Background and Objectives:Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is an alternative therapeutic option for unsuccessful endoscopic retrograde cholangiopancreatography in patients with malignant biliary obstruction. Procedure-related adverse events (AEs), such as bile leakage and peritonitis, can lead to prolonged hospitalization and delay the initiation of chemotherapy for underlying malignancies. This study aimed to identify factors associated with the development of peritonitis following EUS-HGS. Methods:Consecutive patients who underwent initial EUS-HGS between July 2016 and November 2022 were retrospectively evaluated. We assessed the preprocedural characteristics (cholangitis and duodenal invasion) and intraprocedural technical factors (small bile duct diameter, short hepatic parenchymal distance at puncture, antegrade stenting, and the use of a plastic stent for HGS). Multivariate logistic regression analysis was conducted to evaluate the factors associated with peritonitis after EUS-HGS. Results:A total of 188 patients were included. The cause of biliary obstruction was malignancy in 96% of the cases, with the majority being pancreatic cancer. The rate of early AEs was 15% and included peritonitis (7%), pancreatitis (3%), cholangitis (3%), cholecystitis (1%), and bleeding (1%). Multivariable logistic regression analysis revealed that the diameter of a punctured bile duct ≤3 mm (odds ratio, 4.0; 95% confidence interval, 1.1-15; p = 0.039) independently increased the risk of peritonitis after EUS-HGS. Conclusions:A punctured bile duct diameter of ≤3 mm was identified as a significant independent risk factor for the development of peritonitis after EUS-HGS. Trial Registration: N/A.

BACKGROUND AND AIMS:ERCP with metal stent (MS) placement is the standard treatment for biliary drainage in patients with unresectable pancreatic cancer. A 10-mm diameter MS is generally used; however, a larger stent may provide longer patency. This study aimed to compare the outcomes of an uncovered 14-mm MS with those of an uncovered 10-mm MS. METHODS:This multicenter randomized controlled trial enrolled patients with unresectable pancreatic cancer who required biliary drainage. After 1:1 randomization, either an uncovered 10-mm or 14-mm MS was placed through the major duodenal papilla, and the outcomes were compared. The primary end point was time to recurrent biliary obstruction (TRBO), and the secondary end points were adverse events (AEs) and overall survival (OS). RESULTS:A total of 118 patients were enrolled from 20 institutions (60 in the 10-mm group and 58 in the 14-mm group). Recurrent biliary obstruction occurred in 41.7% versus 25.8% of patients (P = .08). The median TRBO was 10.6 months versus not reached (P = .10), and the median OS was 7.5 months versus 8.7 months (P = .95) in the 10- and 14-mm groups, respectively. Early AEs occurred in 6.7% and 8.6% of patients (P = .74). No significant difference in late AEs was observed between the groups (21.7% vs 17.2%, P = .64). CONCLUSIONS:The 14-mm group demonstrated a longer TRBO; however, the difference did not reach statistical significance. No significant differences in AEs were observed between the groups. CLINICAL TRIAL REGISTRATION:The University Hospital Medical Information Network Center (registration no. UMIN000035387).

Background and Aims ERCP with metal stent (MS) placement is the standard treatment for biliary drainage in patients with unresectable pancreatic cancer. A 10-mm diameter MS is generally used; however, a larger stent may provide longer patency. This study aimed to compare the outcomes of an uncovered 14-mm MS with those of an uncovered 10-mm MS. Methods This multicenter randomized controlled trial enrolled patients with unresectable pancreatic cancer who required biliary drainage. After 1:1 randomization, either an uncovered 10-mm or 14-mm MS was placed through the major duodenal papilla, and the outcomes were compared. The primary end point was time to recurrent biliary obstruction (TRBO), and the secondary end points were adverse events (AEs) and overall survival (OS). Results A total of 118 patients were enrolled from 20 institutions (60 in the 10-mm group and 58 in the 14-mm group). Recurrent biliary obstruction occurred in 41.7% versus 25.8% of patients (P = .08). The median TRBO was 10.6 months versus not reached (P = .10), and the median OS was 7.5 months versus 8.7 months (P = .95) in the 10- and 14-mm groups, respectively. Early AEs occurred in 6.7% and 8.6% of patients (P = .74). No significant difference in late AEs was observed between the groups (21.7% vs 17.2%, P = .64). Conclusions The 14-mm group demonstrated a longer TRBO; however, the difference did not reach statistical significance. No significant differences in AEs were observed between the groups. Clinical trial registration: The University Hospital Medical Information Network Center (registration no. UMIN000035387).

OBJECTIVES:Pancreatic cancer frequently presents with tumor necrosis, which may influence the success of comprehensive genomic profiling in endoscopic ultrasound-guided tissue acquisition specimens. This study aimed to evaluate the relationship between tumor necrosis and comprehensive genomic profiling success. METHODS:This single-center retrospective study enrolled patients diagnosed with pancreatic cancer via endoscopic ultrasound-guided tissue acquisition, whose tissue samples were submitted for FoundationOne® CDx analysis between November 2019 and November 2023. Based on the FoundationOne® CDx report, a 'passed' result indicated successful analysis. Histological type, tumor quantity, and necrosis were evaluated as pathological factors. Univariable and multivariable analyses were conducted to identify factors associated with successful FoundationOne® CDx. RESULTS:Among 109 patients included in this study, the overall success rate of FoundationOne® CDx analysis was 67.9%. Extensive tumor necrosis (>50%) was significantly associated with a lower success rate of FoundationOne CDx analysis (28.6% [>50%] vs. 70.6% [≤50%], P = 0.034). Among the 83 cases that met the quantity criteria for FoundationOne® CDx analysis, the success rate was significantly lower in cases with extensive necrosis (>50%) than in those with limited necrosis (40% [2/5] vs. 83% [65/78]; P = 0.036). Multivariate analysis identified extensive necrosis (odds ratio [OR] 0.09, P = 0.015), samples that met the quantity criteria for FoundationOne® CDx analysis (OR 14.90, P < 0.0001), and pancreatic ductal adenocarcinoma histology (OR 4.21, P = 0.038) as significant factors influencing the success of FoundationOne® CDx analysis. CONCLUSIONS:Extensive tumor necrosis observed on pathological examination is associated with a lower success rate of FoundationOne® CDx analysis in pancreatic cancer.

Background and study aims Mapping biopsy (MB) aids in diagnosing superficial mucosal spread of biliary tract cancer. However, conventional MB is technically challenging, which can reduce the diagnostic yield. This study aimed to assess the usefulness of MB using the newly developed Endosheather (ES) (Piolax, Tokyo, Japan).Patients and methods We retrospectively analyzed data from patients who had biliary tract cancer with hilar biliary obstruction and underwent MB. Outcome measures included the overall technical success rate, quality of specimens, impact of MB results on the treatment strategy, and adverse events (AEs), which were compared between the conventional (Conv) group and the ES group.Results A total of 91 patients were included. The overall technical success rate was significantly higher in the ES group (92%, 43/47) than in the Conv group (59%, 26/44) ( P < 0.05). The rate of samples containing both biliary epithelium and stromal tissue was significantly higher in the ES group than in the Conv group (77% [67/87] vs. 47% [32/68]; P < 0.05). MB results affected the treatment strategy in one patient (2.3%) in the Conv group and five patients (11%) in the ES group ( P = 0.11). There was no significant difference between the two groups in terms of AEs.Conclusions MB using ES significantly improved technical success and specimen quality, providing valuable information for preoperative assessment of patients with biliary tract cancer.

BACKGROUND AND AIM:The insulated-tip (IT) knife nano is a high-frequency electrosurgical knife designed to enhance the safety and efficiency of endoscopic submucosal dissection (ESD), particularly in anatomically narrow lumens such as the colorectum. Although it is commonly used in combination with needle knives for colorectal ESD, its efficacy in this context has not been substantiated through randomized controlled trials (RCTs). We aimed to evaluate whether the adjunctive use of the ITknife nano significantly reduces ESD procedure time for colorectal neoplasms. METHODS:A single-center RCT involving patients with colorectal neoplasms measuring 30-50 mm was randomized to receive ESD with either the DualKnife J alone (D-group) or the addition of the ITknife nano (IT-group). Allocation adjustment factors included lesion location, tumor size, and macroscopic type. The primary outcome was the ESD procedure time. Secondary outcomes included submucosal dissection speed, en bloc and R0 resection rate, and incidence of adverse events. RESULTS:A total of 108 and 106 lesions in the D- and IT-groups, respectively, were analyzed. There was no significant difference in procedure time between groups (111.8 min vs. 114.3 min, p = 0.789) nor in submucosal dissection speed (22.9 mm2/min vs. 22.1 mm2/min, p = 0.669). However, subgroup analysis on allocation factors revealed significantly faster dissection speed for rectum lesions in the D-group (24.7 mm2/min vs. 16.2 mm2/min, p = 0.0496). Resection and safety outcomes were comparable between groups. CONCLUSIONS:The adjunctive use of the ITknife nano with the DualKnife J did not significantly reduce procedure time in colorectal ESD (jRCT1042180137). TRIAL REGISTRATION:University Hospital Medical Network Clinical Trials Registry: UMIN000030068; Japan Registry of Clinical Trials: jRCT1042180137.

Background and study aims:Matched therapy based on comprehensive genomic profiling is a potential treatment option for patients with inoperable pancreatic cancer; however, the optimal method for obtaining tissue samples suitable for comprehensive genomic profiling using endoscopic ultrasound-guided tissue acquisition remains unclear. This study aimed to determine the optimal endoscopic ultrasound-guided tissue acquisition method to obtain samples for comprehensive genomic profiling. Patients and methods:This retrospective study included 86 consecutive patients with pancreatic cancer who underwent comprehensive genomic profiling using FoundationOne CDx (Foundation Medicine Inc.) and endoscopic ultrasound-guided tissue acquisition between June 2019 and January 2023. Macroscopic visible core length was measured using on-site macroscopic evaluation in all patients. Foundation Medicine Inc. reported analysis results categorized as passed (successful FoundationOne CDx), qualified, or failed. We investigated factors predicting successful FoundationOne CDx treatment. Results:Needles sized 22, 20, and 19 gauge were used in 63, one, and 23 patients, respectively. The stylet slow-pull and suction techniques were performed in 43 and 41 patients, respectively. Median total macroscopic visible core length in the formalin-fixed paraffin-embedded blocks subjected to FoundationOne CDx was 41 mm. The success rate for FoundationOne CDx was 66%. Multiple linear regression analysis revealed that macroscopic visible core length independently affected successful FoundationOne CDx ( P = 0.0019). Conclusions:In tissue specimens obtained using endoscopic ultrasound-guided tissue acquisition, macroscopic visible core length can be associated with an appropriate sample for FoundationOne CDx.

ABSTRACT Endoscopic ultrasound‐guided biliary drainage (EUS‐BD) is used when biliary drainage using endoscopic retrograde cholangiopancreatography fails. Recently, it has been adopted as a primary biliary drainage method, and its indications have expanded. Since EUS‐BD can cause adverse events (AEs), such as bile leakage and stent migration, which do not occur in endoscopic retrograde cholangiopancreatography, endoscopists need to be well‐versed in its management and preventive techniques. EUS‐BD includes several procedures, such as EUS‐guided choledochoduodenostomy (EUS‐CDS), EUS‐guided hepaticogastrostomy (EUS‐HGS), EUS‐guided antegrade stenting (EUS‐AS), and EUS‐guided rendezvous (EUS‐RV). A recent meta‐analysis reported that the overall AE rate of EUS‐BD was 13.7% (EUS‐CDS, 11.9%; EUS‐HGS, 15.5%; EUS‐AS, 9.9%; and EUS‐RV, 8.8%). Among various EUS‐BD techniques, EUS‐CDS and EUS‐HGS are the most frequently reported. Tubular self‐expandable metal stents have been traditionally used in EUS‐CDS; however, lumen‐apposing metal stents have recently gained popularity. A systematic review showed that the rates of early AEs were similar between self‐expandable metal stents and lumen‐apposing metal stents; however, stent maldeployment was more problematic with lumen‐apposing metal stents. Although tubular self‐expandable metal stents are used in EUS‐HGS, stent maldeployment remains a serious issue, and available devices and technical tips for preventing this AE should be well understood. Furthermore, AEs, such as sepsis, cholangitis, and bleeding, can occur, and strategies to mitigate these risks are essential. In this narrative review, we discussed AEs related to EUS‐BD with a focus on management options and strategies for prevention.

Preoperative localization of colorectal cancer (CRC) is essential for accurate resection and treatment planning. However, colonoscopy-based tumor localization may lack optimal accuracy, potentially affecting surgical outcomes and patient management. This study aimed to evaluate the accuracy of colonoscopic localization of CRC and identify predictors of preoperative endoscopic localization errors. This post hoc analysis utilized data from a prospective observational study conducted between June 2016 and June 2018. The accuracy of preoperative colonoscopic localization was compared with surgical localization, which is considered the gold standard. Endoscopic and surgical tumor locations were categorized into eight segments. Surgical localization was confirmed by the presence of visible tattoos during surgery and pathological examination of the resected specimens. Predictors of preoperative endoscopic localization errors were also analyzed. A total of 342 patients were included in this study. The accuracy of preoperative endoscopic localization compared with surgical localization was 79.2

Background/objectives: The detection of pancreatic cancer (PC) often depends on indirect indicators such as parenchyma atrophy (PPA), main pancreatic duct stenosis, and low echoic areas, particularly when no mass is evident on imaging. While pathological evaluation is the gold standard for differentiating malignant from benign conditions, endoscopic ultrasound-guided fine-needle aspiration/biopsy is not always feasible in such cases. Serial pancreatic juice aspiration cytologic examination (SPACE) via endoscopic nasopancreatic drainage (NPD) has emerged as an alternative diagnostic method, though its accuracy remains underevaluated. This study aimed to evaluate the diagnostic performance of SPACE and explore strategies to enhance its accuracy in diagnosing PC. Methods: This multicenter, retrospective study analyzed patients who underwent SPACE between January 2015 and September 2023. The inclusion criteria focused on cases lacking a clear pancreatic mass but exhibiting indirect signs suggestive of PC. Diagnostic accuracy was determined using surgical pathology or a minimum follow-up period of 12 months as the reference standard. Results: Among 164 patients, 85(51.8 %) were diagnosed with malignancy. The sensitivity and specificity of SPACE were 74.1 % and 87.3 %, respectively, with a area under the receiver operating characteristic curve (ROC-AUC) of 0.807 (95%CI: 0.748-0.867). Incorporating patient age, CEA and PPA with SPACE results further improved diagnostic performance, yielding a ROC-AUC of 0.828 (95%CI: 0.76-0.897, Conclusions: Combining SPACE with clinical and imaging findings significantly enhances diagnostic accuracy in suspected PC cases where conventional imaging fails to detect tumors. This integrated

BACKGROUND AND AIMS:Lesion location's impact on recurrence after T1 colorectal cancer (CRC) resection remains unclear. This study evaluated survival and recurrence differences between colonic and rectal tumors after T1 CRC resection. METHODS:Patients who underwent T1 CRC resection were reviewed on the basis of pathologic risk factors for lymph node metastases according to the Japanese Society for Cancer of the Colon and Rectum guidelines. Participants were divided into low-risk (group A), high-risk after endoscopic resection (ER) only (group B), and high-risk after surgical resection (SR) or ER and SR (group C) groups. Survival and recurrence rates were compared between colonic and rectal tumors. RESULTS:In 987 patients (median follow-up: 60 months), there were no significant differences in the disease-specific survival rate (A: 99.2% vs 100%, P = .582; B: 96.6% vs 100%, P = .577) or cumulative recurrence (A: 2.3% vs 0%, P = .523; B: 3.0% vs 0%, P = .399) between colonic and rectal tumors, respectively, in groups A and B. In group C, rectal lesions showed significantly higher cumulative recurrence (4.8% vs 1.1%, P = .002) and lower disease-specific survival rates (98.2% vs 99.8%, P = .024) than colonic lesions. Rectal tumor location (hazard ratio [HR], 3.25), venous invasion (HR, 9.40), and high budding grade (HR, 3.05) were independent recurrence risk factors in group C. CONCLUSIONS:T1 rectal cancer had a worse prognosis than T1 colonic cancer after high-risk lesion SR. Careful surveillance is required for high-risk T1 rectal cancers with venous invasion or a high budding grade.

BACKGROUND AND AIMS:Patients with autoimmune pancreatitis (AIP) sometimes show characteristic ophthalmologic findings, such as dacryoadenitis and dry eye. However, the ocular findings in AIP patients thus far have not fully been analyzed, especially in patients treated long term with corticosteroids (CS). We aimed to study the current and previous history of ocular diseases in AIP patients and changes of the common ophthalmologic findings during the CS treatment. METHODS:We retrospectively analyzed the history of ophthalmologic diseases in 105 AIP patients and further examined the changes in the ophthalmologic findings and associated factors occurring during CS treatment in 63 patients. RESULTS:Several common ophthalmic diseases, including cataract (33.3%) and glaucoma (6.3%), were recognized in approximately one-third of the AIP patients at their initial diagnosis. Behcet uveitis was seen in the past histories of two AIP patients. During 70 months of CS treatment, exacerbation of cataract was recognized in 31.7%, and new onset of glaucoma in 7.9%. Univariate and multivariate analyses demonstrated the cumulative CS amount as a significant risk of cataract exacerbation (p<0.05) and diffuse pancreatic swelling at the initial diagnosis as a risk of Mikulicz's disease (p<0.01). CONCLUSIONS:An ophthalmologic check at the initial diagnosis and monitoring during CS treatment is required for patients with AIP. Promising steroid-sparing agents are expected to lessen the adverse ophthalmologic events caused by CS.

INTRODUCTION:Preoperative biliary drainage (PBD) is often required for patients with pancreatic cancer accompanied by biliary obstruction to ensure the safe administration of neoadjuvant chemotherapy or to manage cholangitis and jaundice. Although endoscopic retrograde cholangiopancreatography (ERCP) is the standard approach for PBD, it carries a significant risk of post-ERCP pancreatitis. Endoscopic ultrasound-guided biliary drainage (EUS-BD), particularly via hepaticogastrostomy (EUS-HGS), offers a promising alternative that avoids papillary manipulation. However, the clinical utility of EUS-BD as primary drainage for PBD remains unclear due to a lack of prospective studies. This multicentre prospective trial aims to evaluate the safety and efficacy of EUS-HGS as primary drainage for PBD in patients with resectable or borderline resectable pancreatic cancer. METHODS AND ANALYSIS:This multicentre prospective study involves seven institutions in Japan. Eligible patients will undergo EUS-HGS using a 7Fr plastic stent. The primary endpoint is clinical success, defined by improvements in bilirubin or liver enzyme levels within 14 days postprocedure. Secondary endpoints include technical success rate, adverse event incidence, stent patency and surgical outcomes. A total of 30 patients will be enrolled, considering an expected clinical success rate of 90% and a 10% dropout allowance. ETHICS AND DISSEMINATION:This study has been approved by the National Cancer Center Institutional Review Board (Research No. 2024-084). The results of this study will be reported at an international conference and published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER:UMIN ID: 000055173.

Background and study aims:For preoperative biliary drainage of pancreatic cancer (PC), a 10-mm diameter metal stent (MS) is commonly used; however, the rate of pancreatitis is high. It is hypothesized that smaller-diameter MS may reduce the rate of pancreatitis. Therefore, we conducted a multicenter prospective study to evaluate the efficacy and safety of 7-mm MS. Patients and methods:Patients requiring initial biliary drainage for obstructive jaundice caused by PC and scheduled for surgery from six facilities were included. After endoscopic retrograde cholangiography, a 7-mm MS was placed at the site of biliary obstruction. The primary endpoint was the rate of pancreatitis, and the secondary endpoints included early and late adverse events (AEs). The pancreatitis rate was assumed to be 18% and 5% with 10- and 7-mm MS, respectively; with a power of 80% and one-sided significance level of 10%, the planned enrollment was 38 patients. If pancreatitis occurred in no more than three patients, this indicates that the 7-mm MS effectively reduced incidence of pancreatitis. Results:Overall, 38 patients were enrolled, and 35 patients in whom a 7-mm MS was successfully placed were analyzed. All MS were placed after sphincterotomy. Pancreatitis occurred in four patients (11.4%) and no early AEs were observed. Surgery was performed in 24 patients and late AEs included stent occlusion in eight patients (23%) and cholecystitis in four patients (11%). Conclusions:The 7-mm MS did not reduce incidence of pancreatitis among surgical candidates for PC.