Search

Background: Postoperative pancreatic fluid collections (POPFCs) are common adverse events (AEs) after pancreatic surgery and may need interventions. Endoscopic ultrasound (EUS)-guided drainage for POPFCs is increasingly reported, but its appropriate timing has not been fully elucidated. The aim of this meta-analysis was to evaluate treatment outcomes of POPFCs according to the timing of EUS-guided drainage. Methods: Using PubMed, Embase, Web of Science, and the Cochrane database, we identified clinical studies published until December 2022 with data comparing outcomes of early and delayed EUS-guided drainage for POPFCs. We pooled data on AEs, mortality, and technical and clinical success rates, using the random-effects model. Results: From 1415 papers identified in the initial literature search, we identified 6 retrospective studies, including 128 and 107 patients undergoing early and delayed EUS-guided drainage for POPFCs. The threshold of early and delayed drainage ranged from 14 to 30 days. Distal pancreatectomy was the major cause of POPFCs, ranging from 44 to 100%. The pooled odds ratio (OR) for AEs was 0.81 (95% confidence interval [CI] 0.40–1.64, P = 0.55) comparing early to delayed drainage. There was no procedure-related mortality. Technical success was achieved in all cases and a pooled OR of clinical success was 0.60 (95% CI 0.20–1.83, P = 0.37). Conclusion: POPFCs can be managed by early EUS-guided drainage without an increase in AEs. [ABSTRACT FROM AUTHOR]

Simple Summary: Collecting specimens for pathological diagnosis of malignant biliary stricture (MBS) is not easy. This study shows that cell block (CB) of overnight-stored bile is useful for pathological diagnosis of MBS. Cancer detectability using the CB method (62.2%) is superior to that using cytology (37.8%). When the CB method is combined with biopsy, the cancer detectability (75.6%) and accuracy rates (81.4%) are increased. In addition, immunohistochemistry can be applied to the CB method when encountering difficult cases for pathological diagnosis. The CB method utilizing overnight-stored bile can be routinely used for detecting MBS in local hospitals. The specimen collection and subsequent pathological diagnosis of malignant biliary stricture (MBS) are difficult. This study aimed to determine whether the cell block (CB) method using overnight-stored bile is useful in the diagnosis of MBS. This trial was a single-arm prospective study involving a total of 59 patients with suspected MBS. The primary endpoint was cancer detectability and accuracy using the CB method, and a comparison with the detectability and accuracy achieved with bile cytology was made. The immunohistochemical sensitivity for maspin and p53 was also investigated in the CB and surgical specimens. We were able to collect bile from all 59 patients, and 45 of these patients were clinically diagnosed with MBS. The cancer detectability using the CB method (62.2%) was significantly higher than that using cytology (37.8%) (p = 0.0344). When CB was combined with biopsy, the rates of cancer detectability (75.6%) and accuracy (81.4%) increased. In eight patients who received surgical therapy, maspin- and p53-immunohistochemistry was applied to the surgical and CB specimens, and cancer cells in both specimens showed positive cytoplasmic and nuclear staining for maspin and nuclear staining for p53. The CB method is, thus, useful for detecting malignancy (UMIN000034707). [ABSTRACT FROM AUTHOR]

Background/Aims: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) using a 19-gauge needle is an efficient sampling method for the diagnosis of lymphadenopathy. This study compared 19-gauge conventional and Franseen needles for the diagnosis of lymphadenopathy and classification of malignant lymphoma (ML). Methods: Patient characteristics, number of needle passes, puncture route, sensitivity, specificity, and accuracy of cytology/histology for lymphadenopathy were analyzed in patients diagnosed with lymphadenopathy by EUS-FNA using conventional or Franseen needles. Results: Between 2012 and 2022, 146 patients met the inclusion criteria (conventional [n=70] and Franseen [n=76]). The median number of needle passes was significantly lower in the conventional group than in the Franseen group (3 [1-6] vs. 4 [1-6], p=0.023). There were no significant differences in cytological/histological diagnoses between the two groups. For ML, the immunohistochemical evaluation rate, sensitivity of flow cytometry, and cytogenetic assessment were not significantly different in either group. Bleeding as adverse events (AEs) were observed in three patients in the Franseen group. Conclusions: Both the 19-gauge conventional and Franseen needles showed high accuracy in lymphadenopathy and ML classification. Considering sufficient tissue collection and the avoidance of AEs, the use of 19-gauge conventional needles seems to be a good option for the diagnosis of lymphadenopathy. [ABSTRACT FROM AUTHOR]

Background: Extracorporeal shock wave lithotripsy (ESWL) is a common treatment for pancreatic stones in chronic pancreatitis. In contrast, peroral pancreatoscopy-guided lithotripsy (POPS-L) remains underexplored, with limited comparative studies to ESWL. This study compared the treatment outcomes of disposable POPS-L tools and ESWL for pancreatic stones. Methods: A retrospective analysis was conducted on 66 patients who had undergone pancreatic stone treatment at three institutions between 2006 and 2022. The treatment outcomes of POPS-L and ESWL were compared. Results: This study included 19 and 47 patients who had undergone POPS-L and ESWL, respectively. In a comparison between POPS-L and ESWL, the stone clearance rates were 78.9% vs. 70.2% (p = 0.55), while the procedure-related complication rates were 21% vs. 6.3% (p = 0.09). The median total session counts were 1 vs. 5 (p < 0.01). The cumulative stone recurrence rates were comparable in both groups. Multivariate analysis revealed no significant factors influencing the stone clearance rates, and the choice between POPS-L and ESWL did not affect the stone clearance rates. Conclusions: POPS-L and ESWL exhibited comparable treatment outcomes in terms of stone clearance, complications, and recurrence rates. Furthermore, POPS-L is advantageous due to the need for fewer sessions to achieve pancreatic stone clearance. [ABSTRACT FROM AUTHOR]

The process of CO2 adsorption on a Pt electrocatalyst was investigated computationally. We found that CO2 adsorption on Pt crystals proceeds spontaneously in the presence of H2O and H both adsorbed on Pt, attributed to hydrogen bond formation and charge rearrangement interactions. [ABSTRACT FROM AUTHOR]

This Editorial refers to the article by Inoue et al., p 949–956 of this issue. [ABSTRACT FROM AUTHOR]

Objectives: Bilateral self-expandable metallic stent (SEMS) placement for unresectable malignant hilar biliary obstruction (UMHBO) is an effective option for biliary drainage with long-term stent patency. Laser-cut and braided SEMS can be used for bilateral SEMS placement. This study aimed to clarify any differences in the clinical features and proper use of the laser-cut and braided SEMS placement using the stent-in-stent method for UMHBO. Methods: In this study, 78 patients who underwent bilateral stent-in-stent SEMS placement for UMHBO were included. The patients were divided into the laser-cut (n = 33) and braided groups (n = 45). Both groups were compared for technical and clinical success, adverse events (AEs), time to recurrent biliary obstruction (TRBO), overall survival, and endoscopic reintervention (ERI). Results: There were no significant differences in technical and clinical success rates (laser-cut vs. braided group, 97% vs. 95.6%, P = 1.0), AEs (21.2% vs. 15.6%. P = 0.56), median TRBO (242 days vs. 140 days, P = 0.36), and median overall survival (654 days vs. 675 days, P = 0.58). ERI was required in 15 patients in the laser-cut group and in 20 patients in the braided group. The technical and clinical success rates of ERI (60% vs. 85%) were not significantly different (P = 0.13); however, the median ERI procedure time was significantly longer in the laser-cut group (38 min) than in the braided group (22 min; P = 0.02). Conclusion: No significant difference in initial SEMS placement was noted between the laser-cut and braided groups; however, the laser-cut group required a longer ERI procedure time than that required by the braided group. The use of braided SEMS may be a convenient option for ERI. [ABSTRACT FROM AUTHOR]

Background and Aim In patients with unresectable malignant distal biliary obstruction, covered self-expandable metallic stents (CSEMS) may remain patent longer than uncovered self-expandable metallic stents as a result of tumor ingrowth prevention. One main cause of recurrent biliary obstruction (RBO) in CSEMS is sludge formation, which can be prevented using a large-bore stent. Therefore, we developed a novel, 12-mm diameter fully covered SEMS (FCSEMS) and investigated its clinical safety, efficacy, and rate of adverse events. Methods This prospective, multicenter pilot study, which ran between June 2011 and November 2012, included 38 consecutive patients with unresectable malignant distal biliary obstruction. All patients underwent endoscopic insertion of our novel stent. Primary endpoint was non-RBO rate 6 months after placement. Results Technical and functional success rates of the procedures were 100%. Six-month non-RBO rate was 50%, and median time to RBO was 184 days. Median survival time was 241 days. Twelve patients died within 6 months after stent placement without RBO. RBO was observed in 10 patients (26%), with seven experiencing stent occlusion and three experiencing stent migration. Adverse events other than RBO (at <30 days) developed in six patients (16%; cholecystitis, one; pancreatitis, one; hyperamylasemia, one; pancreatic ductitis, one; abdominal pain, two). Stent removal for reintervention was successfully completed in eight patients. Conclusion Our novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events. [ABSTRACT FROM AUTHOR]

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

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

Nonobese diabetic (NOD) mice, a model of type I diabetes mellitus, harbor certain unique defects in their immune system. The aim of this study was to investigate how NOD mice show hepatic injury and subsequent fibrogenic responses. Methods: Hepatic fibrosis was induced by intraperitoneal injections of dimethylnitrosamine (DMN), and assessed biochemically and histologically. Expressions of cytokine messenger RNA (mRNA) in the liver were determined. Results: In a model of liver cirrhosis induced by dimethylnitrosamine (DMN), we found that NOD mice had lower levels of hepatic fibrosis and better survival than control ICR mice. The resistance to DMN-induced lethality in NOD mice was independent of apoptosis and necrosis of hepatocytes, but apparently due to the prevention of hepatic fibrosis. We also found increased inductions of interferon-γ (IFN-γ) mRNA in the liver of NOD mice and of intracellular IFN-γ from intrahepatic T cells following DMN administration. Treatment with neutralizing anti-IFN-γ-antibody cancelled the inhibition of hepatic fibrosis in NOD mice. Conclusions: These results suggest that IFN-γ is effective for inhibiting hepatic fibrosis and that genetic host factors may be important in determining differential responses to injury. [ABSTRACT FROM AUTHOR]

Background: Endoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts. Methods: The WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator's discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs. Discussion: The WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population. Trial registration: ClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023. [ABSTRACT FROM AUTHOR]

The consensus‐based TOKYO criteria were proposed as a standardized reporting system for endoscopic transpapillary biliary drainage. The primary objective was to address issues arising from the inconsistent reporting of stent outcomes across studies, which has complicated the comparability and interpretation of study results. However, the original TOKYO criteria were not readily applicable to recent modalities of endoscopic biliary drainage such as biliary drainage based on endoscopic ultrasound or device‐assisted endoscopy. There are increasing opportunities for managing hilar biliary obstruction and benign biliary strictures through endoscopic drainage. Biliary ablation has been introduced to manage benign and malignant biliary strictures. In addition, the prolonged survival times of cancer patients have increased the importance of evaluating overall outcomes during the period requiring endoscopic biliary drainage rather than solely focusing on the patency of the initial stent. Recognizing these unmet needs, a committee has been established within the Japan Gastroenterological Endoscopy Society to revise the TOKYO criteria for current clinical practice. The revised criteria propose not only common reporting items for endoscopic biliary drainage overall, but also items specific to various conditions and interventions. The term “stent‐demanding time” has been defined to encompass the entire duration of endoscopic biliary drainage, during which the overall stent‐related outcomes are evaluated. The revised TOKYO criteria 2024 are expected to facilitate the design and reporting of clinical studies, providing a goal‐oriented approach to the evaluation of endoscopic biliary drainage. [ABSTRACT FROM AUTHOR]

The identification of anticancer therapies using next-generation sequencing (NGS) is necessary for the treatment of cholangiocarcinoma. NGS can be easily performed when cell blocks (CB) are obtained from bile stored overnight. We compared NGS results of paired CB and surgically resected specimens (SRS) from the same cholangiocarcinoma cases. Of the prospectively collected 64 bile CBs from 2018 to 2023, NGS was performed for three cases of cholangiocarcinoma that could be compared with the SRS results. The median numbers of DNA and RNA reads were 95,077,806 [CB] vs. 93,161,788 [SRS] and 22,101,328 [CB] vs. 24,806,180 [SRS], respectively. We evaluated 588 genes and found that almost all genetic alterations were attributed to single-nucleotide variants, insertions/deletions, and multi-nucleotide variants. The coverage rate of variants in SRS by those found in CB was 97.9–99.2%, and the coverage rate of SRS genes by CB genes was 99.6–99.7%. The NGS results of CB fully covered the variants and genetic alterations observed in paired SRS samples. As bile CB is easy to prepare in general hospitals, our results suggest the potential use of bile CB as a novel method for NGS-based evaluation of cholangiocarcinoma. [ABSTRACT FROM AUTHOR]

Objectives Methods Results Conclusions The placement of plastic stents (PS), including intraductal PS (IS), is useful in patients with unresectable malignant hilar biliary obstruction (UMHBO) because of patency and ease of endoscopic reintervention (ERI). However, the optimal stent replacement method for PS remains unclear.This retrospective study included 322 patients with UMHBO. Among them, 146 received PS placement as initial drainage (across‐the‐papilla PS [aPS], 54; IS, 92), whereas 75 required ERI. Eight bilateral aPS, 21 bilateral IS, and 17 bilateral self‐expandable metallic stent (SEMS) placements met the inclusion criteria. Rates of technical and clinical success, adverse events, recurrent biliary obstruction (RBO), time to RBO (TRBO), overall survival, and secondary ERI were compared.There were no significant intergroup differences in rates of technical or clinical success, adverse events, RBO occurrence, or overall survival. The median TRBO was significantly shorter in the aPS group (47 days) than IS (91 days; P = 0.0196) and SEMS (143 days; P < 0.01) groups. Median TRBO did not differ significantly between the IS and SEMS groups (P = 0.44). On Cox multivariate analysis, the aPS group had the shortest stent patency (hazard ratio 2.67 [95% confidence interval 1.05–6.76], P = 0.038). For secondary ERI, the median endoscopic procedure time was significantly shorter in the IS (22 min) vs. SEMS (40 min) group (P = 0.034).Bilateral IS and SEMS placement featured prolonged patency after first ERI. Because bilateral IS placement is faster than SEMS placement and IS can be removed during secondary ERI, it may be a good option for first ERI. [ABSTRACT FROM AUTHOR]

BACKGROUND : Endoscopic papillary large balloon dilation (EPLBD) has been increasingly used for the management of large common bile duct (CBD) stones. Although EPLBD is often preceded by endoscopic sphincterotomy (EST), EPLBD alone without EST has been increasingly reported as an alternative to EST for large CBD stones. METHODS : This multicenter randomized trial was conducted at 19 Japanese institutions to compare the efficacy and safety of EPLBD alone versus EST for the removal of large (≥ 10 mm) CBD stones. The primary end point was complete stone removal in a single session. The secondary end points included: overall complete stone removal, lithotripsy use, procedure time, adverse events, and cost. RESULTS:  171 patients with large CBD stones were included in the analysis. The rate of single-session complete stone removal was significantly higher in the EPLBD-alone group than in the EST group (90.7 % vs. 78.8 %; P = 0.04). Lithotripsy use was significantly less frequent in the EPLBD group than in the EST group (30.2 % vs. 48.2 %; P = 0.02). The rates of early adverse events were comparable between the two groups: rates of overall adverse events were 9.3 % vs. 9.4 % and of pancreatitis were 4.7 % vs. 5.9 % in the EPLBD and EST groups, respectively. The procedure costs were $1442 vs. $1661 in the EPLBD and EST groups, respectively (P = 0.12). CONCLUSION : EPLBD without EST for the endoscopic treatment of large CBD stones achieved a significantly higher rate of complete stone removal in a single session compared with EST, without increasing adverse events. [ABSTRACT FROM AUTHOR]

Pancreatic fluid collections (PFCs) typically develop as local complications of acute pancreatitis and complicate the clinical course of patients with acute pancreatitis and potentially fatal clinical outcomes. Interventions are required in cases of symptomatic walled‐off necrosis (WON) (matured PFCs with necrosis) and pancreatic pseudocysts (matured PFCs without necrosis). In the management of necrotizing pancreatitis and WON, endoscopic ultrasound‐guided transluminal drainage combined with on‐demand endoscopic necrosectomy (i.e. the step‐up approach) is increasingly used as a less invasive treatment modality compared with a surgical or percutaneous approach. Through the substantial research efforts and development of specific devices and stents (e.g. lumen‐apposing metal stents), endoscopic techniques of PFC management have been standardized to some extent. However, there has been no consensus about timing of carrying out each treatment step; for instance, it is uncertain when direct endoscopic necrosectomy should be initiated and finished and when a plastic or metal stent should be removed following clinical treatment success. Despite emerging evidence for the effectiveness of noninterventional supportive treatment (e.g. antibiotics, nutritional support, irrigation of the cavity), there has been only limited data on the timing of starting and stopping the treatment. Large studies are required to optimize the timing of those treatment options and improve clinical outcomes of patients with PFCs. In this review, we summarize the current available evidence on the indications and timing of interventional and supportive treatment modalities for this patient population and discussed clinical unmet needs that should be addressed in future research. [ABSTRACT FROM AUTHOR]

Background: The necessity of histological analysis is increasing. A 19-gauge histology needle (PC19) in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has recently been developed and has shown high yields of tissue acquisition and histological diagnosis.Aims: To compare the histological diagnostic yield in single-pass EUS-FNA for solid lesions using PC19 and a standard 19-gauge needle (EC19).Patients and Methods: Consecutive patients with solid lesions were enrolled and underwent one pass with each of PC19 and EC19 for EUS-FNA with the randomized order of the needles. The primary endpoint was the histological diagnostic accuracy. The secondary endpoints were the feasibility, yield of histological core, cytological and overall diagnostic accuracies, and adverse events. Subgroup analysis was performed for the optimal situation with PC19.Results: Of the 115 patients, 110 underwent EUS-FNA and five were excluded. EUS-FNA was performed from the esophagus in four, stomach in 80, or duodenum in 26. The final diagnosis was malignancy in 100 and benign in 10. The feasibility was 98.2 and 97.3% with PC19 and EC19, respectively (p = 1.00). The rate of presence of a histological core and the histological, cytological, and overall diagnostic accuracies for PC19 versus EC19 were 84.6 versus 80.9% (p = 0.593), 83.6 versus 73.6% (p = 0.099), 63.6 versus 56.4% (p = 0.335), and 90.0 versus 79.1% (p = 0.039), respectively. PC19 was favored in the trans-esophageal/gastric approaches to obtain a histological diagnosis (p = 0.013). Adverse events were observed in four patients.Conclusion: Single-pass EUS-FNA with PC19 was feasible and showed significantly higher overall diagnostic accuracy and an increased tendency towards histological diagnostic accuracy, especially with trans-esophageal/gastric FNA. [ABSTRACT FROM AUTHOR]

Background: Benign choledochojejunal anastomotic stricture (CJS) is a common complication of pancreaticoduodenectomy and choledochojejunostomy. CJS is generally treated with balloon dilation, using balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography (BE-ERCP); however, its long- and short-term outcomes have not been fully evaluated. Therefore, we evaluated the treatment outcomes of balloon dilation with BE-ERCP for CJS. Methods: We retrospectively analyzed 40 patients who had undergone balloon dilation with BE-ERCP for CJS between January 2009 and December 2022. The primary outcomes were technical and clinical success, and adverse event rates of balloon dilation using BE-ERCP for CJS. The secondary outcomes were long-term treatment outcomes for CJS recurrence, and evaluation of risk factors for recurrence. Result: Technical and clinical success rates were 93% (37/40) and 100% (37/37), respectively. CJS recurrence occurred in 32% (20/37). No procedure-related adverse events were observed. The significant risk factors of CJS after balloon dilation were its early occurrence after surgery (unit hazard ratio [HR] for month, 0.87; 95% confidence interval [CI], 0.76–0.99; p-value = 0.04) and residual waist during balloon dilation (HR, 5.46; 95% CI, 1.18–25.1; p-value = 0.03). Receiver operating characteristic curve analysis of time from surgery to balloon dilation revealed an area under the curve of 0.80 (95% CI, 0.65–0.94) and the cut-off value was 13.2 months. Conclusion: Treatment of CJS with balloon dilation was effective, although CJS recurrence occurred in one-third of the patients. The risk factors for recurrence were early occurrence of CJS after surgery and remaining waist circumference during balloon dilation. [ABSTRACT FROM AUTHOR]

Background: With the increasing popularity of endoscopic ultrasound (EUS)-guided transmural interventions, walled-off necrosis (WON) of the pancreas is increasingly managed via non-surgical endoscopic interventions. However, there has been an ongoing debate over the appropriate treatment strategy following the initial EUS-guided drainage. Direct endoscopic necrosectomy (DEN) removes intracavity necrotic tissue, potentially facilitating early resolution of the WON, but may associate with a high rate of adverse events. Given the increasing safety of DEN, we hypothesised that immediate DEN following EUS-guided drainage of WON might shorten the time to WON resolution compared to the drainage-oriented step-up approach. Methods: The WONDER-01 trial is a multicentre, open-label, superiority, randomised controlled trial, which will enrol WON patients aged ≥ 18 years requiring EUS-guided treatment in 23 centres in Japan. This trial plans to enrol 70 patients who will be randomised at a 1:1 ratio to receive either the immediate DEN or drainage-oriented step-up approach (35 patients per arm). In the immediate DEN group, DEN will be initiated during (or within 72 h of) the EUS-guided drainage session. In the step-up approach group, drainage-based step-up treatment with on-demand DEN will be considered after 72–96 h observation. The primary endpoint is time to clinical success, which is defined as a decrease in a WON size to ≤ 3 cm and an improvement of inflammatory markers (i.e. body temperature, white blood cell count, and C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, and recurrence of the WON. Discussion: The WONDER-01 trial will investigate the efficacy and safety of immediate DEN compared to the step-up approach for WON patients receiving EUS-guided treatment. The findings will help us to establish new treatment standards for patients with symptomatic WON. Trial registration: ClinicalTrials.gov NCT05451901, registered on 11 July 2022. UMIN000048310, registered on 7 July 2022. jRCT1032220055, registered on 1 May 2022. [ABSTRACT FROM AUTHOR]

Background and Aim Endoscopic retrograde cholangiography (ERCP) with biliary stenting for the treatment of unresectable malignant biliary obstruction (MBO) is challenging among patients with surgically altered anatomy. Endoscopic ultrasound-guided antegrade biliary stenting (EUS-ABS) was introduced as an alternative biliary drainage method, although it has not yet been well studied. In this single-center prospective pilot study, we aimed to evaluate the feasibility and safety of EUS-ABS for MBO in patients with surgically altered anatomy. Methods EUS-ABS for MBO was attempted in patients with surgically altered anatomy. In EUS-ABS, the bile duct in the left lobe was accessed from the intestine under EUS guidance, and a guidewire was placed. Thereafter, an uncovered metallic stent was deployed at the MBO through the fistula. All devices were then removed. Technical, clinical, and adverse event rates, as well as patient characteristics and procedure details, were evaluated. Results Twenty patients (10 women; median age, 69 years) were enrolled in the present study. Technical and clinical success rates of EUS-ABS were both 95% (19/20). In one patient, unsuccessful EUS-ABS as a result of failed visualization of the left lobe of the liver with EUS was salvaged with percutaneous biliary drainage. Rate of adverse events was 20% (4/20), including mild pancreatitis in three patients and mild fever in one patient, which were successfully managed conservatively. Conclusions EUS-ABS for MBO in patients with surgically altered anatomy was a feasible and safe procedure. Further large scale comparison studies are needed to confirm its efficacy (Clinical Trial Registration Number: UMIN000008589). [ABSTRACT FROM AUTHOR]

Pancreatic fluid collections (PFCs) commonly develop as complications of acute pancreatitis and ductal disruption due to chronic pancreatitis. In the revised Atlanta classification, PFCs were classified based on the presence of necrosis and duration following the onset of acute pancreatitis. Interventions are required in cases of symptomatic pancreatic pseudocysts or walled-off necrosis (WON). In the management of these PFCs, endoscopic ultrasound-guided transluminal drainage and subsequent direct endoscopic necrosectomy for WON are increasingly utilized as less invasive treatment modalities compared to surgical debridement. To date, researchers have focused predominantly on the technical aspects of endoscopic therapy for symptomatic PFCs. Given the poor physical condition of patients receiving endoscopic treatment for PFCs, systemic support may have a substantial impact on the short- and long-term outcomes of these patients. A multidisciplinary approach is required to improve the clinical outcomes of patients with infected PFCs and their associated comorbidities. However, non-interventional support during the periprocedural period of endoscopic treatment of PFCs has not been fully discussed, and there have been considerable variations in the selection of treatment options between endoscopists and centers. To address these unmet needs in the clinical management of PFCs and promote future research to improve the clinical outcomes, we conducted a review of the literature within a multicenter consortium of expert endoscopists with specific expertise in the endoscopic treatment of PFCs. In this review, we summarize the current evidence on non-interventional supportive care (e.g., continuous lavage, medications, nutritional support, and antimicrobials) and propose potential topics for future research. [ABSTRACT FROM AUTHOR]

Expanding indications for neoadjuvant chemotherapy (NAC) for resectable pancreatic cancer prolong the period from diagnosis to surgery. In resectable pancreatic cancer with malignant biliary obstruction (MBO), the biliary drainage method without any biliary events is ideally required to safely perform NAC as planned. Plastic stents (PS) have been traditionally used for preoperative biliary drainage; however, recently, covered self-expandable metallic stents (CSEMS) have emerged as a tool for preoperative biliary drainage. To compare CSEMS with PS for preoperative biliary drainage in the management of resectable pancreatic cancer with MBO. In this multicenter retrospective cohort study, we compared CSEMS with PS for preoperative biliary drainage in patients with pancreatic cancer at three tertiary care centers between 2008 and 2019. Of the 120 enrolled patients, 45 underwent CSEMS and 75 underwent PS. No significant difference was observed in the basic characteristics between the groups. The rate of recurrent biliary obstruction (RBO) was significantly lower and the time to RBO was significantly longer in the CSEMS group. In multivariate analysis, CSEMS was an independent factor for a longer RBO. However, pancreatitis and cholecystitis were more common in the CSEMS group. The surgery-related adverse events were not significantly different between the two groups, except for longer surgery time and time to discharge in the CSEMS group. CSEMS for preoperative endoscopic biliary drainage in patients with pancreatic cancer reduced RBO, although the risk for pancreatitis or cholecystitis could be increased. [ABSTRACT FROM AUTHOR]

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

Introduction: Image evaluation of contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) and additional time-intensity curve (TIC) analysis enable qualitative and quantitative analyses of pancreatic tumor based on real-time perfusion imaging. Aims: To evaluate the efficacy of CEH-EUS with a combination of qualitative and quantitative analyses of pancreatic solid tumors. Methods: Patients were scheduled to undergo EUS-guided fine needle aspiration (FNA) for pancreatic solid tumors were prospectively enrolled between 11/2016 and 12/2018 and underwent CEH-EUS. The vascular and enhancement patterns were qualitatively evaluated and heterogeneous enhancement was defined to be indicative of malignancy. The echo intensity change during 60 s in the tumor was quantitatively evaluated by time intensity curve analysis. Results: In total, 100 patients were enrolled in this study. The final diagnoses were malignant lesions in 87 patients and benign legions in 13 patients. There were four categories of enhancement and patterns: hypovascular with heterogeneous, hypovascular with homogeneous, hypervascular heterogeneous, and hypervascular homogeneous enhancement. The diagnostic capability of qualitative analysis was the sensitivity, specificity, and accuracy of 89%, 62%, and 85%, respectively. With respect to time intensity curve analysis, the time to peak of malignant lesions was significantly shorter than those of benign lesions (P = 0.0009) with an optimal cutoff value of 12.81 s on the receiver operating characteristic curve analysis. With the combination of qualitative and quantitative analyses, the sensitivity, specificity, and accuracy were improved to 100%, 54%, and 94%, respectively. Conclusions: CEH-EUS with combined qualitative and quantitative analyses for pancreatic tumors might be useful as a complement for EUS-FNA. The UMIN Clinical Trials Registry (UMIN000025192) [ABSTRACT FROM AUTHOR]

Background: Endoscopic sphincterotomy (ES) is widely performed in patients with common bile duct stones (CBDS). However, the long-term outcomes of patients following ES have not been sufficiently elucidated. Impaired papillary function following ES may result in additional late complications. In contrast, endoscopic papillary balloon dilation (EPBD)-another option for treating CBDS-is expected to preserve papillary function. This study aimed to compare the long-term outcomes of patients with CBDS treated with ES to those treated with EPBD in a large cohort. In addition, a subgroup analysis was performed, according to gallbladder (GB) status. Methods: A cohort study was performed using propensity score matching to reduce treatment selection bias. This involved the analysis of follow-up data for 1086 patients who underwent EPBD or ES for CBDS. Results: Propensity score matching extracted 246 pairs of patients. The median (interquartile range) follow-up period after EPBD or ES was 93.5 (46.8-129.2) months and 90 (42-139.3) months, respectively. The incidence of CBDS recurrence after EPBD and ES were 8.5 and 15.0 %, respectively. The hazard ratio (95 % CI) was 0.577 (0.338-0.986) ( P = 0.044). Based on the status of the GB, the incidence of CBDS recurrence was significantly different between post-EPBD and post-ES in the group with cholecystectomy after EPBD/ES ( P = 0.013). Conclusions: The incidence of biliary complications was significantly lower in patients after EPBD than in those after ES, and this outcome appeared most markedly in patients who also underwent cholecystectomy. [ABSTRACT FROM AUTHOR]

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

Recently, endoscopic treatment has been attempted to counter benign biliary strictures. It is expected to be an alternative to surgical operation because of its lower morbidity and its convenience, but the long-term results have not yet been sufficiently elucidated. Here, we evaluate the short- and long-term results of endoscopic stenting in patients with benign biliary strictures, and also describe a new technique using a covered metallic stent (CMS) in the refractory cases. The charts of 22 consecutive patients with benign biliary stricture treated endoscopically at our institutions between December 1995 and December 2002 were analyzed retrospectively. Stricture etiology was as follows: postoperative, nine; chronic pancreatitis, seven; primary sclerosing cholangitis (PSC), three; and other, three. The stent initially placed was a 7 Fr in 11 patients and a 10 Fr in 11 patients. Eighteen of 22 patients (82%) were successfully treated by the initial treatment, and stents were removed after a mean duration of 3.1 months (range: 1–14 months). In the remaining four patients, stents were exchanged once to four times after that, and a CMS was placed as the second endoprosthesis in two patients with chronic pancreatitis. These stents, including CMS, were finally removed from these four patients after a mean duration of 14.8 months (range: 8–22 months). Over a median follow-up period of 26 months (range: 6–78 months), one recurrence has been observed, in which case a CMS was placed in a patient with chronic pancreatitis. The CMS was removed successfully 6 months after the insertion, and no recurrence was observed during the 6-month follow-up period. Endoscopic stenting for benign biliary stricture is an alternative to surgery because it shows satisfactory results. Placement of a CMS would also be an option in refractory strictures, such as those due in chronic pancreatitis, if the certainty of removal is proven by cumulative experience with a large number of patients. [ABSTRACT FROM AUTHOR]

Objectives: To provide updated clinico-epidemiological information on chronic pancreatitis (CP) in Japan. Methods: We conducted a two-stage nationwide epidemiological survey; the number of CP patients was estimated in the first-stage survey, and their clinical features were examined in the second-stage survey. We surveyed patients with CP who had visited hospitals in 2016 and were diagnosed according to the Japanese diagnostic criteria 2009 (DC2009). Furthermore, we validated the new Japanese diagnostic criteria (DC2019) in patients with early CP diagnosed according to DC2009. Results: The number of patients with definite/probable CP in 2016 was 56,520 (prevalence, 44.5 per 100,000 persons), and that of early CP was 4470 (prevalence, 3.5 per 100,000 persons). We obtained detailed clinical information of 2150 patients with definite/probable CP and 249 patients with early CP. Compared with the early CP cases, the definite/probable CP cases had higher proportions of male (4.8 vs. 1.3), alcohol-related etiology (72.0% vs. 45.8%), smoking history (69.6% vs. 41.0%), diabetes mellitus (42.3% vs. 19.3%), and past history of acute pancreatitis (AP) (50.4% vs. 22.1%). Among the patients with early CP diagnosed according to DC2009, 93 (37.3%) were diagnosed with early CP according to DC2019, but the diagnosis of the remaining 156 (62.7%) patients was downgraded. Alcohol-related etiology, smoking history, early disease onset, and past history of AP were associated with the maintenance of early CP diagnosis in DC2019. Conclusion: We clarified the current status of CP in Japan. Further validation studies are warranted to clarify the diagnostic utility of DC2019. [ABSTRACT FROM AUTHOR]

Background: Recently, a novel 22-gauge needle with three symmetric needle points and crown-shaped cutting heels, known as a Franseen needle, has been developed for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB).Aim: To assess the histological material acquisition rate and histological diagnostic capability of the 22-gauge Franseen needle (AC22) during EUS-FNB for solid lesions.Methods: This study was designed as an open-label, multicenter, prospective, single-arm pilot study of EUS-FNB using AC22 for the diagnosis of solid lesions. Three passes of FNB using AC22 were performed for all lesions. The primary endpoints were the histological material acquisition rate and histological diagnostic capability. The secondary endpoints were the technical success rate, quality of histological samples, number of passes for diagnosis, and safety.Results: Between September 2017 and May 2018, 75 patients were enrolled. The final diagnoses were malignancy in 65 and benign in 10. Three passes of FNB were technically successful in all patients. The sensitivity, specificity, and accuracy for the malignancy of histological analyses were 92.3% (60/65), 100% (10/10), and 93.3% (70/75), respectively, for the first pass and 95.4% (62/65), 100% (10/10), and 96% (72/75), respectively, for combined three passes. The diagnostic yield plateaued after the second pass. Sufficient tissue samples for histological interpretation were obtained in 96% (72/75) and 100% (75/75) patients for the single pass and combined three passes, respectively. Two patients (2.7%) developed mild pancreatitis as an adverse event.Conclusion: EUS-FNB using AC22 showed high histological diagnostic capability with the high first pass yield.Clinical Trials Registry: UMIN Clinical Trials Registry (UMIN ID: UMIN000036641). [ABSTRACT FROM AUTHOR]

Background and Aim: An antireflux metal stent (ARMS) for nonresectable distal malignant biliary obstruction (MBO) may prevent recurrent biliary obstruction (RBO) as a result of duodenobiliary reflux and prolong time to RBO (TRBO). Superiority of ARMS over conventional covered self‐expandable metal stents (SEMS) has not been fully examined. Methods: We conducted a multicenter randomized controlled trial to examine whether TRBO of an ARMS with a funnel‐shaped valve was longer than that of a covered SEMS in SEMS‐naïve patients. We enrolled 104 patients (52 patients per arm) at 11 hospitals in Japan. Secondary outcomes included causes of RBO, adverse events, and patient survival. Results: TRBO did not differ significantly between the ARMS and covered SEMS groups (median, 251 vs 351 days, respectively; P = 0.11). RBO as a result of biliary sludge or food impaction was observed in 13% and 9.8% of patients who received an ARMS and covered SEMS, respectively (P = 0.83). ARMS was associated with a higher rate of stent migration compared with the covered SEMS (31% vs 12%, P = 0.038). Overall rates of adverse events were 20% and 18% in the ARMS and covered SEMS groups, respectively (P = 0.97). No significant between‐group difference in patient survival was observed (P = 0.26). Conclusions: The current ARMS was not associated with longer TRBO compared with the covered SEMS. Modifications including addition of an anti‐migration system are required to use the current ARMS as first‐line palliative treatment of distal MBO (UMIN‐CTR clinical trial registration number: UMIN000014784). [ABSTRACT FROM AUTHOR]

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

Background and Aim: Endoscopic sphincterotomy (ES) is a standard procedure for the treatment of common bile duct stones (CBDS). Endoscopic papillary large balloon dilation (EPLBD) is emerging as an effective method to treat difficult CBDS, providing several advantages over ES without increasing early adverse events (AE). However, the late AE of EPLBD have not yet been well studied. The aim of the present study was to compare late AE after EPLBD versus ES for the treatment of CBDS using a propensity score‐based cohort analysis. Methods: Propensity score matching was introduced to reduce the possible bias in baseline characteristics between two treatment groups and formed the matched cohort including 240 patients. Primary endpoint was cumulative as well as estimated 1‐year and 3‐year late AE rates. Secondary outcome was the incidence of early AE. Results: Cumulative late AE rates were 12.5% and 16.7% in the ELPBD and ES groups (P = 0.936) with a median follow‐up period of 915.5 and 1544.5 days, respectively. Estimated 1‐year and 3‐year late AE rates were 8.4% and 13.1% in the EPLBD group and 5.0% and 15.0% in the ES group, respectively. In multivariate analysis, ≥two procedures were identified as independent risk factors for late AE. Overall early AE rate did not differ between the groups. Conclusion: In the present study, late AE rate after EPLBD showed no significant difference compared with that after ES, which had a relatively long follow‐up period. Therefore, EPLBD could be used for the treatment of CBDS, if CBDS are considered difficult to treat. Clinical Trial Registry: UMIN000027798 [ABSTRACT FROM AUTHOR]

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

Background: In Japan and Europe, a retrieval basket is generally used for endoscopic extraction of bile duct stones, while in the US, a retrieval balloon is mainly used. However, the efficacies of these two devices have not been previously compared. Therefore, the present multicenter, prospective, randomized study was performed to compare the efficacies of these two devices for endoscopic biliary stone extraction.Methods: This study was designed as a non-inferiority study in comparing a basket removal with a balloon removal. Six Japanese institutions participated in this study, which included 184 patients with bile duct stones <11 mm in diameter with no limitation in the number of stones. The stones were identified and measured during ERCP, after which the patients were randomly assigned to undergo endoscopic stone extraction using either a basket catheter or a balloon catheter. The primary end point was the rate of complete removals of stones within 10 min, and the secondary end point was the rate of procedure-related complications.Results: There were 91 patients in the basket group and 93 in the balloon group. The rate of successful stone extraction within 10 min was 81.3 % (74/91) in the basket group and 83.9 % (78/93) in the balloon group (p = 0.7000). The complication rate was 6.6 % in the basket group and 11.8 % in the balloon group (p = 0.3092). Complications included bleeding, pancreatitis, and cholangitis.Conclusions: Basket and balloon catheters showed similar efficacies for endoscopic biliary stone extraction when stone size is 11 mm or smaller. [ABSTRACT FROM AUTHOR]

Background: Endoscopic papillary large balloon dilation (EPLBD) is safe and effective in management of common bile duct stones (CBDS). Endoscopic sphincterotomy (EST) prior to EPLBD has been performed as a standard procedure. However, the significance of EST prior to EPLBD has not been well studied yet.Aims: To compare the clinical outcomes of EPLBD with and without EST to evaluate the significance of EST.Methods: Between April 2010 and March 2015, a total of 82 patients with naïve papillae underwent EPLBD with or without EST for the management of CBDS. A retrospective analysis compared the efficacy and safety of EPLBD with and without EST.Results: Basic patient characteristics were not significantly different between the groups that underwent EPLBD with EST (n = 27) and without EST (n = 55). Complete stone removal rates were similar between the groups (100 % in the EST group and 98 % in the non-EST group, p = 1.00). There was no significant difference in the median balloon size (13 mm in both groups, p = 0.445), rate of application of mechanical lithotripsy (26 vs. 35 % in the EST and non-EST groups, respectively, p = 0.463), or the median procedure time (38 vs. 34 min in the EST and non-EST groups, respectively, p = 0.682). The overall adverse event rates were not statistically different (4 vs. 7 % in the EST and non-EST groups, respectively, p = 1.00). Pancreatitis, cholangitis, and hemorrhage rates were also similar in both groups.Conclusions: EST prior to EPLBD may be unnecessary since this study did not demonstrate its benefits. [ABSTRACT FROM AUTHOR]

Background and Aim: Hemorrhage is often encountered after endoscopic submucosal dissection (ESD). In addition to active bleeding after resection, exposed blood vessels and blood clots without active bleeding on the post-dissection ulcer floor have been recognized within our department. We consider exposed and/or observable vessel findings and clots on the ulcer floor after re-section as important risk factors for hemorrhage. Here, we compared and examined the active bleeding frequency and "post-resection ulcer at risk of bleeding" on the day following ESD, in relation to their risk factors. Method: We retrospectively examined 447 patients who underwent second-look endoscopy in our department between August 2008 and March 2018. Logistic regression analyses were performed to determine the hazard ratio and 95% confidence interval. We compared the association of each factor mentioned above with active bleeding on the day after ESD and the presence of ulcers at risk of bleeding after resection. Results: Our retrospective analysis revealed that the risk factors were larger ulcer sizes and the administration of antithrombotic drugs. Additionally, the risk was low for upper body lesions but high for antral lesions. Conclusion: Our results may help determine whether second-look endoscopy should be performed to minimize active bleeding after ESD, reduce postoperative complications, and improve medical safety. [ABSTRACT FROM AUTHOR]

Introduction. Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered upper gastrointestinal anatomy (SAA) is generally challenging despite the use of enteroscopy. After failed biliary cannulation, rendezvous technique (RV) can be an option to assist the biliary access. However, proper needle puncture of biliary ducts, which is critical in the RV procedure, can be difficult because of insufficient biliary dilation. By contrast, the gallbladder can be punctured as a possible access route for RV. Aim. To evaluate the feasibility and safety of percutaneous transgallbladder (PTGB)-RV in patients with SAA. Patients and methods. Six patients who underwent PTGB-RV were included. PTGB drainage was performed in cases without sufficient biliary duct dilation. A guidewire was inserted through the PTGB route with antegrade passage through the cystic duct, common bile duct and duodenal papilla. An enteroscope was inserted up to the papilla, at the guidewire exit site. The guidewire was pulled out through the accessory channel followed by biliary cannulation over the guidewire and endoscopic papillary balloon dilation (EPBD) for stone removal. Results. Six patients with SAA (Roux-en-Y in 4 and Billroth-II in 2) underwent PTGB-RV for removal of bile duct stones. In all patients, a guidewire was successfully inserted into the duodenum followed by insertion of the enteroscope and biliary cannulation. EPBD was then performed, but subsequent stone removal failed in 1 patient. Stone removal was successful in 5 patients without complication, except 1 case of mild pancreatitis. Conclusion. PTGB-RV seems to be a feasible and relatively safe salvage technique in patients with SAA. [ABSTRACT FROM AUTHOR]

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

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

Background: Endoscopic transpapillary brush cytology and forceps biopsy are widely used for the pathological diagnosis of suspected malignant biliary strictures (MBS). However, the sensitivity of these methods remains insufficient, and it can be difficult to confirm the diagnosis. We aimed to evaluate the diagnostic ability of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) and the impact of this technique on clinical management in patients with suspected MBS where endoscopic brush cytology and biopsy yielded negative results. Methods: This study included 225 consecutive patients with suspected MBS, who underwent endoscopic brush cytology and biopsy at our institutions. Negative results were obtained for these pathological tests in 75 patients, and EUS-FNA was performed in 22 of these patients. We retrospectively compared the EUS-FNA results with the final diagnosis and examined the influence of the EUS-FNA diagnosis on treatment selection. Results: FNA specimens were successfully obtained in all patients, and the pathological results confirmed malignancy in 16 cases and predicted that the other 6 cases were benign. Of the 6 cases that were suspected to be benign, 3 patients were diagnosed with xanthogranulomatous cholecystitis by surgical pathology, and the remaining 3 patients were diagnosed with benign diseases at a follow-up after 12-18 months. Thus, the EUS-FNA-based diagnosis was proven correct for all the patients. In addition, the treatment strategy was altered as a result of the EUS-FNA results in the above 6 patients (27%). Conclusions: EUS-FNA is a sensitive and safe diagnostic modality for patients with suspected MBS and can be an additional option in cases where endoscopic brush cytology and biopsy have produced negative results. [ABSTRACT FROM AUTHOR]

Celiac plexus neurolysis (CPN) is an established treatment for upper abdominal cancer pain. Recently, endoscopic ultrasound-guided CPN (EUS-CPN) was introduced and has enabled the performance of CPN under real-time imaging guidance, thereby making this technique much safer and easier. However, this procedure is not always efficacious, and a limited number of patients benefit from it. It should not be recommended for patients suspected of having unfavorable outcomes. We determined the predictive factors for response to EUS-CPN in order to enable rational selection of the therapeutic strategy. Forty-seven consecutive patients who underwent EUS-CPN at our institutions were eligible for this study. Absolute ethanol containing a contrast medium was injected just above the origin of the celiac trunk from the aorta under real-time EUS guidance, and abdominal computed tomography was performed immediately after the procedure to evaluate the distribution of the injected ethanol. The efficacy in pain relief was evaluated based on the pain score at day 7 after EUS-CPN. Pain relief was obtained in 32 patients (68.1%). Multivariate analysis using a multiple logistic regression model revealed that direct invasion of the celiac plexus and distribution of ethanol only on the left side of the celiac artery were significant factors for a negative response to EUS-CPN (odds ratio = 4.82 and 8.67, P = 0.0387 and 0.0224, respectively). EUS-CPN seems to be less effective in patients with direct invasion of the celiac plexus. Ethanol should be injected on both sides of the celiac axis to obtain greater pain relief. [ABSTRACT FROM AUTHOR]

The diagnosis of lymphadenopathy after treatment of malignancy is sometimes difficult, especially in patients whose treatment was deemed curative and without local recurrence or those who have increased serum levels of related tumor markers. We aimed to evaluate the effectiveness of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) as a diagnostic tool in patients with lymphadenopathy after curative treatment of malignancy. Consecutive patients with mediastinal, intraabdominal, or pelvic lymphadenopathy after curative treatment of malignancy who were referred to our hospital between October 2003 and September 2007 were enrolled in this study. A total of 62 patients were included. The lymph nodes were located at the mediastinum in 22 patients, intraabdomen in 38 patients, and intrapelvis in 2 patients. From the pathological findings of the FNA sample, 31 patients (50%) were confirmed to have recurrence of the prior malignancy, and 9 patients (15%) were diagnosed as having a different new malignancy. The remaining 22 patients (35%) were shown to have no recurrence or no other malignancies. However, 1 of them was later diagnosed with recurrence by open laparotomy. The overall sensitivity, specificity, accuracy, and positive and negative predictive values of the EUS-FNA were 97%, 100%, 98%, 100%, and 97%, respectively. Lymphadenopathy after treatment of malignancy is not a definitive sign of recurrence. Therefore, pathological sampling and diagnosis are essential for determining the appropriate treatment. For this purpose, EUS-FNA is a safe, convenient, and minimally invasive procedure with high diagnostic value. [ABSTRACT FROM AUTHOR]

Background and Aim: Radiofrequency ablation (RFA) is a promising, minimally invasive treatment for hepatocellular carcinoma (HCC). However, thermal injury sometimes occurs in the bile duct, potentially leading to a critical situation. The aim of the present study was to investigate whether bile duct injury is reduced by an intraductal chilled saline perfusion (ICSP) through a nasobiliary tube during RFA for HCC. Patients and Methods: The baseline incidence of bile duct injury at Gifu Municipal Hospital was 3.1% (13 patients) in 424 patients with HCC treated by percutaneous RFA. In all patients, the tumor was within 5 mm of the central bile duct on CT images. The incidence of bile duct injury was 46% among the 28 selected patients whose tumor was close to the central bile duct. To prevent complications in such high-risk patients, we placed a nasobiliary tube endoscopically before RFA, and performed ICSP during RFA. Forty consecutive patients with tumors close to the central bile duct were enrolled in this study. Results: Of the 40 enrolled patients, only one had biliary injury, whereas the remaining 39 patients were able to avoid it. The incidence of biliary injury was significantly reduced in the ICSP group (1/40, 2.5%) compared to that in the control group (13/28, 46%) ( P < 0.0001). Moreover, the liver function 6 months after RFA was also better preserved in the ICSP group according to Child–Pugh grading, thus resulting in a better clinical outcome. Conclusions: ICSP through a nasobiliary tube is a potential intervention method to prevent biliary injury by percutaneous RFA. [ABSTRACT FROM AUTHOR]

Background/Aims: Stem cell induction via granulocyte colony-stimulating factor (G-CSF) administration is utilized in the treatment of various diseases. Therefore, we examined the effect of G-CSF administration to a liver fibrosis model induced by dimethylnitrosamine (DMN). Methods: ICR mice were subcutaneously injected with either G-CSF (150μg/kg) or saline at days 0, 3, 7 and 10. Subacute liver injury was established by intraperitoneal injection of DMN (10mg/kg) on three consecutive days of each week. Results: G-CSF administration significantly decreased the survival rate of mice treated with DMN. There was no difference in the degree of liver injury or fibrosis between either group of mice. However, assessment by proliferating cell nuclear antigen (PCNA) revealed that the G-CSF-treated mice experienced a greater degree of inhibition of liver cell proliferation than the control mice. Interleukin-1β (IL-1β) mRNA expression increased in the livers of G-CSF-treated mice. PCNA staining and analysis of cell cycle-related proteins also revealed that passive immunization with anti-IL-1β-neutralizing antibody improved the impaired hepatocellular regeneration and resulted in an improved survival rate of mice treated with G-CSF and DMN. Conclusions: G-CSF administration suppressed liver cell proliferation through the up-regulation of IL-1β expression in DMN-induced liver injury. [Copyright &y& Elsevier]

Diagnosis of the upstream extent of extrahepatic bile duct cancer has been difficult via the transpapillary approach, due to the difficulty of obtaining a biopsy sample above the stricture. We developed a new biopsy technique that allows a sample to be taken above the stricture, and prospectively evaluated the new technique's utility. Twenty-four consecutive patients diagnosed as having possible extrahepatic bile duct cancer by endoscopic retrograde cholangiopancreatography and other imaging tests were included in the study. They initially underwent endoscopic placement of a nasobiliary drainage tube. After improvement of jaundice and cholangitis, the cholangiogram obtained via the tube was examined and transpapillary biopsy was performed using a double lumen catheter under fluoroscopic guidance. The biopsy sampling in the stricture was successful in all cases, and pathological diagnosis was confirmed in all cases. The success rate of the method of upstream diagnosis was also sufficient in cases in which stricture was located below the middle extrahepatic bile duct. However, it was relatively low in cases whose stricture was located in the upper extrahepatic bile duct. Biopsy sampling in the hepatic hilum was also difficult. The transpapillary biopsy technique is useful for determination of the upstream extent of extrahepatic bile duct cancer, especially in cases in which stricture is located in the lower extrahepatic bile duct. Compared to the percutaneous transhepatic approach, it is less invasive and can shorten the preoperative period. It was also seen to be relatively safe, easy and convenient. [ABSTRACT FROM AUTHOR]

(1) Background: Endoscopic management of hilar biliary obstruction is still challenging. Compared with unilateral drainage, bilateral drainage could preserve larger functional liver volume and potentially improve clinical outcomes. To evaluate the effectiveness of bilateral drainage, we conducted this multicenter randomized controlled study. (2) Methods: Patients with unresectable malignant hilar biliary obstruction were assigned to unilateral or bilateral group. At first, patients underwent endoscopic nasobiliary drainage (ENBD), and subsequently underwent self-expandable metallic stent (SEMS) deployment. Primary outcomes were the functional success rate of ENBD and time to recurrent biliary obstruction (TRBO) after SEMS deployment. (3) Results: During the study period, 38 and 39 patients were enrolled in the unilateral and bilateral groups. The functional success rate was similar in the uni- and bi-ENBD group (57% vs. 56%; p = 0.99), but the rate of additional drainage was higher in uni-ENBD group. Although TRBO and overall survival time after SEMS deployment were not different between the groups (p = 0.11 and 0.78, respectively), the incidence of early adverse events tended to be higher in the bi-SEMS group (5.3% vs. 28%; p = 0.11). (4) Conclusions: Our study failed to demonstrate the superiority of bilateral over unilateral biliary drainage in terms of functional success rate and TRBO. [ABSTRACT FROM AUTHOR]

FOLFIRINOX (FX) and gemcitabine (GEM) plus nab-paclitaxel (GnP) have been reported as effective regimens for unresectable advanced pancreatic cancer (APC). FX may be more effective but is also associated with more adverse events (AEs). Therefore, first-line treatment with FX followed by second-line GnP may be appropriate. Aims: To assess the safety and efficacy of second-line GnP for patients with APC after first-line FX failure. Methods: This study was a multicenter prospective phase II study evaluating second-line GnP in patients with APC after failed first-line FX. The primary endpoint was response rate (RR), and the secondary endpoints were overall survival (OS), progression free survival (PFS), and the frequency and degree of adverse events (AEs). Results: Thirty patients (14 male; median age, 64 years) were enrolled. The RR was 13.3%, with a median follow-up time of 9.3 months. The median OS and PFS were 7.6 and 3.8 months, respectively. From the beginning of first-line treatment, the median OS and PFS were 14.2 and 9.3 months, respectively. Grade 3 or 4 AEs were seen in 70% of patients. Conclusion: Second-line GnP after FX failure for patients with APC could be more effective than GEM alone. Further comparison studies are warranted. [ABSTRACT FROM AUTHOR]

Background Hematemesis is one of the most eventful complications in patients with reflux esophagitis (RE). But bleeding is not observed in all patients who have RE with esophageal ulcer. We retrospectively studied the association of bleeding with background factors in patients with RE with esophageal ulcer. Methods Between January 2013 and January 2018, 30 patients were endoscopically diagnosed as RE with Los Angeles classification D (LA-D). These 30 patients were enrolled in our study. Fifteen of them were suddenly admitted to our hospital because the RE exhibited bleeding (B-group). Patients with Mallory-Weiss syndrome, peptic ulcers, and any malignancies were excluded as possible sources of the bleeding. Bleeding was not observed in the remaining 15 RE patients (NB-group). In these 30 patients, we retrospectively studied the relations between the bleeding and the following background factors: age, gender, body mass index (BMI), esophageal hiatal hernia, endoscopical atrophy of the gastric mucosa which is related to the secretion of gastric juice, cognitive decline (so called dementia), diabetes mellitus, and drugs (NSAIDs, PPI). Results The B-group included 5 males and 10 females. The NB-group also included 5 males and 10 females. The mean age of the B-group was 81.7 ± 8.2 (M ± SD) yrs, which was statistically (P  < 0.05) greater than that of the NB-group, which was 71.5 ± 11.0 yrs. Older age, larger esophageal hiatal hernia, and cognitive decline (so-called dementia) were significantly (P  < 0.05) associated with bleeding on logistic regression analysis. Multiple logistic regression analysis showed that older age and dementia were significantly (P  < 0.05) associated with bleeding. Conclusion It is well known that esophageal hiatal hernia is a major factor in erosive RE, such as RE with LA-D. On the other hand, it was speculated that older RE patients and those with cognitive decline could not easily explain their RE complaints, and their condition might be left unattended for long periods. This lack of attention may result in sudden bleeding in patients with non-treated RE. Further studies are needed. Disclosure All authors have declared no conflicts of interest. [ABSTRACT FROM AUTHOR]