Prospective randomized trial of a new multibending versus conventional ultra-slim endoscope for peroral cholangioscopy without device or endoscope assistance (with video).

BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.).

Prospective multicenter international study on the outcomes of a newly developed self-approximating lumen-apposing metallic stent for drainage of pancreatic fluid collections and endoscopic necrosectomy.

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.

Efficacy of 3 fine-needle biopsy techniques for suspected pancreatic malignancies in the absence of an on-site cytopathologist.

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.).

Efficacy of a novel lumen-apposing metal stent for the treatment of symptomatic pancreatic pseudocysts (with video).

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.).

Tissue acquisition for diagnosis of biliary strictures using peroral cholangioscopy or endoscopic ultrasound-guided fine-needle aspiration.

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.

The safety of newly developed automatic temperature-controlled endobiliary radiofrequency ablation system for malignant biliary strictures: A prospective multicenter study.

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.

Vascular enhancement pattern of mass in computed tomography may predict chemo-responsiveness in advanced pancreatic cancer.

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.

Bilateral versus unilateral placement of metal stents for inoperable high-grade malignant hilar biliary strictures: a multicenter, prospective, randomized study (with video).

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 < .01). In a multivariate Cox proportional hazard model to assess stent patency, bilateral SEMS placement was a favorable factor (adjusted hazard ratio 0.30, 95% confidence interval, 0.172-0.521; P < .001). Survival probability and late adverse events were not different between the 2 groups. 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.).

Direct peroral cholangioscopy for diagnosis of bile duct lesions using an I-SCAN ultraslim endoscope: a pilot study.

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.

KRAS mutation analysis by next-generation sequencing in endoscopic ultrasound-guided sampling for solid liver masses.

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.

Wire-guided intraduodenal ultrasonography using a catheter probe in the differential diagnosis of enlarged ampullary lesions.

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.

Efficacy of midazolam- versus propofol-based sedations by non-anesthesiologists during therapeutic endoscopic retrograde cholangiopancreatography in patients aged over 80 years.

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.

A newly modified access balloon catheter for direct peroral cholangioscopy by using an ultraslim upper endoscope (with videos).

BACKGROUND AND AIMS: Direct peroral cholangioscopy (POC) by using an ultraslim upper endoscope has been increasingly applied for diagnosis and treatment of diverse biliary diseases. Recently, an intraductal balloon catheter has been used commonly to guide the flexible ultraslim endoscope. However, accessibility into the bile duct remains a limitation of the procedure. The aim of this study was to evaluate the feasibility and success rate of an intraductal balloon-guided direct POC by using an ultraslim endoscope with a newly modified 5F balloon catheter. METHODS: In total, 36 patients with biliary obstruction were included prospectively for a direct POC by using an ultraslim endoscope with a newly modified intraductal 5F balloon catheter. The main outcome measure was technical success, defined as successful advancement of the ultraslim endoscope into the obstructed segment of the biliary tree or the bifurcation. Secondary outcomes were mean time for the total procedure, intubation into the common bile duct and advancement up to the target site after intubation of the ultraslim endoscope, technical success rates of diagnostic and therapeutic interventions, and adverse events. RESULTS: The intraductal balloon-guided direct POC using a newly modified 5F balloon catheter was completed successfully in 35 of 36 patients (97.2%). The mean times for total procedure, intubation into the distal common bile duct, and advancement up to the obstructed bile duct segment were 27.3 ± 7.2, 2.2 ± 0.5, and 0.8 ± 0.4 minutes, respectively. In total, 49 interventions were performed in 35 patients, excluding 1 patient in whom we failed to perform direct POC. Technical success of the interventions was achieved with 44 of 49 procedures (89.8%). No adverse events, including cholangitis, were observed. CONCLUSIONS: A newly modified 5F balloon catheter seemed to facilitate performing intraductal balloon-guided direct POC for direct visual examination of the bile duct in patients with biliary obstruction. Continued development of endoscopes and accessories are expected to further improve the performance of direct POC.

Effectiveness of a newly designed antireflux valve metal stent to reduce duodenobiliary reflux in patients with unresectable distal malignant biliary obstruction: a randomized, controlled pilot study (with videos).

BACKGROUND AND AIMS: In patients with unresectable distal malignant biliary obstruction (MBO), endoscopic biliary drainage by using self-expandable metal stents (SEMSs) is an established palliative treatment. However, the placement of a SEMS across the major duodenal papilla prompts reflux of duodenal contents. In this study, we evaluated stent patency and duodenobiliary reflux caused by a newly developed SEMS with an antireflux valve (ARV) of the windsock type, compared with a conventional covered SEMS (cSEMS) in patients with MBO. METHODS: Between January 2013 and September 2014, 77 patients with unresectable distal MBO were assigned randomly to groups treated with an ARV metal stent (ARVMS) group (39 patients) or a conventional cSEMS group (38 patients). In all patients, a barium meal examination was performed to evaluate reflux of barium within the SEMS and intrahepatic bile ducts. The primary outcome was stent patency duration. Secondary outcomes were the rates of technical and clinical success, duodenobiliary reflux on barium meal examination, factors causing stent dysfunction, overall patient survival, and adverse events. RESULTS: Stent placement was technically successful in all patients. The clinical success rates were not statistically significantly different between the ARVMS and cSEMS groups (97.4% vs 97.4%, P = 1.000). Overall reflux of barium was significantly lower in the ARVMS group than the cSEMS group (7.7% vs 100%, P < .001). The cumulative duration of stent patency was significantly longer in the ARVMS group than in the cSEMS group (median ± SD, 407 ± 92 vs 220 ± 37 days; P = .013). On multivariate analysis, complete duodenobiliary reflux (odds ratio, 5.7, P = .004) and ampullary cancer (odds ratio, 8.98, P = .012) were identified as independent risk factors for stent dysfunction. There was no significant difference between the 2 groups in overall patient survival or in the incidence of adverse events. CONCLUSIONS: The newly developed ARVMS seemed to have a superior duration of stent patency and comparable safety compared with the cSEMS. In addition, the duodenobiliary reflux related to stent dysfunction can be prevented effectively by ARVMS. Further randomized, controlled trials using large numbers of subjects are required to confirm the benefit of SEMSs with antireflux function. (Clinical trial registration number: UMIN000012734.).

Third metal stent for revision of malignant hilar biliary strictures.

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.

Evaluation of a newly modified nonflared fully covered metal stent, 12 mm in diameter, for intraductal placement in patients with malignant biliary strictures: a feasibility study.

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.

Endoscopic wire-guided papillectomy versus conventional papillectomy for ampullary tumors: A prospective comparative pilot study.

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.

Efficacy and Safety of Therapeutic Endoscopic Retrograde Cholangiopancreatography in the Elderly Over 80 Years.

BACKGROUND/AIMS: 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. METHODS: 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. RESULTS: Choledocholithiasis combined with gallbladder stone was the most common indication for ERCP in both groups. Comorbid diseases (70.5 and 29.8 %, p < 0.001) and the use of anti-thrombotic drugs (18.6 and 1.6 %, p < 0.001) were more frequent in the super-aged group. The mean procedure time was longer, and the frequency of second ERCP was more common in the super-aged group. However, the technical success rate (94.9 and 97.4 %, p = 0.096) and the procedure-related complication rate (4.8 and 5.8 %, p = 0.592) were not different between the two groups. Post-ERCP pancreatitis occurred in 1.3 % of the super-aged group and in 2.9 % of the control group (p = 0.262). Cardiopulmonary complications occurred in 1.9 % of patients in each group (p = 1.0). CONCLUSIONS: Therapeutic ERCP is comparable in terms of efficacy and safety between patients ≥80 years and those <65 years of age, although the elderly group had a higher rate of comorbid diseases and used anti-thrombotic drugs more frequently.

Usefulness of endoscopic ultrasound-guided sampling using core biopsy needle as a percutaneous biopsy rescue for diagnosis of solid liver mass: Combined histological-cytological analysis.

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.

Clinical usefulness of intraductal ultrasonography for the management of acute biliary pancreatitis.

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.