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Competing Interests: H. Isayama was supported by research grants from Boston Scientific Japan and FUJIFILM Corporation. The funding source had no role in the design, practice, or analysis of this study. S. Takahashi, K. Tomishima, Y. Takasaki, A. Suzuki, S. Ishii, and T. Fujisawa declare that they have no conflict of interest.

Objectives: With the emergence of the double-balloon endoscope (DBE), hepaticojejunostomy anastomotic strictures (HJASs) are increasingly managed endoscopically. However, balloon dilation and/or plastic stent placement may be associated with low stricture resolution rates and long treatment duration. We utilized a fully-covered metal stent (FCSEMS), which was designed for temporary placement for benign biliary strictures, and assessed its feasibility for patients with HJASs., Methods: We retrospectively studied 20 patients who underwent DBE-assisted FCSEMS placement for HJASs between June 2017 and March 2019. The FCSEMS was removed endoscopically at three months of stent placement. The outcomes investigated were the stricture resolution at the time of FCSEMS removal, the stricture recurrence, and adverse events., Results: Among 20 patients treated, stricture resolution was achieved in 17 patients (85.0%) at three months of stent placement. The FCSEMS was removed endoscopically without any technical difficulties in all cases except for two with asymptomatic stent migration due to stricture resolution. During a median follow-up period of 11.9 months (interquartile range, 7.5-18.0 months), an HJAS recurred in one patient (5.9%). For two patients without stricture resolution and one patient with recurrent stricture, another FCSEMS placement for 77, 84, and 186 days resolved the stricture. The overall stricture resolution rate was 95.0%. In one patient with FCSEMS-induced de novo stricture, long-term plastic stent placement was required. Procedure-related adverse events included mild cholangitis in two patients and mild pancreatitis in one patient., Conclusions: Endoscopic treatment using a FCSEMS via DB-ERCP was a feasible and effective treatment option for a HJAS., (© 2020 Japan Gastroenterological Endoscopy Society.)

Background: Endoscopic management of hepaticojejunostomy anastomotic strictures is technically demanding due to surgically altered anatomy. The promise of double-balloon endoscope-assisted endoscopic retrograde cholangiopancreatography (DB-ERCP) has been reported in this setting. No large study has examined long-term outcomes of this new treatment modality and predictive factors for the stricture resolution., Methods: We included 102 patients who received DB-ERCP for a hepaticojejunostomy anastomotic stricture between 2008 and 2018. Balloon dilation was performed as a first-line treatment, and plastic stent(s) were placed for refractory cases. Potential predictive factors for the stricture resolution were examined using multivariable logistic regression analyses., Results: DB-ERCP was technically successful in 91 patients (89.2%). Overall, stricture resolution was achieved in 70 patients (76.9%) with a median follow-up period of 30.9 months (range 1-118.5 months). Among 64 patients (71.9%) who underwent successful re-canalization via balloon dilation, anastomotic stricture recurred in 22 patients (34.4%). In cases with refractory or recurrent stricture after balloon dilation, 20 patients (52.6%) underwent stricture resolution via plastic stent placement, and the recurrence was observed in two patients (10%). Post-operative time to DB-ERCP of > 12 months and the scar-like appearance around the anastomosis were associated with a higher rate of stricture resolution (odds ratios, 5.59 [95% CI 1.69-18.5] and 5.22 [95% CI 1.29-21.1], respectively)., Conclusions: Treatment of hepaticojejunostomy anastomotic strictures via DB-ERCP was technically feasible, providing a reasonably high rate of stricture resolution. Alternative treatment should be explored for refractory cases.

Background: Due to increasing opportunities for abdominal imaging studies, bile duct stones are occasionally diagnosed without any symptoms. However, there has been no consensus on the management of asymptomatic bile duct stones. We conducted a retrospective longitudinal cohort study to investigate the natural history of asymptomatic bile duct stones and clinical outcomes according to the timing of endoscopic removal., Methods: We identified consecutive patients who were diagnosed with asymptomatic common bile duct stones and categorized into those who were followed up with stones in situ (wait-and-see group) and those who received early endoscopic stone removal (intervention group). Cumulative incidence functions of biliary complications were estimated and compared between the groups., Results: We included 191 patients (114 patients in the wait-and-see group and 77 patients in the intervention group). In the wait-and-see group, the cumulative incidence of biliary complications was 6.1% at 1 year, 11% at 3 years, and 17% at 5 years. Asymptomatic disappearance of stones was observed in 22 patients (19%). Procedure-related adverse events of early endoscopic stone removal of asymptomatic stones were observed in 25 (32%) patients including 4 (5.2%) with severe pancreatitis. The cumulative incidence function of biliary complications did not differ by treatment strategies (P = 0.55)., Conclusions: Biliary complications occurred in a substantial proportion of patients with asymptomatic bile duct stones, but early endoscopic removal appeared to have little effect on the prevention of further biliary complications. Given the risk of procedure-related pancreatitis, the wait-and-see strategy may become a management option of asymptomatic stones.

Background and Aim: Recurrences after endoscopic treatment of common bile duct stones (CBDS) are common. The aims of this study were to identify risk factors for recurrences of CBDS and to evaluate the effect of interventions for prevention of further recurrences., Methods: A total of 976 patients who underwent endoscopic treatment of CBDS were retrospectively studied. Risk factors for single and multiple recurrent CBDS were evaluated using a Cox hazard regression model. The incidences of further recurrences were evaluated according to the additional interventions., Results: The mean age was 69.3 years, and 39.3% were female. Endoscopic papillary balloon dilation, endoscopic sphincterotomy, and endoscopic papillary large balloon dilation were performed in 858, 77, and 41 patients, respectively. The rates of one or more recurrence and multiple recurrences of CBDS were 12.4% and 2.7%, respectively. In the multivariate analyses, the significant risk factors were the bile duct size (hazard ratio [HR] 1.07, P = 0.012), gallbladder left in situ with stones (HR 1.91, P = 0.046), and pneumobilia after treatment (HR 2.10, P = 0.047) for single recurrence and the number of stones at the first recurrence (HR 1.16, P = 0.021) for multiple recurrences. In five out of nine cases with multiple recurrences, further recurrence was not observed after additional sphincteroplasty in addition to cholecystectomy., Conclusions: The incidence of multiple recurrences was not uncommon after the first recurrence of CBDS., (© 2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Background: Although surgical or endoscopic treatment is effective for pain control in symptomatic calcified chronic pancreatitis, it is still unknown whether early intervention in mild symptomatic pancreatic stones would reduce the frequency of acute exacerbation and improve long-term outcomes. The aim of this randomized-controlled trial was to explore the efficacy of early endotherapy for mild symptomatic pancreatic stones in comparison with the wait-and-see policy., Materials and Methods: Patients with mild symptoms because of pancreatic stones were assigned randomly to the endotherapy or the wait-and-see group. The wait-and-see group received endotherapy only when they developed refractory exacerbation or intractable pain. The primary outcome was the cumulative incidence of intolerable pain attacks and acute exacerbation. The secondary outcomes were the development of pancreatic insufficiency and the progression of pancreatic atrophy., Results: A total of 20 patients were enrolled between March 2008 and March 2011. The study was terminated prematurely because of the poor patient enrollment. Early endotherapy tended to reduce the cumulative incidence of pain attacks and exacerbation, (P=0.17) with the composite incidence of pain attacks and exacerbation of 30% in the endotherapy group and 60% in the wait-and-see group. There were no significant differences in terms of diabetic status and the presence of steatorrhea. The thickness of the pancreas decreased significantly in the wait-and-see group (9.2-6.8 mm, P=0.041), but not in the endotherapy group (8.7-9.0 mm, P=0.60)., Conclusion: In a small group of patients, early endotherapy in mild symptomatic chronic pancreatitis was associated with a trend toward a minor number of acute attacks and atrophy progression of the pancreas.

Background and Aim: Guidewire insertion to a pancreatic duct under wire-guided cannulation (WGC) during endoscopic retrograde cholangiopancreatography (ERCP) is associated with a high incidence of post-ERCP pancreatitis (PEP). Pancreatic stent placement followed by WGC (PS-WGC) is considered for these cases to reduce PEP. This study was aimed to examine the effectiveness of PS-WGC compared with repeated WGC., Methods: The consecutive data of patients without history of ERCP who underwent ERCP for biliary intervention were retrospectively collected from five centers. Patients without guidewire insertion to the pancreatic duct were excluded. Pancreatic stent was immediately placed after guidewire insertion to the pancreatic duct in the PS-WGC group. The association between the method of biliary cannulation (PS-WGC or repeated WGC) and PEP was analyzed using multivariable logistic regression model., Results: A total of 590 patients (183 in the PS-WGC and 407 in the repeated WGC group) were included. PS-WGC decreased PEP (8.7% vs 19%, P = 0.001) and improved its severity (moderate and severe PEP; 2.2% vs 6.4%, P = 0.04) compared with repeated WGC. PS-WGC was associated with reduction of PEP in the multivariable model (Odds ratio 0.31, P < 0.001). The rates of difficult cannulation and overall successful biliary cannulation were not different between the two groups (66% vs 70%, P = 0.39 and 98% vs 96%, P = 0.21 in the PS-WGC and repeated WGC group, respectively)., Conclusions: Pancreatic stent placement followed by WGC reduced PEP in patients with guidewire insertion to the pancreatic duct during WGC for native papilla compared with repeated WGC., (© 2018 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Background: Both fully covered (FC) and partially covered (PC) self-expandable metal stents (SEMSs) are now commercially available for distal malignant biliary obstruction (MBO). While FCSEMS can be easily removed at the time of re-interventions, it is theoretically prone to migration. However, few comparative data between FC and PC SEMSs have been reported., Aims: The aim of this study was to compare clinical outcomes of FCSEMS with those of PCSEMS., Methods: This was a multicenter, prospective study of FCSEMS for unresectable distal MBO with a historical control of PCSEMS, which was previously reported as the WATCH study. The primary outcome was recurrent biliary obstruction (RBO), and secondary outcomes were stent migration, stent removal, stent-related adverse events, and survival., Results: A total of 151 cases with unresectable distal MBO undergoing FCSEMS placement were enrolled and compared with a historical cohort of 141 cases undergoing PCSEMS placement. No significant differences were found in the rate of RBO (29 vs. 33%; P = 0.451), time to RBO (318 vs. 373 days; P = 0.382), and survival (229 vs. 196 days; P = 0.177) between FCSEMS and PCSEMS. The rate of stent migration also did not differ significantly between the two groups (14 vs. 8%; P = 0.113). The removal of FCSEMSs was successful in all 24 attempted cases (100%)., Conclusions: FCSEMSs appeared comparable to PCSEMSs in terms of RBO without a significant increase in stent migration rate in patients with unresectable distal MBO., Clinical Trial Registration Number: UMIN000007131.

Background: Biliary drainage via endoscopic retrograde cholangiopancreatography (ERCP) is the first-line treatment for acute cholangitis. Despite the established effectiveness of urgent biliary drainage in patients with severe acute cholangitis, the indication of this procedure for non-severe acute cholangitis is controversial., Aims: To assess the safety of elective drainage (≥ 12 h of admission) for non-severe acute cholangitis., Methods: We retrospectively identified 461 patients with non-severe acute cholangitis who underwent endoscopic biliary drainage. Using linear regression models with adjustment for a variety of potential confounders, we compared elective versus urgent biliary drainage (< 12 h of admission) in terms of clinical outcomes. The primary outcome was the length of stay., Results: There were 98 and 201 patients who underwent elective and urgent biliary drainage, respectively. The median length of stay was 11 days in both groups (P = 0.52). The timing of ERCP was not associated with length of stay in the multivariable model (P = 0.52). Secondary outcomes including in-hospital mortality and recurrence of cholangitis were not different between the groups., Conclusions: Elective biliary drainage was not associated with worse clinical outcomes of non-severe acute cholangitis as compared to urgent drainage. Further investigation is warranted to justify the elective drainage for non-severe cholangitis.

Bile duct stones in patients with surgically altered anatomy still pose a challenge to endoscopists. For successful endoscopic management of bile duct stones, there are multiple hurdles: Intubation to the afferent limb, biliary cannulation, ampullary intervention and stone extraction. The major advancement in this area is the development of dedicated device-assisted endoscopes for endoscopic retrograde cholangiopancreatography (ERCP). In patients with Billroth II reconstruction, a high technical success rate is reported using a duodenoscope but can be complicated by a potentially high perforation rate. In patients with Roux-en-Y reconstruction, device-assisted ERCP shows high technical success and low adverse event rates. Meanwhile, endoscopic papillary large balloon dilation enables safe and effective stone extraction with less use of endoscopic mechanical lithotripsy in patients with a dilated distal bile duct, but intraductal lithotripsy is sometimes necessary for management of very large bile duct stones. In cases with difficult stones, alternative approaches such as laparoscopy-assisted ERCP and endoscopic ultrasound (EUS)-guided intervention are increasingly reported with preliminary but promising results. However, comparative studies are still lacking in this area and prospective randomized controlled trials are warranted in terms of safety, efficacy and cost-effectiveness., (© 2018 Japan Gastroenterological Endoscopy Society.)

Background/aims: Groove pancreatitis (GP) is an uncommon disease involving the pancreaticoduodenal area. Possible pathogenesis includes obstructive pancreatitis in the duct of Santorini and impaired communication with the duct of Wirsung, minor papilla stenosis, and leakage causing inflammation. Limited data regarding endoscopic treatment have been published., Methods: Seven patients with GP receiving endoscopic treatment were reviewed. The morphology of the pancreatic duct was evaluated by a pancreatogram. Endoscopic dilation of the minor papilla and drainage of the duct of Santorini were performed., Results: There were two pancreatic divisum cases, one ansa pancreatica case and four impaired connections between the duct of Santorini and the main pancreatic duct. Three to 31 sessions of endoscopy, with 2 to 24 sessions of transpapillary stenting and dilation, were performed. Interventions through the minor papilla were successfully performed in six of seven cases. The pancreatic stenting duration ranged from 2 to 87 months. Five patients with evidence of chronic pancreatitis (CP) tended to receive more endoscopic interventions than did the two patients without CP (2-24 vs 2, respectively) for GP and other complications associated with CP., Conclusions: Disconnection or impairment of communication between the ducts of Santorini and Wirsung was observed in all cases of GP. No surgery was required, and endoscopic minor papilla dilation and drainage of the duct of Santorini were feasible for the treatment of GP.

Objective: Endoscopic transpapillary or endoscopic ultrasound (EUS)-guided stent placement is used for nonresectable distal malignant biliary obstruction. We conducted a retrospective study to evaluate endoscopic biliary drainage in patients with duodenal obstruction., Methods: We included consecutive patients who underwent endoscopic biliary drainage combined with a duodenal stent at 16 referral centers in four Asian countries. The primary outcome was time to recurrent biliary obstruction (TRBO). We assessed TRBO according to the sequence of biliary and duodenal obstruction (group 1/2/3, biliary obstruction first/concurrent/duodenal obstruction first, respectively) or the location of duodenal obstruction (type I/II/III, proximal to/affecting/distal to the ampulla, respectively). We also evaluated functional success and adverse events., Results: We included 110 patients (group1/2/3, 67/29/14 patients; type I/II/III, 45/46/19 patients; endoscopic retrograde cholangiopancreatography [ERCP]/EUS-guided choledocoduodenostomy/EUS-guided hepaticogastrostomy, 90/10/10 patients, respectively). The median TRBO of all cases was 450 days (interquartile range, 212-666 days) and functional success was achieved in 105 cases (95%). The TRBO did not differ significantly by the timing or location of duodenal obstruction (p = .30 and .79, respectively). The TRBO of metal stents (n = 96) tended to be longer compared with plastic stents (n = 14, p = .083). Compared with ERCP, EUS-guided biliary drainage was associated with a higher rate of adverse events., Conclusion: Transpapillary or transmural endoscopic biliary drainage with a duodenal stent was effective, irrespective of the timing or location of duodenal obstruction. A prospective study is required considering the tradeoff of technical success rate, stent patency, and adverse events (ClinicalTrials.gov number, NCT02376907).

Background and study aim Endoscopic ultrasound-guided rendezvous (EUS-RV) is increasingly reported as a treatment option after failed endoscopic retrograde cholangiopancreatography. We developed a novel "hitch-and-ride" catheter for biliary cannulation to reduce the risk of guidewire loss during EUS-RV. Patients and methods We retrospectively evaluated safety and technical success of EUS-RV between June 2011 and May 2016. Biliary cannulation during EUS-RV using three methods - over-the-wire, along-the-wire, and hitch-and-ride - were compared. Results A total of 30 EUS-RVs were attempted and the technical success rate was 93.3 %, with two failures (one bile duct puncture and one guidewire insertion). After 28 cases of successful guidewire passage, cannulation was attempted by the over-the-wire (n = 13), along-the-wire (n = 4) or hitch-and-ride (n = 11) method. Only the hitch-and-ride method achieved biliary cannulation without guidewire loss or conversion to the other methods. Time to cannulation was shorter with the hitch-and-ride method (4 minutes) than with over-the-wire and along-the-wire methods (9 and 13 minutes, respectively). The adverse event rate of EUS-RV was 23.3 %. Conclusion A novel hitch-and-ride catheter was feasible for biliary cannulation after EUS-RV., Competing Interests: Competing interests: Drs. Nakai and Isayama have a patent pending with Zeon Medical Inc. (Japanese Patent Application No. 2016-058776)., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Aim: Endoscopic ultrasonography-guided biliary drainage (EUS-BD), first reported as an alternative to percutaneous transhepatic biliary drainage (PTBD) after failed endoscopic retrograde cholangiopancreatography (ERCP), is increasingly reported as a primary procedure without failed ERCP. The present study aims to evaluate the outcomes of therapeutic biliary ERCP and to compare the safety and effectiveness of primary EUS-BD with those of ERCP, rescue EUS-BD and PTBD., Methods: We retrospectively studied therapeutic biliary ERCP as well as subsequent rescue PTBD and EUS-BD. Additionally, indications, safety and technical success of primary EUS-BD were evaluated., Results: Between August 2013 and September 2015, a total of 520 therapeutic biliary ERCP with a native papilla were analyzed. We encountered 23 cases with inaccessible papilla and 22 cases with failed cannulation, which were rescued by 21 PTBD, 16 EUS-BD and two repeat ERCP. Additionally, 40 primary EUS-BD were carried out during the same period as a result of 10 recurrent cholangitis cases after transpapillary drainage, five outside failed cannulation, four altered anatomy, two history of ERCP-related adverse events (AE), two technical difficulties in stenting under enteroscopy-assisted ERCP and 17 on study protocol. Technical success and AE rates were 95.6% and 14.5% in ERCP, 90.5% and 33.3% in rescue PTBD, 93.8% and 18.8% in rescue EUS-BD, and 95.0% and 22.5% in primary EUS-BD, respectively., Conclusions: Rescue EUS-BD was used in 3.1% among all ERCP. Given the comparable technical success and AE rates of both primary and rescue EUS-BD, primary EUS-BD without failed ERCP can be a treatment option if it provides advantages over ERCP., (© 2016 Japan Gastroenterological Endoscopy Society.)

Background/aims: In distal malignant biliary obstruction, an antireflux metal stent (ARMS) with a funnel-shaped valve is effective as a reintervention for metal stent occlusion caused by reflux. This study sought to evaluate the feasibility of this ARMS as a first-line metal stent., Methods: Patients with nonresectable distal malignant biliary obstruction were identified between April and December 2014 at three Japanese tertiary centers. We retrospectively evaluated recurrent biliary obstruction and adverse events after ARMS placement., Results: In total, 20 consecutive patients were included. The most common cause of biliary obstruction was pancreatic cancer (75%). Overall, recurrent biliary obstruction was observed in seven patients (35%), with a median time to recurrent biliary obstruction of 246 days (range, 11 to 246 days). Stent occlusion occurred in five patients (25%), the causes of which were sludge and food impaction in three and two patients, respectively. Stent migration occurred in two patients (10%). The rate of adverse events associated with ARMS was 25%: pancreatitis occurred in three patients, cholecystitis in one and liver abscess in one. No patients experienced nonocclusion cholangitis., Conclusions: The ARMS as a first-line biliary drainage procedure was feasible. Because the ARMS did not fully prevent stent dysfunction due to reflux, further investigation is warranted.

Aim: To determine the optimal method of endoscopic preoperative biliary drainage for malignant distal biliary obstruction., Methods: Multicenter retrospective study was conducted in patients who underwent plastic stent (PS) or nasobiliary catheter (NBC) placement for resectable malignant distal biliary obstruction followed by surgery between January 2010 and March 2012. Procedure-related adverse events, stent/catheter dysfunction (occlusion or migration of PS/NBC, development of cholangitis, or other conditions that required repeat endoscopic biliary intervention), and jaundice resolution (bilirubin level < 3.0 mg/dL) were evaluated. Cumulative incidence of jaundice resolution and dysfunction of PS/NBC were estimated using competing risk analysis. Patient characteristics and preoperative biliary drainage were also evaluated for association with the time to jaundice resolution and PS/NBC dysfunction using competing risk regression analysis., Results: In total, 419 patients were included in the study (PS, 253 and NBC, 166). Primary cancers included pancreatic cancer in 194 patients (46%), bile duct cancer in 172 (41%), gallbladder cancer in three (1%), and ampullary cancer in 50 (12%). The median serum total bilirubin was 7.8 mg/dL and 324 patients (77%) had ≥ 3.0 mg/dL. During the median time to surgery of 29 d [interquartile range (IQR), 30-39 d]. PS/NBC dysfunction rate was 35% for PS and 18% for NBC [Subdistribution hazard ratio (SHR) = 4.76; 95%CI: 2.44-10.0, P < 0.001]; the pig-tailed tip was a risk factor for PS dysfunction. Jaundice resolution was achieved in 85% of patients and did not depend on the drainage method (PS or NBC)., Conclusion: PS has insufficient patency for preoperative biliary drainage. Given the drawbacks of external drainage via NBC, an alternative method of internal drainage should be explored.

In the pancreatobiliary session at Endoscopic Forum Japan (EFJ) 2015, current trends of routine biliary cannulation techniques and salvage techniques for difficult biliary cannulation cases were discussed. Endoscopists from nine Japanese high-volume centers along with two overseas centers participated in the questionnaires and discussion. It was concluded that, currently, in Western countries, the wire-guided cannulation (WGC) technique is favored during initial cannulation attempts. However, the conventional technique using an endoscopic retrograde cholangiopancreatography catheter with contrast medium injection is still used as first choice at most Japanese high-volume centers. The WGC technique is used as the second choice at some institutions only. After failed biliary cannulation attempts, the initial salvage option preferred in most centers includes pancreatic guidewire placement, followed by precut techniques as the second salvage choice. Among several precut techniques, the free-hand needle knife sphincterotomy with cutting upwards from the pancreatic duct is most popular. Endoscopic ultrasonography-guided rendezvous technique is also carried out as a final salvage option at select institutions., (© 2016 The Authors Digestive Endoscopy © 2016 Japan Gastroenterological Endoscopy Society.)

Aim: To assess the utility and safety of single-operator cholangiopancreatoscopy (SOCPS) using the SpyGlass system in widespread clinical application for biliary and pancreatic diseases., Methods: This study was a prospective case series conducted in 20 referral centers in Japan. There were 148 patients who underwent SOCPS; 124 for biliary diseases and 24 for pancreatic diseases. The attempted interventions were SOCPS examination, SOCPS-directed tissue sampling, and therapy for stone removal, among others. The main outcomes were related to the procedure success rate in terms of visualizing the target lesions, SOCPS-directed adequate tissue sampling, and complete stone removal., Results: A total of 148 patients were enrolled for the diagnosis of indeterminate biliary and pancreatic lesions or treatment of biliary and pancreatic disease. The overall procedure success rate of visualizing the target lesions was 91.2% (135/148). The overall procedural success rates of visualizing the target lesions of diagnostic SOCPS in the bile duct and pancreatic duct were 95.5% (84/89) and 88.2% (15/17), respectively., Diagnosis: the overall adequate tissue for histologic examination was secured in 81.4% of the 86 patients who underwent biopsy under SOCPS (bile duct, 60/75, 80.0%; pancreatic duct, 10/11, 90.9%). The accuracy of histologic diagnosis using SOCPS-directed biopsies in indeterminate bile duct lesions was 70.7% (53/75). In the pancreatic duct, the accuracy of SOCPS visual impression of intraductal papillary mucinous neoplasm was 87.5% (14/16). Stone therapy: complete biliary and pancreatic stone clearance combined with SOCPS-directed stone therapy using electrohydraulic lithotripsy or laser lithotripsy was achieved in 74.2% (23/31) and 42.9% (3/7) of the patients, respectively. Others: SOCPS using the SpyGlass system was used in cannulation of the cystic duct in two patients and for passing across the obstructed self-expandable metallic stent for a malignant biliary stricture in two patients. All procedures were successful in both SOCPS-guided therapies. The incidence of procedure-related adverse events was 5.4% (8/148)., Conclusion: SOCPS with direct visualization and biopsy for diagnosis and SOCPS-directed therapy for biliary and pancreatic diseases can be safely performed with a high success rate. The clinical trial was registered at UMIN CTR (http://www.umin.ac.jp). The registration identification number is UMIN000015155.

Background and Study Aims: There are no guidelines for the timing of conversion from a single-guidewire to a double-guidewire technique to facilitate selective bile duct cannulation and reduce post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), when using wire-guided cannulation. We investigated whether early conversion to the double-guidewire method, at first unintentional insertion of a guidewire into the pancreatic duct, facilitated selective bile duct cannulation and reduced PEP compared with repeated single-guidewire attempts., Patients and Methods: A multicenter prospective randomized controlled trial included 274 patients with a naive papilla, undergoing endoscopic retrograde cholangiography (ERC) using wire-guided cannulation in whom there was unintentional insertion of the guidewire into the pancreatic duct. With the guidewire still in the duct, patients were randomly assigned to undergo the double-guidewire technique or repeated single-wire cannulation. Main outcomes were success rates for selective bile duct cannulation and PEP frequency., Results: Success rates for selective bile duct cannulation within 10 attempts and 10 minutes were 75 % and 70 %, respectively, for the early double-guidewire (EDG) and repeated single-guidewire (RSG) cannulation groups (relative rate 1.07, 95 % confidence interval [95 %CI] 0.93 - 1.24, P = 0.42). Corresponding final selective bile duct cannulation rates were 98 % and 97 % (relative rate 1.01, 95 %CI 0.97 - 1.05, P = 1.00). PEP rates were 20 % and 17 %, respectively, for the EDG and RSG cannulation groups (relative risk 1.17, 95 %CI 0.71 - 1.94, P = 0.53). Double-guidewire cannulation was more effective in patients with malignant biliary stricture (relative rate 1.36, 95 %CI 1.05 - 1.77, P = 0.02)., Conclusions: During therapeutic ERC using wire-guided cannulation, converting to a double-guidewire technique neither facilitated selective bile duct cannulation nor decreased PEP incidence compared with repeated use of a single-wire technique., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Wire-guided cannulation (WGC) was reported to decrease post-ERCP pancreatitis (PEP), but risk factors for PEP in WGC are not fully elucidated., Objective: To evaluate the incidence and risk factors of PEP in WGC., Design: Single-center retrospective study., Setting: Academic center., Patients: A total of 800 consecutive patients with a native papilla., Interventions: Biliary therapeutic ERCP by using WGC., Main Outcome Measurements: The rate of PEP and its risk factors., Results: Biliary cannulation was successful by using WGC alone in 70.5%, and the final cannulation rate was 96.1%. Unintentional guidewire insertion and contrast material injection into the pancreatic duct (PD) during cannulation occurred in 55.3% and 21.8%, respectively. The incidence of PEP was 9.5% (mild 5.6%, moderate 2.9%, severe 1.0%). Multivariate analysis revealed a common bile duct (CBD) diameter of <9 mm (odds ratio [OR] 2.03; P = .006) and unintentional guidewire insertion into the PD (OR 2.25; P = .014) as risk factors for PEP. PD opacification was not a risk factor for PEP (OR 1.15; P = .642), but the incremental increase of the PEP rate was seen in patients with CBDs <9 mm: 4.6% without any PD manipulation, 8.3% with contrast material alone, 16.9% with guidewire alone, and 22.1% with both contrast material and guidewire., Limitations: Retrospective design in a single center., Conclusion: Unintentional PD manipulation was not uncommon in WGC. Guidewire insertion into the PD and a small CBD were risk factors for PEP in biliary therapeutic ERCP with the use of WGC., (Copyright © 2015. Published by Elsevier Inc.)

Background: A lumen-apposing stent can be used effectively under endosonographic guidance., Objective: To evaluate a newly designed, fully covered self-expandable metal stent with folding anchoring flanges for lumen apposition assembled on a conventional delivery system., Design: Retrospective case series and animal study., Setting: Tertiary care academic medical centers., Subjects: Six pigs for animal study and 7 patients, 3 of whom underwent endoscopic drainage for acute cholecystitis (AC) and 4 for pancreatic fluid collection (PFC)., Intervention: Stent deployment under EUS guidance after puncturing, passage of an endoscope through the stent into the gallbladder (GB), or PFC with conventional endoscopic procedures., Main Outcome Measurements: Technical and clinical success, adverse events, and removability., Results: In the animal study, the stent was successfully inserted and deployed in the GB via a transgastric approach under EUS guidance without adverse events in all 6 pigs. Contrast injection demonstrated the absence of leakage. Cholecystoscopy with enhanced endoscopy was performed successfully in all animals after stent placement. All stents were intact and were removed successfully at 4 weeks. GB firmly adhered to the stomach with an intact cholecystogastric tract on necropsy and histopathology. The stents were successfully deployed without adverse effects in 7 patients. AC or PFC was resolved after stent placement in all patients. Endoscopic procedures were possible through the stent. Stent migration was not observed. The stent was successfully removed from the 4 patients with PFC after complete resolution., Limitations: Small sample size, retrospective study., Conclusions: Transenteric drainage and endoscopic intervention by using a novel fully covered self-expandable metal stent for lumen apposition under EUS guidance is feasible for the management of AC and PFC. Further study is warranted., (Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background and Aim: Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy is still challenging. We aimed to clarify the current status of ERCP in Japan in patients with surgically altered anatomy., Methods: Questionnaire survey was conducted in 2012 at 11 participating facilities regarding ERCP in patients with surgically altered anatomy., Results: A total of 490 ERCP procedures were carried out in 273 patients with surgically altered anatomy. The breakdown of surgical procedures was as follows: Roux-en-Y (R-Y) reconstruction (n=154 [31.4%]), pancreaticoduodenectomy (PD) (n=136 [27.8%]), hepaticojejunostomy (n=103 [21.0%]), liver transplantation (n=20 [4.1%]), Billroth II reconstruction (n=69 [14.1%]), and interposition after total gastrectomy (n=8 [1.6%]). The overall success rate of reaching the target site was 91.8% (450 of 490 ERCP procedures). According to reconstructive surgical procedures, the target site was reached in 138 of 154 procedures (89.6%) for R-Y reconstruction, 129 of 136 procedures (94.8%) for PD, 89 of 103 procedures (86.4%) for hepaticojejunostomy, 18 of 20 procedures (90.0%) for liver transplantation, 68 of 69 procedures (98.6%) for Billroth II reconstruction, and eight of eight procedures (100%) for interposition after total gastrectomy., Conclusions: The success rate of reaching the target site was high in patients with Billroth II reconstruction and low in patients with hepaticojejunostomy. Although the success rate of endoscopic insertion for ERCP in patients with surgically altered anatomy was high, there are still cases in which it is difficult to achieve technical success., (© 2014 The Authors. Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society.)

Objective: Removal of large bile duct stones by endoscopic papillary large balloon dilation (EPLBD) with endoscopic sphincterotomy (EST) has been proven safe and effective. Little evidence supports the benefits of a preceding EST in reducing complications. Recent studies suggest that large bile duct stone removal by EPLBD alone may be safe and effective., Material and Methods: We removed large bile duct stones by EPLBD with EST from March 2008 to February 2010 and without EST from March 2010 to October 2011. Efficacy and safety of EPLBD with or without EST and late biliary complication outcomes were assessed., Results: Forty-two patients (men/women, 27/15; mean age, 76 years) underwent EPLBD: 14 underwent EPLBD with EST and 28 underwent EPLBD without EST. The mean stone size was 14 mm (9-30 mm). Overall complete stone removal rate was 98%, with 83% achieved in 1 session. Complete duct clearance by EPLBD alone was achieved in 79%. Mechanical lithotripsy was required in 4 (10%) patients. Extracorporeal shock wave lithotripsy and electrohydraulic lithotripsy were required in 4 (10%) and 1 (2%) patients, respectively. Pancreatitis and perforation occurred in 2 (5%) and 1 (2%) patients, respectively. Patients treated by EPLBD with EST and by EPLBD alone did not differ in complication outcomes. Six (14%) patients had recurrent bile duct stones, with a significant correlation to dilated common bile duct (p = 0.0351)., Conclusions: EPLBD is safe and effective in patients with large bile duct stones. Preceding EST may be unnecessary.

Objectives: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis is diagnosed on the basis of pancreatic pain and hyperamylasemia. However, because the diagnosis of abdominal pain is not objective, there may be some cases of painless pancreatitis among patients with post-ERCP hyperamylasemia (PEH). We reviewed the computed tomography (CT) findings of PEH cases to determine the incidence of painless pancreatitis., Methods: Between July, 2005 and December, 2011, CT was performed in 91 patients with hyperamylasemia 18 h after ERCP. We reviewed the CT findings and graded the severity of pancreatitis according to the Balthazar grading system. Grades C, D, and E were defined as pancreatitis., Results: Thirty-four patients (37%) had pancreatitis according to the CT findings. There was a significant difference in the serum amylase levels between the positive- and negative-CT finding groups (1306 ± 833 vs. 786 ± 315 IU/L, respectively; p = 0.0012). Receiver operating characteristic curve analysis showed that the amylase cut-off value for discriminating between the 2 groups was 795 IU/L (6.36 times the upper normal limit)., Conclusions: Thirty-seven percent of PEH patients had painless pancreatitis. CT is useful to determine pancreatitis in patients taking analgesics, steroids, or anti-immunological drugs and those with diabetes mellitus and 18-h serum amylase levels of >6 times the normal upper limit., (Copyright © 2013 IAP and EPC. Published by Elsevier B.V. All rights reserved.)

Background: Our previous study suggested that a combination of ulinastatin and risperidone reduced post-ERCP pancreatitis (PEP) compared with ulinastatin alone., Objective: The aim of this study was to evaluate the efficacy of risperidone alone for prevention of PEP., Design: A multicenter, randomized, placebo-controlled, double-blind clinical trial., Setting: Two academic hospitals and 5 referral hospitals in Tokyo and Saitama, Japan., Patients: Patients undergoing therapeutic or interventional-diagnostic ERCP., Intervention: The patients were randomized to receive 2 mg of oral risperidone or oral placebo at 0.5 to 2 hours before ERCP., Main Outcome Measurements: The primary endpoint was the incidence of PEP. Secondary endpoints were the incidence of hyperenzymemia and enzyme levels (amylase, pancreatic amylase, lipase). Risk factors for PEP were evaluated., Results: We initially enrolled 500 patients in the study (250 in the risperidone group and 250 in the placebo group), but 17 (11 in the risperidone and 6 in the placebo group) were excluded after randomization. PEP developed in 24 patients (10.0%) in the risperidone group and 21 patients (8.6%) in the placebo group (P = .587). Serum amylase levels at 3 hours after ERCP were lower in the risperidone group (P = .007 in a single test of hypothesis, significance removed by Bonferroni correction for multiple testing). In multivariate analysis, a small papilla of Vater, total procedure time ≥40 minutes, and stenosis of the intrahepatic duct were significantly associated with PEP., Limitations: Multiplicity of study centers and a relatively wide time range of drug administration time., Conclusion: Risperidone did not show a benefit in prevention of PEP in this trial. (, Clinical Trial Registration Number: NCT000004592.)., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: A previous study suggested that ulinastatin effectively prevented post-ERCP pancreatitis (PEP) and hyperenzymemia (PEH) in patients at average risk. In experimental models, risperidone, a selective serotonin 2A antagonist, ameliorated acute pancreatitis. We assessed the effect of risperidone combined with ulinastatin for the prevention of PEP in high-risk patients., Methods: In a multicenter, randomized, controlled, phase II trial, patients undergoing therapeutic ERCP were randomly assigned to receive ulinastatin (150000 U) with or without risperidone (1 mg). A risperidone tablet was taken orally 30-60 min before ERCP and ulinastatin was administered intravenously for 10 min immediately prior to ERCP. The primary end point was the incidence of PEP; secondary end points were PEH severity and enzyme levels (amylase, pancreatic amylase, lipase)., Results: A total of 226 patients (113 per group) were included in the study. Six patients in the risperidone + ulinastatin group and ten patients in the ulinastatin group developed pancreatitis (5.3 vs. 8.8 %, p = 0.438). The incidence of moderate/severe PEP was lower in the risperidone + ulinastatin group (1.8 %) than in the ulinastatin group (4.4 %), but this difference was not significant. Although the incidence of PEH did not differ significantly, post-ERCP levels of all pancreatic enzymes were significantly lower in the risperidone + ulinastatin group., Conclusions: Prophylactic oral risperidone administration in combination with ulinastatin did not reduce the incidence and severity of PEP in high-risk patients as compared with ulinastatin alone. However, risperidone showed an additive effect with ulinastatin, reducing serum pancreatic enzyme levels.

Background: Lack of established guidelines for endoscopic papillary large balloon dilation (EPLBD) may be a reason for aversion of its use in removal of large common bile duct (CBD) stones., Aims: We sought to identify factors predictive of adverse events (AEs) following EPLBD., Methods: This multicenter retrospective study investigated 946 consecutive patients who underwent attempted removal of CBD stones ≥10 mm in size using EPLBD (balloon size 12-20 mm) with or without endoscopic sphincterotomy (EST) at 12 academic medical centers in Korea and Japan., Results: Ninety-five (10.0 %) patients exhibited AEs including bleeding in 56, pancreatitis in 24, perforation in nine, and cholangitis in six; 90 (94.7 %) of these were classified as mild or moderate in severity. There were four deaths, three as a result of perforation and one due to delayed massive bleeding. Causative factors identified in fatal cases were full-EST and continued balloon inflation despite a persistent waist seen fluoroscopically. Multivariate analyses showed that cirrhosis (OR 8.03, p = 0.003), length of EST (full-EST: OR 6.22, p < 0.001) and stone size (≥16 mm: OR 4.00, p < 0.001) were associated with increased bleeding, and distal CBD stricture (OR 17.08, p < 0.001) was an independent predictor for perforation. On the other hand, balloon size was associated with deceased pancreatitis (≥14 mm: OR 0.27, p = 0.015)., Conclusions: EPLBD appears to be a safe and effective therapeutic approach for retrieval of large stones in patients without distal CBD strictures and when performed without full-EST.

Background: Although self-expandable metal stents (SEMS) are widely used for distal malignant biliary obstruction, one-step SEMS (direct placement without a prior plastic stent) and two-step SEMS (placement at second endoscopic retrograde cholangiopancreatography [ERCP] following plastic stent placement) have not been fully compared., Methods: In this multicenter retrospective study, patients were included who underwent first-time endoscopic SEMS placement between September 1994 and December 2010. We compared the one-step and two-step strategies using a propensity analysis., Results: In total, 370 patients were identified and one-step SEMS was performed in 59 patients. After adjustment using propensity scores, the median times to dysfunction were 116 and 219 days, respectively, for one-step and two-step SEMS (P = 0.058). Stent migration was more frequently observed in one-step SEMS as compared with two-step SEMS (25 vs. 11 %, P = 0.031). In one-step SEMS, the number of days of hospitalization associated with first-time SEMS placement was shorter compared with that in two-step SEMS (21 vs. 30 days, P = 0.001), and the total costs of SEMS-related interventions within 6 months were lower (6510 and 8100 USD, P = 0.004). The pathological diagnosis rates for pancreatic and biliary tract cancer at initial ERCP were 52 and 61 %. After failed diagnosis at initial ERCP, pathological diagnosis rates for pancreatic cancer were 32 versus 76 % (P = 0.005) by repeated ERCP versus endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA)., Conclusions: One-step SEMS was associated with increased stent migration, despite having potential cost-effectiveness. The additional yield of pathological diagnosis at repeated ERCP was low compared with that yielded by EUS-guided FNA.

Background and Aim: A single-operator cholangiopancreatoscopy was developed to overcome a problem in conventional peroral cholangiopancreatoscopy. The aim of this pilot study was to clarify the clinical utility of single-operator cholangiopancreatoscopy using a SpyGlass probe through an endoscopic retrograde cholangiopancreatography (ERCP) catheter., Methods: Patients undergoing ERCP with a SpyGlass probe passed through a catheter were included in this study. The SpyGlass probe was inserted into the catheter following successful cannulation, and cholangiopancreatoscopy was performed by a single operator. We retrospectively analyzed the successful visualization rate of this technique., Results: Fifteen patients were included in this study. SpyGlass cholangiopancreatoscopy was technically successful in all patients. Successful visualization was obtained in nine patients (60%). The median SpyGlass procedure time was 10 min. Cholangiopancreatoscopic diagnoses were as follows: bile duct carcinoma in three patients; intraductal papillary mucinous adenoma in two; and intraductal pancreatic stone, benign biliary stricture, gallbladder cholesterolosis, and gallbladder carcinoma in one each. There were no cases of post-ERCP pancreatitis., Conclusions: While the low rate of successful visualization must be improved, single-operator cholangiopancreatoscopy using a SpyGlass probe through an ERCP catheter is a safe and effective procedure., (© 2012 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd.)

Endoscopic biliary stent placement is widely accepted as palliation for malignant biliary obstruction or as a treatment of benign biliary stricture. Although various biliary stent designs have become available since self-expandable metallic stents were introduced, no single ideal stent has been developed. An ideal stent should be patent until death, or surgery, in patients with resectable malignant biliary obstruction. Fewer complications, maneuverability, cost-effectiveness, and removability are also important factors. Alternatively, should we develop a novel method for biliary drainage other than biliary stenting via endoscopic retrograde cholangiopancreatography? This article reviews the current status of biliary stenting for malignant biliary obstructions., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: The current management of acute cholangitis consists of antibiotic therapy in combination with biliary drainage. However, the optimal duration of antibiotic therapy after the resolution of clinical symptoms by biliary drainage is unclear. We aimed to evaluate whether discontinuing antibiotic therapy for acute cholangitis immediately after the resolution of clinical symptoms, achieved by endoscopic biliary drainage, was safe and effective., Methods: This prospective study included patients with moderate and severe acute cholangitis. Cefmetazole sodium and meropenem hydrate were used as initial antibiotic therapy for patients with moderate and severe acute cholangitis, respectively. All patients underwent endoscopic biliary drainage within 24 h of diagnosis. When the body temperature of < 37 ° C was maintained for 24 h, administration of antibiotics was stopped. The primary endpoint was the recurrence of acute cholangitis within 3 days after the withdrawal of antibiotic therapy., Results: Eighteen patients were subjected to the final analysis. The causes of cholangitis were bile duct stone (n = 17) and bile duct cancer (n = 1). The severity of acute cholangitis was moderate in 14 patients and severe in 4. Body temperature of < 37 ° C was achieved in all patients after a median of 2 days (range 1-6) following endoscopic biliary drainage. Antibiotic therapy was administered for a median duration of 3 days (range 2-7). None of the patients developed recurrent cholangitis within 3 days after the withdrawal of antibiotics., Conclusions: Fever-based antibiotic therapy for acute cholangitis is safe and effective when resolution of fever is achieved following endoscopic biliary drainage.

Background: No study has compared covered metallic stents with Tannenbaum stents. We evaluated the efficacy of the DoubleLayer stent (DLS) and Covered Wallstent (CWS) in patients with pancreatic head cancer (PHC)., Patients & Methods: This was a multicenter, prospective randomized study. Between October 2005 and December 2007, we enrolled 113 patients (58 DLS, 55 CWS) with unresectable PHC with distal biliary obstructions and observed them for at least 6 months., Results: No significant difference in patient survival was found between groups, with a median survival of 231 and 248 days in the DLS and CWS groups, respectively. The cumulative stent patency was significantly higher (P = 0.0072) in the CWS group. The respective mean and median stent patency was 202 and 133 days in the DLS group and 285 and 419 days in the CWS group. The incidence of DLS occlusion (53.5%) was significantly higher than that of CWS (23.6%; P = 0.0019). The respective causes of occlusion were tumor overgrowth (0, 1), ingrowth (0, 2), sludge (24, 2), food impaction (3, 5), kinking bile duct (2, 0), and other (2, 3). Other complications were cholecystitis (0, 4), pancreatitis (0, 1), migration (1, 5), liver abscess (2, 0), and other (1, 2). No significant difference in the incidence of complications between groups was observed., Conclusion: CWS had significantly longer patency than DLS for the management of PHC with obstructive jaundice. The incidence of complications other than stent occlusion was higher in CWS, but this difference did not reach significance., (© 2011 The Authors. Digestive Endoscopy © 2011 Japan Gastroenterological Endoscopy Society.)

Background and Aim: Wire-guided cannulation (WGC) might increase the biliary cannulation rate and decrease the risk of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). We assessed the learning curve for WGC in therapeutic biliary ERCP (study 1) and compared WGC and conventional contrast-assisted cannulation (CC) by a matched case-control study (study 2)., Methods: Prospectively collected data of 500 therapeutic biliary ERCP cases (250 consecutive cases of WGC and 250 matched controls of CC) were retrospectively studied. Rate and time of biliary cannulation, total procedure time, PEP, and hyperamylasemia were analyzed., Results: In study 1, biliary cannulation by WGC was successful in 96% of the first 50 cases, with a median time to cannulation of 3 min. Rates of hyperamylasemia were within 10% after 100 WGC. In study 2, there were no significant differences in the overall cannulation rate and PEP between WGC and CC, but the total procedure time was shorter in WGC (30 vs 35 min, P = 0.059). Rates of hyperamylasemia and the change in serum amylase levels was lower (9% vs 14%, P = 0.069, and + 62.8 U/L vs+ 169.5 U/L, P = 0.043) in WGC, which was more prominent in experienced endoscopists (9% vs 17%, P = 0.025, and + 68.9 U/L vs+ 229.3 U/L, P = 0.014)., Conclusions: The introduction of WGC was effective in the first 50 cases and did not increase the rate of PEP in biliary therapeutic ERCP., (© 2011 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd.)

Background/purpose: Whether unilateral or bilateral drainage should be performed for malignant hilar biliary obstruction is controversial. Moreover, endoscopic placement of bilateral metallic stents is difficult and complicated., Methods: New metallic stents, such as the Niti-S Y-type stent (Y-stent), BONASTENT M-Hilar, and Niti-S large cell D-type stent (LCD), have recently been developed for bilateral stent-in-stent procedures to facilitate contralateral stent deployment through the interstices of the first metallic stent. We review the features and efficacy of these metallic stents designed for bilateral drainage in patients with hilar biliary obstruction., Results: The newly designed stents examined exhibited high technical success rates, low stent-related complications, and good stent patency. Endoscopic reinterventions for occluded stents could be performed easily, particularly in patients with bilateral LCD placement., Conclusion: Endoscopic bilateral stenting using newly designed metallic stents is feasible, safe, and effective in patients with unresectable malignant hilar biliary obstruction.

Background: Endoscopic retrograde cholangiopancreatography (ERCP) and associated procedures are difficult to perform in patients with surgically altered anatomy. Recently, balloon enteroscopy (BE) has made it easier to perform ERCP in these patients. However, BE-assisted ERCP is often technically demanding and time consuming., Methods: Spiral enteroscopy (SE), which has recently been developed, is a novel method of using a rotating overtube to pleat small bowel onto the enteroscope, thus advancing it through the lumen. We review the mechanism and efficacy of SE, especially in ERCP of patients with surgically altered anatomy, and report on the first patient to undergo ERCP using SE in Japan., Results: Spiral enteroscopy-assisted ERCP seems to be feasible and safe in patients with surgically altered anatomy. Additionally, SE-assisted ERCP appears to be easier to perform than other methods previously described and allows stable positioning of the enteroscope in order to perform delicate therapeutic maneuvers., Conclusions: SE for ERCP is expected to be at least as useful as balloon enteroscopy in patients with surgically altered anatomy.

Background and Purpose: Recently, biodegradable pancreatic stents have been designed and placed in vivo and in vitro. The aim of this study is to investigate the feasibility of endoscopic stenting using the novel, braided, self-expandable, biodegradable, pancreatic and biliary stent in a pig model., Methods: A braided, self-expandable, biodegradable stent was endoscopically placed into the pancreatic duct and bile duct in 4 pigs. Eventually, necropsy was performed to evaluate the stent placement after the procedure., Results: Pancreatic and biliary stents were successfully inserted and easily deployed across the papilla into the main pancreatic duct and bile duct, respectively, in all the animals under endoscopic and fluoroscopic guidance. Necropsy performed immediate following stent placement, found that stents had been placed across the papilla and stent expansion had occurred in all cases., Conclusions: Although this stent is not radiopaque and the number of cases was small in this experimental study, endoscopic stenting using this novel, braided, self-expandable, biodegradable, pancreatic and biliary stent was feasible in the pig model. Further animal studies to evaluate the short-term patency, tissue reactivity and degradability of the stents are warranted.

Background: Tumor involvement to the orifice of the cystic duct (OCD) is a risk factor for cholecystitis after metallic stent (MS) placement., Objective: ERCP and intraductal US (IDUS) were used to assess tumor involvement to the OCD., Design: A prospective consecutive study., Setting: The University of Tokyo Hospital, Japan., Patients and Interventions: Between January 2003 and May 2007, 34 patients with resectable malignant biliary obstruction underwent an ERCP and an IDUS before preoperative biliary drainage., Main Outcome Measurements: ERCP and IDUS findings were confirmed via a histopathologic analysis of surgical specimens., Results: An ERCP showed that the cystic duct was opacified in 22 of 34 patients (64.7%). Eight patients were diagnosed with OCD tumor involvement. In the remaining 12 patients, tumor involvement was impossible to evaluate via an ERCP. An IDUS identified tumor involvement to the OCD in all 34 patients. Tumor involvement to the OCD was diagnosed in 12 patients, including 4 patients with previously negative results during an ERCP. Tumor involvement was confirmed by histopathology of surgical specimens. The sensitivity and specificity of detection were 66.7% (8/12) and 63.6% (14/22), respectively, via ERCP, and 100% (12/12) and 100% (22/22), respectively, via IDUS., Limitation: The small sample size., Conclusions: IDUS, in addition to ERCP, provides an accurate evaluation of tumor involvement to the OCD in patients with malignant biliary obstruction.