A randomized phase II study of gemcitabine plus Z-360, a CCK2 receptor-selective antagonist, in patients with metastatic pancreatic cancer as compared with gemcitabine plus placebo.

Background: We investigated the efficacy and safety of 60, 120, or 240 mg of Z-360, which is a highly potent cholecystokinin2-receptor-selective antagonist, combined with gemcitabine in patients with metastatic pancreatic cancer.

Methods: Patients were randomly assigned in a 1:1:1:1 ratio to one of four treatment groups. Patients received 1000 mg/m gemcitabine for each cycle and Z-360 tablets of 60 mg (GZ 60 mg group), 120, 240 mg or placebo tablets (Gem group) orally twice daily.

Factors associated with the decision of operative procedure for proximal femoral bone metastasis: Questionnaire survey to institutions participating the Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group.

Background: Pathological fracture of the proximal femur is a main cause of cancer patients losing their ability to walk. Although both osteosynthetic devices (predominantly intramedullary nails) and prosthetic replacement have been widely performed for treatment, controversies exist regarding which procedure should be used for the various conditions. In order to decide the eligibility criteria of a planned randomized prospective study about the treatment of pathological fractures of the proximal femur, we assessed the factors affecting the selection of operative procedures using questionnaires sent to the members of the Bone and Soft Tissue Tumor Study Group (BSTTSG) of the Japan Clinical Oncology Group (JCOG).

Evaluating the ability to detect pancreatic lesions using a special ultrasonography examination focusing on the pancreas.

Purpose: The ability to detect pancreatic cysts was compared between special ultrasonography (US) examination focusing on the pancreas (special pancreatic US) and routine upper abdominal ultrasonography to objectively assess the ability of the former to detect cysts.

Subjects And Methods: Of 3704 patients who underwent special pancreatic US at our hospital, 186 underwent routine upper abdominal US within six months, had pancreatic cysts, and underwent magnetic resonance imaging (MRI). In these patients, 447 cysts measuring ≥5mm were detected via MRI, which was used as the gold standard.

Influence of age and comorbidity on prognosis and application of adjuvant chemotherapy in elderly Japanese patients with colorectal cancer: A retrospective multicentre study.

Background: Adjuvant therapy for colorectal cancer (CRC) in patients aged ≥75 years is supported by inadequate evidence, although such patients are increasing in number worldwide.

Patients And Methods: We assessed the influence of age and comorbidities on the prognosis of CRC in elderly patients using pooled data by the Japanese Study Group for Postoperative Follow-up of Colorectal Cancer. In total, 4598 patients (3304 with colon cancer and 1294 with rectal cancer) who underwent curative surgery from 2004 to 2006 were analysed with respect to age, Charlson comorbidity score (CS), tumour marker positivity, adjuvant therapy and prognosis.

Video-Assisted Thoracic Surgery Thymectomy Versus Sternotomy Thymectomy in Patients With Thymoma.

Background: This study was designed to evaluate the feasibility of video-assisted thoracoscopic surgery (VATS) and to compare the oncologic outcomes of VATS with those of sternotomy in patients with thymoma.

Methods: The clinical outcomes of 2,835 patients with thymic epithelial tumors treated between 1991 and 2010 in 32 Japanese institutions were collected retrospectively. The study compared postoperative complications, positive surgical margins, location of recurrence, and survival in 140 of 142 VATS-treated patients (VATS group) matched with 140 of 1,294 sternotomy-treated patients (ST group) by using propensity scores.

Defects in autophagosome-lysosome fusion underlie Vici syndrome, a neurodevelopmental disorder with multisystem involvement.

Vici syndrome (VICIS) is a rare, autosomal recessive neurodevelopmental disorder with multisystem involvement characterized by agenesis of the corpus callosum, cataracts, cardiomyopathy, combined immunodeficiency, developmental delay, and hypopigmentation. Mutations in EPG5, a gene that encodes a key autophagy regulator, have been shown to cause VICIS, however, the precise pathomechanism underlying VICIS is yet to be clarified. Here, we describe detailed clinical (including brain MRI and muscle biopsy) and genetic features of nine Japanese patients with VICIS.

The Clinical Significance of Alpha-Fetoprotein mRNAs in Patients with Hepatocellular Carcinoma.

Background/aims: Alpha-fetoprotein (AFP) mRNA-expressing cells are candidates for circulating tumor cells in hepatocellular carcinoma. We analyzed portal vein blood, peripheral blood, and peritoneal lavage samples to detect the presence of AFP mRNA-expressing cells, and explored their relationship with metastasis.

Methods: We measured the AFP mRNA expression in 112 sets of portal vein and peripheral blood samples and 61 peritoneal lavage samples that had been obtained during surgery.

Effect of Home Blood Pressure on Inducing Remission/Regression of Microalbuminuria in Patients With Type 2 Diabetes Mellitus.

Background: The Home Blood Pressure for Diabetic Nephropathy study is a prospective observational study conducted to determine the effect of home blood pressure (HBP) on remission/regression of microalbuminuria in patients with type 2 diabetes mellitus (DM).

Methods: Patients with type 2 DM having microalbuminuria were followed-up for 3 years. Remission of microalbuminuria was defined as shift from microalbuminuria to normoalbuminuria.

Immediate effects of quick trunk movement exercise on sit-to-stand movement in children with spastic cerebral palsy: a pilot study.

[Purpose] This pilot study examined the immediate effects of quick-seated trunk exercise on sit-to-stand movement in children with cerebral palsy. [Subjects and Methods] Five children with spastic cerebral palsy (hemiplegia, 3; diplegia, 2; age 6-17 years) performed five sessions of natural-seated trunk exercise at a self-selected speed (control). Following a 50-min rest period, five sessions of the quick-seated trunk exercise were conducted (experimental intervention) for each child.

Clinical outcome of patients treated with re-irradiation for spine or pelvic bone metastasis: A multi-institutional analysis of 98 patients.

The present study aimed to describe the clinical results of re-irradiation (Re-RT) for spine or pelvic bone metastasis at the same initial irradiated area. Between April 2010 and March 2014, cases involving 98 patients with spine or pelvic bone metastasis who had undergone Re-RT at five institutions were reviewed. The clinical outcomes following Re-RT were evaluated, including overall survival (OS) and severe adverse events.

Frequency of, and factors associated with, hepatitis B virus reactivation in hepatitis C patients treated with all-oral direct-acting antivirals: Analysis of a Japanese prospective cohort.

Aim: Several case reports have shown that hepatitis B virus (HBV) reactivation developed in hepatitis C patients with a current or previous HBV infection during direct-acting antiviral (DAA) treatment, which led to severe hepatitis or death in some cases. However, its precise frequency and risk factors are not entirely clear. We analyzed a prospective cohort.

Is F-FDG-PET useful for predicting R0 resection after induction therapy for initially unresectable locally advanced esophageal carcinoma?

Objective: Induction therapy followed by surgery is a promising strategy for esophageal cancer patients with invasion of the trachea/bronchus or aorta. However, no diagnostic criteria have been established to diagnose whether R0 resection can be performed. We investigated whether F-2-deoxy-D-glucose positron emission tomography (F-FDG-PET) and other modalities are useful for predicting R0 resection.

Genetic risk score based on the prevalence of vertebral fracture in Japanese women with osteoporosis.

A genetic risk score (GRS) was developed for predicting fracture risk based on the prevalence of vertebral fractures in 441 Japanese females with osteoporosis. A total of 979 (858 nonsynonymous and 121 silent) single-nucleotide polymorphisms (SNPs) located in 74 osteoporosis-susceptibility genes were genotyped and evaluated for their association with fracture prevalence. Four SNPs (protein kinase domain containing, cytoplasmic [; rs4952590], CDK5-regulatory subunit-associated protein 1-like 1 [; rs4712556], wingless-type MMTV-integration site family member 16 [; rs2707466], and G-patch domain-containing gene 1 [; rs10416265]) showed a significant association ( < 0.

Immunosuppressive medication is not associated with surgical site infection after surgery for intractable ulcerative colitis in children.

Pediatric ulcerative colitis (UC) sometimes progresses to an intractable condition for medical therapy. The surgical management of UC is challenging because of difficult procedures and frequent infectious complications. The aim of this study was to survey surgical procedures and infectious complications in pediatric patients with UC in Japan and to assess the relationship between preoperatively administered immunosuppressive drugs and postoperative surgical site infection (SSI).

Surgical Outcome and Prognostic Stratification for Pulmonary Metastasis From Colorectal Cancer.

Background: This study investigated recent clinical outcomes and prognostic factors of metastasectomy for pulmonary metastasis (PM) from colorectal cancer.

Methods: Data for 785 patients with PM from colorectal cancer who underwent curative resection, including 376 patients treated with postmetastasectomy adjuvant chemotherapy, between 2004 and 2008, were collected from 46 Japanese hospitals. Disease-free and overall survival was analyzed.

A nationwide multi-institutional retrospective study to identify prognostic factors and develop a graded prognostic assessment system for patients with brain metastases from uterine corpus and cervical cancer.

Background: The prevalence of brain metastases (BM) from uterine cancer has recently increased because of the improvement of overall survival (OS) of patients with uterine cancer due to its early detection and improved local control as a result of new effective treatments. However, little information is available regarding their clinical characteristics and prognosis, because oncologists have encountered BM from uterine cancer on rare occasions.

Methods: Records from 81 patients with uterine BM were collected from 10 institutes in Japan.

Clinical standard for valve area after common atrioventricular valve plasty for a single ventricle.

Objectives: To determine a clinical standard for post-repair common atrioventricular valve orifice area based on mid- to long-term valve function in patients with a functional single ventricle.

Methods: The medical records of 19 single-ventricle patients who underwent common atrioventricular valve plasty from July 1988 to January 2013 were retrospectively reviewed. Bivalvation valvuloplasty was performed in 7 patients with relatively hypoplastic leaflets.

Randomized Controlled Trial of Adjuvant Chemotherapy with Fluoropyrimidines Surgery-alone for Gastric Cancer.

Aim: This prospective randomized study compared the survival of patients with stage IB-IIIA gastric cancer treated with surgery alone or surgery followed by adjuvant chemotherapy.

Patients And Methods: Patients with pathological stage IB-IIIA disease were randomly assigned to the following groups: surgery alone (n=116), or surgery followed by adjuvant chemotherapy with 5-fluorouracil, doxifluridine, or uracil-tegafur for 12 months (n=113).

Results: The overall survival rate was 86.

Randomized Study Comparing Equal Height Staples With Graduated Height Staples in Bronchial Closure.

Background: There are two forms of staple cartridge available for lung cancer operations, the flat face with equal height staples and the stepped face with graduated height staples. The objective of the study was to evaluate their stapling ability in lobectomy.

Methods: A randomized prospective study was conducted to compare two types of stapling reloads for bronchial closure.

Fetoscopic laser photocoagulation for amniotic fluid discordance bordering on twin-twin transfusion syndrome: Feasibility, perinatal and long-term outcomes.

Aim: This study investigated the feasibility and safety of fetoscopic laser photocoagulation (FLP) for amniotic fluid discordance (AFD) bordering on twin-twin transfusion syndrome (TTTS) with an absent or reverse end-diastolic velocity (AREDV) in the umbilical artery (UA), and evaluated the perinatal and long-term outcomes.

Methods: A prospective intervention study was performed between 20 + 0 and 25 + 6 weeks of gestation (UMIN000004165). AFD bordering on TTTS was defined as maximum vertical pocket (MVP) of amniotic fluid in one twin's sac ≤3 cm and amniotic fluid MVP in the other twin's sac ≥7 cm excluding TTTS.