Background and Aim: Few studies compared endoscopic ultrasound (EUS)‐guided fine needle aspiration (EUS‐FNA) with endoscopic retrograde cholangiopancreatography (ERCP)‐based tissue sampling in terms of diagnostic accuracy in suspected malignant biliary obstruction. We evaluated and compared the diagnostic performance of EUS‐FNA and ERCP‐based tissue sampling.Methods: This multicenter study included 263 patients with suspected malignant biliary obstruction who underwent same‐session EUS and ERCP between 2012 and 2016.Results: Malignancies were confirmed in 239 patients (90.9%) and benign in 24 patients (9.1%). Overall diagnostic sensitivity and accuracy were 73.6% and 76.1% for EUS‐FNA, 56.5% and 60.5% for ERCP, and 85.8% and 87.1% for EUS/ERCP combination. EUS‐FNA showed higher overall performances compared with ERCP (P < 0.001), whereas EUS/ERCP combination was superior to EUS‐FNA alone (P‐value < 0.001). EUS‐FNA showed higher sensitivity and accuracy compared with ERCP for pancreatic masses (n = 187, both P‐values < 0.001) but not for biliary lesions (n = 76, both P‐values = 0.847). Sensitivity and accuracy of EUS/ERCP combination were superior to those of EUS‐FNA for both pancreatic and biliary lesions (both P‐values < 0.001). For patients with large mass (≥ 4 cm), there was no significant differences between ERCP/EUS combination and EUS‐FNA (P‐value = 0.31).Conclusions: Same‐session EUS‐FNA and ERCP combination was superior to EUS‐FNA for both pancreatic masses and biliary lesions. Same‐session EUS/ERCP combination can be considered a proper diagnostic method for suspected malignant biliary obstruction regardless of the origin of lesions. On the other hand, EUS‐FNA alone was sufficient for diagnosis compared with EUS/ERCP combination in cases with large mass. Strategic diagnostic approach, according to clinical features of individual patient, is required.

To clarify the role of neoadjuvant concurrent chemoradiotherapy (NACCRT) followed by surgical resection for localized or locally advanced perihilar cholangiocarcinoma (CCA). We retrospectively reviewed 57 patients who underwent surgical resection with or without NACCRT for perihilar CCA; 12 patients received NACCRT and 45 patients did not received NACCRT. Patients with locally advanced perihilar CCA requiring NACCRT were defined as follows: (1) a mass involving unilateral branches of the portal vein or hepatic artery with insufficient volume of the anticipated remnant lobe; or (2) an infiltrating mass in the main portal vein that was too long for reconstruction, identified at preoperative staging. The median disease-free survival (DFS) durations of the neoadjuvant and non-neoadjuvant CCRT groups were 26.0 and 15.1 mo, respectively (P = 0.91). The median overall survival (OS) durations of the neoadjuvant and non-neoadjuvant CCRT groups were 32.9 and 27.1 mo, respectively (P = 0.26). The NACCRT group showed a downstaging tendency compared to the non-NACCRT group as compared with the tumor stage confirmed by histological examination after surgery and the tumor stage confirmed by imaging test at the time of diagnosis (P = 0.01). NACCRT does not prolong DFS and OS in localized or locally advanced perihilar CCA. However, NACCRT may allow tumor downstaging and improve tumor resectability.

To directly compare the efficacy and toxicity of standard-dose FOLFIRINOX (sFOLFIRINOX) and modified-dose FOLFIRINOX (mFOLFIRINOX, 75% of standard-dose) for pancreatic cancer. One hundred and thirty pancreatic cancer patients who received sFOLFIRINOX (n = 88) or mFOLFIRINOX (n = 42) as their first-line chemotherapy from January 2013 to July 2017 were retrospectively reviewed. For efficacy analysis, the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) were evaluated and compared using Pearson's chi-square test, Kaplan-Meier plot and log-rank test. The adverse events (AEs) were evaluated, and severe (≥ grade 3) AEs rates of the two groups were compared for toxicity analysis. The mFOLFIRINOX group included more female patients (30.7% vs 57.1%; P = 0.004) and older patients [age (median), 57 vs 63.5; P = 0.018] than the sFOLFIRINOX group. In the efficacy analysis, the ORR and DCR were not significantly different between the two groups (ORR: 39.8% vs 35.7%; P = 0.656; DCR: 80.7% vs 83.3%; P = 0.716). The median PFS and OS were also not different between the groups (PFS: 8.7 mo vs 8.1 mo, P = 0.272; OS: 13.9 mo vs 13.7 mo, P = 0.476). In the safety analysis with severe AEs, the rates of neutropenia (83.0% vs 66.7%; P = 0.044), anorexia (48.9% vs 28.6%; P = 0.029) and diarrhea (13.6% vs 0.0%; P = 0.009) were markedly lower in the mFOLFIRINOX group. mFOLFIRINOX showed comparable efficacy but better safety compared to sFOLFIRINOX. If clinically necessary, initiating FOLFIRINOX with 75% of the standard-dose can alleviate toxicity concerns without compromising efficacy.

Background: Approximately 80% of pancreatic ductal adenocarcinoma (PDAC) patients suffer from anorexia, weight loss, and asthenia. Most PDAC patients receive chemotherapy, which often worsens their nutritional status owing to the adverse effects of chemotherapy. Malnutrition of PDAC patients is known to be associated with poor prognosis; therefore, nutritional management during chemotherapy is a key factor influencing the outcome of the treatment. Mobile apps have the potential to provide readily accessible nutritional support for patients with PDAC. Objective: We aimed to evaluate the efficacy of a mobile app–based program, Noom, in patients receiving chemotherapy for PDAC. Methods: We prospectively enrolled 40 patients who were newly diagnosed with unresectable PDAC from a single university-affiliated hospital in South Korea, and randomly assigned them into a Noom user group (n=20) and a non-Noom user group (n=20). The 12-week in-app interventions included meal and physical activity logging as well as nutritional education feedback from dietitians. The non-Noom user group did not receive any nutrition intervention. The primary outcomes were the changes in the nutritional status and quality of life (QoL) from the baseline to 12 weeks. The secondary outcomes included the changes in the skeletal muscle index (SMI) from the baseline to 12 weeks. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Patient-Generated Subjective Global Assessment (PG-SGA) were used as paper questionnaires to assess the QoL and nutritional status of the patients. Intention-to-treat and per-protocol analyses were conducted. Regarding the study data collection time points, we assessed the nutritional status and QoL at the baseline (T0), and at 4 (T1), 8 (T2), and 12 (T3) weeks. Abdominal computed tomography (CT) imaging was conducted at the baseline and after 8 weeks for tumor response and SMI evaluation. The skeletal muscle area (cm2) was calculated using routine CT images. The cross-sectional areas (cm2) of the L3 skeletal muscles were analyzed. Results: Between February 2017 and January 2018, 48 patients were assessed for eligibility. Totally 40 patients with pancreatic cancer were included by random allocation. Only 17 participants in the Noom user group and 16 in the non-Noom user group completed all follow-ups. All the study participants showed a significant improvement in the nutritional status according to the PG-SGA score regardless of Noom app usage. Noom users showed statistically significant improvements on the global health status (GHS) and QoL scales compared to non-Noom users, based on the EORTC QLQ (P=.004). The SMI decreased in both groups during chemotherapy (Noom users, 49.08±12.27 cm2/m2 to 46.08±10.55 cm2/m2; non-Noom users, 50.60±9.05 cm2/m2 to 42.97±8.12 cm2/m2). The decrement was higher in the non-Noom user group than in the Noom user group, but it was not statistically significant (-13.96% vs. -3.27%; P=.11). Conclusions: This pilot study demonstrates that a mobile app–based approach is beneficial for nutritional and psychological support for PDAC patients receiving chemotherapy. Trial Registration: ClinicalTrials.gov NCT04109495; https://clinicaltrials.gov/ct2/show/NCT04109495.