Search

Background and Aims Recently, a newly designed lumen-apposing metal stent (LAMS) with a conventional delivery system was developed. The purpose of this study was to evaluate the effectiveness and safety of a newly designed LAMS for EUS-guided drainage to treat symptomatic pancreatic pseudocysts. Methods This prospective multicenter cohort study included 34 patients with symptomatic pancreatic pseudocysts from 2016 to 2017. The patients underwent EUS-guided drainage with the newly designed LAMS (Niti-S SPAXUS; Taewoong Medical Co, Ltd, Ilsan, South Korea). Effectiveness outcome measurements included technical success rate, clinical success rate, successful stent removal rate, and procedural time. Safety outcome measurements included procedure and/or stent-related adverse events (AEs) and overall AEs. Patients were prospectively followed, and consecutive data were collected at discharge, at stent removal, and 20 days after stent removal. Results Thirty-four patients (mean age 51.7 ± 13.3 years, 26 men) were enrolled. The mean pseudocyst size was 9.23 ± 3.54 cm. The technical success rate was 97.1% (33/34). The clinical success rate was 94.1% (32/34). All stents were successfully removed. The mean procedural time from needle puncture to stent deployment was 10.3 ± 5.7 minutes. Four patients (11.8%) experienced procedure and/or stent-related AEs, including stent maldeployment (n = 1) and pseudocyst infection (n = 3). All patients completely recovered from the AEs. Bleeding caused by the stent or buried LAMS syndrome was not observed. No unplanned endoscopic procedures were required. Conclusions This study showed that EUS-guided drainage using the newly designed LAMS is technically feasible and effective for the treatment of symptomatic pancreatic pseudocysts. (Clinical trial registration number: NCT02730663.)

Background Although endoscopic retrograde cholangiopancreatography (ERCP) is a first-line diagnostic modality for suspected malignant biliary stricture (MBS), the diagnostic yield of ERCP-based tissue sampling is insufficient. Peroral cholangioscopy-guided forceps biopsy (POC-FB) and endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNAB) are evolving as reliable diagnostic procedures for inconclusive MBS. This study aimed to evaluate the usefulness of a diagnostic approach using POC-FB or EUS-FNAB according to the stricture location in patients with suspected MBS. Methods Consecutive patients diagnosed with suspected MBS with obstructive jaundice and/or cholangitis were enrolled prospectively. ERCP with transpapillary forceps biopsy (TPB) was performed initially. When malignancy was not confirmed by TPB, POC-FB using a SpyGlass direct visualization system or direct POC using an ultraslim endoscope was performed for proximal strictures, and EUS-FNAB was performed for distal strictures as a follow-up biopsy. Results Among a total of 181 patients, initial TPB showed malignancy in 122 patients, and the diagnostic accuracy of initial TPB was 71.8 % (95 % confidence interval [CI] 65.3 % – 78.4 %]. Of the 59 patients in whom TPB was negative for malignancy, 32 had proximal biliary strictures and underwent successful POC. The remaining 27 patients had distal strictures and underwent successful EUS-FNAB. The accuracy of malignancy detection using POC-FB for proximal biliary strictures and EUS-FNAB for distal biliary strictures was 93.6 % (95 %CI 84.9 %−100 %) and 96.3 % (95 %CI 89.2 %−100 %), respectively. The overall diagnostic accuracy for the combination of TPB with either POC-FB for proximal strictures and EUS-FNAB for distal strictures was 98.3 % (95 %CI 95.9 %−100 %) and 98.4 % (95 %CI 95.3 %−100 %), respectively. Conclusions An approach using POC-FB or EUS-FNAB according to the stricture location may be useful in the diagnosis of suspected MBS.

Background/Aims In suspected malignant biliary strictures (MBSs), the diagnostic yield of endoscopic retrograde cholangiopancreatography (ERCP)-based tissue sampling is limited. Transpapillary forceps biopsy (TPB) under intraductal ultrasonography (IDUS) guidance is expected to improve the diagnostic accuracy in patients with indeterminate biliary strictures. We evaluated the usefulness of IDUS-guided TPB in patients with suspected MBS. Methods Consecutive patients with suspected MBS were prospectively enrolled in the study. ERCP with IDUS was performed in all patients. Both conventional TPB and IDUS-guided TPB on fluoroscopy were performed in each patient. The primary outcome was the diagnostic accuracy of conventional TPB and IDUS-guided TPB. Results The technical success rate of IDUS-guided TPB was 97.0% (65/67 patients). Of these 65 patients, the final diagnosis was malignancy in 61 patients (93.8%). On IDUS, the most common finding of IDUS was an intraductal infiltrating lesion in 29 patients (47.5%). The overall diagnostic accuracy was significantly higher using IDUS-guided TPB than that using conventional TPB (90.8% vs 76.9%, p=0.027). According to the subgroup analysis based on the tumor morphology, IDUS-guided TPB had a significantly higher cancer detection rate than conventional TPB for intraductal infiltrating lesions (89.6% vs 65.5%, p=0.028). Conclusions IDUS-guided TPB appears to improve the accuracy of histological diagnosis in patients with MBS.

Background and Aims The efficacy of palliative biliary drainage by using bilateral or unilateral self-expandable metal stents (SEMSs) for a malignant hilar biliary stricture (MHS) remains controversial. This prospective, randomized, multicenter study investigated whether bilateral drainage by using SEMSs is superior to unilateral drainage in patients with inoperable MHSs. Methods Patients with inoperable high-grade MHSs who underwent palliative endoscopic insertion of bilateral or unilateral SEMSs were enrolled. The main outcome measurements were the rate of primary reintervention for malfunction after successful placement of SEMSs, stent patency, technical and clinical success rates, adverse events, and survival duration. Results A total of 133 pathology-diagnosed patients were randomized to the bilateral group (n = 67) or the unilateral group (n = 66). The primary technical success rates were 95.5% (64/67) and 100% (66/66) in the bilateral and unilateral groups, respectively ( P = .244). The clinical success rates were 95.3% (61/64) and 84.9% (56/66), respectively ( P = .047). The primary reintervention rates based on the per-protocol analysis were 42.6% (26/61) in the bilateral group and 60.3% (38/63) in the unilateral group ( P = .049). The median cumulative stent patency duration was 252 days in the bilateral group and 139 days in the unilateral group. The risk of stent patency failure was significantly higher in the unilateral group (log-rank test; P P Conclusions Unilateral and bilateral drainage strategies by using SEMSs had similar technical success rates, but bilateral drainage resulted in fewer reinterventions and more durable stent patency in patients with inoperable high-grade MHSs. (Clinical trial registration number: NCT02166970.)

Background/Aims Treatment for cholangitis without common bile duct (CBD) stones has not been established in patients with gallstones. We investigated the usefulness of endoscopic biliary drainage (EBD) without endoscopic sphincterotomy (EST) in patients diagnosed with gallstones and cholangitis without CBD stones by endoscopic retrograde cholangiopancreatography (ERCP) and intraductal ultrasonography (IDUS). Methods EBD using 5F plastic stents without EST was performed prospectively in patients with gallstones and cholangitis if CBD stones were not diagnosed by ERCP and IDUS. After ERCP, all patients underwent laparoscopic cholecystectomy. The primary outcomes were clinical and technical success. The secondary outcomes were recurrence rate of biliary events and procedure-related adverse events. Results Among 187 patients with gallstones and cholangitis, 27 patients without CBD stones according to ERCP and IDUS received EBD using 5F plastic stents without EST. The stents were maintained in all patients until laparoscopic cholecystectomy, and recurrence of cholangitis was not observed. After cholecystectomy, the stents were removed spontaneously in 12 patients and endoscopically in 15 patients. Recurrence of CBD stones was not detected during the follow-up period (median, 421 days). Conclusions EBD using 5F plastic stents without EST may be safe and effective for the management of cholangitis accompanied by gallstones in patients without CBD stones according to ERCP and IDUS.

Background and Aim As society ages, the need for endoscopic retrograde cholangiopancreatography (ERCP) is increasing. This prospective comparative study evaluated the safety and efficacy of midazolam- versus propofol-based sedations by non-anesthesiologists during therapeutic ERCP in patients over 80 years of age. Methods A total of 100 patients over 80 years of age who required therapeutic ERCP were enrolled and randomly received midazolam + fentanyl (MF group) or propofol + fentanyl (PF group) sedation. Endoscopic sedation was titrated to a moderate level and carried out by trained registered nurses. Main outcome measurements were sedation safety in terms of cardiopulmonary components and efficacy measured on a 10-point visual analogue scale (VAS). Results Regarding safety, hypoxia occurred in seven (14%) in the MF group and in eight patients (16%) in the PF group (P = 0.779). Increased O2 supply was more frequent in the PF group (32% vs 42%), albeit not significantly so. There were no differences in the frequency of hypotension, bradycardia or tachycardia between the two groups. Mean VAS score for overall satisfaction with sedation by patients, endoscopists, and nurses and the scores for pain during the procedures were not different between the two groups. There was no significant difference in the procedure outcomes or rate of ERCP-related complications. Conclusions There were no significant differences of safety and efficacy between midazolam- and propofol-based sedation in patients over 80 years of age. Increased O2 supply was more frequent in the propofol group, but the prevalence of hypoxia did not differ significantly.

Background/Aims Controversy still exists regarding the benefits of covered self-expandable metal stents (SEMSs) compared to uncovered SEMSs. We aimed to compare the patency and stent-related adverse events of partially covered SEMSs (PC-SEMSs) and uncovered SEMSs in unresectable malignant distal biliary obstruction. Methods A total of 134 patients who received a PC-SEMS or uncovered SEMS for palliation of unresectable malignant distal biliary obstruction were reviewed retrospectively. The main outcome measures were stent patency, stent-related adverse events, and overall survival. Results The median stent patency was 118 days (range, 3 to 802 days) with PC-SEMSs and 105 days (range, 2 to 485 days) with uncovered SEMSs (p=0.718). The overall endoscopic revision rate due to stent dysfunction was 36.6% (26/71) with PC-SEMSs and 36.5% (23/63) with uncovered SEMSs (p=0.589). Tumor ingrowth was more frequent with uncovered SEMSs (4.2% vs 19.1%, p=0.013), but migration was more frequent with PC-SEMSs (11.2% vs 1.5%, p=0.04). The incidence of stent-related adverse events was 2.8% (2/71) with PC-SEMSs and 9.5% (6/63) with uncovered SEMSs (p=0.224). The median overall survival was 166 days with PC-SEMSs and 168 days with uncovered SEMSs (p=0.189). Conclusions Compared to uncovered SEMSs, PC-SEMSs did not prolong stent patency in unresectable malignant distal biliary obstruction. Stent migration was more frequent with PC-SEMSs. However, tumor ingrowth was less frequent with PC-SEMSs compared to uncovered SEMSs.

Introduction Chemo-responsiveness in pancreatic cancer is known to be dependent on fibrosis and vascularity. The purpose of this study was to assess vascular enhancement in advanced pancreatic adenocarcinoma with or without liver metastasis in computed tomography (CT) and to analyze the correlation between enhancement patterns and chemo-responsiveness. Methods Patients were assigned to either a responder group (partial response or stable disease) or a non-responder group (progressive disease) according to chemo-responsiveness assessed by CT before and after gemcitabine-based chemotherapy. Hounsefield unit (HU) was measured in pancreatic mass and the largest metastatic liver mass using region of interest (ROI). HU differences (ΔHU) between arterial and pre-contrast phase were calculated. Results Of the 101 study subjects, 78(77.2%) were assigned to the pancreas responder group {mean ΔHU (±SD), 36.7(±21.6)} and 23(22.8%) to the pancreas non-responder group {mean ΔHU (±SD), 20.6(±9.9)} (p = 0.001 for ΔHUs). Of the 46 study subjects with liver metastasis, 25(54.3%) were assigned to the liver metastasis responder group {mean ΔHU (±SD), 36.9(±21.0} and 21(45.7%) to the liver metastasis non-responder group {mean ΔHU (±SD), 17.1 (±24.0)}, (p = 0.005 for ΔHUs). Conclusion CT determined mass vascular enhancement patterns may predict chemoresponse in advanced pancreatic cancer.

Background and Aim It can be difficult to identify the cause of an enlarged ampulla of Vater (AOV). This study evaluated the accuracy of wire-guided intraduodenal ultrasonography (US) for the differential diagnosis of an enlarged AOV during endoscopic retrograde cholangiopancreatography (ERCP). Patients and Methods Thirty-four patients with enlarged AOVs of unknown cause identified on imaging studies or endoscopic observations underwent wire-guided intraduodenal US using a catheter probe. Results The final diagnoses were malignant or premalignant tumors in 10 patients (29.4%), stones in nine patients (26.5%), inflammation in 14 patients (41.2%), and cyst in one patient (2.9%). The overall diagnostic accuracy of intraduodenal US for enlarged AOVs was 91.2%. The diagnostic accuracies of stones, inflammation, and AOV tumors were 100.0%, 94.1%, and 91.1%, respectively. Conclusions Wire-guided intraduodenal US using a catheter probe is readily applicable during ERCP and may be useful in the differential diagnosis of enlarged ampullary lesions.

Background and Aim KRAS mutation analysis may provide ancillary diagnostic yield in an endoscopic ultrasound (EUS)-guided histopathological evaluation. We evaluated the clinical impact of KRAS mutation analysis with cytological and histological evaluations in EUS-guided tissue sampling, using a core biopsy needle for solid liver masses. Methods EUS-guided fine needle biopsy (EUS-FNB) using a core biopsy needle was performed in patients with primary or metastatic liver masses that were suspected malignancies. KRAS mutations were analyzed in all specimens obtained. The peptide nucleic acid (PNA)-mediated polymerase chain reaction (PCR) clamping method was compared with a next-generation sequencing (NGS) method for detecting KRAS mutations. Results EUS-FNB with a core biopsy needle was performed in 28 patients with solid liver masses located in the liver's left lobe. The diagnostic accuracies for malignancy of on-site cytology, cytology using Papanicolaou staining, and histology including immunohistochemical stains were 82.1%, 85.7%, and 89.3%, respectively. KRAS gene mutations were observed in 14.3% of patients by the PNA-PCR clamping method. The NGS method detected more KRAS mutations than the PNA-PCR clamping method: in 25% of patients. Adding the results of KRAS mutation analysis to the cytohistopathological evaluation, the overall diagnostic accuracy of EUS-guided tissue sampling was 96.4%. Conclusions EUS-guided tissue sampling for solid liver masses in the left lobe provided high diagnostic accuracy from cytological and histological evaluations. KRAS mutation analysis provided additional diagnostic yield in patients with inconclusive cytohistopathological results from EUS-guided tissue sampling. The NGS method detected additional KRAS mutations in patients with negative PNA-mediated PCR clamping test results.

Currently available peroral cholangioscopy (POC) is a duodenoscopy-assisted procedure that does not involve directly inserting an endoscope into the biliary tree. A prototype multibending (MB) ultra-slim endoscope has been developed as a dedicated cholangioscope to overcome the technical difficulties of direct POC. In this study, we evaluated the efficacy of the new MB ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC without the assistance of accessories.Ninety-two patients with biliary disease requiring diagnostic and/or therapeutic direct POC were assigned randomly to groups examined using an MB ultra-slim endoscope (MB group, n=46) versus a conventional ultra-slim endoscope (conventional group, n=46). The primary outcome was the technical success of free-hand insertion of the endoscope during direct POC, defined as successful insertion of the endoscope through the ampulla of Vater and advancement of the endoscope up to the bifurcation or to the obstructed segment of the biliary tree without any accessories within 15 minutes.Free-hand biliary insertion of the endoscope for direct POC was technically successful in 41 patients (89.1%) in the MB group, which was significantly higher than the rate (14 patients, 30.4%) in the conventional group (P .001). The procedure time (mean ± standard deviation) of direct POC using free-hand biliary insertion of the endoscope was significantly shorter in the MB group than in the conventional group (3.2 ± 1.8 vs 6.0 ± 3.0 minutes, P = .004). Adverse events were observed in 3 patients (6.5%) in the MB group and 2 patients (4.3%) in the conventional group (P = .500), all of whom were treated conservatively. The technical success rates of the diagnostic or therapeutic intervention were not significantly different between the 2 groups in patients undergoing successful direct POC.Free-hand biliary insertion of the MB ultra-slim endoscope showed a high technical success rate without severe adverse events and effectively decreased procedure time compared with a conventional ultra-slim endoscope. Direct POC using the MB ultra-slim endoscope can be used for novel diagnostic and therapeutic procedures of the biliary tree without the assistance of another endoscope or accessory. (Clinical trial registration number: NCT02189421.).

Background A novel self-approximating lumen-apposing metallic stent (LAMS; Niti-S Spaxus, Taewoong Medical, Gyeonggi-do, Korea) has recently become available. The aim of the present study was to evaluate the outcomes for drainage of pancreatic fluid collections (PFC). Methods This was a prospective international multicentered study conducted in six high-volume institutions across Asia. Consecutive patients suffering from pancreatic pseudocyst or walled-off pancreatic necrosis (WOPN) requiring endoscopic ultrasonography-guided drainage were recruited. Outcomes included technical and clinical success, adverse events, procedural events, interventions through the stent and recurrence rates. Results Between August 2016 and November 2017, 59 patients were recruited to this study. Thirty-nine patients (66.1%) had WOPN and mean (SD) size of PFC was 11.5 (5.1) cm. Technical and clinical success rates were 100%. Mean (SD) procedural time was 35.0 (17.2) minutes. Sixteen-millimeter stents were used in 66.1% of the patients. Fifty-four sessions of necrosectomy were carried out with the stent in situ in 17 patients. Stent-related adverse event (AE) rate was 6.8%. Three patients (5.1%) suffered from bleeding after stenting and one required angiographic embolization. Two patients (3.4%) suffered from recurrence during a mean (SD) follow-up time of 325.6 (355.5) days. There were no differences in outcomes between those with pseudocysts or WOPN except for the duration of hospital stay (P = 0.012). Conclusion Use of a self-approximating LAMS for drainage of PFC was safe and effective. Endoscopic necrosectomy could be carried out through the stent with ease. The device was associated with a low rate of stent-related AE.

Objective Acquiring adequate tissue for immunohistochemical (IHC) analysis is important in the differential diagnosis of subepithelial tumors (SETs). In this study, we aimed to compare the diagnostic yield based on IHC analysis between endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) and EUS-guided fine needle biopsy (EUS-FNB) after on-site cytological evaluation for cellularity in gastric SETs. Methods In 22 patients with gastric SETs, EUS-guided tissue sampling was performed on the same SET in a randomized sequence, with EUS-FNA followed by EUS-FNB, or vice versa. After on-site cytological evaluation for cellularity, the cytological and histological examinations were performed. Results There was a significant difference in the median number of needle passes to obtain adequate cellularity in the on-site cytological evaluation (2.0 for EUS-FNA vs 1.0 for EUS-FNB, P = 0.008). The proportion of adequate cellularity on the first needle pass was significantly higher in the EUS-FNB than in the EUS-FNA group (68.2% vs 31.8%, P = 0.034). However, diagnosis based on IHC examination was established in 15 (68.2%) and 18 (81.8%) cases by EUS-FNA and EUS-FNB, respectively (P = 0.488). Conclusions EUS-FNB decreases the number of needle passes to obtain adequate cellularity and yields a higher proportion of adequate cellularity during the first needle pass compared with EUS-FNA in gastric SETs. However, there was no significant difference in diagnostic yield with IHC stain between the two procedures after on-site cytological evaluation for adequate cellularity.

Background and study aim: The nonflared ends of fully covered, self-expandable, metal stents (FCSEMSs) may minimize stent-induced ductal injury. Suprapapillary intraductal placement of nonflared FCSEMSs for malignant biliary stricture might reduce duodenobiliary reflux and pancreatitis. The aim of this study was to evaluate the efficacy of a newly modified, nonflared FCSEMS for intraductal placement in patients with malignant biliary stricture. Patients and methods: A total of 51 patients with nonhilar, extrahepatic, malignant biliary stricture were enrolled prospectively. The nonflared FCSEMS is 12 mm in diameter, and has a central saddle and a distal lasso of 7 cm in length. An FCSEMS was placed above the papilla in all patients, with the central saddle positioned at the stricture to prevent stent migration. Results: The technical and clinical success rates were 100 % and 98 %, respectively. Early adverse events occurred in one patient (2.0 %; mild pancreatitis). A total of 12 patients underwent surgery with curative intent, one of whom (8.3 %) experienced a postoperative adverse event. No stent migration occurred in any of the patients. Cholecystitis developed in one patient (2.0 %) as a late adverse event. Stent occlusion occurred in 44.7 % (17/38), and endoscopic removal of the stent was successful in 87.5 % of patients. The mean stent patency was 297 days (95 % confidence interval, 211 – 383). Conclusions: Intraductal placement of the nonflared FCSEMS, 12 mm in diameter, was feasible for the palliative and preoperative management of patients with malignant biliary stricture. Long-term follow-up and prospective comparative studies are needed to evaluate the usefulness of intraductal placement of this stent.

A reproducible in vivo swine model of bile duct dilation (BDD) was recently established and reported for the preclinical testing of newly developed biliary devices or endoscopic techniques. The aim of this study is to develop more advanced large animal model which is possible to direct examination of the biliary tree. Six mini pigs were prepared for the study. The BDD models were first made by closure of the ampulla of Vater in all swine. Then endoscopic papillary balloon dilation (EPBD) was performed in the animals. The feasibility of single-operator peroralcholangioscopy without assistance of accessories was evaluated using an ultra-slim upper endoscope in the animals. EPBD could be implemented using a dilation balloon catheter (10 ~ 13.5 mm) in all BDD models (6/6, 100%). The success rate of free-hand direct insertion of an ultra-slim endoscope into the common bile duct (CBD) was 100% (6/6), and access to the common hepatic duct with examination was possible using the direct peroralcholangioscopy in five animals (5/6, 83.3%). None of the animals died. In the cholangioscopic examination, a bile duct polyp and a benign biliary stricture occurred naturally, respectively, in two of six swine. An in vivo swine model of biliary dilatation-based direct peroralcholangioscopy was established. This novel animal model may be useful for the preclinical research of new materials or devices because direct visualization of the biliary tree is feasible. This article is protected by copyright. All rights reserved.

Background and Aim: A major concern about endoscopic snare papillectomy (ESP) is the risk of procedure-related pancreatitis. To maintain pancreatic duct access for stent placement after ESP, wire-guided ESP (WP) was introduced. The aim of the study was to compare post-procedure pancreatitis rates, the success rate of pancreatic stent insertion, and complete resection rates between WP and conventional ESP (CP) procedures. Methods: This was a multi-center, prospective, randomized pilot study. Forty-five patients with ampullary tumors were randomly assigned to a WP group (n = 22) or a CP group (n = 23). In the WP group, a guidewire was placed in the pancreatic duct prior to ESP. A 5-Fr pancreatic stent was passed over the guidewire and placed across the pancreatic duct orifice. Results: Complete resection was achieved in 20 patients (91%) in the WP group and 18 patients (78%) in the CP group (P = 0.414). A pancreatic stent was placed successfully in all patients in the WP group but in only 15 patients (65%) in the CP group (P = 0.004). Post-papillectomy pancreatitis occurred in four (18%) patients in the WP and three (13%) patients in the CP groups (P = 0.960). In the CP group, three of eight (37.5%) patients without stents developed pancreatitis compared with zero of 15 patients with stents (P = 0.032). Conclusions: The WP method is a useful technique used to insert a pancreatic stent after ESP, compared with CP. However, there was no significant difference in the post-procedure pancreatitis or complete resection rates between the two methods.

Concern regarding the safety and efficacy of therapeutic endoscopic retrograde cholangiopancreatography (ERCP) in elderly patients is increasing as a result of the aging society. However, there are limited data, especially in the super-aged elderly. This study aimed to evaluate the efficacy and safety of therapeutic ERCP in patients ≥80 years of age. Patients 80 years of age or older (n = 312) and younger than 65 years (n = 312) who underwent therapeutic ERCP from June 2006 to April 2014 were randomly selected and analyzed retrospectively. The main outcome measurements were therapeutic ERCP-related complications and clinical outcomes in the two groups. Choledocholithiasis combined with gallbladder stone was the most common indication for ERCP in both groups. Comorbid diseases (70.5 and 29.8 %, p

Background and aims Catheter-based endobiliary radiofrequency ablation (RFA) is an endoscopic local treatment for patients with malignant biliary stricture (MBS). However, excessive heating of the bile duct by the current RFA system can induce serious complications. Recently, a new RFA system with automatic temperature control was developed. In the present study, we examined the safety of the new RFA system in patients undergoing endobiliary RFA for extrahepatic MBS. Methods This prospective, multicenter study enrolled patients with unresectable or inoperable extrahepatic (> 2 cm from the hilum) MBS. Endobiliary RFA was performed using a newly developed RFA catheter (ELRA™, STARmed, Goyang, Korea) at a setting of 7 or 10 W for 120 s and with a target temperature of 80°C. A self-expandable metallic stent was inserted after endobiliary RFA. The rate of procedure-related adverse events was assessed. Results The 30 patients were enrolled in this study. Cholangiocarcinoma was diagnosed in 19 patients, pancreatic cancer was found in 9, and gallbladder cancers were recorded in 2. The mean stricture length was 22.1 ± 6.6 mm. Post-procedural adverse events occurred in three patients (10.0%; 2 mild pancreatitis and 1 cholangitis) without hemobilia and bile duct perforation. The pancreatitis and cholangitis resolved with conservative treatment. The cumulative duration of stent patency and survival were 236 and 383 days, respectively. Conclusions Automatic temperature-controlled endobiliary RFA using a newly developed catheter was safely applied in patents with extrahepatic MBS. Further prospective studies are needed to confirm the efficacy of endobiliary RFA for MBS.

Recent advances in cholangiopancreatoscopy technology permit image-enhanced endoscopy (IEE) for pancreatobiliary diseases. There are limitations in endoscopy performance and in the study of the clinical role of IEE in bile duct or pancreatic duct diseases. However, currently available IEEs during cholangiopancreatoscopy including traditional dye-aided chromoendoscopy, autofluorescence imaging, narrow-band imaging, and i-Scan have been evaluated and reported previously. Although the clinical role of IEE in pancreatobiliary diseases should be verified in future studies, IEE is a useful promising tool in the evaluation of bile duct or pancreatic duct mucosal lesions.

Background and Aims EUS-guided fine-needle aspiration/biopsy (EUS-FNA/B) has a high diagnostic accuracy for pancreatic tumors. Most reports have focused on the diagnostic yield of cytology or histology; the ability of various FNA/B techniques to obtain an adequate mass of cells or tissue has rarely been investigated. Methods Patients with suspected pancreatic malignancy underwent EUS-FNB using a 22-gauge ProCore needle by either the stylet slow-pull-back technique (group A), conventional negative suction after stylet removal (group B), or non-suction after stylet removal (group C) in the absence of an on-site cytopathologist. The adequacy of the 3 techniques based on the diagnostic yield, cellularity, blood contamination, and core-tissue acquisition was evaluated. Results A total of 50 patients (27 males) were analyzed. The mean tumor size was 21 to 40 mm in 54%. The rate of a good or excellent proportion of cellularity was highest in group A compared with groups B and C (72% vs 60% vs 50%, P = .049). A >25% rate of blood contamination was more prevalent in group B (30% vs 42% vs 10%, P = .009). The rate of adequate core-tissue acquisition was not different (52% vs 34% vs 50%, P = .140). Based on the multivariate generalized estimation equation, the stylet slow-pull-back technique and a tumor size >40 mm were favorable factors for diagnostic adequacy. Conclusions The stylet slow-pull-back technique might enable acquisition of tissue and assessment of cellularity for the diagnosis of pancreatic tumors suspected to be malignant. (Clinical trial registration number: KCT0002190.)

ratio of cholangiocarcinoma (intrahepatic or extrahepatic), gall bladder cancer, and ampulla of Vater cancer was 41 (63.1%):18 (27.7%):6 (9.25%). Half of the patients (33 patients, 50.8%) were treated with gemcitabine-based and 28 patients (43.1%) with 5-fluo- rouracil-based therapy. The response rate was 3.0% and disease control rate was 21.5% in intention-to-treat analysis. Median overall survival (OS) was 7.2 months (95% confidence interval (CI), 3.9 to 10.5 months) and median progression free survival (PFS) was 3.7 months (95% CI, 2.5 to 4.9 months). In multivariate analysis, patients with good performance status (PS) (P = 0.001) and chemo-sensi- tive tumor to 2nd line chemotherapy (P = 0.000) had longer PFS as compared to the others. In addition, patients with good PS (P = 0.003), chemo-sensitive tumor to 1st line (P = 0.046), and 2nd line chemotherapy (P = 0.004) were good prognostic factors for OS. Conclusion: The effect of 2nd line chemotherapy in advanced BTC was modest and maybe beneficial in select patients.

Newly introduced direct peroral cholangioscopy and the development of video choledochoscopes have enabled more defined observation of bile duct mucosal lesions with clearer images. Narrow-band imaging (NBI) is a unique endoscopic imaging technology that provides enhanced endoscopic images of surface mucosal structures and its superficial microvessels. Advanced cholangioscopy and NBI are expected to be useful for precise evaluation and correct diagnosis of biliary tract diseases. However, the diagnostic value of advanced bile duct imaging with cholangioscopy requires further evaluation.

Background and Study Aims Endoscopic ultrasound (EUS)-guided fine needle aspiration (EUS-FNA) is one of the alternative methods for tissue sampling of liver solid mass. However, the diagnostic efficacy using cytology alone was limited. In this study, we evaluate the diagnostic accuracy of EUS-guided fine needle biopsy (EUS-FNB) as a percutaneous biopsy rescue for liver solid mass. Patients and Methods The EUS-FNB using core biopsy needle for liver solid mass was performed prospectively for patients who were failure to acquire a tissue or achieve a diagnosis using percutaneous liver biopsy. The primary outcome was the diagnostic accuracy of EUS-FNB for malignancy and specific tumor type. The secondary outcomes were the median numbers of passes required to establish a diagnosis, the proportions of patients in whom immunohistochemical (IHC) stain was possible and obtained adequate specimen, and safety of EUS-FNB. Results Twenty-one patients (12 women; mean age, 63 years [range, 37–81]) underwent EUS-FNB for solid liver masses. The median number of needle passes was 2.0 (range, 1–5). On-site cytology and cytology with Papanicolaou stain showed malignancy in 16 patients (76.2%) and 17 patients (81.0%), respectively. In histology with HE stain, 19 patients (90.5%) were diagnosed malignancy and optimal to IHC stain. The overall diagnostic accuracy for malignancy and specific tumor type were 90.5% and 85.7%, respectively. No complications were seen. Conclusions EUS-FNB with core biopsy needle for solid liver mass may be helpful in the management of patients who are unable to diagnose using percutaneous liver biopsy.

Direct peroral cholangioscopy (POC) using an ultra-slim upper endoscope is one modality of POC for intraductal endoscopic evaluation and treatment of the bile duct. Choledochoduodenostomy (CDS) is one modality of biliary bypass surgery that provides a new route to the bile duct. We carried out direct POC using an ultra-slim upper endoscope without the use of accessories in 10 patients (four sump syndromes, three bile duct strictures and three intrahepatic duct stones) previously undergoing surgical CDS. Direct POC was successful in all patients. The use of an intraductal balloon catheter was required in one patient for advancement of the endoscope into the bile duct. Distal bile ducts with sump syndromes were cleared using baskets and water irrigation under direct POC. Cholangiocarcinoma was diagnosed in one patient with hilar bile duct stricture after cholangioscopic evaluation and a targeting forceps biopsy under direct POC. Intrahepatic duct stones were successfully extracted after intraductal fragmentation under direct POC. Oozing bleeding occurred during intraductal lithotripsy but stopped spontaneously. Direct POC using an ultra-slim upper endoscope without the assistance of accessories can easily be carried out in patients undergoing CDS.

Background and Aim Identifying a bile duct (BD) stone in patients with acute biliary pancreatitis (ABP) is important for the management and prevention of recurrent attack of pancreatitis. However, small BD stones may not be detected on endoscopic retrograde cholangiopancreatography (ERCP). The aim of this study was to prospectively evaluate the usefulness of intraductal ultrasonography (IDUS) in patients suspected to have ABP but with no evidence of choledocholithiasis on ERCP. Methods A total 92 patients suspected with ABP without evidence of BD stones on imaging studies including ERCP were enrolled. Wire-guided IDUS was performed during ERCP in all patients. Stones or sludge detected by IDUS were confirmed after endoscopic sphincterotomy (EST) and extraction. If IDUS finding was negative, then we swept the BD with a balloon catheter and/or basket without EST. After endoscopic management, comparison between IDUS and endoscopic finding was carried out to determine the diagnostic accuracy of IDUS. Results Among the 92 patients, IDUS revealed BD stones in 33 (35.9%). All 33 patients' stones were confirmed by endoscopic visualization after EST and BD exploration. During the mean follow up of 24 months, recurrent pancreatitis did not occur in 90 of 92 patients (97.9%) with ABP after endoscopic treatment according to the IDUS findings. Conclusions IDUS improves diagnostic accuracy for the detection of clinically occult BD stones in patients suspicious ABP. IDUS-guided endoscopic management for patients with ABP can avoid unnecessary EST and help prevent recurrent pancreatitis.

Background/Aims Endoscopic papillary balloon dilation (EPBD) has been advocated as an alternative therapy to endoscopic sphincterotomy for the treatment of common bile duct (CBD) stones. However, there is no established consensus on the optimal balloon dilation duration (BDD). We prospectively evaluated the efficacy and post-endoscopic retrograde cholangiopancreatography (ERCP) complications between the 20- and 60-second EPBD groups. Methods A total of 228 patients with small CBD stones (≤12 mm) were randomly assigned to undergo EPBD with a 20- or 60-second duration at six institutions. We evaluated baseline patient characteristics, endoscopic data, clinical outcomes, and procedure-related complications. In addition, we analyzed risk factors for postprocedural pancreatitis. Results CBD stones were removed successfully in 107 of 109 patients (98.1%) in the 20-second group and in 112 of 119 patients (94.1%) in the 60-second group (p=0.146). Post-ERCP pancreatitis developed in seven patients (6.4%) in the 20-second group and nine patients (7.5%) in the 60-second group (p=0.408). In multivariate analysis, contrast dye injection into the pancreatic duct is a significant risk factor for post-EPBD pancreatitis. Conclusions Based on the data showing that there were no significant differences in safety and efficacy between the two BDD groups, 20 seconds of BDD may be adequate for treatment of small CBD stones with EPBD.

Article: Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients (Gastroenterology 2016;150:911-917)

Background/Aims Needle-knife precut fistulotomy (NK-F) is a well-known freehand technique for difficult biliary cannulation (DBC). Another approach involves the use of Iso-Tome®, a modified precutting device with an insulated needle tip to prevent direct thermal injury. This comparative study aimed to evaluate the efficacy of the Iso-Tome® precut (IT-P) compared to that of NK-F for DBC. Methods Patients with a naive papilla who underwent early IT-P or NK-F for DBC were enrolled. DBC was defined as failure to achieve selective biliary access by wire-guided cannulation despite 5 minutes of attempted cannulation, ≥5 papillary contacts, or a hooknose-shaped papilla. The primary endpoint was the primary technical success rate, which was based on a noninferiority model. Results A total of 239 DBC cases were enrolled. The primary technical success rates were 74.7% (89/119) in the IT-P group and 91.6% (110/120) in the NK-F group (lower limit of 90% confidence interval, -0.23; p=0.927 for a noninferiority margin of 10%). The total technical success rates were 87.4% and 95.0%, respectively (p=0.038). The mean precutting times for successful biliary access were 11.2 minutes for IT-P and 7.3 minutes for NK-F (p

Background and study aims I-SCAN is a computed virtual chromoendoscopy (CVC) system designed to enhance surface and vascular patterns. In this study, we evaluated the usefulness of direct peroral cholangioscopy (POC) using I-SCAN compared with a conventional white-light image (WLI) to diagnose bile duct lesions. Patients and methods Patients with mucosal lesions in the bile duct detected during direct POC were enrolled prospectively. The quality of endoscopic visualization and the visual diagnosis were assessed using I-SCAN and WLI modes, respectively, during direct POC. Results A total of 20 patients (9 malignant and 11 benign lesions) underwent I-SCAN to evaluate lesions in the bile duct using direct POC. The quality of endoscopic visualization using direct POC with I-SCAN was significantly higher than that of WLI for surface structure (P = 0.04), surface microvascular architecture (P = 0.01), and margins (P = 0.02). Overall diagnostic accuracy of the visual diagnosis was not different between I-SCAN and WLI (90.0 % vs. 75.0 %; P = 0.20). Conclusion Direct POC using CVC by I-SCAN seems to be helpful for evaluating mucosal lesions of the bile duct, without the interference from bile.Clinical trial registration: UMIN000021009

Detection of tumors of the ampulla of Vater, including ampullary adenoma, has been improved by routine screening endoscopic procedures and imaging modalities. Endoscopic resection by endoscopic papillectomy is rapidly replacing classic surgical resection and is a less invasive procedure. Endoscopic resection can have a role not only in the final histopathologic diagnosis but also as a definite therapeutic option. However, the indications for endoscopic resection are not fully established, and endoscopic procedures are not standardized. Significant complications, including severe pancreatitis, intractable bleeding and duodenal perforation, are rare but can occur, especially in less experienced hands. Severe pancreatitis is the most feared complication, but it can be prevented by pancreatic duct stent insertion in most cases. However, in some cases, pancreatic stenting can be challenging after resection. Incomplete resections are sometimes performed to avoid complications. Endoscopic surveillance is also important for identifying and managing remnant adenomatous tissue or recurrent lesions. Further technical development is needed to expand the indications for this procedure, minimize complications and ensure a high success rate.

Background/Aims It is sometimes difficult to incise the distal papillary roof (PR) completely in patients with choledocholiths and choledochoduodenal fistula (CDF). The Iso-Tome® (MTW-Endoskopie W. Haag KG), which is helpful in preventing electrical leakage, has good orientation capabilities and can be easily placed at the orifice of the CDF or ampulla of Vater (AV). We aimed to evaluate the efficacy of endoscopic sphincterotomy (ES) with the Iso-Tome® for cutting the distal PR. Methods Between May 2003 and July 2012, 35 patients were analyzed retrospectively. The distal PR was cut downward and/or upward using the Iso-tome® until the pink intrapapillary mucosa was fully exposed. Downward incisions were performed from the opening of the CDF to the orifice of the AV; upward incisions were performed in reverse. Results Spontaneous or artificial CDF occurred in four and 31 patients, respectively. The technical and therapeutic success rates were 94.3% (33/35) and 94.3% (33/35), respectively. There was no case of electrical damage to the pink intrapapillary mucosa. Adverse events occurred in 2.9% (1/35; 1, mild bleeding) of patients. Conclusions The new technique of ES with the Iso-tome® is feasible and useful for effectively incising the distal PR in patients with CDF and choledocholiths.

New technological developments in endoscopic retrograde cholangiopancreatography (ERCP) for diagnosis and treatment have been slow to progress. However, several informative study results were presented during the 2014 Digestive Disease Week (DDW; 3 - 6 May; Chicago, Illinois, USA) in specific ERCP areas, such as prevention of post-ERCP pancreatitis using nonsteroidal anti-inflammatory drugs and pancreatic duct stenting. Novel and interesting study results regarding preoperative stent selection for periampullary tumors, metal stents for hilar stricture or for prevention of duodenal reflux, and intraductal biliary tumor ablation using photodynamic therapy or radiofrequency ablation were discussed. Study results presented at the meeting regarding single-operator cholangioscopy using the SpyGlass system or direct peroral cholangioscopy have indicated the possibility of future development. Results using peroral pancreatoscopy and confocal laser endomicroscopy for biliary lesions, including strictures, were also presented.

Background and Aim After selective biliary access following precut fistulotomy in difficult biliary cannulations (DBC), there are several methods of completely opening the remaining papillary roof for the removal of biliary stones. We evaluated the efficacy of one-step transfistula balloon dilation following fistulotomy in DBC for the removal of biliary stones. Methods This retrospective multicenter study was performed in four tertiary referral centers. Patients who underwent fistulotomy due to DBC were enrolled. Precut fistulotomy followed by conventional (≤ 10 mm) or large balloon (≥ 12 mm) dilation through the fistulotomy tract was performed to remove biliary stones. The main outcome measures were technical success and transfistula balloon dilation-related complications. Results A total of 154 patients were enrolled. Large balloon and conventional balloon dilation were performed in 57 and 97 patients, respectively. The primary technical success of stone removal was 100% (57/57) for large balloon dilation and 96.9% (94/97) for conventional balloon dilation (P = 0.296). The mean procedure time from biliary access to removal of stones was 29.3 min in large balloon and 22.2 min in conventional balloon dilation (P = 0.042), and the mean numbers of endoscopic retrograde cholangiopancreatography sessions were 1.4 and 1.3, respectively (P = 0.175). Transfistula balloon dilation-related complications were not different between the two groups (10.5% in large balloon dilation vs 16.5% in conventional balloon dilation, P = 0.307). Conclusions One-step transfistula balloon dilation following precut fistulotomy in DBC may be safe and effective for the removal of biliary stones. There were no differences in therapeutic outcomes and complications between large and conventional balloon dilation.

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.

Endoscopic papillary large balloon dilation (EPLBD) after an endoscopic sphincterotomy (EST) is an option for endoscopic removal of large common bile duct (CBD) stones. However, risks or fear of severe adverse events remain. Our aim was to compare the safety and efficacy of delayed EPLBD after EST with concurrent EST and EPLBD in patients with acute cholangitis by large CBD stones. A total of sixty-eight patients with acute cholangitis from large CBD stones were enrolled in this prospective observational study. Thirty-five patients underwent concurrent EST and EPLBD at the same session (group A). Thirty-three patients underwent only EST at the first session, and EPLBD with stone removal was performed during a second session (group B). The complete stone removal rate and adverse events rate were analyzed. Both groups resulted in similar outcomes in terms of overall successful stone removal (100 % in both groups) and the use of additional lithotripsy (22.9 % in group A and 24.2 % in group B). Six patients (17.1 %) in group A had procedural-related adverse events including one patient with death by perforation, one with significant bleeding, and four with pancreatitis, including one moderate grade. However, there was no procedure-related complication in group B (p

Endoscopic biliary sphincterotomy (EBS) results in permanent loss of sphincter function and its long-term complications are unknown. Endoscopic papillary balloon dilation (EPBD) is an alternative procedure that preserves sphincter function, although it is associated with a higher risk of pancreatitis than is EBS. The aim of this study was to evaluate the safety and outcomes of EPBD with limited indications for removal of common bile duct (CBD) stones combined with gallstones in patients younger than 40 years. Young (age

Objectives The mechanism of pancreatitis development following endoscopic papillary balloon dilation (EPBD) remains unknown. Antegrade dilation with percutaneous transhepatic papillary balloon dilation (PTPBD) allows the removal of bile duct stones or fragments during percutaneous choledochoscopic lithotomy, with less mechanical trauma to the papilla than with EPBD-mediated stone removal. Methods A total of 56 patients with bile duct stones underwent antegrade dilation with PTPBD from March 2006 to February 2011. A total of 208 patients with common bile duct stones underwent retrograde dilation with EPBD during the same period. The conditions of papillary balloon dilation were identical in both groups. The frequencies of pancreatitis and hyperamylasemia were compared in both groups. Results Pancreatitis occurred in 14 (6.7%) of 208 patients in the EPBD group (mild, nine; moderate, four; severe, one). There was no case of pancreatitis among 56 patients in the PTPBD group (P

Background Endoscopic management of recurrent bile duct stones after endoscopic sphincterotomy (EST) is effective and safe. However, repeat EST for extension of a previous EST for recurrent bile duct stones may involve substantial risk. The aim of the present study was to evaluate the safety and efficacy of endoscopic papillary large balloon dilation (EPLBD) without repeat EST for recurrent difficult bile duct stones after previous EST. Patients and Methods From January 2006 to October 2010, a total of 52 patients were enrolled; all had undergone EPLBD (balloon diameter: 12–20 mm) to remove recurrent difficult bile duct stones after previous EST. In all patients, stone removal had failed with conventional methods using a basket and/or balloon. The size of the balloon for EPLBD was selected to fit the diameter of the common bile duct or the largest stone. Results The median interval between initial EST and stone recurrence was 2.2 years (range 1–10). Median diameters of thelargest stone and balloon were 20.1 mm (range 12–40) and 14.7 mm (range 12–20), respectively. Complete stone removal was achieved in all patients (100%). The median number of endoscopic retrograde cholangiopancreatography sessions needed for complete stone removal was 1.6 (range 1–3). Additional lithotripsy was required in 16 patients (30.7%). No procedure-related complications were documented, with the exception of four cases of asymptomatic hyperamylasemia. The recurrence rate of CBD stones after bile duct clearance was 17.3% (9/52) during the follow-up period (mean 27.0 ± 14.1 months). Conclusions EPLBD without repeat EST is effective and relatively safe for the extraction of recurrent difficult bile duct stones after previous EST.

Background and Aim Endoscopic biliary drainage (BD) is an effective palliative treatment for acute cholangitis. Transnasal endoscopy (TNE) using an ultraslim endoscope can be less stressful and has limited hemodynamic effects compared with endoscopic retrograde cholangiography using a conventional duodenoscope. Here, we evaluate the clinical usefulness of direct BD by TNE in critically ill patients with acute cholangitis who had undergone endoscopic sphincterotomy (ES) previously. Methods Twenty-three patients with severe-to-moderate acute cholangitis who had undergone ES previously were enrolled prospectively. BD was achieved by TNE, using an ultraslim upper endoscope with a 5-Fr nasobiliary drainage catheter and/or a plastic stent. The technical and clinical success, as well as the safety, of the procedure were investigated. Results A total of 23 patients were enrolled, including 17 with bile duct stones. The severity of the cholangitis was severe in nine (39.1%) and moderate in 14 patients (60.9%). The technical success rate was 95.7% (22/23). Nasobiliary drainage was performed in 15 patients, a plastic stent was placed in three, and both treatments were used in four patients. In three patients, direct BD by TNE was achieved in the intensive care unit without fluoroscopy. Direct cholangioscopy for distal common bile duct was performed in nine patients (40.9%), and three patients underwent immediate stone extraction under endoscopic visualization. Clinical improvement was achieved in 20/23 (87.0%) of patients. No significant procedure-related complications occurred. Conclusion Direct BD by TNE may be useful in critically ill patients with severe-to-moderate acute cholangitis who had undergone ES previously.

Background and study aim: Endoscopic stent-in-stent (SIS) placement of multiple metal stents is technically demanding. In the present study, we explored the technical feasibility and efficacy of endoscopic deployment of a third metal stent to create a triple SIS placement in patients with a bilateral SIS configuration for inoperable high grade malignant hilar biliary stricture (HBS) that had failed clinically. Methods: Eighteen patients with histologically proven inoperable HBS underwent deployment of an additional third metal stent as a revisionary method after early clinical failure following technically successful bilateral SIS placement using cross-wired metal stents. The main outcome measures were the technical and clinical success rates, and adverse events. Results: The overall technical and clinical success rates were 88.9 % (16/18) and 87.5 % (14/16), respectively. The early and late complications were cholangitis (n = 2) and cholecystitis (n = 1). Stent occlusion developed in 35.7 % (5/14) of patients in whom a third metal stent for revision of a bilateral SIS configuration was clinically successful. The median (range) times for stent patency and patient survival were 176 days (49 – 372) and 216 days (52 – 384), respectively. Conclusions: Endoscopic deployment of an additional third metal stent into a bilateral SIS configuration was technically feasible and effective in patients with inoperable high grade malignant HBS in whom bilateral SIS placement had failed clinically.

Background and study aims: Endoscopic bilateral drainage for inoperable malignant hilar biliary strictures (HBS) using metal stents is considered to be technically difficult. Furthermore, endoscopic revision of bilateral stenting after occlusion can be challenging. This study was performed to evaluate the long-term efficacy of endoscopic bilateral stent-in-stent placement of cross-wired metallic stents in high-grade malignant HBS and planned endoscopic bilateral revision. Patients and methods: A total of 84 patients with inoperable high-grade malignant HBS were enrolled from three academic tertiary referral centers. Two cross-wired metal stents were inserted using a bilateral stent-in-stent placement method. Bilateral endoscopic revision was also performed during follow-up using either identical metal stents or plastic stents. The main outcome measurements were technical and functional success, complications, stent patency, and endoscopic revision efficacy. Results: The technical and clinical success rates of endoscopic bilateral stent-in-stent placement of cross-wired metallic stents were 95.2 % (80 /84) and 92.9 % (78 /84), respectively. Median patency (range) and survival were 238 days (10 – 429) and 256 days (10 – 1130), respectively. Obstruction of primary bilateral stents occurred in 30.8 % (24 /78) of patients with functionally successful stent placement. The technical and clinical success rates of planned bilateral endoscopic revision for occluded stents were 83.3 % (20 /24) and 79.2 % (19 /24), respectively. For revision, bilateral metallic stents were placed in 11 patients (55.0 %); the remaining patients received plastic stents. Conclusions: Palliative endoscopic bilateral stent-in-stent placement of cross-wired metallic stents was effective in patients with inoperable HBS. Revision endoscopic bilateral stenting may be feasible and successful in cases where the primary deployed metal stents are occluded.

Objective To report treatment outcomes and complications of uncovered self-expandable metallic stents (SEMS) as a first-line therapy for inoperable malignant duodenal obstructions in our hospital. Methods A retrospective analysis was performed in patients who had undergone placement of uncovered SEMS as a first-line therapy for inoperable malignant duodenal obstruction from August 2001 to July 2011. Treatment outcomes and complications of the procedures were investigated. Results In total, 47 patients (25 men; mean age 65 years) underwent the procedure. The technical and clinical success rates were 93.6% and 83.0%, respectively. Early complications occurred in 8 patients, including two guidewire-induced micro-perforations and six pancreatitis. All these 8 patients recovered with conservative treatment. Six late complications requiring additional procedures consisted of five stent occlusions due to tumor ingrowth and one stent migration. Four stent occlusions and one migration were treated by the placement of an additional covered stent and the remaining case was treated by balloon dilatation. The median primary stent patency period and median survival period after primary stent placement were 103 days and 131 days, respectively. Conclusions Uncovered SEMS placement is effective as a first-line palliative therapy for inoperable malignant duodenal obstruction. Complications such as stent occlusion or migration can be easily managed with additional covered SEMS.

Background/Aims: During endoscopic retrograde cholangiopancreatography (ERCP), all efforts should be made to be aware of radiation hazards and to reduce radiation exposure. The aim of this study was to investigate the status of radiation protective equipment and the awareness of radiation exposure in health care providers performing ERCP in Korean hospitals. Methods: A survey with a total of 42 questions was sent to each respondent via mail or e-mail between October 2010 and March 2011. The survey targeted nurses and radiation technicians who participated in ERCP in secondary or tertiary referral centers. Results: A total of 78 providers from 38 hospitals responded to the surveys (response rate, 52%). The preparation and actual utilization rates of protective equipment were 55.3% and 61.9% for lead shields, 100% and 98.7% for lead aprons, 47.4% and 37.8% for lead glasses, 97.4% and 94.7% for thyroid shields, and 57.7% and 68.9% for radiation dosimeters, respectively. The common reason for not wearing protective equipment was that the equipment was bothersome, according to 45.7% of the respondents. Conclusions: More protective equipment, such as lead shields and lead glasses, should be provided to health care providers involved in ERCP. In particular, the actual utilization rate for lead glasses was very low. (Gut Liver 2013;7:100-105)

Background Post-ERCP pancreatitis (PEP) is the most common and serious complication of ERCP. Difficult biliary cannulation can be a procedure-related risk factor for PEP. Recent studies reported that a prophylactic pancreatic stent (PS) can reduce the frequency and severity of PEP. Objective To evaluate the efficacy and usefulness of a temporary 3F PS to prevent PEP in patients with difficult biliary cannulations. Design A multicenter, prospective, randomized study. Setting Two tertiary-care academic medical centers. Patients In total, 101 patients with a difficult biliary cannulation were randomly divided into the 3F PS placement group (PS group, n=50) or the nonstent (NS) group (NS group, n=51). Interventions Endoscopic placement of a 3F unflanged PS. Main Outcome Measurements The incidence and severity of PEP in the 2 groups, spontaneous dislodgment of stents, and procedure-related complications. Results The technical success rate of 3F PS placement was 96% (48/50). The lengths of the stents were 4 cm (n = 21), 6 cm (n = 15), and 8 cm (n = 12). Spontaneous stent dislodgment within 7 days occurred in 94% of patients (45/48). The mean duration until spontaneous dislodgment was 3.5 days. The incidence rate of PEP was 12% (6/50: mild, 5; moderate, 1) in the PS group and 29.4% (15/51: mild, 12; moderate, 2; severe, 1) in the NS group. Severe pancreatitis occurred in only 1 patient in the NS group. In a multivariate analysis, prophylactic placement of PS was the only prophylactic factor for PEP (odds ratio, 0.126; 95% CI, 0.025-0.632, P = .012). Limitations No comparative results for stent size and diameter and a low-risk cohort group. Conclusions Prophylactic temporary 3F PS placement in patients with a difficult biliary cannulation during ERCP seems to be a safe and effective method for reducing PEP and results in a high rate of spontaneous passage of stents without complications.

Theoretically, the side-by-side bilateral placement of metal stents may be technically easier than stent-in-stent bilateral placement in stent revision. However, side-by-side placement can be technically challenging, as the deployment of the first stent can preclude the passage of the second stent.We explored the technical feasibility and revision efficacy of endoscopic bilateral side-by-side stent placement for malignant hilar biliary strictures.Forty-four patients with Bismuth type II or higher malignant hilar biliary strictures were enrolled in seven academic tertiary referral centers. Endoscopic placement of side-by-side bilateral metal stents with 7F thin delivery shaft was performed. The outcome measurements were the technical and functional success, adverse events, endoscopic revision success rate, and stent patency.Overall, the technical and functional success rates were 91 % (40/44), and 98 % (39/40), respectively. Two of the failed patients were converted successfully with subsequent contralateral stent-in-stent placement, and the other patients underwent percutaneous intervention. Early stent-related adverse events occurred in 10 %. The endoscopic revision rate due to stent malfunction during follow-up (median: 180 days) was 45 % (18/40; tumor ingrowth in 4 and in-stent sludge impaction/stone formation in 14 patients). The endoscopic revision success rate was 92 % (12/13). Five patients with comorbidity underwent initial percutaneous intervention. The median survival and stent patency periods were 180 and 157 days, respectively.The sequential placement of a metal stent with a 7F thin delivery shaft in bilateral side-by-side procedures may be feasible and effective for malignant hilar biliary strictures and for endoscopic stent revision.

Prolonged or complex endoscopic procedures are frequently performed under deep sedation. However, no studies of therapeutic ERCP have yet compared the use of balanced propofol sedation (BPS) to propofol alone, titrated to moderate levels of sedation.This prospective, randomized, double-blind study was planned to compare the sedation efficacy and safety of BPS (propofol in combination with midazolam and fentanyl) and propofol monosedation in therapeutic ERCP and EUS.BPS, or propofol monosedation titrated to a moderate level of sedation, was performed by trained registered nurses under endoscopist supervision. The main outcome measurements included sedation efficacy focusing on recovery time, sedation safety, endoscopic procedure outcomes, and complications.There were no significant differences in sedation efficacy, safety, procedure outcomes, and complications, with the exception of recovery time. Mean recovery time (standard deviation) was 18.37 (7.86) min in BPS and 13.4 (6.24) min in propofol monosedation (P0.001). In a safety analysis, cardiopulmonary complication rates related to BPS and propofol monosedation were 7.8 % (8/102) and 9.6 % (10/104), respectively (P = 0.652). No patient required assisted ventilation or permanent termination of a procedure in either group. Technical success of the endoscopic procedures was 96.3 and 97.2 %, respectively (P = 0.701). Endoscopic procedure-related complications and outcomes did not differ depending on sedation procedure.Propofol monosedation by trained, registered sedation nurses under supervision resulted in a more rapid recovery time than BPS. There were no differences in the sedation safety, endoscopic procedure outcomes, and complications between BPS and propofol monosedation.

BACKGROUND/AIMS Endoscopic sphincterotomy may be limited in Billroth II gastrectomy because of difficulty in orientating the duodenoscope and sphincterotome as a result of altered anatomy. This study was planned to investigate the efficacy and safety of endoscopic transpapillary large balloon dilation (EPBD) without preceding sphincterotomy for removal of large CBD stones in Billroth II gastrectomy. METHODS Between March 2010 and February 2011, one-step EPBD under cap-fitted forward-viewing endoscopy was performed in patients who had undergone Billroth II gastrectomy at two tertiary referral centers. Main outcome measurements were successful duct clearance and EPBD-related complications. RESULTS Successful access to major duodenal papilla was performed in 13 patients, but successful selective CBD cannulation was achieved in 12 patients (92.3%). Median maximum transverse stone size was 11.5 mm (10 to 14 mm). The mean number of stones was 2 (1-5). The median CBD diameter was 15 mm (12 to 19 mm). Mean procedure time from successful biliary access to complete stone removal was 17.8 min. Complete duct clearance was achieved in all patients. Four patients (33.3%) needed one more session of ERCP for removal of remnant stones. Asymptomatic hyperamylasemia in two patients and minor bleeding in another occurred. CONCLUSIONS Without preceding sphincterotomy, one-step EPBD (≥10 mm) under cap-fitted forward-viewing endoscopy may be safe and effective for the removal of large stones (≥10 mm) with CBD dilatation in Billroth II gastrectomy.