2 patients underwent surgical resection and 2 laparoscopic biopsy. There were 8 procedures with an FNA needle, 7 reverse bevel and 20 fork-tip. There were 6 inadequate samples (3 FNA, 2 reverse bevel and 1 fork-tip). Of the 29 adequate samples, 15 (51.7%) met ICDC criteria for diagnosis of AIP all at level 1. 0/13 FNA or reverse bevel samples were diagnostic compared to 15/19 (79%) fork-tip samples (p=0.0001). Obliterative phlebitis was identified in 10/19 (52.6%), storiform fibrosis in 14/19 (70%), dense lymphoplasmocytic infiltrate in 14/19 (70%) and IgG4 positive plasma cell count > 10 per high power field in 14/19 (70%) of adequate fork-tip samples. Of the 17 individuals who underwent 20 procedures (2 repeat and 1 sampling of 2 separate lesions) with a fork-tip needle, 14 (83.2%) had a final ICDC level 1 diagnostic fork-tip biopsy. Conclusion In this the largest study to date of the fork-tip core biopsy needle in the diagnosis of AIP, the needle demonstrated very good overall diagnostic performance. This study supports the preferential use of this needle in suspected type 1 AIP.

Background and study aims Pancreatic fluid collection (PFC) is a common complication of pancreatitis for which endoscopic ultrasound-guided drainage is first-line treatment. A new single-device, lumen-apposing, covered self-expanding metal stent (LAMS) has been licensed for PFC drainage. We therefore present our multicenter experience with the LAMS for PFC drainage in a multicenter prospective case series to assess success and complication rates. Patients and methods All adult patients from 11 tertiary centers who had LAMS placement for PFC from July 2015 to July 2016 were included. Data including indications, technical success, clinical success, collection resolution, stent removal, early and late adverse events (AEs), mortality and recurrence at 6 months were collected. Results 116 patients, median age 52.5 years (range 16 – 80) and 67 % male, were treated with a single LAMS in each case. The indication was walled off necrosis (WON) in 70 and pseudocyst in 46. Median size of the PFC was 11 cm (5 – 21 cm) and the estimated median necrotic volume in WON was 30 % (5 % – 90 %). Stent insertion was technically successful in 115 (99.1 %) and clinically successful in 109 (94 %). Early serious AEs (SAEs): n = 7 sepsis, n = 1 stent blockage with food, n = 1 stent migration requiring laparotomy, n = 1 stent dislodgement and n = 1 bleeding requiring emboliZation. Late AEs: n = 1 buried stent and n = 1 esophageal fistula. Non-procedure-related deaths: n = 3 (2.5 %). Conclusion This multicenter case series demonstrates that use of the new LAMS is feasible, effective and relatively safe in draining PFC with a technical success rate of 99 % and cumulative SAE rate of 11.2 %.

Endoscopic retrograde cholangiopancreatography (ERCP) in the UK has been historically performed under conscious sedation. However, given the increasing complexity of cases, the role of propofol-assisted ERCP (propERCP) is increasing. We describe our experience of propERCP and highlight the importance of this service.Our prospective ERCP database was interrogated between January 2013 and January 2014. Data collection included procedural information, patient demographics, American Association of Anaesthesiologists (ASA) status, Cotton grade of endoscopic difficulty and endoscopic and anaesthetic complications. Comparison was made with patients undergoing conscious sedation ERCP (sedERCP).744 ERCPs were performed in 629 patients (53% male). 161 ERCPs were performed under propofol. PropERCP patients were younger compared with the sedERCP group (54 vs 66 years, p0.0001) but ASA grade 1-2 status was similar (84% vs 78%, p=0.6). An increased number of Cotton grade 3-4 ERCPs were performed in the propERCP group (64% vs 34%, p0.0001). Indications for propERCP included sphincter of Oddi manometry (27%), previously poorly tolerated sedERCP (26%), cholangioscopy (21%) and patient request (8%). 77% of cases were elective, 12% were urgent day-case transfers and 11% were urgent inpatients. 59% of cases were tertiary referrals. ERCP was completed successfully in 95% of cases. Anaesthetic and endoscopic complications were comparable between the two groups (5% and 7% vs 3% and 5%). Where sedERCP had been unsuccessful due to patient intolerance, the procedure was completed successfully using propofol.PropERCP is safe and is associated with high endoscopic success. The need for propERCP is likely to increase given patient preference and the high proportion of complex procedures being undertaken. All endoscopy units should look to incorporate propofol-assisted endoscopy into aspects of their services.

Background Bariatric gastric bypass surgery is being increasingly performed, but endoscopic retrograde cholangiopancreatography (ERCP) in these patients poses a unique challenge because of a lack of per-oral access to the stomach. Small series suggest a higher technical success rate using laparoscopy-assisted ERCP (LA-ERCP) than with an enteroscopic approach via the Roux-en-Y anastomosis. We present initial experience of LA-ERCP in our unit. Design Retrospective case series of consecutive patients undergoing LA-ERCP in our unit between September 2011 and July 2014. Data was retrieved from electronic, clinical and endoscopy records. Results Seven LA-ERCPs were performed. All seven patients were female, with median age 44 years (range 36–71). Indications included symptomatic bile duct stones (5/7), benign papillary fibrosis (1/7) and retained biliary stent (1/7). 5/7 (71%) patients had had a prior cholecystectomy. To facilitate LA-ERCP, laparoscopic gastrostomy ports were created in all patients. Duodenal access, biliary cannulation and completion of therapeutic aim were achieved in all patients. 6/7 (86%) patients required endoscopic sphincterotomy. The median duration of procedures was 94 min (range 70–135). Median postoperative length of stay was 2 days (range 1–9). One patient developed mild postprocedural acute pancreatitis, and another patient developed a mild port-site infection. Otherwise, no procedure-related complications were seen. All patients remained well on follow-up (median 14 months (range 1–35) from date of ERCP), with no evidence of further biliary symptoms. Conclusions Our early experience of LA-ERCP is that it is safe and effective. The technique may require particular consideration, as bariatric surgery is increasingly performed, in a patient group at significant risk of bile duct stones.

Introduction Endoscopic retrograde cholangiopancreatography (ERCP) is used as the first-line modality for biliary drainage in patients with obstructive jaundice. However, anatomical or technical factors may preclude conventional trans-papillary biliary access in less than 10% of cases. Endoscopic ultrasound-guided biliary drainage (EUS-BD) has recently emerged as an alternative method to percutaneous transhepatic biliary drainage (PTBD) or surgical biliary bypass after unsuccessful ERCP in patients with inoperable pancreatobiliary malignancies. We present initial experience of EUS-BD in our unit. Methods A prospectively collected database, of consecutive patients undergoing EUS-BD in our unit, was analysed. Data was retrieved from electronic, clinical and endoscopy records. All EUS-BD procedures were undertaken in the endoscopy department, under conscious sedation, using Pentax echoendoscopes and Hitachi ultrasound workstations. In all cases, conventional diagnostic EUS procedure was performed followed by trans-luminal EUS-guided placement of metal stents. One of three endoscopists (KO/MN/MD) performed the procedures. The primary outcome measurements were technical success, clinical success and adverse events. Results 4 EUS-BD procedures were performed in 4 patients – ¾ were female (75%) with median age 70 years (range 51–79). The primary indication in all patients was malignant biliary obstruction, which was not amenable to either PTBD or surgery. One patient had symptomatic cystic duct obstruction with gallbladder empyema. 1 patient received a Hot AXIOS™ covered lumen apposing metal stent (cLAMS), 1 had a Wallflex™ biliary fully covered self-expanding metal stent (fcSEMS) and the others had NAGI™ covered self-expanding metal stents (cSEMS) inserted. Technical and clinical success was 100% across all procedures with symptomatic improvement noted in all patients. Serum bilirubin measurements decremented post EUS-BD by median 89% (range 85–98%). No procedure related complications were seen. During follow up, 3/4 patients have died (median 7 months (range 3–8) from date of EUS-BD) of end-stage disease (unrelated to the EUS-BD procedure). The 4th patient remains clinically stable on follow-up (2 months after EUS-BD) with no evidence of further biliary symptoms. Conclusion Our early experience of EUS-BD confirms that it is a safe and effective palliative procedure in patients with malignant biliary tract obstruction, in whom surgery and/or PTBD are less favourable. We recommend that EUS-BD is performed after multidisciplinary team discussion and by experienced therapeutic endosonographers. Disclosure of Interest None Declared

Introduction A new core biopsy needle (SharkCore) with a novel design has recently been introduced for endoscopic ultrasound guided biopsy. There is as yet no data on how its diagnostic performance compares to the existing core biopsy needle (Procore) in the diagnosis of pancreatic masses. The aim of this study was to compare the diagnostic performance and yield of the two core biopsy needles i.e. the ProCore and the Sharkcore needles in the biopsy of solid pancreatic lesions. This is the first study in literature to compare 2 core biopsy needles. Methods A retrospective comparison of a prospectively maintained database. Consecutive patients who had EUS guided fine needle biopsy with Procore (100) and Sharkcore (101) were included in the study. Demographic details, site of lesion, number of passes and histological diagnosis. Final diagnosis was based on positive histology or at least 6 months follow up in cases with a benign pathology. Primary outcome was to compare the diagnostic accuracy of the two needles using only samples graded as definitely malignant as diagnostic for malignancy. The secondary outcome was to compare the diagnostic yield for both needles. Results The sensitivity, specificity, negative predictive value and accuracy between the groups were - Procore =71%, 100%, 28% and 74% vs. Sharkcore =91%, 100%, 53% and 94%. There was a significant difference in sensitivity (p = 0.0003) and accuracy (p = 0.006). The proportion of samples classified as adequate for histological analysis was 87% for Procore and 99% for Sharkcore - this was significantly different (p = 0.0009). There were no complications in either group. Conclusion In this study the SharkCore biopsy needle demonstrated significantly better diagnostic accuracy and tissue yield. Prospective randomised studies are required. Disclosure of Interest None Declared

Introduction In cases of obstruction of the gallbladder (GB) or cystic duct where surgery is high risk, EUS guided GB drainage (EUS-GBD) is reported to have comparable efficacy to percutaneous drainage. 1 However, the technique has not been widely adopted due to lack of specific devices and concerns about leakage and stent migration. Lumen apposing metal stents (LAMS) have been developed to minimise the risk and simplify the procedure. A novel (Hot AXIOS™) device has recently become available and this consists of a stent and electrocautery-enhanced delivery system, enabling a single device to be used when previously multiple devices and steps were required. There is a single case report of its use for EUS-GBD in the literature. 2 A 68 year-old female, presented with obstructive jaundice, due to inoperable hilar cholangiocarcinoma. A Percutaneous transhepatic cholangiography (PTC) procedure was performed and an internal external drain placed. Shortly afterwards she developed clinical features of cholecystitis. A CT scan showed gross distension of the GB and a GB stone. There was extensive pericholecystic fluid with fat stranding. Following HPB MDT discussion, a decision was made to perform EUS-GBD using a Hot AXIOS™. Methods The procedure was undertaken under conscious sedation, using a therapeutic echoendoscope. The optimal site for access was identified as being in the antrum. The GB was punctured with the Hot-AXIOS device (15 mm x 10 mm (W x L) 24 mm flange diameter stent) and a cutting current was applied. X-ray screening was used; however, deployment was entirely under EUS control. The stent was dilated with a 10 mm balloon. Results The procedure was well tolerated and completed within 15 minutes. The stent was in a good position on EUS and fluoroscopy. A large amount of pus drained immediately. There was a rapid improvement in clinical condition and inflammatory markers over the next few days. Biliary drainage was internalised with placement of 2 metal stents. CT scans 8 days and 7 weeks post placement showed the stent in a good position with resolution of the cholecystitis. Conclusion Technical and clinical success was achieved in this case which to the best of our knowledge is the first EUS-GBD procedure in the UK utilising this device. Further experience of EUS-GBD with the Hot AXIOS™ and randomised controlled trials against percutaneous drainage are required to delineate its role in high risk surgical cases. References 1 Jang JW, et al. Gastroenterol . 2012 Apr; 142 (4):805–11. 2 Teoh AYB, et al. GIE 2014; 80 (6):1171. Disclosure of Interest None Declared

A 70-year-old man presented with acute coronary syndrome 3 weeks after plastic stent insertion for hilar biliary stricturing secondary to IgG4-related sclerosing cholangitis (IgG4-SC). Imaging demonstrated haemopericardium due to proximal migration of the plastic biliary stent through the liver capsule and diaphragm into the pericardial sac. The stent was endoscopically removed and a pericardiocentesis was performed. The patient's clinical condition rapidly improved. We illustrate an unusual but potentially serious complication that may arise from migration of a biliary stent and discuss a management strategy.

Introduction Symptomatic benign biliary strictures (BBS) in chronic pancreatitis (CP) have historically been treated with surgical biliary bypass or multiple plastic stents. We report our experience of fully covered self-expanding metal stents (fcSEMS) for this indication in a cohort of patients with CP. Methods A prospectively recorded ERCP database including all CP patients undergoing fcSEMS for BBS, between Oct 2008 and Aug 2013, was analysed. Demographics, pathology results, stent data and patient outcomes were collated. Results A total of 256 ERCPs involving biliary SEMS insertion were performed of which 115 (45%) were fcSEMS. 48/115 (42%) fcSEMS were performed in 24 patients (75% Male, median age 55 years) with BBS related to CP. Aetiological factors included alcohol (63%), autoimmune (13%) and idiopathic (8%). Surgical bypass was precluded in 23/24 (96%) patients due to extensive choledochal varices (58%), advanced cirrhosis (13%), medical comorbidities (13%), hostile surgical abdomen (13%) and autoimmune CP (13%). 17/24 (71%) patients had previous plastic biliary stent (s). 10mm diameter fcSEMS (Boston Wallflex or Cook Evolution) of 6 or 8 cm in length were used. They remained in situ for median 9.5 months (range 1–32). 13/24 (54%) patients achieved stricture remodelling, allowing trial of fcSEMS removal and follow up without stenting for median 7 months (range 0–22). These patients required median 3 fcSEMS (range 1–6) over median 24 months (range 2–51) to achieve stricture resolution. 42% (10/24) patients who had not yet achieved stricture resolution had fewer fcSEMS to date (median 1) and a shorter duration of stenting. Complications included proximal (4%) and distal stent migration (16.5%), cholecystitis (6%) and acute pancreatitis (2%). Biliary obstruction +/- cholangitis occurred in 23% at some point. 96% (46/48) fcSEMS were easily removed without needing additional procedures. One fcSEMS was in situ for 18 months (patient lost to follow up) and it was not possible to then remove it (due to tissue in-growth). Another fcSEMS in situ for 32 months (due to tissue in-growth) was removed following a “stent-in-stent” fcSEMS procedure. 2 patients died before planned removal of their first metal stent due to pre-existing comorbidity. Conclusion As suggested by smaller published series (Kaffes, GI Endoscopy 2013), FcSEMS are a safe and effective approach to managing BBS due to CP and may promote stricture remodelling. Endoscopic removal is straightforward if the fcSEMS is in situ for Disclosure of Interest None Declared.

Introduction Biliary Sphincter of Oddi dysfunction (SOD) is a benign but often debilitating condition. Significant improvement in pain following endoscopic sphincterotomy or sphincteroplasty (ES) in patients with Type 1 SOD, is excellent. Symptomatic improvement in patients with type 2 or 3 SOD is less favourable (reported 50–70% and 30–50% respectively). We aim to determine the impact of ES, on pain symptoms and global quality of life (QOL) in these groups, which has not previously been well defined. Methods An ERCP database and electronic clinic lists (from September 2011 to 2013) were analysed to identify all cases of suspected SOD. Patients underwent a telephone questionnaire. The Glasgow Benefit Inventory (GBI), which assesses multiple physical, emotional and social parameters, was used to quantify global post-interventional QOL benefit. Total GBI scores can range from -100 (maximal negative benefit) to +100 (maximal positive benefit). Results 163 new patients with suspected biliary SOD were identified of whom 89 underwent ERCP. 3 patients were excluded due to an alternative diagnosis at ERCP. The remaining cohort was predominantly Female (87%) and White British (86%) with median age 37 years (range 18–69). 88% had undergone prior cholecystectomy. Patients were attributed with the following pre-test diagnoses – 20/86 (23%) SOD1, 53/86 (62%) SOD2, 13/86 (15%) SOD3. Median post-ERCP follow up was 12 months (range 2–27). In patients who underwent endotherapy and completed questionnaires: 93% (14/15) SOD1, 76% (36/48) SOD2 and 83% (10/12) SOD3 subjectively reported pain improvement post-ERCP (within median 1 month). Sustained response (median 6 months) was noted in 60, 30 and 46% of SOD 1/2/3 respectively. Median total GBI scores in the patients who had sustained improvement were +44 (SOD1), +31 (SOD2) and +29 (SOD3). There was a clear correlation between subjective response to ES and GBI scores (see table). Negative total scores were recorded across all SOD subtypes in patients who had no symptom improvement whatsoever following ES. Total GBI scores in all categories were higher in SOD1 than SOD2 than SOD3. Conclusion ES for SOD1 appears to provide sustained benefit in symptoms and QOL above that achieved in SOD2/3. QOL measured by GBI is strongly correlated to symptomatic response to ES despite pain response being only a minor contributor to the GBI rating. Therefore, GBI may be helpful to determine clinical, emotional and social factors that could help to predict those patients who will respond to ES. Disclosure of Interest None Declared.

Introduction In the absence of biochemical or radiological evidence of biliary obstruction, Sphincter of Oddi dysfunction (SOD) is a difficult condition to diagnose and to treat. The Rome III diagnostic criteria clearly state that, to meet a diagnosis of SOD, a patient should have “episodic pain at different time intervals (not daily)”. We observe heterogeneity in symptoms amongst patients referred with suspected SOD with many patients reporting constant daily pain requiring potent analgesia. We aim to determine whether subjective reporting of pain (according to the Rome criteria) correlates with Sphincter of Oddi Manometry (SOM: the gold standard for diagnosis of SOD) and/or response to endoscopic sphincterotomy/plasty (ES). Methods An ERCP database and electronic clinic lists (from September 2011 to 2013) were analysed to identify all cases of suspected SOD. Patients underwent a telephone questionnaire based on subjective recall of pre-ERCP pain according to the Rome criteria and post-ERCP response. Patients were asked to categorise pain as either intermittent with no pattern/not daily (Rome +ve) or daily/constant pain (Rome –ve). Results 163 new patients with suspected biliary SOD were identified of whom 89 underwent ERCP. They were mostly Female (87%), White British (86%) with median age 37 years (range 18–69). 48 patients with SOD2/3, who underwent SOM, agreed to answer the questionnaire. Patients with SOD1 do not routinely undergo SOM. Biliary and/or pancreatic basal pressures were abnormally elevated (>40 mmHg) in 33/37 (89%) SOD2 and 8/10 (80%) SOD3, all of whom underwent ES. There were no significant correlations between Rome +ve pain and either biliary manometry (p = 0.3) or improvement in pain following ES (p = 0.2) in patients with either SOD 2 or 3 (see tables). However, there was a high relapse rate after initial improvement across both groups (SOD2 17/26=65%, SOD3 2/7=29%) irrespective of whether patients had Rome +ve or –ve pain initially. Conclusion Despite the clear recommendations of the Rome criteria requiring intermittent/episodic pain for a diagnosis of SOD, our data suggest that correlation between description of pain and biliary manometry is poor. 30–35% of patients who meet the current gold standards for diagnosis of SOD have constant or daily (Rome –ve) pain. Additionally, description of pain does not predict response to endotherapy suggesting that the Rome criteria and/or SOM for suspected SOD are not clinically useful and may need to be redefined. We note that high rates of positive SOM and recurrence of pain post-ES was seen in our cohort. Disclosure of Interest None Declared.

Introduction There is a significant risk of malnutrition in patients with Chronic Pancreatitis (CP) with evidence to suggest that good dietary counselling for a balanced homemade diet is as good as commercial food supplements to improve nutrition. Pancreatic enzyme replacement therapy (PERT) is associated with improved absorption of nutrients as well as relief of GI symptoms. Proton pump inhibitors (PPI) improve the bioavailability and efficacy of PERT. Data regarding PERT compliance and education is lacking. We aim to determine the prevalence of exocrine insufficiency and compliance to PERT in patients with CP. Methods Prospective study of consecutive patients with CP attending a tertiary clinic between October and December 2013. They were invited to participate in a face-to-face questionnaire study. Faecal elastase (FE) results were collated and the Malnutrition Universal Screening Tool (MUST) score was calculated. Results A cohort of 86 patients identified were predominantly male (67%), White British (62%), median age 58 years (range 18–90), of socio-economic class (SEC) 8 (21% never worked/long-term unemployed) with educational level (EL) 1 (29% degree or equivalent). Aetiologies included alcohol (29%), idiopathic (25%), autoimmune (22%) and gallstones (11%). Median follow up was 27.5 months (range 0–151) from index appointment. 69 patients underwent routine measurement for FE, 61% (42/69) of whom were deficient ( Conclusion Exocrine insufficiency is under-recognised in patients with CP and compliance with PERT is poor. Our data shows that the majority of patients who are not compliant with PERT are at medium to high risk of malnutrition. This highlights the need for structured dietetic involvement in the management of patients with CP in the clinic environment including biochemical testing of exocrine function, education about the natural history of CP, PERT administration and concomitant acid suppression. Disclosure of Interest None Declared.

Introduction Nutrition centred research in pancreatitis has largely focused on acute pancreatitis. There is limited nutritional data in patients with Chronic Pancreatitis (CP), a condition that predisposes to endocrine and exocrine failure, fat-soluble vitamin deficiency and osteoporosis, which may worsen a patient’s quality of life and long-term outcome. We aim to determine the prevalence of malnutrition (using the Malnutrition Universal Screening Tool -MUST), active alcohol consumption and cigarette smoking in patients with CP. Methods Prospective study of consecutive patients with CP attending a tertiary clinic between October and December 2013. They were invited to participate in a face-to-face questionnaire study. Behavioural and socioeconomic data were collated. Results A cohort of 86 patients identified were predominantly male (67%), White British (62%), median age 58 years (range 18–90), of socio-economic class (SEC) 8 (21% never worked/long-term unemployed) with educational level (EL) 1 (29% degree or equivalent). Aetiologies included alcohol (29%), idiopathic (25%), autoimmune (22%) and gallstones (11%). The aetiology in 6% was actively under investigation. Median follow up was 27.5 months (range 0 – 151) from index appointment. Active alcohol exposure was noted in 33% (28/86) with excessive amounts (m >21 u, f >14 u/week) in 8% (7/86). The majority of patients (> 70%) with ongoing exposure to alcohol had primary aetiologies other than alcohol. Active cigarette smoking was noted in 34%. MUST scores ≥ 1 were noted in 38% (33/86) conferring “medium to high risk of malnutrition”. Multiple linear regression analysis of age, gender, ethnicity, SEC, EL, aetiology, alcohol exposure and smoking did not show any statistically significant variables that predicted MUST score. 27% (9/33) patients “at risk of malnutrition” had been referred to or had been seen by a dietitian within the previous 12 months. The remaining 73% (24/33) “at risk” patients all claimed to have received nil or suboptimal nutritional advice with regards to CP within the previous 24 months. Conclusion Patients with CP attending our tertiary clinic are at significant risk of malnutrition, which may be under-recognised. Behavioural and socioeconomic factors do not allow reliable prediction of risk of malnutrition to be made, in this cohort. This data emphasises the need for an algorithmic approach to improve recognition of malnutrition in CP and for implementation of specialist dietetic, alcohol liaison and smoking cessation services within the outpatient environment. Disclosure of Interest None Declared.