SpyGlass Direct Visualization System Research Articles

Prospective registration study of diagnostic yield and sample size in forceps biopsy using a novel device under digital cholangioscopy guidance with macroscopic on-site evaluation.

Although the SpyGlass Direct Visualization System can be clinically useful for diagnosing indeterminate biliary stricture, it employs SpyBite forceps, which typically obtain only a small amount of tissue and have a low sampling rate. An improved forceps biopsy device for SpyGlass DS has recently been released (SpyBite MAX). The aim of this prospective registration study was to assess the diagnostic yield and efficacy of histological biopsy tissue obtained with SpyBite MAX forceps compared with SpyBite forceps in patients with indeterminate biliary stricture. The primary outcome of the study was the diagnostic accuracy of biopsy specimens obtained by SpyBite MAX forceps. The secondary outcomes were tissue size, number of forceps biopsies, rate of obtaining adequate tissue, and adverse events in the SpyBite MAX forceps group compared with the SpyBite group. Forceps biopsies using SpyBite MAX (n=47) and SpyBite (n=50) were performed successfully in all patients. The number of biopsies performed before visible core tissue was obtained was significantly lower in the SpyBite (mean, 1.5 ± 0.7) than in the SpyBite forceps group (mean, 2.3 ± 1.1 mm; P < .001). Tissue sample size was larger in the SpyBite MAX group (mean, 1.8 ± 1.6 mm2 ) than in the SpyBite group (mean, 1.0 ± 0.9 mm2 ; P=.004) but there was no significant difference in diagnostic accuracy. Improvements in dedicated forceps for biopsy in SpyGlass DS may contribute to improving the rates of adequate tissue and tissue sample size obtained, and to reducing the number of forceps biopsies required.

Use of catheter-based cholangioscopy in the diagnosis of indeterminate stenosis: a multicenter experience.

Direct bile ducts visualization through cholangioscopy has gained popularity due to its better diagnostic accuracy than a standard ERCP in indeterminate biliary stricture. We aimed to review our catheter-based cholangioscopy interventions in patients with indeterminate biliary stenosis, using the SpyGlass Direct Visualization System (SDVS) and summarize our experience in terms of procedures and results. We collected 25 consecutive patients with indeterminate biliary stricture over 3 years. The overall procedural success in our cohort amounted to 96% (24/25). If we focus on the diagnostic procedures, the ability to merely visualize the region of interest/lesion and perform biopsy of the lesion was possible in 96% (24/25) In our cohort localization in the common bile duct (P=0.03; 95% CI: 0.27-0.96) was found as positive determining factor for diagnosis. Sensitivity, specificity and accuracy for visual diagnosis by SDVS in our cohort were 100, 83.3 and 96%, respectively. The use of biopsy or obtaining a histological diagnosis to assist in identifying patients with malignant stenosis, to exclude malignancy and to correctly classify diagnosed patients resulted in a sensitivity of 100%, a specificity of 73% with an overall accuracy of 94.4%. Only a mild adverse event (cholangitis, treated conservatively) occurred. Today, the SDVS should be considered essential in diagnosing indeterminate biliary strictures, since the procedure is associated with high procedural success in terms of diagnostic accuracy, alters clinical outcome in over 80% of considered insolvable cases, with an acceptable safety profile.

Spyglass percutaneous transhepatic lithotripsy of symptomatic recurrent lithiasis of the intrahepatic bile duct with distal stenosis.

In patients with symptomatic intrahepatic biliary lithiasis, the treatment is usually discussed by a multidisciplinary team. Although hepatectomy is considered as definitive treatment, when lobar atrophy is absent, endoscopic procedures are frequently proposed as first-line treatment due the low invasiveness and for sparing liver parenchyma. Percutaneous route is used in case of peroral approach failure. We present a case of recurrent symptomatic intrahepatic biliary lithiasis of the right posterior hepatic duct, sustained by downstream biliary stenosis. Peroral cholangioscopy failed to visualize the stone for the accompanying stenosis. Thus, the patient was successfully treated with percutaneous transhepatic lithotripsy performed with Spyglass direct visualization system II (Boston Scientific Inc., Natick, Massachusetts, USA). During the procedure, the biopsy of the biliary stenosis revealed fibrosis, which was treated by cholangioplasty with cutting balloon. After 15 months, the patient is asymptomatic, with moderate residual stenosis in absence of calculi at follow-up magnetic resonance cholangiography.

S3347 Proximal Migration of Pancreatic Stent in Pancreatic Divisum: Challenges in Retrieval and Review of Literature

INTRODUCTION: Pancreatic divisum is the commonest congenital malformation of pancreas. When patients get symptomatic with recurrent attacks of pancreatitis, they undergo ERCP with sphincterotomy and stent placement. Proximal migration of pancreatic stent in Pancreatic divisum is rare and is challenging to manage. We describe an interesting case of proximal migration of pancreatic stent in Pancreatic divisum and perform review of literature. CASE DESCRIPTION/METHODS: A 55-year-old female with past medical history of Pancreas Divisum, Recurrent Pancreatitis presented with sharp epigastric pain radiating to her back associated with nausea and vomiting. On physical exam, she appeared stable with moderate epigastric tenderness. Imaging revealed stones in the main pancreatic duct (PD) with Pancreas Divisum. ERCP was performed, which revealed stenosed minor papilla, which was selectively cannulated and sphincterotomy was performed, ductal stone was removed, and an 8.5 Fr x 9 cm straight plastic stent was placed (Figure 1). During repeat ERCP 3 weeks later, stent was found to have migrated deep into the main PD (Figure 2). The PD was explored endoscopically using SpyGlass Direct Visualization System (Boston Scientific, Natick, Massachusetts, USA). Proximally migrated PD stent was seen which was successfully retrieved using a SpyGlass Retrieval Snare and multiple PD stents were removed. A 5 Fr x 9 cm pigtail PD stent was placed to ensure adequate pancreatic drainage after intraductal intervention. DISCUSSION: Pancreatic stents can migrate both distally as well as proximally into the PD. Migrated stent can cause recurrent pancreatitis, infection, perforation as swell as stenosis of the duct. Incidence of stent migration has been reported at about 1.5% in medical literature.(1) Retrieval of migrated stent is challenging, especially in pancreatic divisum due to anatomical location of main pancreatic duct and the acute angle at which endoscope must be maneuvered. Use of SpyGlass Direct Visualization System enables direct and fluoroscopic visualization of the pancreatic duct. If endoscopic retrieval is not possible, surgical retrieval may be necessary. Risk factors for proximal migration of stent include cholangiocarcinoma, malignant strictures, longer stent use.(1,2).Figure 1.: Cannulation of minor papilla and stone in PD (as pointed by arrow), stent placement.Figure 2.: Migrated PD stent.

S1516 Malignant Biliary Obstruction Diagnosed by Percutaneous Transhepatic Cholangioscopy With Spyglass Direct Visualization System

INTRODUCTION: Malignant biliary obstruction associated with gastric cancer is uncommon. We report a patient with obstructive jaundice due to a new biliary stricture after gastrectomy and loop gastrojejunostomy. Conventionally, enteroscopy-assisted ERCP will be needed to biopsy the stricture which can be difficult and not widely available. Here we describe an easier approach using Percutaneous Transhepatic Cholangioscopy (PTCS) with SpyglassTM Direct visualization system (SDVS). CASE DESCRIPTION/METHODS: 51-year-old male with history of gastric adenocarcinoma status post distal gastrectomy with loop gastrojejunostomy presented 3 years later with painless jaundice. Initial imaging studies including US and CT scan showed severe biliary obstruction with pronounced intrahepatic and extrahepatic ductal dilatation. MRCP revealed a proximal common bile duct stricture with resultant severe intrahepatic ductal dilation spanning approximately 1.5 cm, highly suspicious for malignancy (Image1). ERCP was not attempted due to the altered anatomy and a percutaneous internal biliary drain was placed by Interventional radiology (IR). The drain was placed through the left biliary system into the common duct and into the duodenum. Cholangiogram showed two strictures in the proximal and mid bile duct. In order to obtain the diagnosis, the decision was made to proceed with a combined endoscopic and IR guided approach. A digital cholangioscope was passed through a 12Fr sheath catheter that was placed by IR. The stricture was endoscopically visualized and appeared erythematous, friable with whitish mucosa (Image 2). Multiple biopsies were obtained using a mini biopsy forceps. Pathology revealed poorly differentiated adenocarcinoma with associated fibrosis, inflammation and necrosis. DISCUSSION: Cholangioscopy through a percutaneous transhepatic route is an attractive alternative option when traditional ERCP is technically challenging or not feasible. SDVS provides direct visualization of the biliary system increasing the diagnostic yield, as in our case where it helped to diagnose a malignant biliary stricture in a patient who was in remission from primary gastric carcinoma. PTCS with SDVS also provides therapeutic potential for choledocholithiasis, biliary strictures and local tumor ablative therapy. Though it is an invasive procedure requiring collaboration between a gastroenterologist and an interventional radiologist, as demonstrated, it is a safe and technically easy procedure with unique diagnostic and therapeutic potentials.Figure 1.: blue arrow: Proximal common bile duct stricture causing severe intrahepatic ductal dilation.Figure 2.: Biliary stricture seen using direct visualization system.

S3233 The Safety of Single Operator Per-Oral Cholangioscopy: A Single Center Experience

INTRODUCTION: Single operator per-oral cholangioscopy (SOC) has been increasingly used to provide direct visualization of the biliary tree in conjunction with endoscopic retrograde cholangiopancreatography (ERCP). There is a prevalent notion that SOC increases the risk of pancreatitis and cholangitis in addition to the well-recognized complications of ERCP that also includes pancreatitis, cholangitis, bleeding, and perforation. This study aims to determine the rate of complications when SOC is performed. METHODS: This is a retrospective study which included consecutive adult (> 18 years old) patients who underwent ERCP with SOC from October 2017 until June 2020. SOC was performed utilizing SpyGlass Direct Visualization System. All procedures were performed by endoscopists who annually performed more than 200 ERCPs. Data on patient demographics, procedural indication, type, and complications were obtained. RESULTS: Thirty-three patients (male/female = 18/15) underwent a total of 35 ERCP with SOC procedures with an average of 67 years old. Most were Caucasian (64%) and the average body mass index was 25.3 kg/m2. Majority of the indications included choledocholithiasis (40%), indeterminate biliary stricture (34%), and imaging findings suspicious of cholangiocarcinoma (14%). A greater percentage underwent stone removal (66%), biopsy (46%) and lithotripsy (17%). 29 out of the 33 patients (88%) had previous ERCP. Despite administering rectal indomethacin in 60% (21/35) of the procedures and placement of pancreatic duct stent in 11% (4/35) of the procedures, 1 patient developed post-ERCP pancreatitis the day after the procedure. Pre-procedure intravenous antibiotics were given in 74% (26/35) and no patients developed cholangitis or died within the 30 days of follow-up. CONCLUSION: Although a few studies published in literature demonstrate a higher rate of procedural complications with ERCP and SOC compared to ERCP alone, this study suggests that SOC in addition to ERCP does not confer an additional procedural risk of pancreatitis or cholangitis. Our patient developed post-ERCP pancreatitis despite indomethacin and antibiotic use since balloon dilation and sphincterotomy were also performed which are known post-ERCP pancreatitis risk factors. SOC is a relatively safe procedure and should be performed in addition to ERCP in the evaluation of indeterminate biliary strictures and imaging suspicious of malignancy, and in the treatment of difficult biliary and pancreatic stones.Table 1.: Baseline Characteristics of the Study Population

Possibilities of per-oral transpapillary cholangioscopy in oncological practice

Relevance. Diagnosis of malignant diseases causing bile duct strictures is a big challenge. At admission, patients with suspected biliary tract stricture, initially undergo endoscopic retrograde cholangiopancreatography (ERCP) as a diagnostic and treatment method. The morphological diagnosis of bile duct stricture based on ERCP with brush biopsy or intraductal forceps biopsy is limited by their low sensitivity. Consequently, a significant proportion of strictures remains undiagnosed, which led to the development of methods based on cholangioscopy.&#x0D; Aim. To determine the role of per-oral transpapillary cholangioscopy (TCS) in a specialized cancer clinic.&#x0D; Materials and methods. SpyGlass direct visualization system for per-oral intraductal examination from Boston Scientific was clinically tasted in Blokhin National Medical Research Center of Oncology of the Ministry of Health of Russia. Using this electronic system, TCS was performed in 4 patients with various malignant diseases.&#x0D; Results. In all cases, TCS was successful. In all patients, the diagnosis was confirmed with a forceps intraductal biopsy using Spybite forceps.&#x0D; Conclusion. Single-use electronic direct visualization system for per-oral intraductal examination and interventions like SpyGlass can be recommended for use in specialized cancer centers.

Advances of Peroral Cholangioscopy and EUS for Indeterminate Biliary Lesions

Traditionally, biliary lesions have been considered to be indeterminate when a diagnosis cannot be made after basic laboratory work-up, abdominal imaging and endoscopic retrograde cholangiopancreatography (ERCP) with biliary sampling. Although ERCP is a first-line diagnostic modality for indeterminate biliary lesions, the diagnostic yield of ERCP-based tissue sampling is insufficient. In a recent, peroral cholangioscopy (POC)- guided forceps biopsy and endoscopic ultrasound-guided fine-needle aspiration (EUSFNA) are evolving as reliable diagnostic procedures for indeterminate biliary lesions. In previous studies, EUS-FNA was sensitive and highly specific for diagnosing malignancy in biliary strictures. However, EUS-FNA has several limitations as a routine clinical procedure for all biliary strictures. Newly developed POC systems, such as the SpyGlass direct visualization system and direct POC using an ultra-slim endoscope, have led to excessive improvements in technical performance and diagnostic yields for biliary strictures. However, the performance of POC-guided target biopsy for distal bile duct strictures is technically difficult, and this approach has a limited ability to diagnose biliary strictures caused by non-intraductal, extrinsic compressed malignancies, such as a pancreatic cancer. Therefore, a tailored approach using optimized endoscopic modalities that are specific to the characteristics of a given biliary stricture is needed to achieve a high diagnostic yield for indeterminate biliary lesions.

Use of SpyGlass for peroral cholangioscopy in the diagnosis and treatment of hepatobiliary diseases in over five years follow-up: A single centre experience.

The use of cholangioscopy for the diagnosis and treatment of hepatobiliary diseases is gradually becoming more common. We aimed to review our peroral cholangioscopy interventions, using the first-generation SpyGlass Direct Visualization System (SDVS) and summarize our experience in terms of procedures and results. Forty-one patients who underwent this procedure at our Gastroenterology Clinic between February 2010 and October 2014 were included in this study. Patients were monitored for a median (IQR) of 44 (range 38-72) months. Demographic characteristics of these patients, results of the radiological and biochemical evaluation performed prior to the procedure, cholangioscopy findings together with the data relating to the procedure, histopathological diagnosis, clinical findings and results, and their effects on patient prognosis were assessed. In total, 41 patients underwent 46 cholangioscopy procedures. Of them, 21 (51.2%) were male. The most frequent clinical indications for cholangioscopy was the need to further investigate indeterminate stricture (n=16; 39%) and indeterminate filling defect (n=7; 17.1%). The procedure was considered successful in 39 patients with 41 (95.1%) receiving diagnostic and 33 (80.5%) receiving therapeutic benefits. The sensitivity and specificity for SVDS-guided biopsies and brush cytology were 80% and 87.5%; 26.6% and 75%, respectively. Complications related to the procedure occurred in a total of three patients (7.3%), two with cholangitis and one with perforation of gall bladder. Our experience shows that cholangioscopy procedures, performed with SDVS, are clinically applicable and safe in the diagnosis and treatment of hepatobiliary diseases.

1365 A Rare Case of Neuroendocrine Tumor Originating in Liver Diagnosed by ERCP Using a Spyglass Direct Visualization System

INTRODUCTION: Neuroendocrine carcinoma is predominantly found in the gastrointestinal tract (54-75%) with 44%, 19%, 16%, 10% and 7% in the small intestines, rectum, appendix, colon and stomach respectively. Primary liver neuroendocrine carcinoma comprises around 0.3% of all neuroendocrine tumors. This is a case of a neuroendocrine carcinoma with a focus of cholangiocarcinoma presenting as a biliary stricture diagnosed by ERCP using the spyglass visualization system. CASE DESCRIPTION/METHODS: A 75 year old female with a prior history of rheumatoid arthritis presented with persistent nausea, vomiting, diarrhea and abdominal pain and a 20 lb weight loss since December 2017. An ultrasound revealed intrahepatic biliary ductal dilation in the left lobe with no visible mass and a coarse hepatic echotexture. A subsequent MRI of the abdomen demonstrated left lobe intrahepatic biliary ductal dilation with a hypointense 1 cm region within the liver parenchyma associated with a biliary stricture. The biliary stricture in the left hepatic branch was visualized with the spyglass direct visualization cholangioscope introduced through an ERCP scope. Biopsies obtained through the cholangioscope revealed high grade dysplasia. The patient underwent a left lobectomy of liver with hepatic artery and portal lymph node dissection. Lymph nodes were negative for malignancy. The biliary stricture was from a high grade neuroendocrine carcinoma with a microscopic focus of cholangiocarcinoma with extensive lymphovascular and perineural invasion. The margin of the bile duct and hepatic hilum were involved by neuroendocrine carcinoma. Post operative PET scan showed a small focus of activity without any signs of distant metastasis. DISCUSSION: SpyGlass direct visualization system is a relatively new technique in ERCP. Recently published prospective data confirm that the overall success rates for adequate tissue sampling is nearly 90%. ERCP has limitations for sampling lesions in the bile duct without direct visualization. Conventional ERCP biliary sampling yields are 20% to 30% for cytology brushing to approximately 50% with a combined brush/standard biopsy forceps approach. If sampling is negative, the choice is either radical surgery or continual observation with an MRI. Nowadays, ERCP with spyglass technique and targeted direct visualization biopsy affords vastly higher yields. Direct visualization is now the gold standard to obtain biopsy samples in cases of biliary strictures.

1692 Retrieval of Impacted Extraction Balloon: A Rare Complication of ERCP for Choledocholithiasis

INTRODUCTION: ERCP is an essential tool in the management of biliary disorders. A large variety of rare ERCP related complications have been reported such as an impacting a retrieval basket, and colonic perforation. We report an unusual complication of ERCP with a retained balloon and a successful endoscopic removal at subsequent ERCP. CASE DESCRIPTION/METHODS: A 61-year-old man was transferred from a local hospital after undergoing an ERCP for choledocholithiasis. The ERCP balloon became lodged in the bile duct during stone extraction. The endoscopist tried to retrieve the balloon by pulling on the external part of the balloon catheter, but the catheter broke. He aborted the procedure and removed the ERCP scope by cutting the balloon catheter from outside and pulled the scope out. The patient was left intubated with the balloon catheter in his mouth and was transferred to our facility. Upon arrival, the patient was taken for ERCP. A fluoroscopic film showed the extraction balloon in the right upper quadrant of the abdomen (Figure 1). The duodenoscope was introduced through the mouth next to the balloon catheter. The impacted balloon was seen emerging from the major papilla (Figure 2). It was compressing the upper ampulla, duodenum, and stomach leading to linear pressure erosions (Figure 2). We used the Spyglass direct visualization system ((Boston Scientific, Marlborough, Mass, USA) to visualize the balloon impaction site, which was obstructed by the balloon catheter and the stone (Figure 3). The bile duct was then cannulated using a 0.025-inch × 270 cm angled ERCP guidewire (Olympus VisiGlide) through a 3.9 Autotome sphincterotome (Boston Scientific). The CBD was moderately and diffusely dilated. The impacted balloon catheter was pulled using the external part of the catheter, and it was successfully removed. We placed one fully covered self-expandable metal stent (FCSEMS) (Wallflex, Boston Scientific)10 mm by 4 cm with one 7 Fr by 10 cm double pigtail plastic stent into the CBD to maintain adequate drainage. The ERCP was accomplished without difficulty. The patient was extubated, liver function test improved. He was discharged home in a stable condition. He will have repeated ERCP in 8 weeks to remove the stents. DISCUSSION: Retaining ERCP balloon during stone extraction is extremely rare because it is easy to deflate and remove. Up to our knowledge, it has not been reported in the literature. We have demonstrated a successful retrieval of retained ERCP balloon during stone extraction. Watch the video: http://bit.ly/2JUie2Q.

Spyglass visual impression and Spybite targeted biopsies for diagnosis of biliary strictures of unknown reasons: a meta-analysis

Objective To study the diagnostic value of Spyglass visual impression and Spybite targeted biopsies for biliary strictures of unknown reasons. Methods Several Chinese and English databases were electronically searched for studies on biliary strictures diagnosed with Spyglass visual impression and Spybite targeted biopsies compared with golden standard (pathological biopsy, autopsy and long-term clinical follow-up). The methodological quality of the included studies was assessed according to QUADAS-2 items. The software Meta-DiSc (version 1.4) was used to conduct pooling on sensitivity, specificity, positive likelihood radio, negative likelihood radio and diagnostic odds ratio (DOR). Heterogeneity test was performed and the summary receiver operating characteristic curve (SROC) was drawn for area under the curve (AUC). Results A total of 12 studies met the inclusion criteria, involving 532 patients who received Spyglass visual impression and 525 who received Spybite targeted biopsies. The combined specificity, sensitivity, positive likelihood ratio, negative likelihood ratio and DOR were 0.90 (95%CI: 0.85-0.94), 0.89 (95%CI: 0.85-0.93), 7.12 (95%CI: 4.36-11.64), 0.12 (95%CI: 0.07-0.22)and 82.40 (95%CI: 33.73-201.28)for Spyglass visual impression, and 0.98 (95%CI: 0.96-1.00), 0.66 (95%CI: 0.60-0.71), 13.29 (95%CI: 6.92-25.53), 0.37 (95%CI: 0.28-0.47)and 51.05 (95%CI: 23.58-110.53) for Spybite targeted biopsies, respectively. The AUC on the SROC of Spyglass visual impression and Spybite targeted biopsies were 0.957 4 and 0.939 8, respectively. Conclusion Spyglass visual impression is useful for detecting malignant lesion, whereas Spybite targeted biopsies is better at confirming malignant diagnosis, which indicates combination of the two methods have good diagnostic value for indeterminate biliary strictures, but their negative results are not perfect in excluding biliary cancer. Key words: Meta-analysis; Spyglass direct visualization system; Spybite tageted biopsy; Indeterminate biliary stricture

Application of new endoscopic techniques in diagnosis of pancreaticobiliary diseases

Conventional imaging examinations including transabdominal ultrasound, computerized tomography, and magnetic resonance imaging which have certain limitations in diagnosis of pancreaticobiliary diseases. Endoscopic techniques can scan gallbladder, bile duct and pancreas with high resolution images from which obtained close to digest track. Therefore, they play an important role in diagnosis of pancreaticobiliary diseases. The rapid development of new techniques including endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, intraductal ultrasound, and Spy Glass Direct Visualization System help improving the diagnosis accuracy of pancreaticobiliary diseases. The article reviews the application of new endoscopic techniques in pancreaticobiliary diseases.

Peroral cholangiopancreatoscopy with the SpyGlass® system: what do we know 10 years later.

Smaller endoscopes and catheters have been developed that permit direct visualization of the bile and pancreatic ducts (cholangioscopy and pancreatoscopy, respectively). These endoscopes and catheters are passed through the working channel of a standard therapeutic duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP). The SpyGlass Direct Visualization System (Boston Scientific Corp, Natick, MA, USA) is currently the most widely used and studied device. Cholangioscopy with intraductal lithotripsy has become an established modality in the treatment of difficult biliary lithiasis. When used in the evaluation of indeterminate biliary strictures by experienced endoscopists in recognizing intraductal pathology, it increases the diagnostic yield of tissue sampling. Pancreatoscopy is complementary to other imaging modalities in the evaluation of intraductal papillary mucinous neoplasms of the pancreas and is emerging as a sole or adjunctive therapy to extracorporeal shock wave lithotripsy for the treatment of main pancreatic duct stones. It remains investigational in the diagnosis of pancreatic adenocarcinoma. Complications specific to the performance of cholangiopancreatoscopy include cholangitis, which is related to intraductal fluid irrigation.

Evaluation of Pulmonary Nodules Using the Spyglass Direct Visualization System Combined With Radial Endobronchial Ultrasound: A Clinical Feasibility Study

Background:Sampling of peripheral pulmonary nodules with radial endobronchial ultrasound (p-EBUS) increases diagnostic yield of bronchoscopy. However, diagnostic yield is influenced by numerous factors.Objective:We evaluated the use of SpyGlass, a one millimeter diameter optic fiber, to obtain images of the distal mucosa and of pulmonary lesions detected with p-EBUS to determine if visual aspect of the distal mucosa was predictive of diagnosis.Methods:We prospectively recruited subjects investigated for peripheral nodules. Bronchoscopy was performed and p-EBUS was used to locate the lesion through a guide sheath. The Spyglass fiber was introduced in the sheath to obtain images of the distal bronchial mucosa. Tissue sampling was subsequently done.Results:Fifteen patients were enrolled in the study. A final diagnosis of malignancy was confirmed in 80%. All lesions could be located using p-EBUS (100%). Diagnostic sensitivity for p-EBUS was 58.3%. Distal mucosa could be imaged with SpyGlass in 14/15 patients (93.3%). Mucosal appearance was described as abnormal in 7 out of the 15 subjects. Mean SpyGlass procedure time was 6.5 minutes. No direct complication was reported.Conclusion:Spyglass can be used in combination with p-EBUS to obtain images of the distal bronchial mucosa and peripheral pulmonary nodules. More patients will be needed to confirm whether mucosal appearance can be predictive of malignancy.

Digital, Catheter-Based Single-Operator Cholangiopancreatoscopes: Can Pancreatoscopy and Cholangioscopy Become Routine Procedures?

Working length 214cm Accessory channel diameter 1.2mm (3.6 French) outine visualization of the pancreatobiliary ductal Rsystem is probably the last endoscopic frontier in the alimentary tract. Although miniature endoscopes for insertion into the biliary or pancreatic ducts have been around for many years, cholangioscopy and pancreatoscopy are yet to become routine procedures. Performance of these procedures has remained mostly confined to large academic medical centers because of a variety of factors including lack of access to appropriate equipment, lack of expertise, and lack of user-friendliness of currently available endoscopes. The birth of catheter-based cholangiopancreatoscopes in the last decade by introduction of the Spyglass Direct Visualization System (DVS) (Boston Scientific, Natick, MA) led to more widespread use of cholangiopancreatoscopy. However, due to less that optimal image quality, the initial enthusiasm for routine use of this device soon faded. A new version of this catheter-based system with improved digital image has now been released. This article and the accompanying video present the use of this new technology in the pancreatobiliary ductal system and illustrate how it may lead to more widespread use of cholangiopancreatoscopy.

Efficacy and safety of SpyGlass guided laser lithotripsy for large bile duct stones

Objective To explore the value of SpyGlass (direct visualization system) guided laser lithotripsy for large bile duct stones in ERCP. Methods Thirty-three patients with large bile duct stones were randomly assigned to two groups: SpyGlass guided laser lithotripsy group (n=16) and mechanical lithotripsy group (n=17). All patients underwent ERCP procedures for stones extraction. The success rate of complete stone removal, the early complication rate related to the procedure and procedure time were compared between the two groups. Results The success rate of complete stone removal in SpyGlass guided laser lithotripsy group was higher than that of the mechanical lithotripsy group. There were no significant differences between two groups in either procedure time or the early complication rate related to the procedure (18.8% VS 5.9%, P>0.05). Conclusion SpyGlass guided laser lithotripsy is safe and effective for large bile duct stones. Key words: Common bile duct stones; Laser lithotripsy; SpyGlass system; Endoscopic retrograde cholangiopancreatography

Interobserver agreement for single operator choledochoscopy imaging: can we do better?

Background. The SpyGlass Direct Visualization System (Boston Scientific, Natick, MA) is routinely used during single operator choledochoscopy (SOC) to identify biliary lesions or strictures with a diagnostic accuracy up to 88%. The objective of this study was to determine the interobserver agreement (IOA) of modified scoring criteria for diagnosing biliary lesions/strictures. Methods. 27 SPY SOC video clips were reviewed and scored by 9 interventional endoscopists based on published criteria that included the presence and severity of surface structure, vasculature visualization, lesions, and findings. Results. Overall IOA was “slight” for all variables. The K statistics are as follows: surface (K = 0.12, SE = 0.02); vessels (K = 0.14, SE = 0.02); lesions (K = 0.11, SE = 0.02); findings (K = 0.08, SE = 0.03); and final diagnosis (K = 0.08, SE = 0.02). The IOA for “findings” and “final diagnosis” was also only “slight.” The final diagnosis was malignant (11), benign (11), and indeterminate (5). Conclusion. IOA using the modified criteria of SOC images was slight to almost poor. The average accuracy was less than 50%. These findings reaffirm that imaging criteria for benign and malignant biliary pathology need to be formally established and validated.

Su1700 SPYGLASS Direct Visualization System As a Diagnostic and Therapeutic AID to ERCP - a Nationwide, Register Based Study

Su1700 SPYGLASS Direct Visualization System As a Diagnostic and Therapeutic AID to ERCP - a Nationwide, Register Based Study

Efficacy of combined endoscopic lithotomy and extracorporeal shock wave lithotripsy, and additional electrohydraulic lithotripsy using the SpyGlass direct visualization system or X-ray guided EHL as needed, for pancreatic lithiasis.

Introduction. To evaluate the efficacy of combined endoscopic lithotomy and extracorporeal shock wave lithotripsy (ESWL), and additional electrohydraulic lithotripsy (EHL) as needed, for the treatment of pancreatic duct stones, we retrospectively evaluated 98 patients with chronic pancreatitis and pancreatic lithiasis. Methods. For the management of main pancreatic duct (MPD) stones in 98 patients, we performed combined endoscopic treatment (ET)/ESWL therapy as the first treatment option. When combined ET/ESWL was unsuccessful, EHL with the SpyGlass Direct Visualization system or X-ray guided EHL was performed. Outpatient ESWL was reserved as one of the final treatment options. Results. Fragmentation was successful in 80 (81.6%) patients as follows: combined ET/ESWL: 67 cases; SpyGlass EHL: 4 cases; X-ray guided EHL: 3 cases; and outpatient ESWL: 6 cases. Successful outcome was obtained by combined ET/ESWL in 67 of the 98 patients (74.5%), by EHL in 7 of 14 patients (7.1%), and by outpatient ESWL in 6 of 6 patients (6.1%). Negotiating the guidewire through a severe MPD stricture was significantly associated with a higher rate of stone fragmentation (P = 0.0003). Conclusions. In cases where combined ET/ESWL was not successful for stone clearance, EHL using the SpyGlass system or X-ray guided EHL was effective in cases where the guidewire could be negotiated through the MPD stricture and it increased the fragmentation rate.