Linda J. Taylor

Pathologic evaluation of a new endoscopic ultrasound needle designed to obtain core tissue samples: A pilot study

Background and Objectives: Standard endoscopic ultrasound-fine-needle aspiration (EUS-FNA) needles are in widespread use. Meaningful differences between the available needles have been difficult to identify. Recently, a new EUS needle (Shark Core®, Covidien, Dublin, Leinster, Ireland), has been introduced in an attempt to improve diagnostic accuracy, tissue yield, and to potentially obtain a core tissue sample. We performed a pilot study prospectively to evaluate this new needle when compared to a standard EUS-FNA needle. Materials and Methods: Analysis of the first 15 patients undergoing EUS-FNA with the Shark Core needle was performed and it was compared to EUS-FNA in 15 patients who underwent EUS-FNA with a standard needle. Results: The Shark Core needle required fewer needle passes to obtain diagnostic adequacy than the standard needle [(χ2(1) = 11.3, P < 0.001]. The Shark Core needle required 1.5 passes to reach adequacy, whereas the standard needle required three passes. For cases with cell blocks, the Shark Core needle produced diagnostic material in 85% of cases [95% confidence interval (CI): 54–98], whereas the standard needle produced diagnostic material in 38% of the cases (95% CI: 9-76). The Shark Core needle produced actual tissue cores 82% of the time (95% CI: 48–98) and the standard needle produced no tissue cores (95% CI: 0-71) (P = 0.03). Conclusion: This pilot study found that the Shark Core needle had a high rate of producing adequate cytologic material for the diagnosis of pancreatic and peri-pancreatic lesions sampled by EUS with fewer passes required to obtain a definitive diagnosis and with a high rate of tissue cores being obtained when compared to a standard FNA needle.

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.

Efficacy and safety of therapeutic ERCP in patients with cirrhosis: a large multicenter study.

BACKGROUND AND AIMS Patients with cirrhosis may be less than optimal candidates for ERCP because of underlying ascites, coagulopathy, encephalopathy, and other problems. Although the risks of surgery in patients with cirrhosis are well known, few data are available regarding ERCP in patients with cirrhosis. We performed a retrospective, multicenter study of ERCP in patients with cirrhosis to evaluate outcomes, efficacy, and safety. METHODS Multicenter retrospective study. RESULTS A total of 538 ERCP procedures were performed on 328 patients with cirrhosis. A total of 229 patients had Child-Pugh (CP) class A, 229 patients had CP class B, and 80 patients had CP class C. Thrombocytopenia and coagulopathy were corrected before ERCP. The 30-day, procedure-related adverse events included post-ERCP pancreatitis (n = 25, 4.6%: 21 mild, 3 moderate, 1 severe), hemorrhage (n = 6, 1.1%), cholangitis (n = 15, 2.8%), perforation (n = 2, 0.4%), aspiration pneumonia (n = 5, 0.9%), bile leakage (n = 1, 0.2%), cholecystitis (n = 1, 0.2%), and death (n = 1, 0.2%). There was a higher incidence of adverse events in patients with CP class B and C disease when compared with those with CP class A disease (11.4%, 11.3%, and 6.1%, respectively; P = .048). There was no correlation between the risk of significant hemorrhage and the presence of coagulopathy or CP class, even in those who underwent a sphincterotomy. The presence of poorly controlled encephalopathy correlated with a higher overall adverse event rate (P = .003). Sub-analysis revealed that patients without primary sclerosing cholangitis had a significantly higher overall rate of adverse events, pancreatitis, bleeding, and cardiopulmonary adverse events after ERCP when compared with those with primary sclerosing cholangitis. CONCLUSIONS Our study was performed on a large series of patients with cirrhosis undergoing ERCP. Overall, the adverse events seen in patients with cirrhosis are similar to those seen in the general population of patients undergoing ERCP, although patients with CP classes B and C have higher adverse event rates compared with those with CP class A. Patients with cirrhosis without primary sclerosing cholangitis had significantly greater adverse event rates when compared with patients with primary sclerosing cholangitis.

Endoscopic Management of Esophagorespiratory Fistulas: A Multicenter Retrospective Study of Techniques and Outcomes

Background and AimsEsophagorespiratory fistulas (ERF) are a devastating complication of benign and malignant etiologies. ERF are associated with high mortality, short survival, and poor quality of life. We performed a multicenter analysis of patients with ERF undergoing endoscopic treatment.MethodsMulticentre retrospective study.ResultsWe analyzed 25 patients undergoing 35 procedures over an 8-year period. Our data showed high technical success rates (97.1% of procedures) and with good, but not ideal, clinical success rates (60% of procedures, 80% of patients), which were defined as fistula closure confirmed by radiographic or repeat endoscopic evaluation and/or a lack of recurrent episodes of clinical aspiration to focus on durable ERF closure as opposed to only initial success. Proximal ERF were the most difficult to manage with the lowest overall clinical success rates, highest rates of recurrent aspiration despite endoscopic therapy, highest adverse events, and shortest survival times. Adverse events occurred in 40.0% of our patients and were all minor. Treatment allowed for diet advancement in 75% of patients.ConclusionThis represents the largest recent collection of US data and the first multicenter study evaluating the clinical success of multiple treatment modalities while stratifying data by fistula etiology and esophageal location. The endoscopic approaches detailed in this study offer a minimally invasive and safe choice for intervention with the potential to improve quality of life despite overall suboptimal clinical success and survivorship rates for in with ERF.

A retrospective study evaluating endoscopic ultrasound-guided drainage of pancreatic fluid collections using a novel lumen-apposing metal stent on an electrocautery enhanced delivery system.

Objectives: To report the safety and clinical efficacy with the novel lumen-apposing metal stent (LAMS) with an electrocautery enhanced delivery system for the drainage of pancreatic fluid collections (PFCs). Methods: This was a retrospective analysis of all consecutive patients with PFCs who underwent endoscopic ultrasound (EUS)-guided drainage using the LAMS with an electrocautery enhanced delivery system in 2 US centers. Results: Thirteen patients with PFCs (69% with walled-off necrosis [WON]) underwent drainage using the study device. Successful stent placement was accomplished in all patients. Direct endoscopic necrosectomy was carried out in all nine patients with WON complete resolution of the PFC was obtained in all 13 cases, with no recurrence during follow-up. There was one procedure-related adverse event. In one patient, the LAMS was dislodged immediately after deployment, falling into the stomach where it was removed. A second electrocautery enhanced LAMS was placed in this patient immediately afterward. Conclusions: EUS-guided drainage using the LAMS with the electrocautery-enhanced delivery system is a safe, easily performed, and a highly effective for the drainage of PFCs.

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.

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.

ERCP performed through previously placed duodenal stents: a multicenter retrospective study of outcomes and adverse events

BACKGROUND AND AIMS ERCP performed through previously placed enteral stents is an uncommon procedure without a significant amount of supporting literature and with a wide reported range of technical success. The purpose of this study was to evaluate and better define the technical feasibility and safety of performing ERCP through enteral stents in patients with combined malignant biliary and gastric outlet obstruction. METHODS We conducted a multicenter, retrospective study on 71 patients with combined gastric outlet and biliary obstruction who underwent ERCP through a previously placed enteral stent at 2 tertiary care centers. Outcomes included but were not limited to technical success, clinical success, need for repeat ERCP, adverse events, and survival time. RESULTS Overall technical success was achieved in 60 of 71 patients (85%), with technical success of 40 of 46 (87%) in type I obstructions (gastric outlet obstruction above the ampulla), 16 of 21 (76%) in type II obstructions (gastric outlet obstruction at the level of the ampulla), and 4 of 4 (100%) in type III obstructions (gastric outlet obstruction distal to the ampulla). In general, patients who achieved technical success also achieved clinical success. Adverse events occurred in 3 patients (3/71): 2 patients with acute cholangitis and 1 patient with perforation. Average survival time after the procedure was 4.6 months overall. CONCLUSIONS ERCP performed through enteral stents is safe, with a high technical and clinical success rate, but may be more technically challenging in the setting of type II obstructions. This procedure could be considered first line in the unique setting that a patient requires ERCP through a previously placed enteral stent for malignant gastric outlet and biliary obstruction.

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

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.

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.