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Pancreatic duct guidewire placement (P-GW) techniques include both the injection cannulation technique with a contrast medium and wire-guided cannulation without contrast injection for selective biliary cannulation; the latter is the so-called "double-guidewire technique" (D-GW). The aim of this study was to compare the outcomes between P-GW and D-GW for biliary cannulation.The procedures for biliary cannulation with a naïve papilla were performed in a total of 363 cases. We divided the patients chronologically, according to the time period during which the procedures were performed, into two groups: group A, P-GW performed from March 2008 to June 2009; and group B, D-GW performed from July 2009 to December 2010. The success rates and complication rates were evaluated in each group.Biliary cannulation was successful in 31 (81.6%) patients in the P-GW group and 34 patients (82.9%) in the D-GW group. The onsets of postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) occurred in the P-GW and D-GW groups were four (10.5%) and three (7.3%) patients, respectively, and all were mild cases (P = 0.616). The frequency of hyperamylasemia and the serum amylase level tended to be lower in the D-GW group than in the P-GW group (P = 0.213). There was a statistically significant difference on the onsets of PEP in the GW and non-GW groups (P = 0.04, 8.9% and 1.1%, respectively).Both the D-GW and P-GW techniques were equally effective for difficult biliary cannulation. Furthermore, the complication rates, including PEP, were similar in both techniques. A prospective randomized trial is warranted.

Background. Recent diagnostic imaging tests contribute to improving the diagnosis of pancreatobiliary cancers. However, it is not practical to perform these tests for all patients as screening. Thus, less-invasive and simple screening tests are still required. A method to detect the IgG antibody induced in serum against the p53 protein accumulating due to p53 gene mutation, as a biomarker, was developed around 1990.Method. 35 patients with pancreatic cancer, 12 patients with biliary tract cancer, and 31 patients with benign pancreatobiliary diseases were entered into this study. Measurement of serum anti-p53 antibody was conducted in all patients. In addition, the rate of p53 protein overexpression was examined in those cases that could be examined pathologically.Result. Among all patients in the pancreatic cancer and biliary tract cancer groups, there was no patient with serum anti-p53 antibody positive value that exceeded the standard value. The rate of p53 protein overexpression was 48.0% in the patients with pancreatobiliary cancers and 0% in the benign pancreatobiliary diseases group.Conclusion. Serum anti-p53 antibody measurement does not contribute to the diagnosis of pancreatobiliary cancers. Instead, traditional p53 immunostaining still appears to be valuable in combination with standard procedures.

Background Although peroral direct cholangioscopy (PDCS) is emerging as an alternative to traditional mother-daughter cholangioscopy, it is associated with high failure rates. The aim of the present study was to evaluate the ability to insert and carry out interventions using a prototype multi-bending PDCS. Patients and Methods Prospective, observational clinical feasibility study was done in 41 patients with a variety of biliary diseases. A multi-bending PDCS prototype was inserted using a free-hand technique, a guidewire alone, or with a 5-Fr diameter anchoring balloon. Diagnostic and therapeutic procedures were carried out. Results The free-hand direct insertion technique failed in all attempted cases (n = 7). Of the remaining 34 cases, successful rate of PDCS insertion into the distal bile duct was achieved by passing the PDCS over a guidewire alone (n = 6) and/or with a guidewire plus anchoring balloon (n = 28) for an overall successrate of 88.2% (30/34). In 13 (92.9%) patients without an underlying biliary stricture, PDCS insertion proximal to the bifurcation was possible. In 25 cases, biliary interventions were attempted including biopsy (n = 13), stone removal (n = 6), stent removal (n = 1), and intraductal electrohydraulic lithotripsy (n = 2) and were successful in 22 (88%). Other than two patients with procedure-related cholangitis with a mild grade of severity, no complications were observed. Conclusions Using a novel multi-bending prototype peroral direct cholangioscope, cholangioscopy had a high diagnostic and therapeutic success rate only when passed over a guidewire and anchoring balloon but not with the free-hand insertion technique. Comparative studies of direct cholangioscopy are warranted.

Biliary self-expandable metallic stent (SEMS) is the preferred and first-line therapy for unresectable malignant biliary obstruction. To date, several reports have revealed the relatively high incidence of acute complications such as pancreatitis and cholecystitis due to mechanical stent compression. In the present case, we encountered fatal pancreatitis following fully covered metal stent placement. An 85-year-old man had middle bile duct strictures due to cholangiocarcinoma. A 10-mm diameter fully covered SEMS was placed across the papilla for biliary decompression. Laboratory data and physical evidence the following day revealed acute pancreatitis. Therefore, antibiotics and protein degeneration enzyme inhibitors were given. However, his condition did not improve. Two days after the procedure, we removed the stent and returned him to his original hospital. Serum amylase level decreased below 400 mg/dL 6 h after the procedure. However, the acute pancreatitis worsened. Although we treated the patient in the intensive care unit, he died 32 days after the second admission.

ERCP-related procedures involve radiation exposure of patients and medical staff. We developed a novel protective lead shield which is attached around the fluoroscopy generator. Here we examine levels of radiation exposure to patients, endoscopists and assistants, and evaluate the usefulness of the newly designed protective shield.Four-hundred and seventy-one ERCP procedures were performed from April 2006 to April 2007. At first, we compared the radiation dose of consecutive fluoroscopy conditions with pulse fluoroscopy of 15 per second and then the radiation dose with and without the protective shield. Next, we measured the radiation exposure of endoscopists and assistants in the clinical setting monitored by digital dosimeter during ERCP procedure.The radiation dose was the most at the 45° direction. Using pulse fluoroscopy of 15 per second the radiation dose of patients and endoscopists decreased by about half. Using both pulse fluoroscopy of 15 per second and the protective shield, the radiation dose at the endoscopist's position was reduced up to 97%. The total fluoroscopy time was 5851 minutes in the 471 ERCP cases. Using pulse 15 and the protective lead shield, the radiation exposure dose of one endoscopist and two assistants were 2430.8, 2673.9 and 1375.0µSv, respectively.Novel protective lead shield in combination with pulse fluoroscopy can significantly reduce the radiation exposure leading to avoid unnecessary radiation exposure to patients and medical staff.

Background/aims Recently, controllable biopsy forceps (MTW, D°sseldorf, Germany) have been developed. This biopsy forceps were 90° adjustable. In the present study, the feasibility and efficacy of the controllable biopsy forceps were compared with those of conventional biopsy forceps in patients with biliary tract disease. Methodology A total of 27 patients with biliary tract lesions were enrolled. We evaluated the procedure time, the sample tissue size and the diagnostic accuracy. In addition, the physicians performing the procedure rated their impressions about operability into 3 classes: excellent, fair and poor. Results The sensitivity in distinguishing benign from malignant lesions was 71.4% (15/21) for the 90° adjustable type and 66.7% (14/21) for the conventional type. The accuracy rate was 77.8% (21/27) for the 90° adjustable type and 74.0% (20/27) for the conventional type. In terms of operability as rated by each physician, the 'excellent' rate was given more frequently to the 90° adjustable type 25.9% than for the conventional type 11.1% (p=0.047). Conclusions This preliminary study showed that controllable biopsy forceps compared to conventional type biopsy forceps, despite a larger diameter, enables biopsy in a similar procedure time and its ease of use was rated better.

Background Tubular plastic and metal stents have inherent shortcomings when used for transenteric drainage of fluid collections. Objective To evaluate a novel lumen-apposing, self-expandable metal stent for EUS-guided drainage of pancreatic pseudocysts and the gallbladder. Design Retrospective case series. Setting Tertiary-care academic medical center. Patients This study involved 15 patients (median age 54 years) with symptomatic pancreatic pseudocysts who underwent 12 transgastric and 3 transduodenal pseudocyst drainage procedures. Five patients (median age 69.5 years) with acute cholecystitis underwent 4 cholecystoduodenostomies and 1 cholecystogastostomy. Intervention Stent deployment under EUS guidance, passage of an endoscope through the stent lumen for pseudocystoscopy or cholecystoscopy, transenteric endoscopy-guided interventions including biopsy, necrosectomy, and stone removal. Main Outcome Measurements Technical and clinical success. Results All stents were successfully deployed without complication, with a median time to removal of 35 days. All pseudocysts resolved after a single drainage procedure. One stent migrated into the stomach, and the remaining 14 were found to be patent at the time of removal. There was no pseudocyst recurrence during the 11.4-month median follow-up period. One gallbladder stent remains indwelling and fully patent at 12 months. Resolution of acute cholecystitis was observed immediately after stent implantation. No recurrence of symptoms was observed during a median follow-up period of 9 months. Limitations Retrospective study, small sample size, lack of control patients. Conclusion Transenteric drainage of pancreatic pseudocysts and the gallbladder by using a novel, lumen-apposing, metal stent was accomplished with high technical and clinical success in this pilot observational study. Further studies are warranted.

To evaluate the efficacy and safety of endoscopic removal and trimming of self-expandable metallic stents (SEMS).All SEMS had been placed for distal biliary strictures. Twenty-seven endoscopic procedures were performed in 19 patients in whom SEMS (one uncovered and 18 covered) removal had been attempted, and 8 patients in whom stent trimming using argon plasma coagulation (APC) had been attempted at Tokyo Medical University Hospital. The APC settings were: voltage 60-80 W and gas flow at 1.5 L/min.The mean stent indwelling period for all patients in whom stent removal had been attempted was 113.7 ± 77.6 d (range, 8-280 d). Of the 19 patients in whom removal of the SEMS had been attempted, the procedure was successful in 14 (73.7%) without procedure-related adverse events. The indwelling period in the stent removable group was shorter than that in the unremovable group (94.9 ± 71.5 d vs 166.2 ± 76.2 d, P = 0.08). Stent trimming was successful for all patients with one minor adverse event consisting of self-limited hemorrhage. Trimming time ranged from 11 to 16 min.Although further investigations on larger numbers of cases are necessary to accumulate evidence, the present data suggested that stent removal and stent trimming is feasible and effective for stent-related complications.

There are few reports on the histological diagnostic ability of endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) in a large-series of pancreatic masses. In the present study therefore we retrospectively evaluated the histological diagnostic ability of EUS-FNA in pancreatic masses without on-site cytopathologist. In 355 patients with pancreatic solid masses, EUS-FNA was carried out. EUS-FNA histology showed accuracy, 90.7%; sensitivity, 89.5%; specificity, 95.6%; positive predict value, 98.8%; negative predict value, 68.8% by intention-to-treat analysis. Except for 10 with inadequate materials, EUS-FNA histology showed accuracy, 93.3%; sensitivity, 91.8%; specificity, 100%; positive predict value, 100%; negative predict value, 77.6%. The mean number of puncture was 2.88 (range 1 to 8). There was two (0.6%) procedure-related bleeding. In conclusion, diagnostic ability of EUS-FNA by histological materials was similar to previous literature on the EUS-FNA without on-site cytopathologist.

Pancreatic duct stones are a common complication of chronic pancreatitis. We describe successful endoscopic removal of a large pancreatic duct stone using large-balloon dilation in combination with pancreatic sphincterotomy. A 63-year-old woman was admitted for endoscopic treatment of acute on chronic pancreatitis with diabetes and epigastric pain with liver dysfunction due to a large impacted stone within the distal main pancreatic duct. Endoscopic pancreatic sphincterotomy was carried out using a wire-guided pull-type sphincterotome. Although we could carry out a relatively large incision, the stone could not be extracted. We therefore carried out papillary dilation using a large balloon (diameter 12 to 15 mm) to make room alongside the stone. A 10 × 20-mm white pancreatic duct stone was extracted during the process of pulling a dilating balloon into the working channel of the endoscope. Eventually, the second stone was removed without any procedure-related complication.

Magnetic compression anastomosis (MCA) is a revolutionary, minimally invasive method of performing choledochoenterostomy or choledochocholedochostomy without using surgical techniques in patients with biliary stricture or obstruction. Herein, we describe a case series of MCA for severe biliary stricture or obstruction, which could not be treated with conventional therapies. Two patients with biliary obstruction were treated using MCA for choledochocholedochostomy and choledochoenterostomy at Tokyo Medical University Hospital and Tokyo Medical University Hachioji Medical Center. Endoscopically, a samarium–cobalt (Sm–Co) rare-earth magnet was placed at the superior site of obstruction through the percutaneous transhepatic biliary drainage route and another Sm–Co magnet was placed at the inferior site of obstruction. A comprehensive computer-aided literature search for MCA was performed up to September 2009 by using MEDLINE and EMBASE. MCA techniques enabled complete anastomosis in both cases without procedure-related complications. The MCA technique is a revolutionary method of performing choledochocholedochostomy and choledochoenterostomy interventionally in patients with biliary obstruction, for whom the conventional endoscopic procedure is not available, or in candidates who are deemed unsuitable for surgery.

The aim of this study is to evaluate a prototype variable stiffness duodenoscope (VSD) for diagnostic and therapeutic ERCP in comparison with standard duodenoscopes. We performed retrospective analysis on the success rate of intubation of the second duodenum, overall procedural success rate, and comparative frequency of the necessity to change duodenoscopes from standard JF-260V and TJF 260V or to change stiffness using the VSD. A total of 213 nonconsecutive procedures in 196 patients with pancreaticobiliary diseases. There was no statistically significant difference in endoscope intubation rate or technical success rate between the different duodenoscopes. In one patient with severe duodenal stenosis, the VSD using the moderately stiff mode allowed the major papilla to be reached when the TJF-260V endoscope could not. There were no serious procedure-related adverse events. In conclusion, while the VSD performed well, the present models do not appear to offer obvious advantages over the standard duodenoscopes for routine diagnostic and therapeutic ERCP. Prospective studies may be warranted to identify those patients who would benefit from this new technology.

Magnetic compression anastomosis (MCA) is a minimally invasive method of performing choledochocholedochostomy without surgery in patients with biliary stricture or obstruction. We describe a successful case involving magnetic compression duct-to-duct biliary reconstruction in right-lobe living donor liver transplantation (RL-LDLT). Endoscopically, a samarium-cobalt (Sm-Co) rare-earth magnet was placed at the superior site of obstruction via the percutaneous transhepatic biliary drainage route, and another Sm-Co magnet was also placed at the inferior site of obstruction with the aid of an endoscope. MCA techniques enabled complete anastomosis without procedure-related complications. In conclusion, the MCA technique is a revolutionary method of performing choledochocholedochostomy in patients with biliary obstruction after LDLT.

Recently, the usefulness of endoscopic ultrasound (EUS) elastography has been reported for the diagnosis of pancreatic lesions. In the present study, we retrospectively assessed EUS elastography as a diagnostic tool by evaluating tissue elasticity distribution and elasticity semiquantification, using the strain ratio (SR) of tissue elasticity, in patients with pancreatic masses. One hundred and nine patients who underwent EUS elastography between September 2006 and May 2009 were retrospectively evaluated. The final diagnosis was chronic pancreatitis (CP) in 20 patients [6 with non-mass-forming pancreatitis, 7 with mass-forming pancreatitis (MFP), and 7 with autoimmune pancreatitis (AIP)], pancreatic cancer (PC) in 72, pancreatic neuroendocrine tumor (PNET) in 9, and normal pancreas in 8. The tissue elasticity distribution calculation was performed in real time, and the results were represented in color in fundamental B-mode imaging. In addition, we performed quantification using the SR (non-mass area/mass area). Elastography for all PC patients showed intense blue coloration, indicating malignant lesions. In contrast, MFP presented with a mixed coloration pattern of green, yellow, and low-intensity blue. Normal controls showed an even distribution of green to red. The mean SR was 23.66 ± 12.65 for MFP and 39.08 ± 20.54 for PC (P

Endoscopic therapy of pancreatic duct (PD) strictures using balloon dilation and pancreatic duct stent (PS) placement has been reported to improve the severity of abdominal pain in selected patients with chronic pancreatitis (CP). However, some strictures are refractory and require frequent PS exchange to control symptoms. We describe two cases of successful endoscopic PD incision for difficult PD stricture using a wire-guided snare. The snare is partially opened within the strictured pancreatic duct while applying current, thus incising the duct. Although both cases were successful without complications we do not advocate that this method be used routinely because of the potential for severe complications, e.g. bleeding, ductal perforation or pancreatic parenchymal damage. In order to prevent these complications, we developed a wire-guided technique under fluoroscopic control. We think this procedure may be useful in patients with short, straight PD strictures. Although further study is required, this approach may have potential for selected patients with refractory PD strictures due to CP.

Background Recently, endoscopic biliary sphincterotomy (EBS) followed by large-diameter balloon dilation has been used for the removal of large bile duct stones. A limitation is the need for 2 accessories: a sphincterotome and a dilating balloon. Objective To evaluate a new device, a combination of a large-diameter dilating balloon and sphincterotome (LDDBS). Design Retrospective study. Setting University hospital. Patients Eighteen patients with large bile duct stones. Interventions After performing EBS by using the LDDBS, the catheter was then advanced into the bile duct and balloon dilation was performed by gradual inflation with diluted contrast medium under endoscopic and fluoroscopic guidance until it reached a diameter adequate to allow stone removal. Main Outcome Measurements Feasibility and efficacy of stone removal by using an LDDBS. Results Technical success of large-diameter balloon dilation after EBS was achieved in all cases. Bile duct clearance was accomplished in 94% (17/18) of cases in the first session. Bile duct clearance was eventually completed in all patients. Mechanical lithotripsy was required in 4 patients (22%). There were no major intraprocedural or postprocedural complications. Limitations Single-institution study, small sample size. Conclusions The prototype LDDBS is safe and effective to facilitate the removal of large bile duct stones by using one accessory.

To develop a novel dendritic cell (DC)-based vaccine for inducing antigen-specific CD8+ T cell responses by cross-presentation, we tested a novel antigen delivery system that introduces soluble antigens into the cytosol of cells by an endocytosis-mediated mechanism which avoids damaging the plasma membrane (“Endo-Porter”™). Proteins released from endosomes into the cytoplasm are degraded by the proteasome, and fragmented antigenic peptides are presented to the classical cytosolic MHC class I pathway. DCs pulsed with OVA protein in the presence of Endo-Porter efficiently stimulate OVA peptide-specific CD8+ T (OT-I) cells. Although this agent diverts some of the endocytosed antigens away from the classical MHC class II-restricted presentation pathway to the class I pathway, the activation of CD4+ T cells was found not to be hampered by Endo-Porter-mediated antigen delivery. On the contrary, it was rather augmented, probably due to the increased uptake of antigen. Because specific CD4+ T cell help is required to license DCs for cross-priming, Endo-Porter-mediated antigen delivery is a promising approach for developing more efficient cancer vaccines targeting both CD4+ and CD8+ T cells.

The aim of this study was to evaluate the usefulness of single-balloon enteroscopy (SBE)-assisted endoscopic retrograde cholangiopancreatography (ERCP) in patients with Billroth II gastrectomy (B-II) or Roux-en-Y anastomosis (R-Y).Thirteen SBE procedures were performed in 2 patients with B-II and 11 patients with R-Y at Tokyo Medical University Hospital. SBE was replaced with a conventional forward-viewing upper endoscope after reaching the papilla. This is a retrospective cohort study.In all cases but one (92.3%, 12/13), the papilla or anastomotic site could be reached with the SBE. The rate for B-II and R-Y were 100% (2/2) and 90.9% (10/11), respectively. The mean time required to reach the papilla or anastomotic site was 33.3 min (range, 5-86 min). In cases of R-Y, the mean time required to reach the papilla or anastomotic site was 35.5 min (range, 12-76 min). The overall success rate of the therapeutic ERCP on the first session was 76.9% (10/13). In patients with an intact papilla, the success rate on the first session was 72.3% (8/11). With regard to the type of surgery, the success rate of the procedure in patients with B-II and R-Y was 100% (2/2) and 72.3% (8/11), respectively. The mean procedural time for 10 successful groups on the first session was 66.4 min (range, 25-152 min). No adverse events occurred.SBE-assisted ERCP using an overtube-assisted technique appears to be promising for performing therapeutic ERCP in patients with B-II or R-Y.

Background There have been a few previous reports on attempted double-balloon endoscopy (DBE)-assisted endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y anastomosis and an intact papilla. This study was designed to evaluate the usefulness of DBE-assisted ERCP in patients with Roux-en-Y anastomosis and an intact papilla of Vater. Methods Thirteen DBE procedures were performed in nine patients who had undergone Roux-en-Y reconstruction combined with eight total gastrectomies and one partial gastrectomy. Both short-type and long-type DBE were used. Long-type DBE was replaced with a conventional forward-viewing upper endoscope after reaching the papilla. Technical success rate, measurement of procedure times, and adverse events were evaluated in the retrospective study. Results In all cases, the scopes could reach the papilla. The mean time required to reach the papilla was 48 (range, 13–90) min. There was a statistically significant difference with the short and long scope (29.0 ± 19.2 min vs. 64.8 ± 24.7 min, respectively; P = 0.044). The success rate of bile duct cannulation, resulting in achieving therapeutic ERCP on the first session was 66.7% (6/9). The mean procedural time in the successful cases was 128 (range, 47–183) min. Finally, therapeutic ERCP was achieved in all nine cases. There was one adverse event in which retroperitoneal perforation during lithotripsy, but that was successfully treated by conservative therapy alone. Conclusion DBE-assisted ERCP seems to be a promising option to perform therapeutic ERCP for intact papilla in patients with a Roux-en-Y anastomosis.

Nowadays, EUS-guided FNA is a safe and precise procedure to obtain tissue samples from several masses, eg, pancreatic masses, lymph nodes, submucosal lesions, or extrinsic lesions, to provide important information. Although in most cases echoendoscopists can accomplish the procedure, there are some cases in which it is very difficult or impossible to perform the EUS-guided FNA because of the anatomical location of masses, such as lesions in the uncinate process, the hilum of the bile duct, or the large intestine, excluding the rectum or in cases previously treated by Billroth-II or Roux-en-Y reconstruction.

To investigate if contrast-enhanced ultrasonography (CE-US) is useful for determining treatment efficacy and outcome in the early stages of pancreatic cancer chemotherapy by assessing changes in intratumor hemodynamics using CE-US with a contrast agent.The subjects were 34 patients with unresectable advanced pancreatic cancer treated by chemotherapy. CE-US was assessed after every treatment (course) completion under the same conditions, and patients were divided into two groups according to the intratumor enhancement pattern: Vascular rich (R) group and vascular poor (P) group.After the second course of treatment, R group in intratumor hemodynamics had 18 patients, and P group had 16 patients. The reduction rates of serum CA19-9 level after chemotherapy which decreased to half or less of the baseline level were 2/15 (0.1%) in P group, but 11/16 (69%) in R group (P = 0.006). When the mean number of courses of chemotherapy and outcome were compared, P group had a mean number of courses of 4.9 (R group, 10.2) and mean survival time (MST) of 246 d (R group, 402 d), showing that outcome was significantly better in R group (P = 0.006).CE-US revealed that the change in intratumor blood flow correlated with both serum CA19-9 level and outcome. Patients with serum CA19-9 that decreased to less than half the baseline level, and patients with an abundant intratumor blood flow, had a significantly better outcome. Thus, CE-US is potentially useful for evaluating treatment efficacy and outcome in the early stages of pancreatic cancer chemotherapy.

Endoscopic papillectomy (EP) has been recognized as a safe and reliable treatment for tumor of the duodenal papilla. For complete resection, precise assessment of not only the intraductal extent but also the lateral margins of the tumor is mandatory before resection.Our purpose was to prospectively assess the enhancement of the lateral margins of tumor of the duodenal papilla for the treatment of EP by comparing narrow-band imaging (NBI) and indigo carmine (IC) chromoendoscopy.Prospective study.This procedure was performed in Tokyo Medical University Hospital.Fourteen consecutive cases of tumors of the major duodenal papilla.All patients underwent EP after evaluation by NBI and IC.Histologic evaluation of diagnosis of NBI and IC by comparison with en bloc tissue.In all lesions, either IC or NBI were superior to conventional white-light imaging except in 1 IC case. The ability of NBI observation to emphasize the tumor margin was statistically significantly better than IC observation (P.05). The en bloc EP was endoscopically successful in all cases, without fatal adverse events. En bloc tissue revealed 13 adenomas and 1 adenoma with focal adenocarcinoma. There was no residual adenoma in lateral margin specimens, either endoscopically or histologically.The lesions resected were all relatively small. This was not a blinded randomized study.This study demonstrated the feasibility and a certain degree of efficacy of NBI for enhancement of the tumor margin of duodenal papilla. Further blinded randomized studies involving large duodenal papillary tumors are required.

Background Endoscopic biliary drainage has been established as providing effective treatment for acute obstructive jaundice and cholangitis. A recently developed ultrathin transnasal videoendoscope is less invasive, even for patients who were critically ill, and can be performed without conscious sedation. Objective To evaluate the clinical efficacy and safety of biliary drainage (BD) by using transnasal videoendoscopy (TNE) without conscious sedation. Design Case series. Setting This procedure was performed at Tokyo Medical University Hospital. Patients Three patients with bile-duct stones and acute cholangitis and with a previous biliary endoscopic sphincterotomy (ES) were included in this study. Intervention All patients underwent BD by using a front-viewing TNE. Two 5F stents were placed into the bile duct across the major papilla. Main Outcome Measurement The efficacy and safety of the TNE technique. Results Transnasal insertion of a TNE endoscope was feasible in all patients, without epistaxis. TNE BD was achieved in all patients. Abdominal pain, fever, and jaundice improved 24 hours after the procedure in all patients. Despite the absence of intravenous conscious sedation, all patients would agree to undergo the procedure again, if necessary. Limitations Maneuverability of the TNE endoscope; limited to patients with a previous ES. Conclusions In this small series, unsedated TNE can be used to successfully drain the biliary system in patients with a previous ES. Additional studies to validate this hypothesis are needed.

916 Endoscopic Ultrasound-Guided Pancreatic Duct Rendezvous in Child With Traumatic PD Disruption Kentaro Ishii*, Takao Itoi, Atsushi Sofuni, Fumihide Itokawa, Takayoshi Tsuchiya, Toshio Kurihara, Shujiro Tsuji, Nobuhito Ikeuchi, Junko Umeda, Reina Tanaka, Ryosuke Tonozuka, Mitsuyoshi Honjo, Shuntaro Mukai, Fuminori Moriyasu Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan Background and Patient: Endoscopic retrograde cholangiopancreatography (ERCP) for a patient with traumatic pancreatic duct (PD) disruption is minimally invasive but always challenging. Here, we describe the successful PD stenting in a 9-year-old boy in whom the PD was disrupted by trauma and the initial ERCP failed. The boy fell down and seriously hurt his abdomen on the way home from school. He later developed pancreatic injury and complete PD disruption. Transpapillary PD stenting failed in the previous hospital. Endoscopic Methods: ERCP was re-attempted in our hospital. Endoscopic retrograde pancreatography revealed the complete PD disruption and pooling of contrast medium at the pancreatic body. A guidewire (GW) could not be advanced into the distal PD. Thus, a therapeutic curved linear array echoendoscope was positioned in the stomach. After excluding the blood vessels by Doppler ultrasonography, the distal PD was punctured transluminally using a 22-guage fine needle aspiration (FNA) needle under endoscopic ultrasound (EUS) guidance. PD access was confirmed by EUS imaging and fluoroscopy. A contrast agent was injected via the FNA needle. Then, a 0.018-inch GW was inserted into the PD. However, the GW could not be advanced to the proximal PD from the PD disruption site even with a hydrophilic GW. Therefore, the GW was left in the disruption cavity as long as possible and the echoendoscope was removed. The echoendoscope was then advanced to the major papilla. Thereafter, the GW could be grasped with a biopsy forceps and pulled out through the working channel. A 9-Fr dilation catheter was inserted into the PD over the rendezvous GW, and another wire could be inserted into the distal PD through the dilation catheter (i.e., over-thewire double GW technique). Finally, a 5-Fr PD stent was retrogradely inserted into the distal PD across the disruption cavity. The PD stent was changed every 1 or 2 months, and removed after 7 months. The patient has remained symptom-free. Clinical Implications: EUS-PD rendezvous appears to be useful even in a child in whom the PD was disrupted by trauma and the initial ERCP failed.

66 Creation of a Choledochoduodenostomy Using a Novel Lumenal Apposition Device: First Clinical Experience Takao Itoi*, Kenneth Binmoeller, Fumihide Itokawa, Atsushi Sofuni, Toshio Kurihara, Takayoshi Tsuchiya, Kentaro Ishii, Shujiro Tsuji, Nobuhito Ikeuchi, Fuminori Moriyasu Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan; Interventional Endoscopy Services, California Pacific Medical Center, California, CA Introduction: Recently we reported on the feasibility and safety of transenteric drainage of pancreatic pseudocysts and gallbladders using a newly developed lumenal apposition device (GIE 2012). We now report on the first clinical experience of creation of a transenteric choledochoduodenostomy using the Lumenal Apposition Device (LAD). Aim: To evaluate the feasibility and, safety of transenteric biliary drainage using the LAD for palliation of obstructive jaundice. Materials: The LAD consists of braided nitinol heat-set into a dual flange configuration. Fully expanded, the stent diameter and length measure 6 mm and 8 mm, respectively. The flange diameter is 14 mm. The LAD is constrained within a 10 Fr delivery catheter. Patients and Methods: In 8 patients (3 male, mean age 61.1, range 62-99) with distal biliary obstruction and jaundice due to 4 pancreatic cancers, 3 ampullary cancers, and 1 distal bile duct cancer, the LAD was placed using a 3.7 mm channel curved array echoendoscope (Olympus). The bile duct was punctured with a 19G FNA needle under endoscopic ultrasound (EUS) guidance and a guidewire inserted. The fistula tract was primed for LAD placement with a bougie catheter and/or cautery needle and/or 4 mm non-compliant balloon. The LAD was deployed under combined EUS and endoscopic guidance. After deployment, the LAD lumen was dilated with a noncompliant balloon catheter to 6 mm to optimize drainage when indicated. Nasobiliary catheters were placed across the LAD for irrigation at the discretion of the endoscopist. Results: All LADs were safely placed without acute complications, including bleeding or perforation. The LAD did not migrate, dislodge or otherwise change position after deployment. Four patients had self-limited abdominal pain after the procedure with mild elevation of the white cell count. Acute cholecystitis occurred in one patient, who proceeded to percutaneous transhepatic gallbladder drainage. The percutaneous drain was removed one month later. In all cases, translumenal biliary drainage via the anastomosis created by the LAD resulted in palliation of obstructive jaundice with improved liver enzymes and bilirubin. Conclusion: EUS-guided deployment of the LAD is feasible and safe for translumenal bile duct drainage and provides effective palliation of obstructive jaundice.

Safety and Effectiveness of Endoscopic Sphincterotmy Plus Large Balloon Dilation: Single Center Mid-Term Outcome Fumihide Itokawa*, Takao Itoi, Atsushi Sofuni, Takayoshi Tsuchiya, Nobuhito Ikeuchi, Reina Tanaka Tokyo Medical University, Tokyo, Japan Background: Endoscopic sphincterotmy plus large balloon dilation (ESLBD) would theoretically favorable for extracting large bile duct stones. Although there are many studies on the feasibility and short-term outcome, there is no midto long-term outcome after ESLBD. The aim of our study is to evaluate the mid-term outcome of ESLBD. Methods: 168 patients with large bile duct stones who underwent ESLBD from November 2006 through December 2011 were retrospectively reviewed. The patients were observed till November 2012. In the present study, inclusion criteria were used to select patients with large and/or multiple bile-duct stones: 1) bile duct stone, 13 mm or more in shortest dimensionor 2) multiple ( 3) bile-duct stones, with the smallest more than 10 mm in shortest dimension. Exclusion criteria included coagulopathy, marked thrombocytopenia, anticoagulation therapy, acute pancreatitis, septic shock. After endoscopic sphincterotomy or prior sphincterotomy, the papillary balloon catheter (maximum diameter 15 mm, 18 mm, or 20 mm) was passed over the guidewire and positioned across the main duodenal papilla. The size of balloon was matched to the diameters of the bile duct and the stones. Results: The patients mean age were 76.8 9.8years. The history of gastric operation was 140 with none (normal), 2 with Billroth 1, 11 with Billroth 2 and 15 with Rouxen Y. 70 patients (41.7%) had periampullary diverticulum. The presence of Gallstone was 65 (38.7%), the history of cholecystectomy was 42(25%), the previous sphincterotomy was 33 (19.6%). The mean follow up period were 39.85 13.7 months (range 11-69). 7 patients (4.2%) occurred stone recurrence (Mean age 72.8 7.8, surgically altered anatomy: none 6, Billroth 2 1, Gallstone 3, Periampullary diverticulum 1, History of sphincterotomy 6 (85.7%), History of stone recurrence 6 (85.7%)). There were no recurrence who had first ESLBD treatment. Conclusions: ESLBD can be safely and effectively performed. Furthermore, our mid-term outcome revealed that ESLBD is low risk of recurrence of bile duct stones. Thus, although further lon-term outcome seems to be mandatory, it will be promising treatment in patients with difficult bile duct stones.

Background Intraductal papillary mucinous neoplasms (IPMN) of the pancreas are associated with substantially increased risk of malignant transformation when compared to other types of pancreatic lesions such as serous cystadenoma (SCA) and mucinous cystadenoma (MCA). A recent study suggests that detection of a mutation in codon 201 of GNAS in pancreatic cyst fluid DNA may be able to distinguish IPMN from other lesions of the pancreas, including both MCA and SCA [1]. This study found the detection of a GNAS mutation to be 100% specific, and the presence of either a GNAS or KRAS mutation to be 96% sensitive for IPMN. We examined the diagnostic significance of GNAS mutations in a cohort of pancreatic cyst fluid specimens and correlated the results with the associated diagnostic information. Methods 200 residual pancreatic cyst fluid DNA specimens from 198 distinct patients were retrieved from specimen archives and tested. These specimens were chosen so that there was an equal mix of KRAS mutated and wildtype results, and a range of CEA results above and below 192 ng/mL. DNA was amplified with primers targeting the codon 201 region, and sequenced using capillary electrophoresis and Sanger sequencing. The clonality of the mutation was identified as the ratio of mutant to wildtype, with a limit of detection of 10%. IPMN was determined to be present if there was duct dilation or connectivity to the duct system together with observation of mucinous characteristics of the fluid (e.g. gross mucin, mucin stain, elevated CEA, etc.). Results GNAS mutations were found in 50/200 (25%) specimens. A significant association between the presence of KRAS mutation and GNAS mutation was found, with more GNAS mutations present among KRAS-mutated than KRASwildtype cysts (odds ratio=4, p=7.0e-5). There was no significant difference in mean CEA values between according to GNAS mutation status. Two small ( CAT) that has not been previously reported in IPMN; this mutation was present in only that one specimen. In 20/50 (40%) of GNAS mutated-specimens neither duct dilation nor cyst communication with the duct system was observed. Conclusions Based on the present evaluation, GNAS is found to be mutated in a significant number of cases lacking the classic features of IPMNs. Further work is needed to better understand the role of GNAS in discriminating IPMNs from other cystic neoplasms of the pancreas and in evaluating the malignant potential of either; additional surgical outcomes would be valuable for this assessment. 1. Sci. Transl. Med. 3, 92ra66 (2011).

Endoscopic biliary stenting for malignant biliary obstruction is currently the gold standard for biliary drainage. Biliary cancer treatment is crucial. Cases of gastric outlet obstruction that includes the duodenum because of cancer invasion and biliary obstruction are seldom observed. The required treatment for such cases is simple biliary stenting and a different treatment for duodenal obstruction. Hence, double stenting for bile duct and duodenal obstruction has drawn attention. In the present review, we state different treatment strategies for malignant duodenal obstruction and then describe double stenting in biliary obstruction that also includes non-biliary cancer malignant lesions and duodenal obstruction.