Japanese Multicenter Cohort Research Articles

The effect of noninvasive positive pressure ventilation in amyotrophic lateral sclerosis patients from a Japanese multicenter prospective cohort

The effect of noninvasive positive pressure ventilation in amyotrophic lateral sclerosis patients from a Japanese multicenter prospective cohort

Pouch functional outcomes after restorative proctocolectomy with ileal-pouch reconstruction in patients with ulcerative colitis: Japanese multi-center nationwide cohort study.

Although several complications capable of causing pouch failure may develop after restorative proctocolectomy (RPC) for ulcerative colitis (UC), the incidences and causes are conflicting and vary according to country, race and institution. To avoid pouch failure, this study aimed to evaluate the rate of pouch failure and its risk factors in UC patients over the past decade via a nationwide cohort study. We conducted a retrospective, observational, multicenter study that included 13 institutions in Japan. Patients who underwent RPC between January 2005 and December 2014 were included. The characteristics and backgrounds of the patients before and during surgery and their postoperative courses and complications were reviewed. A total of 2376 patients were evaluated over 6.7±3.5years of follow-up. Twenty-seven non-functional pouches were observed, and the functional pouch rate was 98.9% after RPC. Anastomotic leakage (odds ratio, 9.1) was selected as a risk factor for a non-functional pouch. The cumulative pouch failure rate was 4.2%/10years. A change in diagnosis to Crohn's disease/indeterminate colitis (hazard ratio, 13.2) was identified as an independent risk factor for pouch failure. The significant risk factor for a non-functional pouch was anastomotic leakage. The optimal staged surgical procedure should be selected according to a patient's condition to avoid anastomotic failure during RPC. Changes in diagnosis after RPC confer a substantial risk of pouch failure. Additional cohort studies are needed to obtain an understanding of the long-standing clinical course of and proper treatment for pouch failure.

P5466Sex difference in the response to cardiac resynchronization therapy in patients with cardiac sarcoidosis: from Japanese multi-center retrospective cohort analysis

P5466Sex difference in the response to cardiac resynchronization therapy in patients with cardiac sarcoidosis: from Japanese multi-center retrospective cohort analysis

393 Short-Term Outcomes of Japanese Multicenter Prospective Cohort Study of Endoscopic Resection for Early Gastric Cancer Using Web Registry (J-Web/EGC)

A Japanese multicenter prospective cohort study was conducted on endoscopic resection (ER) for early gastric cancer (EGC) using a Web registry system developed to determine short-term and long-term outcomes based on the absolute and expanded indications (Clinical Trial Registration: UMIN000005871).1) We hereby present the data of the short-term outcomes, which are the secondary endpoints of this study.

Recovery of renal function after radical nephrectomy and risk factors for postoperative severe renal impairment: A Japanese multicenter longitudinal study.

To investigate longitudinal changes in renal function after radical nephrectomy, and to explore risk factors of postoperative severe renal impairment in a Japanese multicenter cohort. The present retrospective study included 701 patients who had no metastasis, end-stage kidney disease or bilateral kidney cancer, who underwent radical nephrectomy and who were followed up for at least 1 year. The longitudinal change in postoperative renal function during a 10-year follow-up period was evaluated according to the presence or absence of potential risk factors including greater age, chronic kidney disease, hypertension, diabetes mellitus and cardiovascular disease. A slope of annual change in estimated glomerular filtration rate was analyzed using a linear mixed model. Associations between the potential risk factors and a >50% estimated glomerular filtration rate decrease were evaluated using a multivariate Cox regression model. Overall, the postoperative estimated glomerular filtration rate recovered over time with a significant positive slope of 0.34 mL/min/1.73 m(2)/year. Renal function did not tend to recover in patients with chronic kidney disease, hypertension, diabetes mellitus or cardiovascular disease. The multivariate analysis showed that greater age and diabetes mellitus were independent risk factors for severe renal impairment. Overall, patients who had deteriorated renal function immediately after radical nephrectomy recovered over time. However, patients with chronic kidney disease, hypertension, diabetes mellitus and cardiovascular disease did not tend to recover renal function postoperatively. Greater age and diabetes mellitus were independent risk factors for a >50% decrease in estimated glomerular filtration rate.

Life events, emotional responsiveness, and the functional prognosis of patients with rheumatoid arthritis.

BackgroundStressors may differently affect human physiological systems according to the host properties relevant to psycho-behavioral processes that the stressors invoke. In a Japanese multicenter cohort study of patients with rheumatoid arthritis (RA), we examined if major life events differently contribute to the patients’ functional prognosis according to their ability to identify emotions as manifest feelings when encountering the events (emotional responsiveness).Methods460 patients with RA completed a self-administered baseline questionnaire about psychosocial factors including emotional responsiveness. Two years later, they checked on a list of positive/negative personal events that happened during the two-year study period. Rheumatologists evaluated their functional status at baseline and follow-up using the ACR classification system.ResultsIn a multiple logistic regression model that included baseline demographic, disease activity/severity-related, therapeutic, and socioeconomic factors as covariates, none of the counts of positive, negative, or all life events was associated with the functional status at follow-up. In the subgroup with poor emotional responsiveness, however, these life event counts were all associated with a poorer functional prognosis (odds ratio of ACR class 3–4 vs. 1–2 associated with one increment in the all life-event count = 2.39, 95 % confidence interval = 1.27-4.48, p = .007), while no such relationship was evident for the rest of the patients.ConclusionsMajor life events, whether positive or negative in nature, may have an impact on the disease course of patients with RA when the patient has poor emotional responsiveness to the event(s).

Prediction of reclassification at repeat biopsy with PSA and [-2]proPSA doubling time during active surveillance for low-risk prostate cancer: Prospective longitudinal analysis of a Japanese multicenter study cohort.

e16069 Background: Prostate-specific antigen (PSA) kinetics, such as PSA doubling time (PSADT), are used for prediction of tumor progression during active surveillance (AS) for favorable prostate c...

834 Long-Term Outcomes of 844 Patients Who Underwent Endoscopic Submucosal Dissection for Colorectal Neoplasms: Results From a Japanese Multicenter Cohort Study

834 Long-Term Outcomes of 844 Patients Who Underwent Endoscopic Submucosal Dissection for Colorectal Neoplasms: Results From a Japanese Multicenter Cohort Study Kinichi Hotta*, Yutaka Saito, Toshio Uraoka, Yuichiro Yamaguchi, Naoto Sakamoto, Hiroaki Ikematsu, Masakatsu Fukuzawa, Nozomu Kobayashi, Junichiro Nasu, Tomoki Michida, Hisatomo Ikehara, Yosuke Otake, Takeshi Nakajima, Takahisa Matsuda, Masayoshi Yamada, Keita Harada, Tomoaki Shinohara, Shinichiro Hori, Shigeaki Yoshida Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan; Endoscopy division, National Cancer Center Hospital, Tokyo, Japan; Keio University, Tokyo, Japan; Juntendo University, Tokyo, Japan; National Cancer Center Hospital East, Kashiwa, Japan; Tokyo Medical University, Tokyo, Japan; Tochigi Cancer Center, Utsunomiya, Japan; Okayama University Hospital, Okayama, Japan; Osaka Koseinenkin Hospital, Osaka, Japan; Hyogo College of Medicine, Nishinomiya, Japan; Saku Centrao Hospital, Saku, Japan; Shikoku Cancer Center, Matsuyama, Japan; Aomori Prefectural Central Hospital, Aomori, Japan Background: The introduction of endoscopic submucosal dissection (ESD) was extremely important for the treatment of large colorectal neoplasms. However,

The impact of baseline [−2]proPSA-related indices on the prediction of pathological reclassification at 1 year during active surveillance for low-risk prostate cancer: the Japanese multicenter study cohort

PurposeActive surveillance (AS) is one potential solution to avoiding the overtreatment of favorable prostate cancer. By handling the AS strategy more safely, tumor aggressiveness may be evaluated more accurately. The aim of the present study was to evaluate the predictive impact of baseline prostate-specific antigen (PSA) isoform [−2]proPSA (p2PSA)-related indices on the pathological reclassification at 1 year during an AS program.MethodsBetween 2002 and 2003, 134 males diagnosed with low-risk prostate cancer were registered in the Japanese multicenter study cohort as candidates for AS, and 118 (88 %) males actually proceeded to AS. Of the 118 patients, the 67 that underwent protocol biopsy at 1 year after beginning AS were enrolled in the present study. The predictive significance of various baseline clinicopathological features and p2PSA-related indices on pathological reclassification at 1 year after beginning AS were investigated.ResultsThe pathological reclassification rate was 37.3 %. According to the univariate analysis, prostate volume (p = 0.049), number of biopsy cores (p = 0.047), percentage of positive biopsy cores (p = 0.023), p2PSA to free PSA ratio (%p2PSA) (p = 0.003) and prostate health index (phi) (p = 0.010) at baseline were significantly different between the reclassification and non-reclassification groups. By multivariate logistic regression analysis, baseline %p2PSA (p = 0.008) and phi (p = 0.008) were the only independent predictive factors for pathological upgrade at 1 year after AS commencement.ConclusionsBaseline %p2PSA and phi may predict the pathological reclassification at 1 year after starting AS, which could be due to the under detection of clinically significant prostate cancer at AS enrollment.

Undermining incision and healing of deep pressure ulcers: A prospective cohort study of pressure ulcers by the Japanese National Hospital Organization

Undermining is one of the most challenging complications of deep pressure ulcers. Recommendations in most guidelines are based only on expert opinions. Here, we examined the relationship between surgical incision of the undermined space and pressure ulcer healing through a Japanese multicenter prospective cohort study. A total of 162 patients with undermining in 40 national hospitals in Japan were enrolled from July 2007 to June 2009. The incision group included 39 patients (24.1%) whose undermining was surgically incised during the observational period. Their 4-week follow-up data on pressure ulcer severity and areas of healthy granulation tissue were recorded as outcome variables using the DESIGN-R pressure ulcer assessment tool. The 4-week follow-up was restarted after the incision in the incision group. The outcome variables over time were compared between the two groups using a linear mixed model with or without adjustment for demographic and other variables. The incision group showed more rapid improvement in the total and granulation DESIGN-R scores compared with the nonincision group (p < 0.001 and p = 0.007, respectively, in the crude models). This study may provide the first considerable evidence to support that surgical incision of undermining may promote healing of deep pressure ulcers.

Prediction of reclassification at repeat biopsy with [-2]proPSA during active surveillance for low-risk prostate cancer: Prospective longitudinal analysis of a Japanese multicenter study cohort.

e16054 Background: Biomarkers that predict aggressiveness and tumor burden of prostate cancer are needed for patients who undergo AS. One of such candidates is [-2]proPSA. It has been reported that expression of [-2]proPSA is specific to prostate cancer and associated with grade and stage. The aim of this research is to evaluate the predictive ability of [-2]proPSA and its related parameters for the biopsy reclassification during AS. Methods: 13 institutions participated in the multi-center Japanese AS study (a prospective one-arm cohort study). 134 patients were enrolled in this study between January 2002 and December 2003. Inclusion criteria are as follows; (1) stage T1cN0M0, (2) age from 50 to 80, (3) serum PSA = 20 ng/ ml or less, (4) one or two positive cores per 6 to 12 systematic biopsy cores, (5) Gleason score = 6 or less and (6) maximum cancer involvement in positive core = 50% or less. We prospectively collected blood samples from patients who opted AS as an initial treatment. The serum samples were stocked frozen until testing. The patients who remained on AS for 1-year were recommended to undergo repeat biopsy. Reclassification was judged by a central pathologist who was also involved in the initial diagnosis at inclusion. Results: 67 patients underwent repeat biopsy at 1-year after AS. Biopsy reclassification was histopathologically found in 25 of 67 patients (37.3%). Table shows the patients’ backgrounds and the cutoff values of predictive variables at 90% and 80% sensitivity and specificity. p2PSA, %p2PSA and phi; (p2PSA/fPSA) × √(tPSA) levels at baseline and p2PSA and phi at 1-year after AS were significantly higher in the reclassification group than those in the non-reclassification group. At 90% sensitivity, the cutoff values of p2PSA, %p2PSA and phi at baseline were 12.52, 1.51 and 37.91 with a specificity of 23.81%, 26.19% and 26.19%, respectively. In both 90% and 80% sensitivity, p2PSA and its related parameters have higher specificity than PSA and its related parameters. Conclusions: [-2]proPSA and its related parameters could predict pathological reclassification in repeat biopsy during AS.

Design of Japanese multicenter prospective cohort study of endoscopic resection for early gastric cancer using Web registry (J-WEB/EGC)

A Japanese multicenter prospective cohort study is currently being conducted on endoscopic resection (ER) for early gastric cancer (EGC) using a Web registry system developed to determine short-term and long-term outcomes based on the absolute and expanded indications. All consecutive patients with EGC or suspected EGC undergoing ER at the 41 participating institutions from July 2010 to June 2012 are being enrolled in the study cohort using the Web registry system, and each patient will be followed up for a minimum of 5years. The study investigation includes baseline patient and lesion characteristics as well as short-term and long-term outcomes. A survey program to collect information on long-term outcomes is also being introduced for patients subsequently followed up in institutions other than their original participating institutions, as well as patients for whom the original participating institutions have been losing track of their follow-up. The primary endpoint is 5-year overall survival, with en bloc resection, curative resection, complication, local recurrence, distant metastasis, metachronous EGC, and recurrence-free survival being secondary endpoints in addition to the successful collection of long-term outcome data on enrolled patients utilizing the survey program.

Prognostic value of myocardial perfusion and ventricular function in a Japanese multicenter cohort study (J-ACCESS): the first-year total events and hard events

To determine the prognostic value of myocardial ischemia, function and coronary risk factors on total and hard cardiac events using myocardial perfusion imaging in a Japanese population. A prospective cohort study was performed in 117 Japanese hospitals, each with a nuclear cardiology facility. A total of 4,031 patients with suspected or confirmed ischemic heart disease were registered. The patients were followed up for a year to investigate total and hard events, and those who had any events were followed up for 3 years to evaluate subsequent hard events. A stress-rest gated myocardial perfusion study was performed with (99m)Tc-tetrofosmin using gated single-photon emission computed tomography (SPECT) and analyzed by semi-quantitative scores. During the 1-year follow-up period, 263 (6.5%) patients had total events comprising all-cause death, non-fatal myocardial infarction (MI), heart failure, unstable angina, angina pectoris and coronary revascularization. Cardiac death occurred in 23 patients (0.6%) and non-fatal MI in 11 (0.3%). Among patients with ejection fraction (EF) of <45% and a summed difference score (SDS) of >/=2, 18.7% (2.4% for cardiac death and 0.6% for non-fatal MI) experienced total events compared with 3.9% (0.3% for cardiac death and 0.2% for non-fatal MI; P < 0.0001) of those with EF >/= 45% and SDS < 2. Multivariate analysis identified EF, SDS, age, history of revascularization and diabetes as significant predictors of all events, while the significant predictors were age and EF for hard events. When the patients who had heart failure in the first year were followed up, 9 of 41 (22.0%) experienced cardiac death in the subsequent 3-year follow-up period. Myocardial ischemia defined by SDS and ventricular function were the main predictors of total events despite the relatively low incidence of hard events in this Japanese population. In patients with cardiac events in a year, closer attention should be paid to subsequent hard events particularly in patients with heart failure.