Local Postprocedural Cryoprevention Significantly Reduces the Incidence of Post-ERCP Pancreatitis: A Multicenter Randomized Controlled Trial.

Introduction: Postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a common, potentially serious adverse event of ERCP. Although rectal nonsteroidal anti-inflammatory drugs are recommended for prevention, their use in Japan is limited due to dosage concerns. This multicenter randomized controlled trial evaluated the efficacy and safety of ice water irrigation to the papilla in reducing PEP.

A prospective, randomized, double-blind, placebo-controlled trial of the Kampo formula daiobotanpito combined with antibiotic therapy for acute diverticulitis.

Daiobotanpito (DBT) is a Kampo formula traditionally used to treat abscesses in intestinal disorders. This double-blind, multicenter, randomized controlled trial was conducted at participating hospitals in Japan. Patients with CT-proven moderate acute diverticulitis received conventional therapy along with an oral DBT (treatment group) or placebo (control group) administered thrice a day for 10 days (Registration: jRCTs041180063).

A multicenter Phase II study of mFOLFOX6 plus nivolumab for gastric cancer with severe peritoneal metastases: WJOG16322G.

Advanced gastric cancer (AGC) patients with severe peritoneal metastases (SPM), characterized by massive ascites and/or inadequate oral intake, have a poor prognosis with the median overall survival of around 7 months, even when treated with fluorouracil/l-leucovorin plus oxaliplatin (mFOLFOX6), despite being a treatment options for these patients demonstrated in the WJOG10517G study. However, these patients were excluded from pivotal Phase III trials, including the CheckMate 649 study, which demonstrated the benefit of adding nivolumab to mFOLFOX6, due to tumor-related complications. Given the lack of data on the efficacy and safety of combining nivolumab with mFOLFOX6 for AGC patients with SPM, we initiated a Phase II study to evaluate this combination.

Treatment of Intermediate-Risk Hepatoblastoma Using a Combined Cisplatin and Doxorubicin (PLADO) Regimen and Optimized Surgical Resection.

Background: Complete resection of the primary tumor is critical for the survival of children with hepatoblastomas (HBs). This prospective clinical study aimed to clarify the outcome of a chemotherapy regimen comprising cisplatin and doxorubicin (PLADO) followed by definitive surgery conducted at the appropriate time in patients with intermediate-risk HB.

Methods: Intermediate-risk HB was defined as patients without evidence of metastatic disease who met any of the following criteria: age ≥3 years; PRETEXT IV disease; presence of more than one PRETEXT annotation factor.

Intensity-Modulated Radiotherapy for Locally Advanced Lung Cancer in the Immunotherapy Era: A Prospective Study WJOG12019L.

Introduction: Chemoradiotherapy (CRT) followed by durvalumab is the standard of care for unresectable locally advanced NSCLC. Limited prospective data have been reported on intensity-modulated radiotherapy (IMRT)-adapted CRT in the immunotherapy era.

Methods: In this multicenter prospective observational study, patients underwent IMRT-adapted CRT (platinum-doublet chemotherapy plus 60 Gy IMRT in 30 fractions under a prespecified radiation protocol), followed by consolidative durvalumab.

Prognostic Benefit of Segmentectomy for Patients with Low Muscle Mass in Early-Stage Lung Cancer.

Background: Although segmentectomy is less invasive than lobectomy, little is known about the effect of these procedures on postoperative outcomes of patients with low muscle mass. This study examined the postoperative prognosis of patients with non-small cell lung cancer according to the surgical procedure type and preoperative muscle mass.

Methods: This study retrospectively reviewed data of patients who underwent lobectomy or segmentectomy for early-stage non-small cell lung cancer with ground glass opacity-dominant tumor up to 3 cm in size or solid-dominant tumor up to 2 cm in size between 2010 and 2020.

Suppressed water availability in winter buds delays the bud burst of broad-leaved trees in a heavy snow forest.

Early snowmelt is known to accelerate budburst. Budburst and leaf expansion require water absorption, and current-year vessels, which function as water pathways, begin to mature in early spring. However, whether the limitation of xylem reactivation by snow affects budburst and leaf expansion remains unclear.

Synthesis of Spirocyclic Phthalans via Ru-Catalyzed [2 + 2 + 2] Cycloaddition of 1,6-Diynes with Ex-Situ Generated Acetylene.

Spirocyclic motifs are attracting increasing attention owing to their three-dimensional geometries that endow bioactive molecules with superior physical and biological properties. We developed an efficient method for constructing spirocyclic phthalans via the Ru-catalyzed [2 + 2 + 2] cycloaddition of cycloalkanone-derived 1,6-diynes with acetylene gas ex-situgenerated from calcium carbide and HO.

Real-world incidence of and risk factors for abemaciclib-induced interstitial lung disease in Japan: a nested case-control study of abemaciclib-induced interstitial lung disease (NOSIDE).

Purpose: The exact incidence of and risk factors for interstitial lung disease (ILD), a serious side effect of abemaciclib, remain unknown in real-world settings. We examined the incidence of and risk factors for abemaciclib-induced ILD in patients with advanced breast cancer (ABC) in Japan.

Patients And Methods: Retrospective clinical information was collected from charts of patients with ABC who had started abemaciclib treatment at 77 participating institutions between November 30, 2018 and December 31, 2019.

Japanese living donor liver transplantation criteria for hepatocellular carcinoma: nationwide cohort study.

Background: Validating the expanded criteria for living donor liver transplantation for hepatocellular carcinoma using national data is highly significant. The aim of this study was to evaluate the validity of the new Japanese criteria for living donor liver transplantation for hepatocellular carcinoma patients and identify factors associated with a poor prognosis using the Japanese national data set.

Methods: The study population comprised patients who underwent living donor liver transplantation for hepatocellular carcinoma at 37 centres in Japan between 2010 and 2018.

End-of-treatment 18[F]-FDG PET can predict early progression in patients receiving bendamustine-rituximab for follicular lymphoma in first relapse: a prospective West Japan hematology Study Group (W-JHS) NHL01 trial.

Response determined by 18[F]-fluoro-2-deoxy-D-glucose (F-FDG) positron emission tomography (PET)-CT after induction therapy can predict progression-free survival (PFS) in follicular lymphoma (FL). However, little prospective research has examined the significance of PET after second-line therapy. We conducted a prospective multicenter phase II trial (W-JHS NHL01) of bendamustine plus rituximab (BR) without rituximab maintenance for FL in first relapse.

Phase 2 study of glucarpidase in patients with delayed methotrexate elimination after high-dose methotrexate therapy.

Purpose: High-dose methotrexate therapy (HD-MTX) is a standard treatment for various malignant tumors, but approximately 1-10% of patients experience delayed MTX elimination (DME) that can induce organ damage. Glucarpidase can hydrolyze MTX and thereby lower the level of active MTX in the blood. A multicenter, open-label, phase II investigator-initiated trial (CPG2-PII study) was conducted to evaluate glucarpidase rescue therapy in Japanese patients who showed DME after HD-MTX treatment.

Differences in the impact of newly diagnosed type 2 diabetes on cardiovascular mortality between normotensive and hypertensive individuals.

Objective: We investigated the interrelationship between hyperglycemia and hypertension on cardiovascular mortality in the middle-aged and elderly people.

Methods: In this retrospective cohort study that used data from the Hiroshima Study on Glucose Metabolism and Cardiovascular Diseases, we included 16,564 participants without cardiovascular disease (mean age: 65.8 years; 6179 normoglycemic people, 3017 people with newly diagnosed type 2 diabetes, and 7368 people with prediabetes per the 75-g oral glucose tolerance test).

A Phase II Study of FOLFIRI Plus Ziv-Aflibercept After Trifluridine/Tipiracil Plus Bevacizumab in Patients with Metastatic Colorectal Cancer: WJOG 11018G.

Background: Non-inferiority of trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) to irinotecan/fluoropyrimidine plus BEV in metastatic colorectal cancer was investigated in the phase III TRUSTY study, and we conducted a phase II study of FOLFIRI (5-FU+leucovorin+irinotecan) plus zib-aflibercept (AFL) after FTD/TPI plus BEV. However, the TRUSTY study failed during the recruitment of our patients.

Objective: We present the findings of a phase II study on the efficacy of FOLFIRI plus zib-aflibercept (AFL) after FTD/TPI plus BEV, including clinical results with plasma biomarker analyses.

A Multi-Institutional, Randomized, Phase III Trial Comparing Anatomical Segmentectomy and Lobectomy for Clinical Stage IA3 Pure-Solid Non-Small-Cell Lung Cancer: West Japan Oncology Group Study WJOG16923L (STEP UP Trial).

Introduction: Although the standard treatment for patients with resectable early-stage non-small-cell lung cancer (NSCLC) is pulmonary lobectomy, recent clinical trials have demonstrated the efficacy of anatomical segmentectomy for small-sized early-stage NSCLC measuring ≤2 cm. Segmentectomy is gaining attention as an alternative procedure to lobectomy for early-stage NSCLC.

Patients And Methods: In January 2024, we have initiated a randomized phase III trial in Japan to confirm the noninferiority of anatomical segmentectomy to lobectomy in patients with peripheral clinical stage IA3 pure-solid NSCLC (tumor measuring >2 cm and ≤3 cm; consolidation-to-tumor ratio = 1.

Association of cumulative low-density lipoprotein cholesterol exposure with vascular function.

Background: The relationship between cumulative low-density lipoprotein cholesterol (LDL-C) exposure and progression of atherosclerosis remains uncertain.

Objective: The aim of this study was to determine the relationship between cumulative LDL-C level and flow-mediated vasodilation (FMD), nitroglycerine-induced vasodilation (NID) and the presence of plaque in the common carotid artery (CCA).

Methods: This was a cross-sectional study.