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Serum albumin and gamma gap levels, and combined effect for risk of mortality in a Japanese population from the J-MICC study

by Kenichi Shibuya, Rie Ibusuki, Daisaku Nishimoto, Shiroh Tanoue, Chihaya Koriyama, Shuhei Niiyama, Yasuyuki Kakihana, Toshiro Takezaki, Megumi Hara, Yuichiro Nishida, Sadao Suzuki, Takeshi Nishiyama, Mako Nagayoshi, Takashi Tamura, Yudai Tamada, Rieko Okada, Teruhide Koyama, Satomi Tomida, Kiyonori Kuriki, Jun Otonari, Hiroaki Ikezaki, Asahi Hishida, Masashi Ishizu, Sakurako Katsuura-Kamano, Kenji Wakai, Keitaro Matsuo, for the J-MICC Study group

Although the clinical importance of serum albumin and gamma gap levels is well established, it is unclear how these levels are associated with health risks in the general population. This cohort study aimed to clarify the association between serum albumin and gamma gap levels, and their combined effect, and mortality risk in a Japanese population. The participants totaled 35,746 (17,160 men and 18,586 women) aged 35–69 years from the Japan Multi-Institutional Collaborative Cohort (J-MICC) Study. The mean follow-up period was 11.8 years, with 1,529 deaths and 1,907 censoring. The Cox proportional hazards model was used to estimate hazard ratios (HRs) and 95% confidence intervals after adjusting for related factors. Increased HRs of low albumin and high gamma gap levels were respectively observed for deaths from all-causes, cancer, cardiovascular diseases, respiratory system diseases without pneumonia, and other-causes; and the HR was the highest on respiratory system diseases without pneumonia (HR = 7.31, 4.15–12.9). Low albumin and low gamma gap levels were strongly associated for pneumonia death (HR = 12.4, 3.98–38.5). The interaction between albumin and gamma gap levels was significant for deaths from all-causes, pneumonia and other-causes. The dose relationship for each association was dose-dependent in albumin and threshold-type in gamma gap, except for other-causes. This study suggests that albumin and gamma gap levels are independent indicators of an increased risk of mortality in a Japanese population. Combined effect was apparent for mortality from all-causes, pneumonia, and other-causes.

Prospective, multicentre trial on preoperative biliary drainage by endoscopic ultrasound-guided hepaticogastrostomy for resectable/borderline resectable pancreatic cancer with biliary obstruction: the PROLOGUE study - a study protocol

Por: Yagi · S. · Hijioka · S. · Nagashio · Y. · Harai · S. · Agarie · D. · Yamashige · D. · Okamoto · K. · Fukuda · S. · Kuwada · M. · Komori · Y. · Kurita · Y. · Hasegawa · S. · Kubota · K. · Ishida · Y. · Ushio · J. · Takeshita · K. · Yoshino · K. · Ishiwatari · H. · Okusaka · T.
Introduction

Preoperative biliary drainage (PBD) is often required for patients with pancreatic cancer accompanied by biliary obstruction to ensure the safe administration of neoadjuvant chemotherapy or to manage cholangitis and jaundice. Although endoscopic retrograde cholangiopancreatography (ERCP) is the standard approach for PBD, it carries a significant risk of post-ERCP pancreatitis. Endoscopic ultrasound-guided biliary drainage (EUS-BD), particularly via hepaticogastrostomy (EUS-HGS), offers a promising alternative that avoids papillary manipulation. However, the clinical utility of EUS-BD as primary drainage for PBD remains unclear due to a lack of prospective studies. This multicentre prospective trial aims to evaluate the safety and efficacy of EUS-HGS as primary drainage for PBD in patients with resectable or borderline resectable pancreatic cancer.

Methods and analysis

This multicentre prospective study involves seven institutions in Japan. Eligible patients will undergo EUS-HGS using a 7Fr plastic stent. The primary endpoint is clinical success, defined by improvements in bilirubin or liver enzyme levels within 14 days postprocedure. Secondary endpoints include technical success rate, adverse event incidence, stent patency and surgical outcomes. A total of 30 patients will be enrolled, considering an expected clinical success rate of 90% and a 10% dropout allowance.

Ethics and dissemination

This study has been approved by the National Cancer Center Institutional Review Board (Research No. 2024-084). The results of this study will be reported at an international conference and published in an international peer-reviewed journal.

Trial registration number

UMIN ID: 000055173.

Neurological outcomes with hypothermia versus normothermia in patients with moderate initial illness severity following resuscitation from out-of-hospital cardiac arrest: protocol for a multicentre randomised controlled trial (R-CAST OHCA)

Por: Naito · H. · Nishikimi · M. · Okada · Y. · Maeyama · H. · Kiguchi · T. · Yorifuji · T. · Nishida · K. · Matsui · S. · Kuroda · Y. · Nishiyama · K. · Iwami · T. · Nakao · A. · JAAM R-CAST OHCA Trial Group · Nishikimi · Otani · Ryosuke · Yumoto · Hayakawa · Sakurai · Fukushima · Tanaka
Introduction

Temperature control is a fundamental intervention for neuroprotection following resuscitation from cardiac arrest. However, evidence regarding the efficacy of hypothermia in post-cardiac arrest syndrome (PCAS) remains unclear. Retrospective studies suggest that the clinical effectiveness of hypothermia may depend on the severity of PCAS. The R-CAST OHCA trial aims to compare the efficacy of hypothermia versus normothermia in improving 30-day neurological outcomes in patients with moderately severe PCAS following out-of-hospital cardiac arrest.

Methods and analysis

The multicentre, single-blind, parallel-group, superiority, randomised controlled trial (RCT) is conducted with the participation of 35 emergency and critical care centres and/or intensive care units at academic and non-academic hospitals. The study enrols moderately severe PCAS patients, defined as those with a revised post-Cardiac Arrest Syndrome for induced Therapeutic Hypothermia score of 5.5–15.5. A target number of 380 participants will be enrolled. Participants are randomised to undergo either hypothermia or normothermia within 3 hours after return of spontaneous circulation. Patients in the hypothermia group are cooled and maintained at 34°C until 28 hours post-randomisation, followed by rewarming to 37°C at a rate of 0.25°C/hour. Patients in the normothermia group are maintained at normothermia (36.5°C–37.7°C). Total periods of intervention, including the cooling, maintenance and rewarming phases, will occur 40 hours after randomisation. Other treatments for PCAS can be determined by the treating physicians. The primary outcome is a favourable neurological outcome, defined as Cerebral Performance Category 1 or 2 at 30 days after randomisation and compared using an intention-to-treat analysis.

Ethics and dissemination

This study has been approved by the Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee (approval number: R2201-001). Written informed consent is obtained from all participants or their authorised surrogates. Results will be disseminated via publications and presentations.

Trial registration number

jRCT1062220035.

Relationship Between Weight Loss and Problems With Oral Intake in Institutionalised Older Adults: A Japanese Multi‐Institutional 1‐Year Follow‐Up Study

ABSTRACT

Aim

To examine the relationship between weight loss and problems with oral intake in institutionalised older adults.

Design

A 1-year longitudinal observational study.

Methods

Data were obtained from a prospective study conducted in three nursing homes and two long-term care facilities in Japan. Participants' problems with oral intake were assessed using items published in 2021 by the Japanese Ministry of Health, Labour and Welfare. Baseline and follow-up factors were compared between individuals who experienced a weight loss of 5% or more and those who did not. Separate multivariable logistic regression models were constructed for each oral intake assessment item to examine its independent association with weight loss of 5% or more, accounting for transitions in each item between baseline and the 1-year follow-up.

Results

In total, 172 institutionalised older adults were included in the analysis. Among them, 57 (33.1%) participants experienced a weight decrease of 5% or more. The emergence of somnolence or clouding of consciousness during meals at the 1-year follow-up in participants without these signs at baseline was independently associated with a weight loss of 5% or more, after adjustment for baseline characteristics.

Conclusion

Recognising signs of somnolence or clouding of consciousness during meals may be useful for the early detection and prevention of weight loss in institutionalised older adults.

Implications for the Profession and/or Patient Care

Early detection of individuals at risk is essential to prevent significant weight loss and its associated adverse outcomes. Recognising somnolence or clouding of consciousness during meals may enable earlier detection and intervention to prevent weight loss and improve the quality of care for older adults.

Reporting Method

Strengthening the Reporting of Observational Studies in Epidemiology.

Patient or Public Contribution

No patient or public contribution.

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