Robust circulating microRNA signature for the diagnosis and early detection of pancreatobiliary cancer.

Background: A new circulating biomarker superior to carbohydrate antigen 19-9 (CA19-9) is needed for diagnosing pancreatobiliary cancer (PBca). The aim of this study was to identify serum microRNA (miRNA) signatures comprising reproducible and disease-related miRNAs.

Methods: This multicenter study involved patients with treatment-naïve PBca and healthy participants.

Appropriate Relevancy and Reliability of Real-World Data for the Utilization of Regulatory Submission.

The extraction of data that contribute to regulatory approval from real-world data (RWD) is difficult because of the lack of a standardized data format and extraction methodology. Additionally, when real-world evidence (RWE) is used as an external control group, the similarity between internal and external control data is not evaluated. To investigate the data extraction methodology for the external control data of rare molecular subtypes, we have initiated the "REALISE" study.

A novel fully covered metal stent for unresectable malignant distal biliary obstruction: results of a multicenter prospective study.

Background/aims: Endoscopic self-expandable metal stent (SEMS) placement is currently the standard technique for treating unresectable malignant distal biliary obstructions (MDBO). Therefore, covered SEMS with longer stent patency and fewer migrations are required. This study aimed to assess the clinical performance of a novel, fully covered SEMS for unresectable MDBO.

The impact of nutritional status in nivolumab-treated patients with advanced esophageal cancer.

Although phase III trials have reported improved overall survival in patients with advanced esophageal squamous cell carcinoma following treatment with nivolumab, as compared with chemotherapy (paclitaxel or docetaxel), the treatment was effective only in a limited number of patients. Therefore, the aim of this study is to determine whether there is a correlation between nutritional status (Glasgow prognostic score, prognostic nutritional index, and neutrophil-to-lymphocyte ratio) and prognosis of advanced esophageal cancer in patients treated with taxane or nivolumab therapy. The medical records of 35 patients who received taxane monotherapy (paclitaxel or docetaxel), for advanced esophageal cancer between October 2016 and November 2018 (taxane cohort) were reviewed.

Trajectory for the Regulatory Approval of a Combination of Pertuzumab Plus Trastuzumab for Pre-treated HER2-positive Metastatic Colorectal Cancer Using Real-world Data.

Utilizing real-world data (RWD) for effective clinical implementation is becoming more and more appealing as the cost of drug development rises, especially for patients with rare diseases and rare molecular subtypes for whom conducting randomized controlled trials is challenging. If a regulatory approval methodology based on RWD as an external control group can be established, drug development for rarer fractions can be accelerated by lowering costs and time, as well as reducing physical and emotional burdens on both patients and healthcare professionals. Since 2017, we have been prospectively collecting the clinical data of standard therapies in patients with rare molecular fractions under the SCRUM-Japan Registry platform, which is a qualified registry utilized as external control data for regulatory submission.

Assessment of photodynamic therapy as a salvage treatment for local failure after chemoradiotherapy or radiotherapy for esophageal cancer in patients aged 80 years or older.

Objectives: Chemoradiotherapy (CRT) or radiotherapy (RT) alone is often the treatment of choice for elderly patients with esophageal cancer with the expectation of organ preservation. However, salvage treatment remains a problem when endoscopic resection is not indicated for local failure after CRT/RT. Photodynamic therapy (PDT) is indicated for local failure after CRT/RT, but there are few reports on its efficacy and safety in elderly patients.

Combined plasma metabolomic and transcriptomic analysis identify histidine as a biomarker and potential contributor in SLE pathogenesis.

Objectives: To investigate metabolite alterations in the plasma of SLE patients to identify novel biomarkers and provide insight into SLE pathogenesis.

Methods: Patients with SLE (n = 41, discovery cohort and n = 37, replication cohort), healthy controls (n = 30 and n = 29) and patients with RA (n = 19, disease control) were recruited. Metabolic profiles of the plasma samples were analysed using liquid chromatography-time-of-flight mass spectrometry and capillary electrophoresis-time-of-flight mass spectrometry.

Successful embolization of an intrahepatic portosystemic shunt using balloon-occluded retrograde transvenous obliteration: A case report.

Background: A congenital intrahepatic portosystemic shunt (IPSVS) is a rare vascular abnormality that is characterized by an anomalous intrahepatic venous tract that connects the intrahepatic portal vein with the hepatic venous system. Hepatic encephalopathy is an indication for IPSVS embolization, which is technically challenging because rapid blood flow through shunts can induce the migration of embolization material to systemic veins. This case report discusses the efficacy of percutaneous balloon-occluded retrograde transvenous obliteration for treating patients with IPSVSs.

A Comparison of Outcomes Based on Vessel Type (Native Artery vs. Bypass Graft) and Artery Location (Below-Knee Artery vs. Non-Below-Knee Artery) Using a Combination of Multiple Endovascular Techniques for Acute Lower Limb Ischemia.

Background: To evaluate outcomes of endovascular treatment (EVT) using a combination of multiple endovascular techniques for acute lower limb ischemia (ALLI) and to compare outcomes based on vessel type and artery location.

Methods: A total of 95 consecutive patients with ALLI (mean age, 72.0 years; 65 males; 104 lower limbs) who received emergency EVT using a combination of multiple endovascular techniques including thrombolysis, aspiration thrombectomy, stenting, and balloon angioplasty with or without surgical thromboembolectomy, between January 2005 and December 2017 were included.

Pretreatment Glasgow prognostic score as a predictor of outcomes in nivolumab-treated patients with advanced gastric cancer.

In Japan, South Korea, and Taiwan, nivolumab might provide overall survival benefits for patients with advanced gastric cancer. However, it is effective only in a limited number of patients. The Glasgow prognostic score is an indicator of the systematic inflammatory response and nutritional status.

FMS-like tyrosine kinase 3 (FLT3) amplification in patients with metastatic colorectal cancer.

FMS-like tyrosine kinase 3 (FLT3) plays a key role in hematopoiesis. However, the oncogenic role of FLT3 amplification in patients with metastatic colorectal cancer (mCRC) remains unclear. Here, we aimed to evaluate the characteristics, prognosis, and treatment efficacy of an FLT3 inhibitor (regorafenib) in patients with mCRC with FLT3 amplifications.

Clinical utility of circulating tumor DNA sequencing in advanced gastrointestinal cancer: SCRUM-Japan GI-SCREEN and GOZILA studies.

Comprehensive genomic profiling enables genomic biomarker detection in advanced solid tumors. Here, to evaluate the utility of circulating tumor DNA (ctDNA) genotyping, we compare trial enrollment using ctDNA sequencing in 1,687 patients with advanced gastrointestinal (GI) cancer in SCRUM-Japan GOZILA (no. UMIN000016343), an observational ctDNA-based screening study, to enrollment using tumor tissue sequencing in the same centers and network (GI-SCREEN, 5,621 patients).

Feasibility study of cancer genome alterations identified by next generation sequencing: ABC study.

Background: To confirm the feasibility and explore the clinical applicability of amplicon sequencing by next generation sequencing (NGS) of biopsy samples from patients with advanced solid tumors, we conducted a prospective study.

Methods: Patients with unresectable, advanced, or recurrent solid tumors were included. Key eligibility criteria were as follows: 20 years or older, any planned systemic therapy, adequate lesion for biopsy, and written informed consent.

Evaluation of the relationship between hepatocellular carcinoma location and transarterial chemoembolization efficacy.

Aim: To evaluate the relationship between the location of hepatocellular carcinoma (HCC) and the efficacy of transarterial chemoembolization (TACE).

Methods: We evaluated 115 patients (127 nodules), excluding recurrent nodules, treated with TACE between January 2011 and June 2014. TACE efficacy was evaluated according to mRECIST.

Clinical Factors of Delayed Perforation after Endoscopic Submucosal Dissection for Gastric Neoplasms.

Background: Delayed perforation is a rare but severe complication of endoscopic submucosal dissection (ESD) for early gastric neoplasm (EGN). The aim of this study was to clarify clinical factors related to delayed perforation after ESD.

Methods: A total of 1158 consecutive patients with 1199 EGNs underwent ESD at our hospital between January 2000 and December 2015.

Endovascular Treatment Strategy Using Catheter-Directed Thrombolysis, Percutaneous Aspiration Thromboembolectomy, and Angioplasty for Acute Upper Limb Ischemia.

Purpose: To evaluate the usefulness and safety of endovascular treatments for acute upper limb ischemia (AULI) by using multiple techniques, and to compare catheter-directed thrombolysis (CDT) and percutaneous aspiration thromboembolectomy (PAT) as initial procedures.

Materials And Methods: The study included 18 patients (4 men and 14 women) with AULI, who underwent a total of 20 sessions of endovascular treatment using various endovascular techniques between January 2005 and April 2016. The patients were initially treated with CDT [n = 9, CDT-based group (C-G)], PAT [n = 6, PAT-based group (P-G)], or angioplasty (n = 3).

Epidemiology of Adverse Events and Medical Errors in the Care of Cardiology Patients.

Objectives: There have been epidemiological studies of adverse events (AEs) among general patients but those of patients cared by cardiologist are not well scrutinized. We investigated the occurrence of AEs and medical errors (MEs) among adult patients with cardiology in Japan.

Methods: We conducted a cross-sectional study of adult outpatients at a Japanese teaching hospital from February through November 2006.

Combination Therapy of Interventional Radiology and Surgery for Infarction of the Small Intestine Caused by Portal Vein and Mesenteric Vein Thrombosis: A Patient Report.

We report the case of a man in his 70s who suffered from intestinal infarction caused by acute portal vein and mesenteric vein thrombosis (PVMVT). Combination therapy with percutaneous transcatheter thrombectomy and surgical bowel resection was successfully performed, and a satisfactory outcome was achieved. Intestinal infarction caused by PVMVT can be fatal and has a high mortality rate even if surgical resection is performed.

Haemodynamic changes in hepatocellular carcinoma and liver parenchyma under balloon occlusion of the hepatic artery.

Objectives: To investigate haemodynamic changes in hepatocellular carcinoma (HCC) and liver under hepatic artery occlusion.

Methods: Thirty-eight HCC nodules in 25 patients were included. Computed tomography (CT) during hepatic arteriography (CTHA) with and without balloon occlusion of the hepatic artery was performed.