EUS-guided drainage of pancreatic fluid collections using lumen apposing metal stents: An international, multicenter experience.

INTRODUCTION: Lumen apposing metal stents (LAMS) have been used increasingly for drainage of pancreatic fluid collections (PFC). We present an international, multicenter study evaluating the safety and efficacy of LAMS in PFCs. METHODS: Consecutive patients undergoing LAMS placement for PFC at 12 international centers were included (ClinicalTrials.gov NCT01522573). Demographics, clinical history, and procedural details were recorded. Technical success was defined as successful LAMS deployment. Clinical success was defined as PFC resolution at three-month follow-up. RESULTS: 192 patients were included (140 males (72.9%), mean-age 53.8 years), with mean follow-up of 4.2 months ±â€¯3.8. Mean PFC size was 11.9 cm (range 2-25). The median number of endoscopic interventions was 2 (range 1-14). Etiologies for PFC were gallstone (n = 82, 42.7%), alcohol (n = 50, 26%), idiopathic (n = 26, 13.5%), and other (n = 34, 17.7%). Technical success was achieved in 189 patients (98.4%). Clinical success was observed in 125 of 135 patients (92.6%). Adverse events included bleeding (n = 11, 5.7), infection (n = 2, 1%), and perforation (n = 2, 1%). Three or more endoscopy sessions were a positive predictor for PFC resolution and the only significant predictor for AEs. CONCLUSION: LAMS has a high technical and clinical success rate with a low rate of AEs. PFC drainage via LAMS provides a minimally invasive, safe, and efficacious procedure for PFC resolution.

Safety and efficacy of non-anesthesiologist administration of propofol sedation during esophagogastroduodenoscopy in the intensive care unit.

Background and study aims Propofol sedation is an increasingly popular method of sedation for gastrointestinal endoscopic procedures. The safety and efficacy of the non-anesthesiologist administration of propofol (NAAP) sedation has been demonstrated in the ambulatory setting. However, NAAP sedation in intensive care unit (ICU) patients has not been reported. The purpose of this study is to determine safety and efficacy of NAAP sedation in an ICU population. Methods We retrospectively reviewed esophagogastroduodenoscopies (EGD) performed with NAAP sedation in our intensive care units from June 2014 to September 2016. All EGDs were performed for evaluation of gastrointestinal bleeding. The primary end point of this study was to analyze the incidence of sedation-related adverse events (AEs). The secondary end points included successful completion of procedure and any endoscopic interventions performed. Results Two of 161 procedures (1.2 %) had sedation-related AEs requiring procedure termination. One hundred forty-six of 161 procedures (90.7 %) were successfully completed. Incomplete procedures were due to excess heme, retained food or obstructive lesions (13/161, 8.1 %). Endoscopic intervention was performed successfully in 17/24 cases (70.8 %) that had endoscopically treated lesions identified. One hundred six of 161 patients (66 %) were American Society of Anesthesiologists (ASA) classification III or IV. Conclusion Our retrospective analysis demonstrated that EGDs can be successfully completed in ICU patients using NAAP sedation. When procedures cannot be completed, it is rarely due to sedation-related AEs. NAAP sedation further allows adequate examination and successful treatment of high-risk lesions. NAAP sedation appears safe and effective for endoscopic procedures in the ICU setting.

A Multicenter comparative trial of a novel EUS-guided core biopsy needle (SharkCore™) with the 22-gauge needle in patients with solid pancreatic mass lesions.

BACKGROUND AND OBJECTIVES: The ability to obtain adequate tissue of solid pancreatic lesions by EUS-guided remains a challenge. The aim of this study was to compare the performance characteristics and safety of EUS-FNA for evaluating solid pancreatic lesions using the standard 22-gauge needle versus a novel EUS biopsy needle. METHODS: This was a multicenter retrospective study of EUS-guided sampling of solid pancreatic lesions between 2009 and 2015. Patients underwent EUS-guided sampling with a 22-gauge SharkCore (SC) needle or a standard 22-gauge FNA needle. Technical success, performance characteristics of EUS-FNA, the number of needle passes required to obtain a diagnosis, diagnostic accuracy, and complications were compared. RESULTS: A total of 1088 patients (mean age = 66 years; 49% female) with pancreatic masses underwent EUS-guided sampling with a 22-gauge SC needle (n = 115) or a standard 22-gauge FNA needle (n = 973). Technical success was 100%. The frequency of obtaining an adequate cytology by EUS-FNA was similar when using the SC and the standard needle (94.1% vs. 92.7%, respectively). The sensitivity, specificity, and diagnostic accuracy of EUS-FNA for tissue diagnosis were not significantly different between two needles. Adequate sample collection leading to a definite diagnosis was achieved by the 1st, 2nd, and 3rd pass in 73%, 92%, and 98% of procedures using the SC needle and 20%, 37%, and 94% procedures using the standard needle (P < 0.001), respectively. The median number of passes to obtain a tissue diagnosis using the SC needle was significantly less as compared to the standard needle (1 and 3, respectively; P< 0.001). CONCLUSIONS: The EUS SC biopsy needle is safe and technically feasible for EUS-FNA of solid pancreatic mass lesions. Preliminary results suggest that the SC needle has a diagnostic yield similar to the standard EUS needle and significantly reduces the number of needle passes required to obtain a tissue diagnosis.

Efficacy and Safety of Digital Single-Operator Cholangioscopy for Difficult Biliary Stones.

BACKGROUND & AIMS: It is not clear whether digital single-operator cholangioscopy (D-SOC) with electrohydraulic and laser lithotripsy is effective in removal of difficult biliary stones. We investigated the safety and efficacy of D-SOC with electrohydraulic and laser lithotripsy in an international, multicenter study of patients with difficult biliary stones. METHODS: We performed a retrospective analysis of 407 patients (60.4% female; mean age, 64.2 years) who underwent D-SOC for difficult biliary stones at 22 tertiary centers in the United States, United Kingdom, or Korea from February 2015 through December 2016; 306 patients underwent electrohydraulic lithotripsy and 101 (24.8%) underwent laser lithotripsy. Univariate and multivariable analyses were performed to identify factors associated with technical failure and the need for more than 1 D-SOC electrohydraulic or laser lithotripsy session to clear the bile duct. RESULTS: The mean procedure time was longer in the electrohydraulic lithotripsy group (73.9 minutes) than in the laser lithotripsy group (49.9 minutes; P < .001). Ducts were completely cleared (technical success) in 97.3% of patients (96.7% of patients with electrohydraulic lithotripsy vs 99% patients with laser lithotripsy; P = .31). Ducts were cleared in a single session in 77.4% of patients (74.5% by electrohydraulic lithotripsy and 86.1% by laser lithotripsy; P = .20). Electrohydraulic or laser lithotripsy failed in 11 patients (2.7%); 8 patients were treated by surgery. Adverse events occurred in 3.7% patients and the stone was incompletely removed from 6.6% of patients. On multivariable analysis, difficult anatomy or cannulation (duodenal diverticula or altered anatomy) correlated with technical failure (odds ratio, 5.18; 95% confidence interval, 1.26-21.2; P = .02). Procedure time increased odds of more than 1 session of D-SOC electrohydraulic or laser lithotripsy (odds ratio, 1.02; 95% confidence interval, 1.01-1.03; P < .001). CONCLUSIONS: In a multicenter, international, retrospective analysis, we found D-SOC with electrohydraulic or laser lithotripsy to be effective and safe in more than 95% of patients with difficult biliary stones. Fewer than 5% of patients require additional treatment with surgery and/or extracorporeal shockwave lithotripsy to clear the duct.

Diagnostic yield and accuracy of a new cytology brush design compared to standard brush cytology for evaluation of biliary strictures.

BACKGROUND: The sensitivity of brush cytology for biliary strictures has typically been low, usually 30%-60%. We compared the cellular yield and diagnostic accuracy using a new cytology brush (n = 16) versus standard biliary brushings (n = 16) in 32 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) with brushings for evaluation of a biliary stricture for malignancy. METHODS: We performed retrospective chart reviews of 16 consecutive ERCPs with brushings performed for the cytologic evaluation of a biliary stricture for malignancy using the new cytology brush between January 2016 and February 2017 at our institution. Our control cohort was 16 consecutive ERCP cases performed for the same indication directly preceding the availability of the new cytology brush. RESULTS: The biliary brushing cases performed using the new cytology brush demonstrated a significantly increased number of total cell clusters per representative ×20 field compared with cases using the standard brush (mean 24.6 versus 14.4, P = .03). This trend continued when assessing large (>50 cells) clusters (mean 5.8 vs. 3.3, P = .02) and medium (6-49 cells) clusters (11.1 vs. 5.8, P = .03). Nonetheless, there were no statistically significant differences with regards to diagnostic accuracy for the new cytology brush versus standard biliary brushings. CONCLUSION: We found that the Infinity brush significantly increased diagnostic yield with regards to total cell clusters, large (>50 cells) clusters, and medium (6-49 cells) clusters, however, this did not lead to increased diagnostic accuracy overall. Further studies of this and other brush designs are warranted to optimize biliary brushing specimens.

Use of fully covered self-expanding metal stents for benign biliary etiologies: a large multi-center experience.

BACKGROUND: Fully-covered self-expandable metal stents (FCSEMS) have been used in benign biliary diseases although reported data is limited. These devices are most commonly used to treat biliary leaks, strictures, or both. The aim of this study was to evaluate effectiveness of FCSEMS in treating benign biliary disease and recognize the associated complications. METHODS: We performed a multicenter longitudinal retrospective cohort study of patients with benign biliary disease needing FCSEMS between 2011 and 2016. Descriptive statistics were performed using SPSS version 24 (SPSS Inc, Chicago, IL, USA) and continuous variables were presented as mean±standard deviation. RESULTS: 75, 57% M/43% F, with a mean age of 58.5±14.9 years, were included. 64 (85%) had benign strictures, 7 patients had leaks, and 4 patients had both a leak and a stricture. Chronic pancreatitis was the most common cause of BBS (47%) and cholecystectomy was the most common cause of leaks. FCSEMS placement was technically successful in all patients. Four patients died of unrelated causes. A recurrent stricture was observed in 24 (32%) of the patients. Recurrent strictures were most commonly seen in patients with chronic pancreatitis 12/35 (34%). Stent migration occurred in 8/75 patients (10.7%). Seven patients (9.3%) had adverse events, acute pancreatitis (N.=4) was most common. CONCLUSIONS: FCSEMS are safe and effective for treating biliary strictures and leaks. We report decreased rates of stent migration compared to previous studies. Prospective studies are needed to compare plastic stents with FCSEMS, determine optimal stent in-dwell times and cost effectiveness of FCSEMS.

Efficacy, Safety, and Outcomes of Endoscopic Retrograde Cholangiopancreatography With Per-Oral Pancreatoscopy: A Multicenter Experience.

INTRODUCTION: Per-oral pancreatoscopy can be used for both evaluation and treatment of pancreatic duct stones during endoscopic retrograde cholangiopancreatography, evaluating and treating pancreatic duct strictures of indeterminate etiology, and visual inspection and direct biopsy of pancreatic duct mucosa for diagnosis of intraductal papillary mucinous neoplasm (IPMN). We aim to describe the efficacy, safety, and outcomes of pancreatoscopy in a large, multicenter series of patients. MATERIALS AND METHODS: A multicenter retrospective review was conducted of all patients who underwent per-oral pancreatoscopy at 2 large tertiary-care medical centers. Review of relevant medical records, laboratory data, imaging studies, endoscopic procedure notes, telephone follow-up notes, and progress notes was performed. RESULTS: Thirty-three patients underwent 41 pancreatoscopy procedures. Indications included: 20 (48.8%) for diagnosis and treatment of pancreatic duct stones, 16 (39%) for investigation of IPMN, and 5 (12.2%) for evaluation of pancreatic duct strictures.In 20 procedures performed for stone disease, complete pancreatic duct clearance was achieved in 17 of 20 (85%) cases. Strictures were successfully dilated in 5 of 5 (100%) procedures. Direct visualization and biopsy demonstrated IPMN in 11 of 11 (100%) cases. Adverse events occurred in 3 of 41 (7.3%) of procedures, all of which were mild. CONCLUSIONS: In this large series, we demonstrate that in patients with difficult to manage stone disease, strictures and possible malignant ductal pathology, pancreatoscopy is an effective and safe tool that can facilitate both diagnosis and effective therapy. Adverse events in our study were mild and within acceptable limits, further demonstrating that this is a safe procedure that should be offered to appropriate patients.

Elevated Serum Bilirubin Level Correlates With the Development of Cholangiocarcinoma, Subsequent Liver Transplantation, and Death in Patients With Primary Sclerosing Cholangitis.

INTRODUCTION: Predicting the clinical course of primary sclerosing cholangitis (PSC) is difficult. There are currently a paucity of studies evaluating serum chemistries as predictors of conventional clinical endpoints. The purpose of this study was to prognosticate key clinical endpoints in patients with PSC who had elevated serum liver chemistries at the time of their initial presentation. METHODS: We performed a retrospective cohort study of PSC patients at our institution. The aim of our study was to determine the association between elevated liver chemistries at initial presentation-bilirubin, alanine transaminase, aspartate transaminase, or alkaline phosphatase-with a primary outcome of either cholangiocarcinoma, liver transplantation, death, or composite of the 3. The secondary endpoints examined were development of severe biliary ductal disease and need for biliary stent placement. RESULTS: Eighty-one PSC patients (61 males and 20 females) were included in this study. By univariate analysis, there was a significant association between initial bilirubin elevation >2x the upper limit of normal (ULN) and death (P<0.009). Multivariate regression analysis revealed that an elevated initial serum total bilirubin >2xULN (P<0.017) significantly predicted the composite endpoint. By univariate analysis of pre-endoscopic retrograde cholangiopancreatography labs, serum bilirubin level elevation >2xULN showed an association with severity of biliary ductal disease (P<0.0001). A logistic regression of outcome variables also proved that >2xULN serum bilirubin levels predicted the ductal disease severity (P<0.0001). CONCLUSIONS: An initial elevation of serum total bilirubin >2xULN in PSC patients correlates positively with the development of cholangiocarcinoma, subsequent liver transplantation, and death. Elevated bilirubin also correlates positively with the severity of cholangiographic findings.

Clinical Outcomes, Efficacy, and Adverse Events in Patients Undergoing Esophageal Stent Placement for Benign Indications: A Large Multicenter Study.

INTRODUCTION: Esophageal stents are commonly used to treat benign esophageal conditions including refractory benign esophageal strictures, anastomotic strictures, fistulae, perforations and anastomotic leaks. Data on outcomes in these settings remain limited. METHODS: We performed a retrospective multicenter study of patients who underwent fully or partially covered self-expandable stent placement for benign esophageal diseases. Esophageal stent placements were performed for the following indications: (1) benign refractory esophageal strictures, (2) surgical anastomotic strictures, (3) esophageal perforations, (4) esophageal fistulae, and (5) surgical anastomotic leaks. RESULTS: A total of 70 patients underwent esophageal stent placement for benign esophageal conditions. A total of 114 separate procedures were performed. The most common indication for esophageal stent placement was refractory benign esophageal stricture (48.2%). Global treatment success rate was 55.7%. Treatment success rate was 33.3% in refractory benign strictures, 23.1% in anastomotic strictures, 100% in perforations, 71.4% in fistulae, and 80% in anastomotic leaks. Stent migration was noted in 28 of 70 patients (40%), most commonly seen in refractory benign strictures. CONCLUSIONS: This is one of the largest studies to date of esophageal stents to treat benign esophageal diseases. Success rates are lowest in benign esophageal strictures. These patients have few other options beyond chronic dilations, feeding tubes, and surgery, and fully covered self-expandable metallic stent give patients a chance to have their problem fixed endoscopically and still eat by mouth. Perforations, fistulas, and leaks respond very well to esophageal stenting, and stenting should be considered as a first-line therapy in these settings.