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Abstract Background Lymph node (LN) metastasis is an important prognostic factor in the ampulla of Vater (AoV) adenocarcinoma. Various LN parameters have been proposed, but their prognostic efficacy has not been compared in the same population. We aimed to evaluate the prognostic values of LN parameters in AoV adenocarcinoma patients who underwent surgical resection and adjuvant treatment based on the long-term follow-up data. Methods A total of 86 patients with surgically resected AoV adenocarcinoma followed by adjuvant treatment were analyzed. We evaluated the prognostic values of various LN parameters such as pathologic N stage, number of metastatic regional LN (LNN), LN ratio (LNR), and log odds of positive LNs (LODDS). Each LN parameter was separately analyzed using Cox regression models with the same confounders. Results The median follow-up period was 69.4 months, and the median overall survival (OS) was 114 months. The median number of dissected LNs is 15, with an interquartile range of 8 to 25. In the univariable analyses, all LN parameters showed significant prognostic efficacy for OS, disease-free survival (DFS), and distant metastasis-free survival (DMFS). In the multivariable Cox regression analyses, LNN ≥ 2 was a statistically significant prognostic factor for OS (hazard ratio (HR) 2.10, 95% confidence interval (CI), 1.11–3.97; p = 0.022), DFS (HR 2.51, 95% CI 1.28–4.93; p = 0.007), and DMFS (HR 2.74, 95% CI 1.39–5.41; p = 0.004). LNR showed significant prognostic performance for DFS (HR 2.35, 95% CI 1.23–4.50; p = 0.010), and DMFS (HR 2.26, 95% CI 1.17–4.35; p = 0.015). N stage showed significant prognostic performance in DFS (HR 1.55 for pN1; p = 0.243 and HR 4.31 for pN2; p = 0.003), DMFS (HR 1.46 for pN1; p = 0.323 and 4.59 for pN2; p = 0.002). LODDS and the presence of LN metastasis, did not demonstrate significant prognostic value across survival outcomes. Conclusions LN parameters showed good long-term predictive performance in AoV adenocarcinoma patients treated with curative resection and adjuvant treatments. Among LN parameters, LNN ≥ 2 showed better prognostic value than others. Further large-scale studies are needed to validate the clinical usefulness of various LN parameters.

Abstract This study aimed to develop a machine learning (ML) model for predicting pulmonary embolism (PE) in patients with gastrointestinal cancers, a group at increased risk for PE. We conducted a retrospective, multicenter study analyzing patients who underwent computed tomographic pulmonary angiography (CTPA) between 2010 and 2020. The study utilized demographic and clinical data, including the Wells score and D-dimer levels, to train a random forest ML model. The model’s effectiveness was assessed using the area under the receiver operating curve (AUROC). In total, 446 patients from hospital A and 139 from hospital B were included. The training set consisted of 356 patients from hospital A, with internal validation on 90 and external validation on 139 patients from hospital B. The model achieved an AUROC of 0.736 in hospital A and 0.669 in hospital B. The ML model significantly reduced the number of patients recommended for CTPA compared to the conventional diagnostic strategy (hospital A; 100.0% vs. 91.1%, P

Objective The unilateral biportal endoscopic posterior cervical foraminotomy (UBE-PCF) has been recently adopted for unilateral radiating arm pain due to cervical herniated intervertebral disc or foraminal stenosis. We systematically meta-analyzed clinical outcomes and complications of the UBE-PCF and compared them with those of full-endoscopic PCF (FE-PCF). Methods We systematically searched the PubMed, Embase, and Web of Science until February 29, 2024. Clinical outcomes and complications of the UBE-PCF and FE-PCF were collected and analyzed using the fixed-effect or random-effects model. Clinical outcomes of the UBE-PCF were compared with minimal clinically important difference (MCID) following PCF to evaluate the efficacy of UBE-PCF. Results Ten studies were included in the meta-analysis. In the random-effects meta-analysis, the Neck Disability Index (NDI), visual analogue scale (VAS) neck, and VAS arm were significantly decreased after the UBE-PCF (p0.05). Overall incidence of complications of the UBE-PCF was 6.2% (24 of 390). The most common complication was dura tear (2.1%, 8 of 390). The incidence in overall complications was not significantly different between the UBE-PCF and FE-PCF (p=0.813). Conclusion We found that the UBE-PCF significantly improved clinical outcomes. Regarding clinical outcomes and complications, the UBE-PCF and FE-PCF were not significantly different. Therefore, the UBE-PCF would be an advantageous surgical option comparable to FE-PCF for unilateral radiating arm pain.

Background/Aims: Acute pancreatitis (AP) is a leading cause of emergency hospitalization. We present the current diagnostic and therapeutic status of AP as revealed by analysis of a large multicenter dataset. Methods: The medical records of patients diagnosed with AP between 2018 and 2019 in 12 tertiary medical centers in Korea were retrospectively reviewed. Results: In total, 676 patients were included, of whom 388 (57.4%) were male, and the mean age of all patients was 58.6 years. There were 355 (52.5%), 301 (44.5%), and 20 (3.0%) patients with mild, moderate, and severe AP, respectively, as assessed by the revised Atlanta classification. The most common etiologies of AP were biliary issues (41.6%) and alcohol consumption (24.6%), followed by hypertriglyceridemia (6.8%). The etiology was not identified in 111 (16.4%) patients at the time of initial admission. The overall mortality rate was 3.3%, increasing up to 45.0% among patients with severe AP. Notably, 70.0% (14/20) of patients with severe AP and 81.5% (154/189) of patients with systemic inflammatory response syndrome had received

Background/Aims Chronic hepatitis B (CHB) is related to an increased risk of extrahepatic malignancy (EHM), and antiviral treatment is associated with an incidence of EHM comparable to controls. We compared the risks of EHM and intrahepatic malignancy (IHM) between entecavir (ETV) and tenofovir disoproxil fumarate (TDF) treatment. Methods Using data from the National Health Insurance Service of Korea, this nationwide cohort study included treatment-naïve CHB patients who initiated ETV (n=24,287) or TDF (n=29,199) therapy between 2012 and 2014. The primary outcome was the development of any primary EHM. Secondary outcomes included overall IHM development. E-value was calculated to assess the robustness of results to unmeasured confounders. Results The median follow-up duration was 5.9 years, and all baseline characteristics were well balanced after propensity score matching. EHM incidence rate differed significantly between within versus beyond 3 years in both groups (P

Objective We propose that cervical intrafacetal fusion (cIFF) using bone chip insertion into the facetal joint space additional to minimal PLF is a supplementary fusion method to conventional posterolateral fusion (PLF). Methods Patients who underwent posterior cervical fixation accompanied by cIFF with minimal PLF or conventional PLF for cervical myelopathy from 2012 to 2023 were investigated retrospectively. Radiological parameters including Cobb angle and C2–7 sagittal vertical axis (SVA) were compared between the 2 groups. In cIFF with minimal PLF group, cIFF location and PLF location were carefully divided, and the fusion rates of each location were analyzed by computed tomography scan. Results Among enrolled 46 patients, 31 patients were in cIFF group, 15 in PLF group. The postoperative change of Cobb angle in 1-year follow-up in cIFF with minimal PLF group and conventional PLF group were 0.1° ± 4.0° and -9.7° ± 8.4° respectively which was statistically lower in cIFF with minimal PLF group (p = 0.022). Regarding the fusion rate in cIFF with minimal PLF group in postoperative 6 months, the rates was achieved in 267 facets (98.1%) in cIFF location, and 244 facets (89.7%) in PLF location (p < 0.001). Conclusion Postoperative sagittal alignment was more preserved in cIFF with minimal PLF group compared with conventional PLF group. Additionally, in cIFF with minimal PLF group, the bone fusion rate of cIFF location was higher than PLF location. Considering the concerns of bone chip migration onto the spinal cord and relatively low fusion rate in PLF method, applying cIFF method using minimized PLF might be a beneficial alternative for posterior cervical decompression and fixation.

Background: KRAS , TP53 , CDKN2A , and SMAD4 have been the main driver mutations in pancreatic ductal adenocarcinoma (PDAC). Studies on the clinical significance and treatment response to 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) regimen in terms of the presence of these mutations remain inconclusive. Objectives: This study aimed to compare the survival outcome and response to FOLFIRINOX chemotherapy based on the presence of four driver mutation genes. Design: A multi-center retrospective study conducted at two tertiary medical centers. Methods: This study analyzed PDAC patients who were treated with FOLFIRINOX chemotherapy as the initial treatment. Tumor specimens were analyzed by a targeted next-generation sequencing platform at two tertiary referral hospitals from January 2016 to March 2022. Patients’ demographics, survival outcomes, and chemotherapeutic response were investigated and compared according to the presence of driver mutations. Results: The analysis included 100 patients. KRAS mutation was identified in 92 (92.0%) patients, followed by TP53 , CDKN2A , and SMAD4 in 63 (63.0%), 18 (18.0%), and 17 (17.0%) patients, respectively. The TP53 wild-type group demonstrated longer overall survival (OS) than the TP53 mutated group (median OS: 29 vs 19 months, p = 0.03), and TP53 served as a prognostic factor for survival (hazard ratio = 1.74, 95% confidence interval: 1.00–3.00, p = 0.048). The difference in OS according to TP53 mutation was intensified in localized pancreatic adenocarcinoma (37 vs 19 months, p = 0.01). The TP53 wild-type group demonstrated a higher objective response rate to FOLFIRINOX chemotherapy than the TP53 mutation group in localized pancreatic adenocarcinoma (50.0% vs 17.6%, p = 0.024). Conclusion: PDAC patients with wild-type TP53 demonstrated longer OS than those with TP53 mutation, and this trend was intensified in patients with localized disease. This result may be due to an impaired response to FOLFIRINOX chemotherapy in patients with TP53 mutation.

Abstract To investigate the influence of preoperative smoking history on the survival outcomes and complications in a cohort from a large multicenter database. Many patients who undergo radical cystectomy (RC) have a history of smoking; however, the direct association between preoperative smoking history and survival outcomes and complications in patients with muscle-invasive bladder cancer (MIBC) who undergo robot-assisted radical cystectomy (RARC) remains unexplored. We conducted a retrospective analysis using data from 749 patients in the Korean Robot-Assisted Radical Cystectomy Study Group (KORARC) database, with an average follow-up duration of 30.8 months. The cohort was divided into two groups: smokers (n = 351) and non-smokers (n = 398). Propensity score matching was employed to address differences in sample size and baseline demographics between the two groups (n = 274, each). Comparative analyses included assessments of oncological outcomes and complications. After matching, smoking did not significantly affect the overall complication rate (p = 0.121). Preoperative smoking did not significantly increase the occurrence of complications based on complication type (p = 0.322), nor did it increase the readmission rate (p = 0.076). There were no perioperative death in either group. Furthermore, preoperative smoking history showed no significant impact on overall survival (OS) [hazard ratio (HR) = 0.87, interquartile range (IQR): 0.54–1.42; p = 0.589] and recurrence-free survival (RFS) (HR = 1.12, IQR: 0.83–1.53; p = 0.458) following RARC for MIBC. The extent of preoperative smoking (≤ 10, 10–30, and ≥ 30 pack-years) had no significant influence on OS and RFS in any of the categories (all p > 0.05). Preoperative smoking history did not significantly affect OS, RFS, or complications in patients with MIBC undergoing RARC.

Abstract Background Sarcopenia or visceral adipose tissue has been reported to be related to pancreatic cancer prognosis. However, clinical relevance of the comprehensive analysis of body compositions and their longitudinal changes is lacking. This study analysed the association between body composition changes after chemotherapy and survival in patients with metastatic pancreatic cancer. Methods We retrospectively included 456 patients (mean age ± standard deviation, 61.2 ± 10.0 years; 272 males and 184 females) with metastatic pancreatic cancer who received palliative chemotherapy from May 2011 to December 2019. Using deep learning‐based, fully automated segmentation of contrast‐enhanced computed tomography (CT) at the time of diagnosis, cross‐sectional areas of muscle, subcutaneous adipose tissue and visceral adipose tissue were extracted from a single axial image of the portal venous phase at L3 level. Skeletal muscle index (SMI), visceral adipose tissue index (VATI), subcutaneous adipose tissue index (SATI) and mean skeletal muscle attenuation (MA) were calculated, and their effect on overall survival (OS) was analysed. Longitudinal changes in body composition and prognostic values were also analysed in a subgroup of patients with 2‐ and 6‐month follow‐up CT (n = 349). Results A total of 452 deaths occurred during follow‐up in the entire cohort. The survival rate was 49.3% (95% confidence interval [CI], 44.9–54.2) at 1 year and 3.7% (95% CI, 2.0–6.8) at 5 years. In multivariable analysis, higher MA (≥44.4 HU in males and ≥34.8 HU in females) at initial CT was significantly associated with better OS in both males and females (adjusted hazard ratio [HR], 0.706; 95% CI, 0.538–0.925; P = 0.012 for males, and HR, 0.656; 95% CI, 0.475–0.906; P = 0.010 for females), whereas higher SATI (≥42.8 cm2/m2 in males and ≥65.8 cm2/m2 in females) was significantly associated with better OS in female patients only (adjusted HR, 0.568; 95% CI, 0.388–0.830; P = 0.003). In longitudinal analysis, SMI, VATI and SATI significantly decreased between initial and 2‐month follow‐up CT, whereas mean MA significantly decreased between 2‐ and 6‐month follow‐up CT. In multivariable Cox regression analysis of longitudinal changes, which was stratified by disease control state, SATI change was significantly associated with OS in male patients (adjusted HR, 0.513; 95% CI, 0.354–0.745; P

Background/Aims: The optimal duration and interval of follow-up for cystic lesions of the pancreas (CLPs) is not well established. This study was performed to investigate the optimal duration and interval of follow-up for CLPs in clinical practice. Methods : Patients with CLPs without worrisome features or high-risk stigmata underwent follow-up with computed tomography at 6, 12, 18, and 24 months and then every 12 months thereafter. A retrospective analysis of prospectively collected data was performed. Results : A total of 227 patients with CLPs detected from 2000 to 2008 (mean initial diameter, 1.3±0.6 cm) underwent follow-up for a median of 120 months. Twenty-two patients (9.7%) underwent surgery after a median of 47.5 months. Malignancies developed in four patients (1.8%), one within 5 years and three within 10 years. One hundred and fourteen patients (50.2%) were followed up for more than 10 years. No malignancy developed after 10 years of follow-up. During surveillance, 37 patients (16.3%) experienced progression to surgical indication. In patients with CLPs less than 2 cm in diameter, development of surgical indications did not occur within 24 months of follow-up. Conclusion : s: CLPs should be continuously monitored after 5 years because of the persistent potential for malignant transformation of CLPs. An interval of 24 months for initial follow-up might be enough for CLPs with initial size of less than 2 cm in clinical practice.

Objective Stereotactic radiosurgery (SRS) has been performed for spinal tumors. However, the quantitative effect of SRS on postoperative residual cervical dumbbell tumors remains unknown. This study aimed to quantitatively evaluate the efficacy of SRS for treating postoperative residual cervical dumbbell tumors. Methods We retrospectively reviewed cases of postoperative residual cervical dumbbell tumors from 1995 to 2020 in 2 tertiary institutions. Residual tumors underwent SRS (SRS group) or were observed with clinical and magnetic resonance imaging (MRI) follow-up (observation group). Tumor regrowth rates were compared between the SRS and observation groups. Additionally, risk factors for tumor regrowth were analyzed. Results A total of 28 cervical dumbbell tumors were incompletely resected. Eight patients were in the SRS group, and 20 in the observation group. The mean regrowth rate was not significantly lower (p = 0.784) in the SRS group (0.18 ± 0.29 mm/mo) than in the observation group (0.33 ± 0.40 mm/mo). In the multivariable Cox regression analysis, SRS was not a significant variable (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.18–1.79; p = 0.336). Conclusion SRS did not significantly decrease the tumor regrowth rate in our study. We believe that achieving maximal resection during the initial operation is more important than postoperative adjuvant SRS.

Objective The cervical spine presents challenges in treating metastatic cervical spinal tumors (MCSTs). Although the efficacy of cervical pedicle screw placement (CPS) has been well established, its use in combination with 5.5-mm rods for MCST has not been reported. This study aimed to evaluate the efficacy of CPS combined with 5.5-mm rods in treating MCST and compare it with that of CPS combined with traditional 3.5-mm rods. Methods This retrospective study analyzed 58 patients with MCST who underwent posterior cervical spinal fusion surgery by a single surgeon between March 2012 and December 2022. Data included demographics, surgical details, imaging results, numerical rating scale score for neck pain, Eastern Cooperative Oncology Group performance status, and Spine Oncology Study Group Outcomes Questionnaire responses. Results Preoperative Spinal Instability Neoplastic Scores were significantly higher in the 5.5-mm rod group. Greater kyphotic changes in the index vertebra were observed in the 3.5-mm rod group. Neck pain reduction was significantly better in the 5.5-mm rod group. Conclusion CPS with 5.5-mm rods provides superior biomechanical stability and effectively resists forward bending momentum in posterior MCST fusion surgery. These findings support the use of 5.5-mm rods to enhance surgical outcomes.

Since its development, the use of endoscopic ultrasonography (EUS) in the pancreas and the biliary tract has become increasingly important. The accuracy of EUS varies depending on the experience of the endoscopist. Hence, quality control measures using appropriate indicators are required to reduce these variations. American Society for Gastrointestinal Endoscopy and European Society of Gastrointestinal Endoscopy have announced the EUS quality indicators. Here, we reviewed the quality indicators of the EUS procedure in the current published guidelines.

Introduction Endoscopic retrograde cholangiopancreatography (ERCP) plays an indispensable role in treating pancreato-biliary diseases but carries a risk of post-ERCP pancreatitis (PEP). Despite advances in the prevention strategies, prevention of PEP remains imperfect, necessitating more refined hydration methods. This study investigates the effectiveness of lactated Ringer’s solution versus plasma solution in preventing PEP.Method and analysis This multicentre, double-blind, randomised controlled trial, will be initiated by the investigator-sponsor, and conducted in three tertiary centres in South Korea. The aim of this study is to assess the effectiveness of hydration in preventing PEP in patients with naïve papillae. It will target patients with naïve papillae, focusing on those at medium to high risk of PEP. Patients aged ≤18 years and those with serious comorbidities, acute/chronic pancreatitis and various other medical conditions will be excluded. Eligible participants will be randomly assigned into two arms in equal numbers: (1) PEP prevention using lactated Ringer’s solution and (2) PEP prevention using plasma solution. The primary outcome of this study will be the occurrence of PEP, and secondary outcomes will be additional risk factors and potential adverse events related to ERCP. With a total enrolment of 844 patients, the study will be able to detect significant differences between the intervention arms.Ethics and dissemination Ethical approval is obtained from each institution (Asan Medical Centre, 2023-0382; Seoul National University Hospital, H-2302-05-1404; Samsung Medical Centre, SMC 2023-02-001-009). All participants provided informed consent following clear explanation of the study procedures. The results of the study will be disseminated in peer-reviewed journals and research conferences.Trial registration number NCT05832047.Protocol version Ver 4.1 (2023).

Background/Aims: Patients with active cancer frequently develop venous thromboembolism (VTE). However, there is little data about VTE in patients with advanced cholangiocarcinoma (CCA). Therefore, we investigated the clinical significance of VTE in patients with advanced CCA. Methods: We analyzed the data of a total of 332 unresectable CCA patients diagnosed between 2010 and 2020 in this retrospective study. We investigated the incidence and risk factors for VTE, and its effect on survival in patients with advanced CCA. Results: During a median follow-up of 11.6 months, 118 patients (35.5%) developed VTE. The cumulative incidence of VTE was 22.4% (95% confidence interval [CI], 0.18 to 0.27) at 3 months and 32.8% (95% CI, 0.27 to 0.38) at 12 months. Major vessel invasion was an independent risk factor for VTE (hazard ratio, 2.88; 95% CI, 1.92 to 4.31; p

Objective Romosozumab is increasingly employed to manage osteoporosis. However, no studies have analyzed its effects on recent osteoporotic vertebral compression fractures (OVCFs). Therefore, this study aimed to evaluate the efficacy of romosozumab compared with teriparatide in managing OVCFs. Methods The electronic medical records of postmenopausal patients with recent OVCFs who were administered romosozumab or teriparatide for one year from March 2018 to August 2022 were retrospectively reviewed. We compared the 2 groups for demographics, radiological outcomes (compression ratio, Cobb angle, and bone mineral density [BMD]), and clinical outcomes (Numerical Rating Scale [NRS] for back pain). Results Fifty-five patients with OVCFs, 32 patients treated with romosozumab and 23 with teriparatide, were included in this study. The change of BMD (g/cm2) values was significantly higher (p = 0.016) in the romosozumab (0.04 ± 0.06) than in the teriparatide group (0.00 ± 0.08) in the femur total. Furthermore, in subgroup analysis, the change of BMD (g/cm2) values in the lumbar spine was significantly higher (p = 0.016) in the romosozumab (0.12 ± 0.06) than in the teriparatide group (0.07 ± 0.06) in the lumbar spine. The decrease in NRS was significantly higher (p = 0.013) in the romosozumab (6.6 ± 2.0) than in the teriparatide group (5.5 ± 2.1). However, there was no significant difference in radiologic outcomes between the 2 groups. Conclusion Our findings suggest that romosozumab may be more effective than teriparatide in treating OVCFs in postmenopausal females, particularly in improving BMD and reducing back pain as measured by NRS.

Objective Cerebrospinal fluid (CSF) leakage is a major concern related to anterior cervical decompression and fusion for ossification of the posterior longitudinal ligament (OPLL). We propose a management algorithm for CSF leakage following anterior cervical decompression and fusion for OPLL involving the use of pump-regulated volumetric continuous lumbar drainage. Methods We retrospectively reviewed patients who underwent anterior cervical decompression and fusion for OPLL and were managed with the proposed algorithm between March 2018 and July 2022. The proposed management algorithm for CSF leakage by pump-regulated volumetric continuous lumbar drainage was as follows. On exposure of the arachnoid membrane with or without CSF leakage, a dural sealant patch was applied to manage the dural defect. In case of persistent CSF leakage despite application of the dural sealant patch, patients underwent pump-regulated volumetric continuous lumbar drainage. Results Fifty-one patients were included in the study. CSF leakage occurred in 14 patients. Of these 14 patients, 9 patients underwent lumbar drain insertion according to the proposed management algorithm. Successful resolution of CSF leakage was observed in 8 of the 9 patients who underwent lumbar drainage. All patients were encouraged to ambulate without concern of CSF overdrainage due to gravity, because it could be avoided with pump-regulated volumetric continuous CSF drainage. Therefore, complications associated with absolute bed rest or CSF overdrainage were not observed. Conclusion The proposed management algorithm with pump-regulated volumetric continuous lumbar drainage showed safety and efficacy for management of CSF leakage following anterior decompression and fusion for OPLL.

Summary: In pancreatic ductal adenocarcinoma (PDAC), no recurrent metastasis-specific mutation has been found, suggesting that epigenetic mechanisms, such as DNA methylation, are the major contributors of late-stage disease progression. Here, we performed the first whole-genome bisulfite sequencing (WGBS) on mouse and human PDAC organoid models to identify stage-specific and molecular subtype-specific DNA methylation signatures. With this approach, we identified thousands of differentially methylated regions (DMRs) that can distinguish between the stages and molecular subtypes of PDAC. Stage-specific DMRs are associated with genes related to nervous system development and cell-cell adhesions, and are enriched in promoters and bivalent enhancers. Subtype-specific DMRs showed hypermethylation of GATA6 foregut endoderm transcriptional networks in the squamous subtype and hypermethylation of EMT transcriptional networks in the progenitor subtype. These results indicate that aberrant DNA methylation contributes to both PDAC progression and subtype differentiation, resulting in significant and reoccurring DNA methylation patterns with diagnostic and prognostic potential.

Background: Endoscopic ultrasound-guided biliary drainage (EUS-BD), classified as choledochoduodenostomy (CDS) and hepaticogastrostomy (HGS), is a feasible and effective alternative for distal malignant biliary obstruction (MBO) in failed endoscopic retrograde cholangiopancreatography. However, the preferred technique for better outcomes has not yet been evaluated. Objectives: We compared the long-term outcomes between the techniques. Design: Retrospective comparative study. Methods: We reviewed consecutive patients who underwent EUS-CDS or EUS-HGS with transmural stent placement for distal MBO between 2009 and 2022. The primary outcome was the stent patency. The secondary outcomes were technical and clinical success, adverse events (AEs) of each technique, and independent risk factors for stent dysfunction. Results: In all, 115 patients were divided into EUS-CDS ( n = 56) and EUS-HGS ( n = 59) groups. Among them, technical success was achieved in 98.2% of EUS-CDS and 96.6% of EUS-HGS groups. Furthermore, clinical success was 96.4% in EUS-CDS and 88.1% in EUS-HGS groups, without significant difference ( p = 0.200). The mean duration of stent patency for EUS-CDS was 770.3 days while that for EUS-HGS was 164.9 days ( p = 0.010). In addition, the only independent risk factor for stent dysfunction was systematic treatment after EUS-BD [hazard ratio and 95% confidence interval 0.238 (0.066–0.863), p = 0.029]. The incidence of stent dysfunction of EUS-HGS was higher than EUS-CDS (35.1% versus 18.2%, 0.071), despite no significant differences even in late AEs. Conclusion: In distal MBO, EUS-CDS may be better than EUS-HGS with longer stent patency and fewer AEs. Furthermore, systematic treatment after EUS-BD is recommended for the improvement of stent patency.

Background/Aims A previous history of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a risk factor for PEP, suggesting that there may be a genetic predisposition to PEP. However, nothing is known about this yet. The aim of this study was to identify genetic variations associated with PEP. Methods A cohort of high-risk PEP patients was queried from December 2016 to January 2019. For each PEP case, two propensity score-matched controls were selected. Whole exome sequencing was performed using blood samples. Genetic variants reported to be related to pancreatitis were identified. To discover genetic variants that predispose to PEP, a logistic regression analysis with clinical adjustment was performed. Gene-wise analyses were also conducted. Results Totals of 25 PEP patients and 50 matched controls were enrolled. Among the genetic variants reported to be associated with pancreatitis, only CASR rs1042636 was identified, and it showed no significant difference between the case and control groups. A total of 54,269 non-synonymous variants from 14,313 genes was identified. Logistic regression analysis of these variants showed that the IRF2BP1 rs60158447 GC genotype was significantly associated with the occurrence of PEP (odds ratio 2.248, FDR q value = 0.005). Gene-wise analyses did not show any significant results. Conclusions This study found that the IRF2BP1 gene variant was significantly associated with PEP. This genetic variant is a highly targeted PEP risk factor candidate and can be used for screening high-risk PEP groups before ERCP through future validation. (ClinicalTrials.gov no. NCT02928718)

Background/Aims: The combinatorial effects of prophylactic methods for postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) in patients with risk factors remain unclear. In this network meta-analysis, we compared the efficacy of various prophylactic strategies to decrease the risk of PEP among patients with risk factors. Methods: A systematic review was performed to identify randomized controlled trials from PubMed, Embase, and the Cochrane Library through July 2021. We used frequentist network meta-analysis to compare the rates of PEP among patients who received prophylactic treatments as follows: class A, rectal nonsteroidal anti-inflammatory drugs; class B, prophylactic pancreatic stent; class C, aggressive hydration; or control, no prophylaxis or active control. We selected those studies that included patients with risk factors for PEP. Results: We identified 19 trials, comprising 4,328 participants. Class ABC (odds ratio [OR], 0.08; 95% confidence interval [CI], 0.03 to 0.24), class AC (OR, 0.10; 95% CI, 0.02 to 0.47), class AB (OR, 0.12; 95% CI, 0.05 to 0.26), class BC (OR, 0.13; 95% CI, 0.04 to 0.41), class A (OR, 0.16; 95% CI, 0.05 to 0.50), and class B (OR, 0.26; 95% CI, 0.14 to 0.46), were associated with a reduced risk of PEP as compared to that of the control. The most effective prophylaxis was ABC (0.87), followed by AC (0.68), AB (0.65), BC (0.56), A (0.49), and B (0.24) according to P-score. Conclusions: The results of this network meta-analysis suggest that the more prophylactic methods are employed, the better the outcomes. It appears that for patients with risk factors, we need to prevent PEP through the use of these well proven combination strategies.

This article provides evidence-based recommendations and expert opinions to aid urologists in making optimal decisions regarding managing urolithiasis in various clinical scenarios. The most frequently asked questions by urologists in their clinical practice have been collected and answered in the form of FAQs; based on the latest evidence and expert opinions. The natural history of urolithiasis is divided into active treatment and silent phases, with the active treatment stage divided into typical and special situations and peri-treatment management. The authors address 28 key questions, offering practical guidance for the proper diagnosis, treatment, and prevention of urolithiasis in clinical practice. This article is expected to be served as a valuable resource for urologists.

Abstract Background The natural course of polypoid lesions in the ureter during ureteroscopic stone surgery was not yet clarified. Methods Patient data were collected prospectively from six teaching hospitals between 2019 and 2021. Patients with polypoid lesions in the ureter distal to ureteral stones were included during ureteroscopy. Computed tomography was performed on all enrolled patients three months after the procedure. Follow-up ureteroscopy was performed only if the patient consented, due to the need for general anesthesia and ethical considerations. Results Among the 35 patients who were followed up, 14 had fibroepithelial polyps and 21 had inflammatory polyps. Twenty of the followed-up patients underwent ureteroscopy, and nine of them had fibroepithelial polyps. Although fibroepithelial polyps did not disappear in the follow-up ureteroscopy (p = 0.002), the rate of postoperative hydronephrosis was not higher in the fibroepithelial group than in the inflammatory group. Postoperative ureteral stricture and moderate-to-severe hydronephrosis were found to be closely related to the number of resected polyps, regardless of the type of polyp (p = 0.014 and 0.006, respectively). Conclusion Fibroepithelial polyps in the ureter may persist after treatment of adjacent ureter stones. However, conservative management may be preferable to active removal of ureteral polyps because fibroepithelial polyps may not contribute to clinically significant hydronephrosis after surgery, and inflammatory polyps disappear spontaneously. Hasty resections of polyps may increase the risk of ureteral stricture.

Abstract Background CT prediction of resectability and prognosis following neoadjuvant treatment (NAT) in patients with pancreatic ductal adenocarcinoma (PDAC) remains challenging. This study aims to determine whether addition of 18F-fluorodeoxyglucose (FDG) postiron emission tomography (PET)/MRI and carbohydrate antigen (CA) 19–9 to contrast-enhanced CT (CECT) can improve accuracy of predicting resectability compared to CECT alone and predict prognosis in PDAC patients after NAT. Methods In this retrospective study, 120 PDAC patients (65 women; mean age, 66.7 years [standard deviation, 8.4]) underwent CECT, PET/MRI, and CA 19–9 examinations after NAT between January 2013 and June 2021. Three board-certified radiologists independently rated the overall resectability on a 5-point scale (score 5, definitely resectable) in three sessions (session 1, CECT; 2, CECT plus PET/MRI─no FDG avidity and no diffusion restriction at tumor-vessel contact indicated modification of CECT scores to ≥ 3; 3, CECT plus PET plus CA 19–9─no FDG avidity at tumor-vessel contact and normalized CA 19–9 indicated modification of CECT scores to ≥ 3). Jackknife free-response receiver operating characteristic method and generalized estimating equations were used to compare pooled area under the curve (AUC), sensitivity, and specificity of three sessions. Predictors for recurrence-free survival (RFS) were assessed using Cox regression analyses. Results Each session showed different pooled AUC (session 1 vs. 2 vs. 3, 0.853 vs. 0.873 vs. 0.874, p = 0.026), sensitivity (66.2% [137/207] vs. 86.0% [178/207] vs. 84.5% [175/207], p

Abstract Background Although diabetes is reportedly associated with the occurrence of acute pancreatitis (AP), the risk of AP according to the duration and severity of diabetes is not yet clear. We aimed to investigate the risk of AP based on glycemic status and the presence of comorbidities using a nationwide population-based study. Methods We enrolled 3,912,496 adults who underwent health examinations under the National Health Insurance Service in 2009. All participants were categorized by glycemic status as normoglycemic, impaired fasting glucose (IFG), or diabetes. Baseline characteristics and the presence of comorbidities at the time of health check-up were investigated, and the occurrence of AP was followed up until 31 December 2018. We estimated the adjusted hazard ratios (aHRs) for AP occurrence according to the glycemic status, duration of diabetes (new-onset, duration

Acute pancreatitis can range from a mild, self-limiting disease requiring no more than supportive care, to severe disease with life-threatening complications. With the goal of providing a recommendation framework for clinicians to manage acute pancreatitis, and to contribute to improvements in national health care, the Korean Pancreatobiliary Association (KPBA) established the Korean guidelines for acute pancreatitis management in 2013. However, many challenging issues exist which often lead to differences in clinical practices. In addition, with newly obtained evidence regarding acute pancreatitis, there have been great changes in recent knowledge and information regarding this disorder. Therefore, the KPBA committee underwent an extensive revision of the guidelines. The revised guidelines were developed using the Delphi method, and the main topics of the guidelines include the following: diagnosis, severity assessment, initial treatment, nutritional support, convalescent treatment, and the treatment of local complications and necrotizing pancreatitis. Specific recommendations are presented, along with the evidence levels and recommendation grades.

Abstract Patients with acute pancreatitis (AP) may have an increased risk of cardiovascular disease (CVD). Few studies have dealt with the association between AP and the risk of CVD in diabetic patients. This study aimed to investigate the risk of CVD and mortality in patients with diabetes and AP history by analyzing a large-scale national claims database in Korea. Data from the Korean National Health Insurance Service database was analyzed. A total of 2,746,988 participants with type 2 diabetes mellitus that underwent a general health examination between 2009 and 2012 were enrolled. The participants were divided into two groups according to AP history (yes or no) prior to the examination date, and follow-up data until 2018 was analyzed. The primary endpoint was the occurrence of stroke, myocardial infarction (MI), or death. The Cox proportional hazards regression analysis was used to evaluate the association between AP history and the risk of stroke, MI, and mortality. After exclusion, the included number of participants with and without AP history were 3,810 and 2,258,910, respectively. The presence of AP history showed a significantly higher incidence of stroke, MI, and mortality. The adjusted hazard ratios (95% confidence interval) for the risk of stroke, MI, and mortality were 1.534 (1.342–1.753), 1.998 (1.733–2.303), and 2.353 (2.200–2.515), respectively. Age

Objectives The hypertriglyceridaemic waist (HTGW) phenotype, an indicator to assess metabolic syndrome, could be a useful predictive marker for the risk of acute pancreatitis. This study aimed to evaluate the association between the HTGW phenotype and the risk of acute pancreatitis with a nationwide population-based cohort.Design A retrospective, nationwide cohort study.Setting Registry of health check-up result from Korean National Health Insurance Service.Participants A total of 3 912 551 adults who underwent health checkups under the National Health Insurance Service in 2009 were enrolled in this study.Interventions Subjects with both increased waist circumference (WC) and elevated blood triglyceride concentrations were defined as the HTGW phenotype. The participants were divided into four groups, classified as NWNT (normal WC-normal triglycerides), EWNT (elevated WC-normal triglycerides), NWET (normal WC-elevated triglycerides) and HTGW. The WC triglyceride index (WTI) is a quantitative indicator of the HTGW phenotype which is calculated by multiplying WC (cm) by triglyceride levels (mmol/L).Primary outcome measure The subjects were followed until 31 December 2018. The adjusted HRs of acute pancreatitis in each group were estimated.Results During the follow-up, there were a total of 8933 of acute pancreatitis occurrences. The incidence of acute pancreatitis in all subjects was 0.278 per 1000 person-year. The HTGW group had the highest incidence (0.444), followed by the NWET (0.381), and EWNT (0.316) groups. The HTGW group had a significant higher incidence of acute pancreatitis than the NWNT groups (HR 1.364 (95% CI 1.279 to 1.454)). The risk of acute pancreatitis steadily increased as the WTI increased (HR 1.847 (95% CI 1.657 to 2.058) in 10th decile).Conclusions The HTGW phenotype is confirmed to be an independent risk factor that increases the risk of acute pancreatitis.

Background/Aims: Three-dimensional cultures of human pancreatic cancer tissue also known as “organoids” have largely been developed from surgical specimens. Given that most patients present with locally advanced and/or metastatic disease, such organoids are not representative of the majority of patients. Therefore, we used endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) to collect pancreatic cancer tissues from patients with advanced pancreatic cancer to create organoids, and evaluated their utility in pancreatic cancer research. Methods: Single-pass EUS-FNA samplings were employed to obtain the tissue for organoid generation. After establishment of the organoid, we compared the core biopsy tissues with organoids using hematoxylin and eosin staining, and performed whole exome sequencing (WES) to detect mutational variants. Furthermore, we compared patient outcome with the organoid drug response to determine the potential utility of the clinical application of such organoid-based assays. Results: Organoids were successfully generated in 14 of 20 tumors (70%) and were able to be passaged greater than 5 times in 12 of 20 tumors (60%). Among them, we selected eight pairs of organoid and core biopsy tissues for detailed analyses. They showed similar patterns in hematoxylin and eosin staining. WES revealed mutations in KRAS, TP53, CDKN2A, SMAD4, BRCA1, and BRCA2 which were 93% homologous, and the mean nonreference discordance rate was 5.47%. We observed moderate drug response correlations between the organoids and clinical outcomes in patients who underwent FOLFIRINOX chemotherapy. Conclusions: The established organoids from EUS-FNA core biopsies can be used for a suitable model system for pancreatic cancer research.

A lumen-apposing metal stent (LAMS) is a saddle-shaped stent with large flanges at both ends, thereby preventing stent migration and helping with approximation of the adjacent structures. We report the case of a 25-year-old female with remnant choledochal cyst which was successfully treated with LAMS after initial treatment failure with a plastic stent. Although complete excision of the cyst is the definite treatment of choledochal cysts, endoscopic ultrasonography-guided cystoduodenostomy can be considered in cases wherein surgery is not feasible and dysplasia is not present. LAMS may be preferred to plastic stents for effective resolution of remnant choledochal cyst and prevention of ascending infection.

Endoscopic ultrasound (EUS)-guided ablation procedures are emerging as minimally invasive therapeutic methods that address unmet needs in treatment methods for pancreatic cystic lesions (PCLs). Several studies have been published on the feasibility and efficacy of EUS-guided chemical ablation for PCLs, but further research on the actual treatment effects and real clinical benefits is needed. EUS-guided radiofrequency ablation for PCLs has recently been introduced. This review aimed to describe the broad framework of EUS-guided ablation treatments for PCLs and to present a blueprint for the future of these treatment methods.

Background/Aims: Endoscopic ultrasonography (EUS) provides high-resolution images and is superior to computed tomography (CT) scan in diagnosing small pancreatic ductal adenocarcinoma (PDAC). As a result, the use of EUS for early detection of PDAC has attracted attention. This study aimed to identify the clinical and radiological characteristics of patients with PDAC diagnosed by EUS but not found on CT scan. Methods: The medical records of patients diagnosed with PDAC at 12 tertiary referral centers in Korea from January 2003 to April 2019 were reviewed. This study included patients with pancreatic masses not clearly observed on CT scan but identified on EUS. The clinical characteristics and radiological features of the patients were analyzed, and survival analysis was performed. Results: A total of 83 patients were enrolled. The most common abnormal CT findings other than a definite mass was pancreatic duct dilatation, which was identified in 61 patients (73.5%). All but four patients underwent surgery. The final pathologic stages were as follows: IA (n=31, 39.2%), IB (n=8, 10.1%), IIA (n=20, 25.3%), IIB (n=17, 21.5%), III (n=2, 2.5%), and IV (n=1, 1.4%). The 5-year survival rate of these patients was 50.6% (95% confidence interval, 38.8% to 66.7%). Elevated liver function testing and R1 resection emerged as significant predictors of mortality in the multivariable Cox regression analysis. Conclusions: This multicenter study demonstrated favorable long-term prognosis in patients with PDAC diagnosed by EUS but indeterminate on CT scan. EUS should be considered for patients with suspected PDAC but indeterminate on CT scan.

Abstract Background Nafamostat mesilate decreases the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, no studies have administered nafamostat mesilate after ERCP. So we investigated if the infusion of nafamostat mesilate after ERCP can affect the post-ERCP pancreatitis (PEP) in high-risk patients. Methods In a tertiary hospital, 350 high-risk patients of PEP were reviewed retrospectively. Among them, 201 patients received nafamostat mesilate after ERCP. Patient-related and procedure-related risk factors for PEP were collected. We performed a propensity score matching to adjust for the significant different baseline characteristics. The incidence and severity of PEP were evaluated according to the infusion of nafamostat mesilate. The risk factors of PEP were also analyzed by multivariate logistic regression. Results The baseline characteristics were not different after the matching. The PEP rate (17.4% vs. 10.3%, P = 0.141) was insignificant. Among the PEP patients, mild PEP was significantly higher in the nafamostat mesilate group (85.7% vs. 45.5%, P = 0.021). Only one patient in the nafamostat mesilate group developed severe PEP. Although young age (odds ratio [OR] 3.60, 95% CI 1.09–11.85, P = 0.035) was a risk factor, nafamostat mesilate (odds ratio [OR] 0.30, 95% CI 0.09–0.98, P = 0.047) was a protective factor for moderate to severe PEP. Conclusions The administration of nafamostat mesilate after ERCP in high-risk patients was not effective in preventing PEP, but may attenuate the severity of PEP.

Purpose: A prostate-specific antigen (PSA) cutoff of 4 ng/mL has been widely used for prostate cancer screening in population-based settings. However, the accuracy of PSA below 4 ng/mL as a cutoff for diagnosing prostate cancer in a hospital setting is inconclusive. We systematically reviewed the accuracy of PSA below 4 ng/mL cutoff in a hospital setting. Materials and Methods: We systematically reviewed the literature by searching major databases until March 2020, and a meta-analysis and quality assessment were performed. Results: A total of 11 studies were included at the completion of the screening process. The meta-analysis showed a sensitivity of 0.92 and a specificity of 0.16 for a PSA cutoff below 4 ng/mL. The area under the hierarchical summary receiver operating characteristic curve was 0.87, the positive likelihood ratio was 1.23, the negative likelihood ratio was 0.46, and the diagnostic odds ratio was 2.64. PSA sensitivities and specificities varied according to the cutoff range: 0.94 and 0.17 for 2 to 2.99 ng/mL, and 0.92 and 0.16 for 3 to 3.99 ng/mL, respectively. No significant differences in the sensitivity and specificity of PSA cutoffs in the range of 2 to 2.99 ng/mL and 3 to 3.99 ng/mL were found. Conclusions: Although a PSA cutoff

Common bile duct (CBD) stones are prevalent in 11% to 21% of patients with gallstones and can cause various clinical manifestations, from biliary colic to biliary sepsis. The treatment of choice is endoscopic retrograde cholangiopancreatography, but approximately 5% to 10% of CBD stones are difficult to remove using these conventional endoscopic methods. Although percutaneous transhepatic cholangioscopy and lithotripsy can be used as an alternative, it can be technically demanding and risky if the intrahepatic duct is not dilated. We report a case of a large CBD stone that was successfully removed using percutaneous transcholecystic cholangioscopy.

Purpose: Robot-assisted radical cystectomy (RARC) optimizes patient recovery and has outcomes comparable with those of open surgery. This study aimed to compare the perioperative and oncologic outcomes of RARC in female and male patients. Materials and Methods: A retrospective cohort study of the Korean Robot-Assisted Radical Cystectomy Study Group database from 2007 to 2019 identified 749 patients (111 females and 638 males). Female were matched 1:1 to male by propensity score matching using a logistic regression. We compared perioperative outcomes, oncologic outcomes, and complications between the two groups. Results: The female group had comparable perioperative outcomes to the male group in terms of operation time, lymph node yield, positive surgical margin, blood transfusion rate, and hospitalization days. Complication rate and grade were not significantly different between the two groups. The most common complication was infection in female and gastrointestinal complications in male. We compared the 5-year overall, disease-specific, and recurrence-free survival of female and male: 58.2% vs. 68.0% (p=0.495), 75.7% vs. 79.3% (p=0.645), and 40.8% vs. 53.5% (p=0.913), respectively. On multivariable analysis, T stage (>T2), postoperative complications, and positive surgical margin were prognostic factors of poor outcome. Sex was not an independent predictor of the three survivals. Conclusions: The current study suggests that RARC in female has comparable perioperative and oncologic outcomes to those in male. The complication rate of RARC in female was comparable to that in male, but the type of complications differed by sex.

BackgroundAs of date, endoscopic biliary stenting with plastic stent (PS) and self-expandable metal stent (SEMS) have been widely used for the palliation of biliary tract strictures. However, these two stents have several limitations regarding the management of biliary strictures caused by intrahepatic and hilar cholangiocarcinoma. PS has short patency and also risks bile duct injury and bowel perforation. SEMS is difficult to revise when occluded by tumor overgrowth. To compensate for such shortcomings, we developed a novel biliary metal stent with coil-spring structure. The aim of this study was to investigate the feasibility and efficacy of the novel stent in a swine model.MethodsThe biliary stricture model was prepared in six mini-pigs using endobiliary radiofrequency ablation. Conventional PS (n=2) and novel stents (n=4) were deployed endoscopically. Technical success was defined as successful stent placement and clinical success was defined as >50% reduction of serum bilirubin level. Adverse events, stent migration, and endoscopic removability for one month after stenting were also assessed.ResultsThe biliary stricture was successfully created in all animals. The technical success rate was 100 %, and the clinical success rate was 50% in the PS group and 75% in the novel stent group. In the novel stent group, the median pre- and post-treatment serum bilirubin levels were 3.94 and 0.3 mg/dL. Stent migration occurred in two pigs and two stents were removed by endoscopy. There was no stent-related mortality.ConclusionsThe newly designed biliary metal stent was feasible and effective in a swine biliary stricture model. Further studies are needed to verify the usefulness of the novel stent in the management of biliary strictures.

ABSTRACT Background This multicenter multinational RCT designed to compare the efficacy of suppository indomethacin and NAC for prevention of PEP. Methods: During a 6-month period, all of the ERCP cases in seven referral centers were randomly assigned to receive either 1200 mg oral NAC, indomethacin suppository 100 mg, 1200 mg oral NAC plus indomethacin suppository 100 mg or placebo 2 hours before ERCP. The primary outcomes were the rate and severity of any PEP. Results: A total of 432 patients included (41.4% male). They were originally citizens of 6 countries (60.87% Caucasian). They were randomly allocated to receive either NAC (group A, 84 cases), rectal indomethacin (group B, 138 cases), NAC + rectal indomethacin (group C, 115 cases) or placebo (group D, 95 cases). The rate of PEP in groups A, B and C in comparison with placebo were 10.7%, 17.4%, 7.8% vs 20% (P=0.08, 0.614 & 0.01 respectively). The NNT for NAC, indomethacin and NAC + indomethacin was 11, 38 and 8 respectively. Conclusion: Oral NAC is more effective than rectal indomethacin when compared to placebo for prevention of PEP and the combination of NAC and Indomethacin had the lowest incidence of PEP and may have synergistic effect in preventing of PEP (IRCT20201222049798N1; 29/12/2020).

BackgroundThe complete resection rate of pancreatic cancer has increased because of the advent of efficacious first-line treatments for unresectable pancreatic cancer. Still, strategies regarding adjuvant therapy after neoadjuvant FOLFIRINOX treatment remain to be established.MethodsData on 144 patients with borderline resectable and locally advanced pancreatic cancer who underwent resection after neoadjuvant FOLFIRINOX between January 2013 and April 2021 were retrospectively reviewed.ResultsAmong the study patients, 113 patients (78.5%) were diagnosed with borderline resectable pancreatic cancer and 31 patients (21.5%) were diagnosed with locally advanced pancreatic cancer. Seventy-five patients (52.1%) received radiotherapy before surgery. After radical resection, 84 patients (58.3%) received 5-fluorouracil-based adjuvant therapy and 60 patients (41.7%) received non-5-fluorouracil-based adjuvant therapy. Adjuvant therapy with 5-fluorouracil-based regimen [hazard ratio (HR), 0.43 (95% CI, 0.21–0.87); p = 0.019], preoperative assessment as locally advanced pancreatic cancer [HR, 2.87 (95% CI, 1.08–7.64); p = 0.035], positive resection margin [HR, 3.91 (95% CI, 1.71–8.94); p = 0.001], and presence of pathologic lymph node involvement [HR, 2.31 (95% CI, 1.00–5.33), p = 0.050] were associated with decreased recurrence-free survival. Adjuvant therapy with 5-fluorouracil-based regimen [HR, 0.35 (95% CI, 0.15–0.84); p = 0.018], positive resection margin [HR, 4.14 (95% CI, 1.75–9.78); p = 0.001], presence of pathologic lymph node involvement [HR, 3.36 (95% CI, 1.23–9.15); p = 0.018], poor differentiation [HR, 5.69 (95% CI, 1.76–18.36); p = 0.004], and dose reduction during adjuvant therapy [HR, 1.78 (95% CI, 1.24–24.37); p = 0.025] were associated with decreased overall survival.ConclusionsThe 5-fluorouracil-based adjuvant therapy seems to be the proper adjuvant therapy for patients who received neoadjuvant FOLFIRINOX for borderline resectable and locally advanced pancreatic cancer.

Background: Nanoliposomal encapsulation of irinotecan (nal-IRI) with 5-fluorouracil and leucovorin (5-FU/LV) has shown a survival benefit for gemcitabine-pretreated patients with metastatic pancreatic adenocarcinoma (mPAC). The aim of this study was to evaluate the effectiveness and safety of nal-IRI with 5-FU/LV for use beyond second-line treatment after standard frontline therapy for mPAC. Method: This multicenter, retrospective, non-comparative observational study included mPAC patients who received nal-IRI plus 5-FU/LV as third- or later-line therapy after disease progression on first-line FOLFIRINOX (FFX) or gemcitabine plus nab-paclitaxel. Results: In all, 128 patients who received nal-IRI plus 5-FU/LV beyond second-line treatment between October 2017 and July 2021 were analyzed. Most patients (82%) received nal-IRI plus 5-FU/LV as a third-line treatment. The median overall survival (OS) was 4.9 months and the median progression-free survival (PFS) was 2.4 months. Patients with better Eastern Cooperative Oncology Group (ECOG) performance status experienced significantly longer OS (ECOG 0, 8.7 months; ECOG 1, 4.8 months; ECOG 2, 2.9 months; p < 0.001) and PFS (3.9 months; 2.1 months; 1.5 months; p = 0.019). Patients who had not been previously treated with FFX or had a time to progression of 7 months or more on FFX experienced longer OS and PFS than those who did not (6.1 months and 5.6 versus 4.1 months, p = 0.053; 3.6 months and 2.4 versus 2.1 months, p = 0.002). The most common adverse events were neutropenia (56%) and anemia (51%). Conclusion: Our real-world data indicated that nal-IRI plus 5-FU/LV can be effective not only as second-line therapy, but also as third-line or later-line treatment in selected patients. Nal-IRI plus 5-FU/LV may be particularly beneficial for the survival of patients that maintain good general condition or those with favorable prior experience to irinotecan.

Background/Aims: Although many studies have reported the promising effect of neoadjuvant treatment for borderline resectable pancreatic cancer (BRPC) to increase resectability, only a few studies have recommended the use of first-line chemotherapeutic agents as neoadjuvant treatment for BRPC. The current study compared clinical outcomes between gemcitabine and FOLFIRINOX (5-fluorouracil, leucovorin, oxaliplatin, and irinotecan) in patients with BRPC. Methods: In this single-center retrospective study, 100 BRPC patients treated with neoadjuvant chemotherapy and resection from 2008 to 2018 were reviewed. Clinical outcomes included overall survival, resectability, and recurrence patterns after gemcitabine or FOLFIRINOX treatment. Results: For neoadjuvant chemotherapy, gemcitabine was administered to 34 patients and FOLFIRINOX to 66. Neoadjuvant radiotherapy was administered to 27 patients (79.4%) treated with gemcitabine and 19 (28.8%) treated with FOLFIRINOX (p

Abstract Background FOLFIRINOX (FFX) and Gemcitabine plus nab-paclitaxel (GnP) have been recommended as the first-line chemotherapy for metastatic pancreatic cancer (mPC). However, the evidence is lacking comparing not only two regimens, but also sequential treatment (FFX–GnP vs. GnP–FFX). Methods Data of 528 patients (FFX, n = 371; GnP, n = 157) with mPC were collected retrospectively. Propensity score matching was conducted to alleviate imbalance of the two groups. Overall survival (OS), progression free survival (PFS), and toxicity of patients were analyzed. Results In the whole population, OS (12.5 months vs. 10.3 months, P = 0.05) and PFS (7.1 months vs. 5.8 months, P = 0.02) were longer in the FFX group before matching and after matching (OS: 11.8 months vs. 10.3 months, P = 0.02; PFS: 7.2 months vs. 5.8 months, P

Abstract Background There is a lack of studies regarding the optimal timing for endoscopic retrograde cholangiopancreatography (ERCP) in patients with cholangitis caused by distal malignant biliary obstruction (MBO). This study aims to investigate the optimal timing of ERCP in patients with acute cholangitis associated with distal MBO with a naïve papilla. Methods A total of 421 patients with acute cholangitis, associated with distal MBO, were enrolled for this study. An urgent ERCP was defined as being an ERCP performed within 24 h following emergency room (ER) arrival, and early ERCP was defined as an ERCP performed between 24 and 48 h following ER arrival. We evaluated both 30-day and 180-day mortality as primary outcomes, according to the timing of the ERCP. Results The urgent ERCP group showed the lowest 30-day mortality rate (2.2%), as compared to the early and delayed ERCP groups (4.3% and 13.5%) (P

Background/Aims: There has been growing evidence on the utility of neoadjuvant FOLFIRINOX in borderline resectable (BR) or locally advanced (LA) pancreatic cancer. However, factors predicting survival in these patients remain to be identified, and we aimed to identify these prognostic factors. Methods: Between January 2013 and April 2017, patients with BR or LA pancreatic cancer who received FOLFIRINOX as their initial treatment were identified. Demographic data and clinical outcomes, including the chemotherapy response, conversion to resection, and survival, were reviewed. Results: A total of 117 patients with BR (n=39) or LA (n=78) pancreatic cancer were included. Of these patients, 29 (24.8%) underwent curative surgery, and R0 resection was achieved in 21 patients (72.4%). The median progression-free survival and overall survival time of all patients were 11.6 and 19.0 months, respectively. In resected patients, the median relapse-free survival and overall survival times were 14.8 and 28.6 months, respectively. In the multivariate Cox model, the lowest level of serum carbohydrate antigen 19-9 (CA 19-9) and resection after FOLFIRINOX were independent factors for improved overall survival. In the subgroup analysis of patients with initial 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET) images, the maximum standardized uptake value (SUVmax) of the pancreatic mass was also shown as an independent factor for improved overall survival. Conclusions: In patients with BR or LA pancreatic cancer, FOLFIRINOX is a valuable neoadjuvant treatment that enables curative surgery in approximately one-quarter of patients and significantly improves overall survival. In these patients, the prognosis can be estimated using the lowest level of serum CA 19-9, operative status, and initial FDG-PET SUVmax.

Background/Aims Cholangiocarcinoma (CCA) is a rare but aggressive disease with a poor survival. Recent trials have shown improved survival with intraductal radiofrequency ablation (RFA) therapy. We performed a systematic review with meta-analysis to determine the survival benefit of endoscopic RFA for unresectable extrahepatic CCA with malignant biliary obstruction (MBO). Methods A systematic search from 1970 to 2020 was performed in MEDLINE, EMBASE, Cochrane Library, and ClinicalTrials. gov. We selected eligible studies reporting relative risks, hazard ratios (HRs), or odds ratios, adjusted by controlling for confounding factors of survival rate and stent patency duration, among patients with extrahepatic CCA with MBO treated with RFA with stent insertion or stent insertion only. Results A total of eight trials (three randomized and five nonrandomized) with a total of 420 patients were included in the metaanalysis. Pooled overall survival analysis favored RFA treatment with stent insertion (HR, 0.47; 95% confidence interval [CI], 0.34– 0.64; I2=47%; p=0.09); however, no significant difference was found in the duration of stent patency between the groups (HR, 0.79; 95% CI, 0.57–1.09; I2=7%; p=0.36). Conclusions RFA therapy with stent insertion may confer a survival benefit compared with stent insertion only in patients with CCA and MBO.

Abstract Background Several systemic inflammatory response (SIR) markers, including platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), lymphocyte-to-monocyte ratio (LMR), and albumin-to-globulin ratio (AGR), have emerged as prognostic markers in various cancers. The aim of this study was to explore the impact of SIR markers on the survival outcomes of unresectable intrahepatic cholangiocarcinoma (IHC) patients. Methods Patients with histologically confirmed, unresectable IHC treated with gemcitabine plus cisplatin (GP) chemotherapy in a single tertiary hospital from 2012 to 2016 were retrospectively reviewed. Progression-free survival (PFS) and overall survival (OS) were determined using unadjusted Kaplan-Meier and adjusted Cox-proportional-hazards analysis. Time-dependent receiver operating characteristic (ROC) analysis was performed to compare the performance of the SIR markers in predicting OS. Results A total of 137 patients received a median of six cycles (interquartile range [IQR], 3–11) of GP chemotherapy with a median observation time of 9.9 months (range, 1.8–54.7 months). The median PFS and OS of all patients were 7.8 months and 9.9 months, respectively. Among the SIR markers, high PLR (> 148) and high NLR (> 5) were associated with a short PFS (Hazard ratio [HR] 1.828, P = 0.006; HR 1.738, P = 0.030, respectively) and short OS (HR 2.332, P

Abstract Background Endoscopic retrograde biliary drainage (ERBD) is the treatment of choice for patients with malignant distal common bile duct (CBD) obstruction. Self-expandable metal stents (SEMS), which are commonly used in unresectable cases, have many clinical advantages, including longer stent patency. Although the expected patency of SEMS is around 8 months, it has recently been reported that the duration of SEMS’ patency in patients using aspirin is prolonged. Our study, therefore, aims to investigate the effect of aspirin on SEMS’ patency. Methods/design This is an investigator-initiated, prospective, multicenter, double-blind, randomized placebo-controlled trial that will be conducted from November 2017 in four tertiary centers in South Korea. We intend to include in our study 184 adult (aged ≥ 20 years) patients with malignant distal CBD obstruction for whom ERBD with SEMS was successfully performed. The patients will be randomly allocated to two groups, which will comprise patients who have either taken 100 mg aspirin or a placebo for 6 months after index ERBD. The primary outcome will be the rate of stent dysfunction, and the secondary outcomes will be the duration of patency, the rate of reintervention, and the occurrence of adverse events. Discussion The aspirin for metal stents in malignant distal common bile duct obstruction (AIMS) study should determine the efficacy of aspirin in maintaining metal-stent patency in patients with malignant distal CBD obstructive. Trial registration ClinicalTrials.gov, ID: NCT03279809. Registered on 5 September 2017.

Benign prostatic hyperplasia is a commonly diagnosed disease in elderly men, but elderly men with benign prostatic hyperplasia are more likely to have a lower quality of life and depressive symptoms. This study aims to examine the association benign prostatic hyperplasia patients with suicide death relative to a control group comprising individuals without benign prostatic hyperplasia. We used the Korean National Health Insurance Service-National Sample Cohort from 2006 to 2015 comprising of 193,785 Korean adults ≥40 years old, and followed-up for suicide death during the 8.7 years period. Cox-proportional hazard model was used to estimate hazard ratios for suicide among patients with benign prostatic hyperplasia. From 2006 to 2010, a total of 32,215 people were newly diagnosed with benign prostatic hyperplasia. The suicide rate of people without benign prostatic hyperplasia was 61.6 per 100,000 person-years, whereas that of patients with benign prostatic hyperplasia was 97.3 per 100,000 person-years, 1.58 times higher than the control group (p

Abstract Background Although several studies have suggested that aspirin and statins may help prevent pancreatic ductal adenocarcinoma (PDAC), this concept has been controversial. This study aimed to evaluate the association between use of statin or aspirin and PDAC in a nationwide large cohort. Methods In this nested case‐control study, we used data from a 12‐year nationwide longitudinal cohort in Korea. Cases with PDAC and controls who were matched to cases by age, sex, income, and index year at a 1:5 ratio were established. We used multivariate logistic regression analyses to identify the independent risk factors of PDAC. Results We identified a total of 827 patients with PDAC between 2007 and 2013, and included 4135 matched controls. Diabetes mellitus, chronic and acute pancreatitis, pancreatic cystic lesions, and cholelithiasis were independent risk factors for PDAC. Statin use (odds ratio [OR], 0.92; 95% confidence interval [CI] 0.76‐1.11; P = .344; adjusted OR [aOR], 0.70; 95% CI 0.56‐0.87; P = .001) was associated with a reduced risk of PDAC after correction of the confounding factors, but aspirin use (OR, 0.98; 95% CI 0.84‐1.15; P = .838; aOR 0.84; 95% CI 0.70‐1.01, P = .068) was not associated with PDAC. Among the patients with risk factors, both statin use (OR, 0.50; 95% CI 0.38‐0.66; P

Background: The aim of this study was to evaluate the efficacy and safety of gemcitabine plus nab-paclitaxel (GnP) as second-line chemotherapy following first-line FOLFIRINOX treatment failure in advanced pancreatic cancer. Methods: This was a multicenter, single-arm, open-label, phase 2 trial done at three tertiary centers in South Korea from May 2018 to December 2019. Eligible patients were aged 20 years or older, had histologically confirmed advanced pancreatic ductal adenocarcinoma, and disease progression after receiving first-line FOLFIRINOX. Patients received a second-line GnP regimen as intravenous nab-paclitaxel at a dose of 125 mg/m 2 and gemcitabine at a dose of 1000 mg/m 2 , on days 1, 8, and 15 every 4 weeks until disease progression or unacceptable toxicity. The primary outcome was survival rate at 6 months and the secondary outcomes were median progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and adverse events. This study is registered with Clinicaltrials.gov. (NCT03401827) Results: Forty patients were enrolled in the study. The survival rate at 6 months was 72.5% [95% confidence interval (CI), 59.9–87.7], achieving superiority over prespecified assumed 6-month OS rate of 20% for best supportive care only ( p