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Covered self-expandable metallic stents have longer patency than uncovered self-expandable metallic stents for unresectable malignant distal biliary obstruction because of the prevention of tumor ingrowth, and they are removable during reintervention. One main cause of recurrent biliary obstruction in covered self-expandable metallic stents is sludge formation, which can be prevented by using large-bore stents. We evaluated the treatment results of 12-mm and 10-mm covered self-expandable metallic stents for unresectable malignant distal biliary obstructions using a randomized controlled trial. This study was conducted between May 2016 and January 2019 and included 81 consecutive patients with unresectable malignant distal biliary obstruction. The primary endpoint was the rate of nonrecurrent biliary obstruction at 6 months after stent placement. The primary endpoint in the 12-mm group was significantly higher than that in the 10-mm group (P =.0369). Therefore, the median time to recurrent biliary obstruction was 172 days in the 12-mm group and 120 days in the 10-mm group. The median time to recurrent biliary obstruction in the 12-mm group was significantly longer than that in the 10-mm group (P =.0168). Using the 12-mm covered self-expandable metallic stents and receiving chemotherapy were factors affecting the rate of recurrent biliary obstruction in the multivariate analysis. The 12-mm covered self-expandable metallic stents provide a longer time to recurrent biliary obstruction than do 10-mm covered self-expandable metallic stents for managing unresectable malignant distal biliary obstruction. (Clinical trial registration number: UMIN000016911.) [ABSTRACT FROM AUTHOR]

Intraductal plastic stent (IS) placement for unresectable malignant hilar biliary obstruction (UMHBO) is an effective option for biliary drainage. However, the effectiveness of bilateral IS placement compared with bilateral self-expandable metal stent (SEMS) placement remains unclear. Overall, 301 patients with UMHBO were enrolled; 38 patients underwent bilateral IS placement (IS group) and 38 patients underwent SEMS placement (SEMS group) in the propensity score–based cohort. Both groups were compared for technical and clinical success, adverse events (AEs), recurrent biliary obstruction (RBO), time to RBO (TRBO), overall survival (OS), and endoscopic reintervention (ERI). No significant differences were observed between the groups regarding technical and clinical success, AEs and RBO occurrence rates, TRBO, or OS. The median initial endoscopic procedure time was significantly shorter in the IS group (23 vs 49 minutes, P <.01). ERI was performed on 20 and 19 patients in the IS and SEMS groups, respectively. The median ERI procedure time was significantly shorter in the IS group (22 vs 35 minutes, P =.04). Median TRBO after ERI with plastic stent placement tended to be longer in the IS group (306 vs 56 days, P =.068). A Cox multivariate analysis showed that the IS group was the significant related factor for TRBO after ERI (hazard ratio,.31; 95% confidence interval,.25-.82; P =.035). Bilateral IS placement can reduce the duration of the endoscopic procedure and provide sufficient stent patency both initially and after ERI stent placement, and the stents are removable. Bilateral IS placement is considered a good option for initial UMHBO drainage. (Clinical trial registration number: UMIN000050546.) [Display omitted] [ABSTRACT FROM AUTHOR]

A novel EUS-guided fine-needle biopsy sampling (EUS-FNB) needle enabled physicians to obtain sufficient pathologic samples with fewer to-and-fro movements (TAFs) within the lesion. We compared the diagnostic yields of EUS-FNB with 3 and 12 TAFs at each puncture pass. The primary endpoint of this multicenter, noninferiority, crossover, randomized controlled trial involving 6 centers was diagnostic sensitivity. Secondary endpoints were diagnostic accuracy and quantity and quality evaluation of EUS-FNB specimens. Length of the macroscopically visible core (MVC) and microscopic histologic quantity were used for quantitative evaluation. Macroscopic visual and microscopic histologic evaluations were performed for qualitative evaluation. Among 110 patients (220 punctures, 110 for 3 TAFs and 12 TAFs each), 105 (210 punctures) had malignant histology. Diagnostic sensitivity for malignancy of 3 TAFs (88.6%) was not inferior to that of 12 TAFs (89.5%; difference, –.9%; 95% confidence interval, –9.81 to 7.86). Diagnostic accuracy for malignancy was 92.7% for 3 TAFs and 94.6% for 12 TAFs. Overall median MVC length was 13.5 mm in both groups. The 3-TAF group had a significantly higher rate of score ≥3 on macroscopic visual quality evaluation than the 12-TAF group (71.8% vs 52.7%, P =.009). No significant intergroup differences existed in microscopic histologic quantity and quality evaluations (quantity evaluation, 88.2% for 3 TAFs vs 83.6% for 12 TAFs; quality evaluation, 90.0% for 3 TAFs vs 89.1% for 12 TAFs). Diagnostic sensitivity and accuracy of EUS-FNB with 3 TAFs were not inferior to those with 12 TAFs for solid pancreatic lesions. The 3-TAF group showed significantly less blood contamination in sampled tissues than the 12-TAF group. (Clinical trial registration number: UMIN000037309.) [Display omitted] [ABSTRACT FROM AUTHOR]

Contrast-enhanced EUS (CE-EUS) allows qualitative and quantitative evaluation based on real-time perfusion imaging and may improve the diagnostic capability. The aim of this study was to evaluate the efficacy of CE-EUS in differentiating malignant from benign lymphadenopathy. Patients undergoing EUS-FNA for abdominal or mediastinal lymphadenopathy were prospectively enrolled. The echofeatures on B-mode EUS and the vascular and enhancement patterns in CE-EUS were qualitatively evaluated. The echo intensity change during 60 seconds in the lymphadenopathy was quantitatively evaluated by time intensity curve (TIC) analysis. One hundred consecutive patients with 70 malignant and 30 benign lesions were enrolled. The sensitivity, specificity, and accuracy of the qualitative assessment in B-mode EUS were 77%, 17%, and 59%, respectively. When the heterogeneous enhancement was defined as malignancy, the sensitivity, specificity, and accuracy of the qualitative assessment in CE-EUS were 67%, 87%, and 73%, respectively. In TIC analysis, the velocity of reduction for homogeneous lesions showed a significant difference between malignant and benign lesions (P =.0011), and the receiver operating characteristic analysis showed an optimal cut-off value of.149 dB/s. The sensitivity, specificity, and diagnostic capabilities of CE-EUS for malignancy were improved to 89%, 77%, and 85%, respectively, on combining the qualitative and quantitative analyses. With regard to diagnostic accuracy, CE-EUS with combined qualitative and quantitative analyses was significantly higher than those of B-mode EUS or qualitative assessment of CE-EUS. CE-EUS with the combined qualitative and quantitative analyses for lymphadenopathy might be useful to complement regular EUS and EUS-FNA. (Clinical trial registration number: UMIN000024298.) [ABSTRACT FROM AUTHOR]

Sludge occlusion is a primary reason for recurrent biliary obstruction (RBO) after self-expandable metallic stent (SEMS) placement. However, the efficacy of ursodeoxycholic acid (UDCA) for SEMS occlusion remains unexplored to date. This study aimed to evaluate the efficacy of UDCA after SEMS placement for malignant distal biliary obstruction (MDBO). Three hundred fifty-four patients were included, of which 60 received UDCA. Additionally, we conducted a propensity score–matched cohort analysis on 110 patients with SEMS placement for MDBO to reduce selection bias. Patients were categorized into 2 groups of 55 each, based on whether they received UDCA. In the UDCA group, the treatment was administered for more than a month. The primary endpoint was the time to RBO (TRBO) after SEMS placement. The secondary endpoint was to evaluate SEMS occlusion rate and early adverse events (AEs). The cumulative SEMS occlusion rate was 41.8% and 18.2% in the groups with and without UDCA, respectively (P =.0119). Median TRBO was significantly longer in the control group than in the UDCA group (528 vs 154 days, P =.0381). In the multivariate analysis, UDCA administration was identified as the independent risk factor for reducing TRBO (hazard ratio, 2.28; 95% confidence interval, 1.06-4.88; P =.0348). The overall early AE rate showed insignificant differences between groups. Administering UDCA after SEMS placement was not efficacious for prolonging the TRBO in MDBO. Moreover, administering UDCA beyond a month might increase the risk of stent sludge occlusion. (Clinical trial registration number: UMIN000046862.) [ABSTRACT FROM AUTHOR]

Background and Aims Biliary cannulation is necessary in therapeutic ERCP for biliary disorders. EUS-guided rendezvous (EUS-RV) can salvage failed cannulation. Our aim was to determine the safety and efficacy of EUS-RV by using a standardized algorithm with regard to the endoscope position in a prospective study. Methods EUS-RV was attempted after failed cannulation in 20 patients. In a standardized approach, extrahepatic bile duct (EHBD) cannulation was preferentially attempted from the second portion of the duodenum (D2) followed by additional approaches to the EHBD from the duodenal bulb (D1) or to the intrahepatic bile duct from the stomach, if necessary. A guidewire was placed in an antegrade fashion into the duodenum. After the guidewire was placed, the endoscope was exchanged for a duodenoscope to complete the cannulation. Results The bile duct was accessed from the D2 in 10 patients, but from the D1 in 5 patients and the stomach in 4 patients because of no dilation or tumor invasion at the distal EHBD. In the remaining patient, biliary puncture was not attempted due to the presence of collateral vessels. The guidewire was successfully manipulated in 80% of patients: 100% (10/10) with the D2 approach and 66.7% (6/9) with other approaches. The overall success rate was 80% (16/20). Failed EUS-RV was salvaged with a percutaneous approach in 2 patients, repeat ERCP in 1 patient, and conservative management in 1 patient. Minor adverse events occurred in 15% of patients (3/20). Conclusions EUS-RV is a safe and effective salvage method. Using EUS-RV to approach the EHBD from the D2 may improve success rates. [ABSTRACT FROM AUTHOR]

Background Although rapid on-site cytologic evaluation provides high efficacy of EUS-guided FNA (EUS-FNA), its availability is limited. Alternatively, macroscopic on-site quality evaluation (MOSE) may increase the efficacy of EUS-FNA. Objective To assess the efficacy of MOSE in estimating the adequacy of histologic core specimens obtained by EUS-FNA using a standard 19-gauge needle (19GN) for solid lesions. Design A prospective pilot study. Setting Tertiary-care referral center. Patients One hundred patients with solid lesions (n = 111 lesions). Interventions EUS-FNA using 19GN Main Outcome Measurements The relation of a macroscopic visible core (MVC) in the FNA specimens on MOSE with histologic core and the diagnostic yields were studied. Results The feasibility of EUS-FNA using a 19GN was 99%. The final diagnoses were malignancy in 83 lesions and benign in 28. MOSE revealed MVC in 91.1% with the median length of 8 mm. Histologic core was confirmed in 78.9%. The receiver-operating characteristic curve of the length of MVC for the presence of histologic core showed the cut-off MVC length of 4 mm with area under the curve of .893. Comparisons of per-pass diagnostic yields showed significantly superior histologic, cytologic, and overall diagnostic yields in MVC ≥ 4 mm as compared with <4 mm. The multivariate analysis for false-negative pass identified lesion in the pancreas and MVC < 4 mm as significant risk factors. No adverse events were seen. Limitations Single center, limited operators Conclusion MVC of ≥4 mm on MOSE can be an indicator of specimen adequacy and can improve diagnostic yield; however, additional FNA may be recommended for pancreatic lesions. (Clinical trial registration number: UMIN000010417 .) [ABSTRACT FROM AUTHOR]

Background Although rapid on-site cytologic evaluation provides high efficacy of EUS-guided FNA (EUS-FNA), its availability is limited. Alternatively, macroscopic on-site quality evaluation (MOSE) may increase the efficacy of EUS-FNA. Objective To assess the efficacy of MOSE in estimating the adequacy of histologic core specimens obtained by EUS-FNA using a standard 19-gauge needle (19GN) for solid lesions. Design A prospective pilot study. Setting Tertiary-care referral center. Patients One hundred patients with solid lesions (n = 111 lesions). Interventions EUS-FNA using 19GN Main Outcome Measurements The relation of a macroscopic visible core (MVC) in the FNA specimens on MOSE with histologic core and the diagnostic yields were studied. Results The feasibility of EUS-FNA using a 19GN was 99%. The final diagnoses were malignancy in 83 lesions and benign in 28. MOSE revealed MVC in 91.1% with the median length of 8 mm. Histologic core was confirmed in 78.9%. The receiver-operating characteristic curve of the length of MVC for the presence of histologic core showed the cut-off MVC length of 4 mm with area under the curve of .893. Comparisons of per-pass diagnostic yields showed significantly superior histologic, cytologic, and overall diagnostic yields in MVC ≥ 4 mm as compared with <4 mm. The multivariate analysis for false-negative pass identified lesion in the pancreas and MVC < 4 mm as significant risk factors. No adverse events were seen. Limitations Single center, limited operators Conclusion MVC of ≥4 mm on MOSE can be an indicator of specimen adequacy and can improve diagnostic yield; however, additional FNA may be recommended for pancreatic lesions. (Clinical trial registration number: UMIN000010417 .) [ABSTRACT FROM AUTHOR]

Background: Covered self-expandable metal stents (CSEMSs) were developed to prevent tumor ingrowth, but stent migration is one of the problems with CSEMSs. Objective: To evaluate a new, commercially available CSEMS with flared ends and low axial force compared with a commercially available CSEMS without the anti-migration system and high axial force. Design: Multicenter, prospective study with a historical cohort. Setting: Twenty Japanese referral centers. Patients: This study involved patients with unresectable distal malignant biliary obstruction. Intervention: Placement of a new, commercially available, partially covered SEMS. Main Outcome Measurements: Recurrent biliary obstruction rate, time to recurrent biliary obstruction, stent-related complications, survival. Results: Between April 2009 and March 2010, 141 patients underwent partially covered nitinol stent placement, and between May 2001 and January 2007, 138 patients underwent placement of partially covered stainless stents as a historical control. The silicone cover of the partially covered nitinol stents prevented tumor ingrowth. There were no significant differences in survival (229 vs 219 days; P = .250) or the rate of recurrent biliary obstruction (33% vs 38%; P = .385) between partially covered nitinol stents and partially covered stainless stents. Stent migration was less frequent (8% vs 17%; P = .019), and time to recurrent biliary obstruction was significantly longer (373 vs 285 days; P = .007) with partially covered nitinol stents. Stent removal was successful in 26 of 27 patients (96%). Limitations: Nonrandomized, controlled trial. Conclusion: Partially covered nitinol stents with an anti-migration system and less axial force demonstrated longer time to recurrent biliary obstruction with no tumor ingrowth and less stent migration. (Clinical trial registration number: UMIN000002293.) [Copyright &y& Elsevier]

Background & Aims: Histologic techniques are used to distinguish autoimmune pancreatitis (AIP) from pancreatic malignancies and to confirm the etiology of pancreatitis. Endoscopic ultrasound–guided fine-needle aspiration (EUS-FNA) is a well-established technique used in the diagnosis of pancreatic cancer. However, it is unclear whether specimens obtained from pancreatic lesions by EUS-FNA are adequate for the histologic diagnosis of AIP, because the evaluation of tissue architecture and immunostaining assays usually require larger samples. Methods: We evaluated samples collected by EUS-FNA with a conventional 19-gauge needle by histologic analysis, looking for features of AIP. We analyzed data from 44 patients who were diagnosed with AIP and underwent EUS-FNA with a 19-gauge needle from January 2004 to September 2010. The FNA specimens were reviewed by histologic analysis; AIP was diagnosed based on the presence of lymphoplasmacytic sclerosing pancreatitis or immunoglobulin (Ig)G4-positive plasma cells in the infiltrate. Results: The specimen amount was inadequate from 3 patients. Among the remaining 41 patients, histopathologic analysis revealed lymphoplasmacytic sclerosing pancreatitis in 17 samples and IgG4-positive plasma cells in 5 (3 samples were positive for both); no samples had granulocytic epithelial lesions. Therefore, 19 patients (43%) were diagnosed with AIP based on histologic analysis. One patient had temporary abdominal pain. Conclusions: EUS-FNA, with a 19-gauge needle, is a safe and reliable procedure for obtaining pancreatic samples for the histologic analysis of AIP. Although it does not have a high diagnostic yield, it might be useful in patients without typical features of AIP because it would allow patients to avoid surgery. [Copyright &y& Elsevier]

Background & Aims: Pancreatitis is the most common and potentially serious complication of post-endoscopic retrograde cholangiopancreatography (ERCP). Post-ERCP pancreatitis (PEP) is caused mostly by postprocedural papillary edema and retention of pancreatic juice. We conducted a randomized controlled trial to determine whether placement of a temporary-type, pancreatic duct stent prevents PEP and to identify risk factors for PEP. Methods: We analyzed data from 426 consecutive patients who underwent ERCP-related procedures at 37 endoscopic units. The patients were assigned randomly to groups that received stents (S group, n = 213) or did not (nS group, n = 213). The stent used was temporary, 5F in diameter, 3 cm long, and straight with an unflanged inner end. Results: The overall frequency of PEP was 11.3%. The frequencies of PEP in the S and nS groups were 7.9% and 15.2%, respectively; the lower incidence of PEP in the S group was statistically significant based on the full analysis set (P = .021), although there was no statistically significant differences in an intention-to-treat analysis (P = .076). There were significant differences in PEP incidence between groups in multivariate analysis for the following risk factors: pancreatography first, nonplacement of a pancreatic duct stent after ERCP, procedure time of 30 minutes or more, sampling of pancreatic tissue by any method, intraductal ultrasonography, and difficulty of cannulation (≥15 min). Patients with more than 3 risk factors had a significantly greater incidence of pancreatitis. Conclusions: Placement of a pancreatic duct stent reduces the incidence of PEP. Several risk factors are associated with PEP. [ABSTRACT FROM AUTHOR]

Background EUS-guided FNA (EUS-FNA) has become the most efficacious way to obtain specimens from a solid lesion adjacent to the GI tract. Previous reports regarding the use of a stylet during EUS-FNA were all based on cytological diagnosis and have showed no significant superiority in terms of diagnostic yield. Objective To clarify the noninferiority of EUS-FNA without a stylet (S−) compared with EUS-FNA with a stylet (S+) on histological assessment. Design A prospective, single-blind, randomized, controlled crossover study. Setting Five tertiary referral centers in Japan. Patients Patients referred for EUS-FNA of a solid lesion. Intervention EUS-FNA S+ and S− in a total of 4 alternate passes with randomization to S+ first or S− first. Main Outcome Measurements The primary endpoint was the acquisition rate of an appropriate and sufficient specimen for histological assessment. The secondary endpoints were cellularity, contamination, bloodiness, diagnostic ability, and diagnostic accuracy. Results We enrolled 107 patients (110 lesions) and analyzed 220 specimens each in the S+ and S− groups. The acquisition rate of appropriate and sufficient specimens in the S+ group was 121 of 220 (55.0%) and 122 of 220 (55.5%) in the S− group. The difference in the acquisition rate of the specimen (S− minus S+) based on the generalized estimating equation was 0.42% (95% confidence interval, −6.72% to 7.56%), which was less than 10% of the prespecified noninferiority margin of this study. With regard to cellularity, contamination, bloodiness score, diagnostic ability, and diagnostic accuracy, there were no significant differences between both groups. There were no dropouts in the study. Limitations A variety of target lesions, multiple pathologists, lack of an assessment of intraobserver and interobserver variability, and a single-blind study for the pathologists. Conclusion EUS-FNA S− is noninferior to EUS-FNA S+ on histological assessment. (Clinical trial registration number: UMIN000008695.) [ABSTRACT FROM AUTHOR]

Background EUS-guided FNA (EUS-FNA) has a high diagnostic accuracy for pancreatic diseases. However, although most reports have typically focused on cytology, histological tissue quality has rarely been investigated. The effectiveness of EUS-FNA combined with high negative pressure (HNP) suction was recently indicated for tissue acquisition, but has not thus far been tested in a prospective, randomized clinical trial. Objective To evaluate the adequacy of EUS-FNA with HNP for the histological diagnosis of pancreatic lesions by using 25-gauge needles. Design Prospective, single-blind, randomized, controlled crossover trial. Setting Seven tertiary referral centers. Patients Patients referred for EUS-FNA of pancreatic solid lesions. From July 2011 to April 2012, 90 patients underwent EUS-FNA of pancreatic solid masses by using normal negative pressure (NNP) and HNP with 2 respective passes. The order of the passes was randomized, and the sample adequacy, quality, and histology were evaluated by a single expert pathologist. Intervention EUS-FNA by using NNP and HNP. Main Outcome Measurements The adequacy of tissue acquisition and the accuracy of histological diagnoses made by using the EUS-FNA technique with HNP. Results We found that 72.2% (65/90) and 90% (81/90) of the specimens obtained using NNP and HNP, respectively, were adequate for histological diagnosis ( P = .0003, McNemar test). For 73.3% (66/90) and 82.2% (74/90) of the specimens obtained by using NNP and HNP, respectively, an accurate diagnosis was achieved ( P = .06, McNemar test). Pancreatitis developed in 1 patient after this procedure, which subsided with conservative therapy. Limitations This was a single-blinded, crossover study. Conclusion Biopsy procedures that combine the EUS-FNA with HNP techniques are superior to EUS-FNA with NNP procedures for tissue acquisition. (Clinical trial registration number: UMIN000005939.) [ABSTRACT FROM AUTHOR]

Background: Wire-guided cannulation (WGC) with a sphincterotome (S) for selective bile duct cannulation (SBDC) has been reported to have a higher success rate and lower incidence of post-ERCP pancreatitis (PEP) than conventional methods in some randomized, controlled trials (RCTs) that were both single center and limited to only a few endoscopists. Objective: To estimate the difference in SBDC according to the method and catheter used in a multicenter and multiendoscopist study. Design: A prospective, multicenter RCT with a 2 × 2 factorial design. Setting: Fifteen referral endoscopy units. Patients: In total, 400 consecutive patients with naive papillae who were candidates for ERCP were enrolled and randomized. Interventions: Patients were assigned to 4 groups according to combined catheter (S or catheter [C]) and method (with/without guidewire [GW]). Main Outcome Measurements: Success rate of SBDC performed in 10 minutes, SBDC time, fluoroscopy time, and incidence of complications. Results: There was no significant difference in the SBDC success rate between the groups with and without GW, between C and S, or among the 4 groups (C+GW, C, S+GW, S). WGC had a tendency to significantly shorten cannulation and fluoroscopy times only in approximately 70% of patients in this study in whom SBDC was achieved in 10 minutes or less (P = .036 and .00004, respectively). All 4 groups resulted in similar outcomes in PEP (4%, 5.9%, 2%, and 2.1%, respectively). Limitations: Non–double-blind study. Conclusions: WGC appears to significantly shorten cannulation and fluoroscopy times. However, neither the method nor type of catheter used resulted in significant differences in either SBDC success rate or incidence of PEP in this RCT. (Clinical trial registration number: UMIN000002572.) [Copyright &y& Elsevier]