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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. [ABSTRACT FROM AUTHOR]

Background and Aim: Percutaneous transhepatic drainage is the most common method for non‐operative gallbladder drainage, but the technique does have several disadvantages because of its invasive nature and requirement for continuous drainage. To overcome these disadvantages, we developed a novel procedure, endoscopic gallbladder lavage followed by stent placement, carried out in a single endoscopic session. Our aim was to prospectively evaluate the efficacy and safety of this procedure in patients with acute cholecystitis. Methods: Patients diagnosed with moderate cholecystitis at four tertiary care centers were enrolled in this study. We initially placed a 5‐Fr tube to carry out gallbladder lavage. The tube was then cut to the optimal length and placed as a stent. Main outcomes were procedural and clinical success rates. Results: The procedure was attempted in 40 patients and was successful in 30 (75.0%). Minor adverse events occurred in two (5.0%) patients: perforation of the cystic duct by the guidewire in one patient and pancreatitis in the other. Among the 30 patients in whom the procedure was successfully done, clinical resolution was obtained in 29 (96.6%). Elective cholecystectomy was carried out in 37 patients (92.5%), with a median delay after drainage of 42 days (range, 12–138 days). There were no adverse events during the waiting period. Conclusions: Gallbladder rinsing followed by internal drainage using a 5‐Fr nasobiliary tube is considered an effective and safe alternative to other techniques, providing an acceptable success rate in patients with acute cholecystitis prior to elective surgery. Clinical trial information: http://www.umin.ac.jp/ctr/index.htm (ID: UMIN‐000009680). [ABSTRACT FROM AUTHOR]

Background: In patients with unresectable malignant biliary obstruction (MBO), anticancer treatment is often administered. The impact of anticancer treatment on recurrent biliary obstruction in covered self-expandable metallic stents (SEMS) has not been fully elucidated. Methods: Data on 279 patients enrolled in a multicenter prospective cohort study of two different covered SEMS for distal MBO, WATCH study (141 partially covered WallFlex stents and 138 partially covered Wallstents) were retrospectively analyzed. The rates and causes of recurrent biliary obstruction (stent occlusion or migration) were compared between anticancer treatment group ( n = 173) and best supportive care alone (BSC) group ( n = 106). Cumulative time and prognostic factors for recurrent biliary obstruction were analyzed, using a proportional hazards model with death without recurrent biliary obstruction as a competing risk. Results: The overall rate (43 vs. 25 %, P = 0.002) and the cumulative incidence (16.1 vs. 8.2, 27.9 vs. 18.9 and 44.1 vs. 26.6 % at 3, 6 and 12 months, P = 0.030 by Gray’s test) of recurrent biliary obstruction were significantly higher in anticancer treatment group compared with BSC group. The multivariate analysis revealed anticancer treatment [subdistribution hazard ratio (SHR) 1.93, P = 0.007) as well as the use of a partially covered WallFlex stent (SHR 0.65, P = 0.049) as prognostic factors. Conclusions: Anticancer treatment was a risk factor for recurrent biliary obstruction in covered SEMS for distal MBO. The superiority of a partially covered WallFlex stent was again confirmed in this competing risk analysis; UMIN-CTR: UMIN000002293. [ABSTRACT FROM AUTHOR]

Introduction: Endoscopic retrograde cholangiopancreatography in patients with surgically altered anatomy is challenging. Several endoscopic ultrasound (EUS)-guided biliary access techniques have been reported as effective alternatives. EUS-guided antegrade treatments (AG) have been developed more recently but have not yet been studied well. Aims: To evaluate the feasibility and safety of EUS-AG for biliary disorders in patients with surgically altered anatomies. Methods: We retrospectively identified all the patients who underwent EUS-AG. The left intrahepatic bile duct (IHBD) was initially punctured from the intestine followed by cholangiography, antegrade guidewire manipulation, and bougie dilation of the fistula. Either antegrade biliary stenting (ABS) or antegrade balloon dilation (ABD) was performed depending on the biliary disorders. In stone cases, the stones were antegradely pushed out using a balloon. After ABD, a nasobiliary drainage tube was placed to prevent possible bile leak and to keep an access route for any possible repeat procedures. Results: EUS-AG was attempted in seven patients including choledocholithiasis in five, malignant biliary obstruction in one, and bilioenteric anastomosis stricture in one. EUS-AG was not performed in one patient because EUS-cholangiography did not indicate the presence of stones. In the remaining six patients, the IHBD was successfully punctured, followed by cholangiography, guidewire insertion, and bougie dilation. ABS and ABD were successfully performed in one and five patients, respectively. Antegrade procedures with ABD were repeated twice in one patient. Mild complications were observed in two patients. Conclusions: EUS-AG for biliary disorders in patients with surgically altered anatomy is feasible. Further studies are warranted. [ABSTRACT FROM AUTHOR]

The present review compared unilateral versus bilateral stenting in order to determine the optimal stenting strategy for malignant hilar biliary strictures based on the previous literature. The role of preoperative biliary drainage prior to liver resection for hilar cholangiocarcinoma remains under discussion. However, in Japan, endoscopic placement of single nasobiliary drainage in the future remnant hepatic lobe is currently considered the most suitable method. In most unresectable cases, unilateral stenting appears to be adequate for ameliorating jaundice. It is technically easier and less expensive than bilateral stenting, with reintervention for stent dysfunction also being considerably easier. However, contrast medium injection into undrained bile ducts is associatedwith uncontrolled cholangitis and poor prognosis. To prevent this complication, bilateral stenting may be preferred to unilateral stenting. Additionally, previous studies have demonstrated bilateral stenting to be associated with longer stent patency as compared to unilateral stenting. We consider that further large-scale studies are required to clarify whether unilateral or bilateral stenting is a better therapeutic technique for malignant hilar biliary stricture. [ABSTRACT FROM AUTHOR]

Purpose: In order to confirm the impact of adding S-1 to gemcitabine, we conducted a randomized phase II study to compare the combination therapy of gemcitabine plus S-1 to gemcitabine monotherapy in patients with advanced biliary tract cancer. Methods: Sixty-two patients with advanced cholangiocarcinoma or gallbladder cancer were randomized to either the combination therapy of gemcitabine and S-1 (gemcitabine 1,000 mg/m on days 1 and 15 and S-1 40 mg/m b.i.d. on days 1-14, repeated every 4 weeks) or gemcitabine monotherapy (gemcitabine 1,000 mg/m on days 1, 8, and 15, repeated every 4 weeks). The primary endpoint of this study was response rate, and the regimen which showed the better response rate was selected as a candidate of phase III study. Tumor response was assessed every two cycles using Response Evaluation Criteria in Solid Tumors criteria version 1.0. Results: The response rates of the combination therapy and the monotherapy were 20.0 and 9.4 %, respectively. The median time-to-progressions and overall survivals of these two treatments were nearly the same (5.6 vs. 4.3 months; 8.9 vs. 9.2 months). Adverse events occurred more frequently in the combination arm. Conclusions: The combination therapy of gemcitabine and S-1 showed the better response rate, but the superiority of this combination therapy was not clear in total. Because the standard of care changed to the combination therapy with gemcitabine and cisplatin during this study, it is difficult to select this combination therapy with a 4-week regimen as a candidate of phase III study. [ABSTRACT FROM AUTHOR]

Background and Aim: Currently, endoscopic intervention is widely attempted as the first-line treatment of benign biliary strictures because of its convenience and low morbidity. Plastic tube stents (PS) are usually used for such treatment; however, covered self-expandable metallic stents (C-SEMS) are becoming more commonly used at some institutions. The temporary placement of C-SEMS may lead to better outcomes because of their larger diameter and, therefore, better dilation of the stricture, especially in refractory cases. The aim of the present study was to evaluate the efficacy of the temporary placement of C-SEMS in the management of benign biliary strictures. Methods: We retrospectively reviewed our endoscopic retrograde cholangiopancreatography (ERCP) database (May 1996 to December 2010), and extracted the data of patients who underwent endoscopic treatment for benign biliary strictures. Then, the follow-up data from patient charts were reviewed to determine the long-term outcomes of those procedures. Results: All patients ( n = 56) initially had a PS placed, with or without balloon dilation. However, C-SEMS placement was later attempted in 12 patients because the stricture was refractory to placement of the PS. During their follow-up periods, two patients died of unrelated diseases after 15 and 17 months, and another two still had the C-SEMS in place after 9 and 50 months. In the remaining eight patients, the C-SEMS was removed after a median placement period of 6 months (range, 2-15). Seven patients in this group have not experienced a recurrence at a median follow-up time of 48 months. However, in one patient, stenosis did recur 8 months after the C-SEMS was removed. Conclusions: Temporary placement of C-SEMS can be a treatment option for benign biliary strictures, especially in refractory cases. [ABSTRACT FROM AUTHOR]

Background: Endoscopic ultrasound-guided pancreatic pseudocyst drainage (EUS-PPD) has recently become popular. However, this technique has not yet been standardized, and the available instruments have not been sufficiently developed. Therefore, it is difficult to determine the treatment strategy and the choice of devices. Aims: To evaluate the current status of EUS-PPD. Methods: Between May 2001 and February 2008, EUS-PPD was attempted in 26 patients. Initially, an external drainage was placed, which was replaced with an indwelling tube in cases where the discharge continued more than 2 weeks. The early and late outcomes of EUS-PPD were retrospectively analyzed. Results: Placement of a naso-cystic drainage was successful in 24 (92%) of the 26 patients. Insertion of the drainage tube failed in other 2 patients due to a thickened cystic wall. The pseudocyst was completely resolved after the placement in 23 patients, while the remaining patient underwent a surgical operation. Discharge of the cystic fluid was stopped and the naso-cystic tube was removed in 12 patients after a median duration of 14.5 days. In the remaining 11 patients, it was replaced with indwelling tubes due to continuous discharge after 2 weeks. Thereafter, the indwelling tubes were removed in all cases after a median duration of 4 months. Recurrence of the pseudocyst occurred in 4 patients during a median follow-up period of 48 months. All 15 patients without cystic infection were successfully treated by EUS-PPD, and 9 (60%) of them were treated by only an external drainage. On the other hand, one patient (11%) failed treatment by EUS-PPD and 5 patients (56%) required subsequent internal drainage among the 9 patients with cystic infection. Conclusions: Endoscopic ultrasound-guided pancreatic pseudocyst drainage is a promising treatment for a pancreatic pseudocyst. However, the insertion of the tube is difficult in cases with a thickened cystic wall. Infected pseudocysts are often difficult to treat by only short-term external drainage, thus additional treatments should be considered at an early stage. [ABSTRACT FROM AUTHOR]