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Background and Objectives: A needle with Franseen geometry for fine needle aspiration is now available. However, no reports have described prospective evaluations of the Franseen needle or comparisons with the standard needle. The aim of this comparative prospective study was to evaluate the histological diagnostic yield of the Franseen needle and the standard needle using tissue obtained by a single pass of each for the same lesion. Patients and Methods: In this study, only tissue obtained by the first pass using the Franseen needle was used. As a comparison group, only tissue obtained from the same lesion by a second pass using the standard needle was used. Evaluation of the histological diagnostic yield of the needles was based on tissue obtained by each single pass with no additional passes. Results: A total of 56 patients were prospectively enrolled. The rate of adequate tissue obtained was significantly higher for the Franseen needle than for the standard needle (89.4% vs. 62.5%, respectively; P < 0.05). The sensitivity and accuracy of the Franseen needle were 80.7%, and 84.6%, respectively, while those for the standard needle were 59.6% and 63.5%, respectively. Conclusions: The Franseen needle offers a better rate of obtaining adequate tissue and higher diagnostic accuracy than the standard needle.

Background and Aim The clinical impact of catheter-based radiofrequency ablation (RFA) under endoscopic retrograde cholangiopancreatography (ERCP) guidance has recently been reported; however, severe adverse events have also been noted. If tumor is not present in the biliary tract, severe adverse events such as perforation or bleeding as a result of vessel injury around the biliary tract may occur. In addition, the effectiveness of RFA may not be sufficient based solely on radiographic guidance. The aim of the present study was to evaluate the actual feasibility of intraductal RFA by peroral cholangioscope (POCS) evaluation before/after RFA. Methods In this retrospective study carried out between July and September 2016, consecutive patients who underwent RFA for malignant biliary stricture and POCS evaluation before/after RFA were enrolled. Primary endpoint of this study was technical feasibility of RFA, which was evaluated by POCS. Secondary endpoints were rates and types of adverse event. Results A total of 12 consecutive patients were retrospectively enrolled in this study. Stent placement using uncovered metal stents had been previously done in six patients before RFA. Tumor was seen in the biliary tract in all patients. RFA was technically successful in all patients, and clinical success was confirmed in all patients by POCS imaging. Adverse events were seen in only one patient. Median stent patency was 154 days. Conclusions RFA for malignant biliary stricture may be safe. To confirm the feasibility and efficacy of RFA, additional cases, prospective studies, and a comparison study between with and without endobiliary RFA are needed.

Background and Aim On endoscopic ultrasound (EUS)-guided biliary drainage, fistula dilation may be accompanied by leakage of bile juice, potentially along with bacteria or air, so this procedure should be kept as simple and short as possible. To date, various techniques to dilate the fistula have been reported. This prospective, single-center, single-arm study evaluated the technical feasibility and safety of EUS-guided biliary drainage using novel balloon catheters. Methods Tip of novel balloon catheters is only 3 Fr and tapered, and the catheters also show favorable push ability. First, biliary tract was punctured using 19-G fine needle aspiration needle. Next, we immediately inserted the novel balloon catheter, and the biliary tract and intestinal wall were dilated. Then, we performed metallic stent placement without any dilation fistula. Results A total of 20 patients were prospectively enrolled in this study. Technical success rate was 100%. Eleven patients underwent EUS-guided choledochoduodenostomy, and nine patients underwent EUS-guided hepaticogastrostomy. Median procedure time was only 11 min (range, 8–16 min) for EUS-guided choledochoduodenostomy and 14 min (range, 11–18 min) for EUS-guided hepaticogastrostomy. Adverse events were seen in 15% (3/20; self-limited abdominal pain n = 2, peritonitis n = 1). Conclusions Although additional cases and a randomized controlled comparison with another dilation technique such as the graded dilation or cystotome dilation technique are needed, our technique may be helpful for EUS-guided biliary drainage.

Background and aim Re-intervention after stent placement for malignant hepatic hilum obstruction (HBO) is challenging. endoscopic ultrasound-guided biliary drainage (EUS-BD) has been developed as an alternative method for failed endoscopic retrograde cholangiopancreatography (ERCP). In this retrospective study, the clinical utility of EUS-BD as a rescue drainage technique for HBO patients who failed re-intervention under ERCP guidance was evaluated. Methods Between April 2012 and August 2015, patients with HBO were enrolled. Patients' characteristics, kinds of metallic stents, configuration of stent placement, overall survival, stent patency, and results of re-intervention were reviewed, along with the re-intervention technical success rate. Results The biliary stricture type was Bismuth type IV in 59% (23/39) and types IIIa and b in 20.5% (8/39) each. Biliary metallic stent placement was bilateral in 38.5% (15/39), and unilateral in 61.5% (24/39). Primary stent dysfunction was observed in 71.8% (28/39) of cases. Planned re-intervention under ERCP guidance was attempted in 26 patients. The technical success rate was 62% (16/26). For the 10 patients who failed re-intervention under ERCP guidance, EUS-BD was planned. The technical success rate was 100% (10/10). The procedure time was 25.8 min. Adverse events were not seen in any patients. Stent patency after re-intervention was not significantly different between ERCP (165 days) guidance and EUS-BD (152 days) guidance (P = 0.463) CONCLUSIONS: In conclusion, EUS-BD as a re-intervention method for metallic stent obstruction was safe and feasible. If ERCP was failed, EUS-BD may be one of option as re-intervention method for high-grade hilar stricture.

A 75-year-old Japanese man with type 2 diabetes mellitus suffered from unresectable pancreatic head cancer and was admitted to our institution due to acute cholangitis. A partially covered metal stent was placed at that time. 11 months later, he was readmitted for acute cholangitis. Upper endoscopy revealed complete stent distal migration and a small hole on the oral side of the ampulla. While attempting cannulation into the hole, an upstream biliary tract was revealed. Accordingly, we diagnosed the patient to have a choledochoduodenal fistula. After metal stent removal and balloon dilation, we placed two 7 Fr plastic stents, which successfully relieved the patient's cholangitis.

BACKGROUND AND STUDY AIM Despite high technical and functional success rates with endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS), rates of adverse events have also been high. No reports have focused on EUS-HGS alone with a large sample size about predictors of stent patency. The present study examined predictors of stent patency in patients who underwent EUS-HGS. PATIENTS AND METHODS The consecutive 51 patients who underwent EUS-HGS using one metallic stent were retrospectively enrolled in this study. Baseline characteristics, stent length from the hepatic portion and in the luminal portion, kinds of stent dysfunction, and stent patency were reviewed. RESULTS Median duration of stent patency was significantly shorter with stent length in the luminal portion

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has been established as a method to obtain tissues of various organs. To obtain sufficient tissue has clinical impact to facilitate the diagnosis by clinical pathologists, the assessment and subtyping of various neoplasms, and for further immunohistochemical investigations of tumor type. Recently, a novel 20G core trap with a forward-cutting beveled FNA needle (ProC-F) has become available. The aim of this prospective study was to evaluate the feasibility and diagnostic yield of EUS-FNA for pancreatic lesions using this needle. In this study, the first puncture was performed using the ProC-F. Only tissue obtained with the first puncture using the ProC-F was used to evaluate diagnostic yield of ProC-F. The second puncture was performed using a 22G standard FNA needle using the same technique as for the first puncture. Second puncture was performed if the endosonographer did not feel that sufficient tissue had not been obtained by first puncture. Fifty-three consecutive patients who underwent EUS-FNA for pancreatic lesions were prospectively enrolled. The technical success rate of EUS-FNA using the ProC-F was 98.1% (52/53). The rate of adequate tissue obtained by ProC-F was 96.2% (50/52). On the other hand, the rate of adequate tissue obtained by the standard needle was 71.1%. The sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and accuracy of the ProC-F and the standard needle were 92.5, 100, 100, 76.9, and 94.0%, and 85.2, 100, 100, 55.6, and 87.5%, respectively. Diagnostic yield of ProC-F about sensitivity (P = 0.027), NPV (P = 0.035), and accuracy (P = 0.004) was significantly higher than of standard needle. Adverse events were not seen in any patients. Although only tissue obtained by the first puncture was evaluated, the rate of adequate tissue and the histologic diagnostic yield for pancreatic lesions were extremely high using the ProC-F.

Background and Aim Recently, the digital single-operator cholangioscope (SPY-DS) has become available. This system may allow diagnosis by direct visualization and allow performance of various therapeutic procedures. The aim of the present study was to prospectively evaluate the clinical utility of DSOCS for diagnostic and therapeutic procedures for biliary disease. Methods Technical success was defined as successful visualization of target lesions in the biliary tract and carrying out forceps biopsy as a diagnostic procedure, and successfully carrying out treatment such as guidewire insertion for the area of interest, electrohydraulic lithotripsy (EHL), or migrated stent removal. Also, the present study aimed at investigating diagnostic yield of the cholangioscopic findings and biopsy specimens. Results A total of 55 consecutive patients were prospectively enrolled in this study; a diagnostic procedure was done in 33 patients, and a therapeutic procedure was done in 22 patients. Overall accuracy of visual findings was 93%, with a sensitivity of 83%, a specificity of 89%, positive predictive value (PPV) of 83%, and negative predictive value (NPV) of 100%. However, the overall accuracy of forceps biopsy was 89%, with a sensitivity, specificity, and PPV of 100%, and NPV of 90%. Overall technical success rate of therapeutic procedures such as selective guidewire insertion, EHL or migrated stent removal was 91% (20/22). Finally, adverse events were seen in two cases in the diagnostic group, but were not seen in the therapeutic group. Conclusion Although additional cases and a randomized, controlled study with another cholangioscope are needed, diagnostic and therapeutic procedures using SPY-DS appear to be feasible and safe.

Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) is not normally indicated for an obstructed right intrahepatic bile duct (IHBD). The technical feasibility and clinical efficacy of a novel technique of EUS-BD for right IHBD obstruction were evaluated. A total of 11 patients underwent drainage using either a left or a right biliary access route. The causes of obstructive jaundice were cholangiocarcinoma (n = 6), pancreatic cancer (n = 3), gastric cancer (n = 1), and colon cancer (n = 1). After placement of an uncovered metal stent to bridge the obstruction, a hepaticogastrostomy was completed using a covered stent. Mean procedure time was 33.9 ± 10.0 minutes. Technical and functional success were achieved in all patients, and no adverse events occurred. This novel method appears to be safe and effective for right IHBD obstruction.

On endoscopic ultrasound (EUS)-guided biliary drainage, fistula dilation may be accompanied by leakage of bile juice, potentially along with bacteria or air, so this procedure should be kept as simple and short as possible. To date, various techniques to dilate the fistula have been reported. This prospective, single-center, single-arm study evaluated the technical feasibility and safety of EUS-guided biliary drainage using novel balloon catheters.Tip of novel balloon catheters is only 3 Fr and tapered, and the catheters also show favorable push ability. First, biliary tract was punctured using 19-G fine needle aspiration needle. Next, we immediately inserted the novel balloon catheter, and the biliary tract and intestinal wall were dilated. Then, we performed metallic stent placement without any dilation fistula.A total of 20 patients were prospectively enrolled in this study. Technical success rate was 100%. Eleven patients underwent EUS-guided choledochoduodenostomy, and nine patients underwent EUS-guided hepaticogastrostomy. Median procedure time was only 11 min (range, 8-16 min) for EUS-guided choledochoduodenostomy and 14 min (range, 11-18 min) for EUS-guided hepaticogastrostomy. Adverse events were seen in 15% (3/20; self-limited abdominal pain n = 2, peritonitis n = 1).Although additional cases and a randomized controlled comparison with another dilation technique such as the graded dilation or cystotome dilation technique are needed, our technique may be helpful for EUS-guided biliary drainage.

Re-intervention after stent placement for malignant hepatic hilum obstruction (HBO) is challenging. endoscopic ultrasound-guided biliary drainage (EUS-BD) has been developed as an alternative method for failed endoscopic retrograde cholangiopancreatography (ERCP). In this retrospective study, the clinical utility of EUS-BD as a rescue drainage technique for HBO patients who failed re-intervention under ERCP guidance was evaluated.Between April 2012 and August 2015, patients with HBO were enrolled. Patients' characteristics, kinds of metallic stents, configuration of stent placement, overall survival, stent patency, and results of re-intervention were reviewed, along with the re-intervention technical success rate.The biliary stricture type was Bismuth type IV in 59% (23/39) and types IIIa and b in 20.5% (8/39) each. Biliary metallic stent placement was bilateral in 38.5% (15/39), and unilateral in 61.5% (24/39). Primary stent dysfunction was observed in 71.8% (28/39) of cases. Planned re-intervention under ERCP guidance was attempted in 26 patients. The technical success rate was 62% (16/26). For the 10 patients who failed re-intervention under ERCP guidance, EUS-BD was planned. The technical success rate was 100% (10/10). The procedure time was 25.8 min. Adverse events were not seen in any patients. Stent patency after re-intervention was not significantly different between ERCP (165 days) guidance and EUS-BD (152 days) guidance (P = 0.463) CONCLUSIONS: In conclusion, EUS-BD as a re-intervention method for metallic stent obstruction was safe and feasible. If ERCP was failed, EUS-BD may be one of option as re-intervention method for high-grade hilar stricture.

Background: Few reports have described endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) for biliary lesions. In addition, adverse events were not completely examined in previous reports, due to the inclusion of cases in which biliary stents had already been placed. The present study aimed to investigate the diagnostic yield and adverse events of EUS-FNA for biliary lesions as the first-line diagnostic modality for consecutive prospectively registered patients. Methods: Inclusion criteria were as follows: (1) patients with suspected cholangiocarcinoma (CCA) based on computed tomography or other imaging modalities; (2) patients who had not previously undergone endoscopic retrograde cholangiopancreatography or EUS-FNA; (3) absence of surgically altered anatomy, such as Roux-en-Y anastomosis or duodenal obstruction caused by tumor invasion, through which an endoscope could not pass; and (4) provision of written informed consent to all procedures associated with the study. Results: A total of 47 consecutive patients with suspected CCA were registered to this study. Sensitivity and accuracy were 89% and 87%, respectively. On multivariate analysis, puncture site was the only factor associated with reduced diagnostic yield (hazard ration, 6.879; 95% confidence interval, 1.172–40.374; P = 0.033). Remarkably, no adverse events such as bleeding or bile leakage were associated with EUS-FNA in any of the 47 patients. Conclusions: Our results suggest that EUS-FNA can be safely performed for biliary disease without biliary stenting. Furthermore, this procedure may warrant use as the first-line diagnostic method, although our results need to be validated in future prospective studies.

Background: Recently, endoscopic ultrasound-guided gall bladder drainage (EUS-GBD) has been reported using a self-expandable metallic stent. To prevent stent migration and food flowing into the common bile duct through the cystic duct, we perform a novel EUS-guided cholecystoduodenostomy. The aim of our study was to evaluate the safety and feasibility of EUS-guided cholecystoduodenostomy with an anti-stent migration and anti-food impaction system. Methods: A total of 16 consecutive patients who underwent EUS-guided cholecystoduodenostomy for acute cholecystitis were included in this study. Results: Technical and clinical success was obtained in all patients. The median procedure time was 26.9 min (range 19–42 min). Median follow-up time was 181.5 days (range 18–604 days), and in this time, recurrence of acute cholecystitis was not seen in all patients. Adverse events such as stent migration and cholangitis were not seen in any patients, although pneumoperitoneum was seen in one patient. Conclusion: Our technique may be favorable and effective for the prevention of adverse events on EUS-GBD.

We herein describe the case of a 67-year-old woman with a duodenal ulcer thought to be caused by elevated pancreatic ductal pressure. The patient complained of continuous upper abdominal pain. Her medical history included idiopathic chronic pancreatitis. Endoscopy revealed a huge duodenal ulcer located on the inferior duodenal angle, which had not been seen on endoscopic retrograde pancreatography two months previously. A combination study using endoscopy and contrast imaging confirmed the relationship between the duodenal ulcer and the pancreatic branch duct. To our knowledge, this is the first case of duodenal ulcer thought to be caused by elevated pancreatic ductal pressure.

Duodenal stent placement has been developed as an alternative to surgical gastrojejunostomy [1]. Compared with uncovered metallic stents, duodenal fully covered metallic stents offer advantages, such as the prevention of tumor ingrowth, and thus lower occlusion rates [2]. However, duodenal fully covered metallic stents also have several disadvantages, such as stent migration [3]. Acute pancreatitis is another adverse event associated with duodenal stent placement, occurring at a frequency of approximately 4% [4,5]. In previous reports, acute pancreatitis has been treated conservatively. If a fully covered metallic stent is placed in the duodenum, the frequency of acute pancreatitis may be increased, and the treatment of acute pancreatitis may prove difficult. We report herein a novel treatment for acute pancreatitis due to duodenal placement of a fully covered metallic stent. A 78-year-old man was admitted to our hospital because of vomiting and obstructive jaundice. He was undergoing chemotherapy for bladder cancer. Computed tomography showed a duodenal stenosis, attributed to lymph node metastasis. No other site of stenosis was detected, so we attempted duodenal stent placement. First, we advanced the endoscope into the duodenum, and contrast medium was injected. The second part of the duodenum was obstructed (●" Fig.1). Then, we placed a fully covered metallic stent (ComVi, 20mm×12 cm; TaeWoong Medical, Seoul, South Korea) in the duodenum (●" Fig.2). Although the vomiting resolved completely, acute pancreatitis developed. Computed tomography showed dilatation of the Fig.1 A duodenal stenosis is apparent (arrows) in a 78-year-oldmanadmittedwith vomitingand obstructive jaundice.

Despite high technical and functional success rates with endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS), rates of adverse events have also been high. No reports have focused on EUS-HGS alone with a large sample size about predictors of stent patency. The present study examined predictors of stent patency in patients who underwent EUS-HGS.The consecutive 51 patients who underwent EUS-HGS using one metallic stent were retrospectively enrolled in this study. Baseline characteristics, stent length from the hepatic portion and in the luminal portion, kinds of stent dysfunction, and stent patency were reviewed.Median duration of stent patency was significantly shorter with stent length in the luminal portion3 cm (52 days) than with ≥3 cm (195 days; P 0.01). On the other hand, median duration of stent patency did not differ significantly between ≥4 cm (194 days) and4 cm (127 days; P = 0.1726). Length of stent in the luminal portion ≥3 cm (Hazard ration [HR], 9.242; 95% confidence interval [CI], 3.255-26.244, P 0.05) and performance of chemotherapy (HR, 3.022; 95% CI, 1.448-6.304, P 0.05) were also associated with long stent patency on the Cox proportional hazards model.In conclusion, to obtain long-term stent patency, our data suggest that a stent length ≥3 cm in the luminal portion may be suitable for EUS-HGS.

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Supplemental Digital Content is available in the text, Recently, the novel SpyGlass DS Direct Visualization system (SPY DS) has become available. This system offers several advantages over the conventional SPYGlass system. This study evaluated the clinical feasibility and efficacy of diagnostic and therapeutic procedures for biliary disorder using SPY DS. In this retrospective study, consecutive patients who had biliary disorder were enrolled between November 2015 and February 2016. All patients could not be diagnosed or treated by standard endoscopic retrograde cholangiopancreatography in our hospital or at another hospital. A total of 28 consecutive patients (21 men and 7 women; median age, 73 years; age range, 55–87 years) were retrospectively enrolled in this study. Among them, diagnostic procedure was performed in 20 patients, and 8 patients underwent therapeutic procedures. The technical success rate for diagnostic procedures was 100% (20/20). Diagnostic accuracy was 100% (19/19). The technical success rate for therapeutic procedures was 88% (7/8). Among these 8 patients, 4 patients with common bile duct stones underwent electrohydraulic lithotripsy. One patient successfully underwent guidewire insertion to remove a migrated plastic stent. The 3 remaining patients underwent SPY DS to insert a guidewire for left bile duct obstruction and for posterior bile duct branch. In the patient who underwent guidewire insertion for left hepatic bile duct obstruction cause by primary sclerosing cholangitis, we could not advance the guidewire into the left hepatic bile duct. No adverse events were seen. Median SPY DS insertion time was 21 min (range, 8–32 min). Single-operator cholangioscopy using SPY DS was feasible and had a marked clinical impact in patients with biliary disease. Additional case reports and prospective studies are needed to examine further applications of this system.