Prospective comparison study of franseen needle and standard needle use for pancreatic lesions under EUS guidance.

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.

Prospective histological evaluation of a 20G core trap with a forward-cutting bevel needle for EUS-FNA of pancreatic lesions.

BACKGROUND: 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. PATIENTS AND METHOD: 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. RESULTS: 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. CONCLUSIONS: 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.

A feasibility study of digital single-operator cholangioscopy for diagnostic and therapeutic procedure (with videos).

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.

Prospective evaluation of digital single-operator cholangioscope for diagnostic and therapeutic procedures (with videos).

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.

Evaluation of the safety of endoscopic radiofrequency ablation for malignant biliary stricture using a digital peroral cholangioscope (with videos).

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.

Clinical utility of endoscopic ultrasound-guided biliary drainage as a rescue of re-intervention procedure for high-grade hilar stricture.

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.

Prospective clinical study of endoscopic ultrasound-guided biliary drainage using novel balloon catheter (with video).

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.

Placement of a 6 mm, fully covered metal stent for main pancreatic head duct stricture due to chronic pancreatitis: a pilot study (with video).

BACKGROUND: Temporary stent placement is widely performed for pancreatic duct stenosis due to chronic pancreatitis. A fully covered self-expandable metal stent (FCSEMS) has a larger diameter, and therefore longer stent patency, and the effect of expansion of the main pancreatic duct stricture may be obtained. However, if stent migration upstream occurs, stent removal is extremely difficult. In addition, because of the diameter gap between the FCSEMS and the main pancreatic duct, stent-induced ductal change may occur. To prevent these adverse events, the technical feasibility, safety and efficacy of the placement of a novel 6 mm diameter FCSEMS with a long suture, to facilitate its removal in cases of stent migration upstream, were evaluated in a pilot study. METHODS: Between December 2014 and August 2015, symptomatic chronic pancreatitis patients with abdominal pain and a main pancreatic head duct stricture were enrolled. Stent placement for main pancreatic duct stricture was performed under endoscopic retrograde cholangiopancreatography (ERCP) guidance and stent removal was performed within 6 months. RESULTS: A total of 13 patients were retrospectively enrolled in this study. Metal stent insertion was successfully performed in all patients and clinical success was high (12/13, 92%). As adverse events, stent migration upstream was seen in two patients. Another 11 patients successfully underwent stent removal without any adverse events. During follow up (median 258 days), 2 patients still underwent pancreatic duct stenting because of continuing main pancreatic duct stricture. CONCLUSION: In conclusion, this novel FCSEMS is acceptable for stent placement in cases of chronic pancreatitis with a main pancreatic duct stricture.

Choledochoduodenal Fistula after the Placement of a Partially Covered Metal Stent for Unresectable Pancreatic Cancer.

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.

EUS-guided FNA for biliary disease as first-line modality to obtain histological evidence.

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.

EUS-guided cholecystoduodenostomy for acute cholecystitis with an anti-stent migration and anti-food impaction system; a pilot study.

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.

A Duodenal Ulcer Caused by Pancreatic Ductal Hypertension with Chronic Pancreatitis.

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.