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Extensive intraoperative peritoneal lavage (EIPL) for gastric cancer with positive peritoneal lavage and/or stamp cytology: An exploratory phase II study

by Gen Tsujio, Masakazu Yashiro, Yuichiro Miki, Kohei Matsuoka, Koji Maruo, Mami Yoshii, Tatsuro Tamura, Katsunobu Sakurai, Takahiro Toyokawa, Naoshi Kubo, Shigeru Lee, Tomohisa Okuno, Kishu Kitayama, Go Masuda, Masaichi Ohira, Kiyoshi Maeda

Background

Our group revealed that the combination of intra-operative stamp cytology and peritoneal lavage cytology (CY) improved the identification of individuals with high risk of peritoneal metastasis. In this exploratory Phase II study, we aimed to evaluate the effect on relapse-free survival (RFS) of extensive intraoperative peritoneal lavage (EIPL) for gastric cancer with positive peritoneal cytology (CY1) and/or stamp cytology positive (stamp+).

Materials and methods

This study was a single arm, multi-institutional, exploratory phase 2 trial to assess the effects of EIPL after open gastrectomy for gastric cancer with CY1 and/ or stamp+. The primary endpoint was RFS. Secondary endpoints were overall survival (OS), postoperative recurrence site and incidence of postoperative adverse events.

Results

Between 2017 and 2021, 13 patients from 2 institutions were enrolled in this study. Because of the recent decline in open abdominal surgery, the number of cases did not increase and the trial was closed due to lack of applicants at 13 cases. Median 3-year RFS was 14.5 months (95% CI 5.4-NA), median 3-year OS was not reached (95% CI 14.5-NA) and median3-year peritoneal RFS was 16.0 months (95% CI 5.4-NA). Median 3-year peritoneal RFS rate was 83% in CY0 and stamp+ cases (n=6), and 0% in CY1 and stamp+/- cases (n=7). (Log-rank p=0.015).

Conclusion

Because of the slow accrual pace and early stop of the trial, we were not able to evaluate the prespecified endpoints thoroughly. However, EIPL might be effective to prevent perineal recurrence, especially in CY0 and stamp+ case.

Positive and Negative Appraisals and Quality of Life Among Family Caregivers of Adults With Formal Long‐Term Care Needs: An Exploration of Model Using Structural Equation Modelling

ABSTRACT

Aims

To examine a model of the caregiving adaptation process among family caregivers supporting care recipients at home.

Background

Global demand for the support of adults with long-term care needs and family caregivers is increasing. Caregivers' quality of life is affected by positive and negative appraisals of care; however, few studies have simultaneously investigated these factors.

Design

A cross-sectional study.

Method

The STROBE checklist for cross-sectional studies was followed. Seventy-four randomly selected home-visit nursing stations in Japan participated in this study from June 2023 to June 2024. A self-administered anonymous questionnaire was provided to family caregivers with care recipients at home. A total of 168 questionnaires were analysed. The variables included in the model were the European Quality of Life five-dimension five-level (EQ-5D-5L) instrument, positive and negative appraisals of care scale, four external resources and three internal resources, and six characteristics of caregivers and care recipients. Descriptive statistics and correlations between variables were analysed. The model was tested using structural equation modelling.

Results

Family caregivers' negative appraisal of care directly and negatively affected quality of life, and positive appraisal of care had no statistically significant association with quality of life. Positive appraisal of care had a direct negative association with negative appraisal of care. External resources such as support from nurses directly affected the positive appraisal of care. Internal resources such as caregivers' coping strategies had a significant negative effect on negative appraisal of care.

Conclusion

The findings suggest that improving caregivers' quality of life requires support to decrease negative appraisal of care by increasing internal resources and increase positive appraisal of care by providing external resources. Understanding the caregivers' adaptation process model is essential to prevent the deterioration of their quality of life.

Reporting Method

STROBE guidelines.

Patient or Public Contribution

Seventy-four home visit nursing stations and participants who care for family members through home visit nursing were involved in the survey investigation and answering the questionnaires.

Implications for the Profession and Patient Care

For supporting family caregivers' QoL, a reduction in negative appraisals of care is essential, increasing internal resources such as caregivers' coping and positive appraisal of care directly reduces negative appraisal of care.

Cohort profile: Sub-cohort study on the second phase of the Chiba Study of Mother and Child Health (C-MACH), Japan

Purpose

The second phase of the Chiba Study of Mother and Child Health (C-MACH) was initiated to investigate how environmental exposures from the fetal period to early childhood influence maternal and child health outcomes. The sub-cohort focuses specifically on detailed assessments of indoor environmental factors and neighbourhood-built and social environments. By integrating environmental metrics with biological, behavioural and sociodemographic data, the study aims to elucidate their role in the development of allergies, neurodevelopmental disorders and other non-communicable diseases in early life.

Participants

Between June 2021 and April 2023, 505 pregnant women were enrolled in the second phase of the C-MACH main study. Of these, 298 participants consented to join the sub-cohort study, including 258 in the sleep and physical activity monitoring option (Option 1) and 148 in the indoor allergen exposure sub-study (Option 2). The study includes biological sampling, environmental monitoring and repeated questionnaire surveys. At baseline, 253 live births were recorded from 251 pregnancies.

Findings to date

Of the 298 women, 272 completed early pregnancy questionnaires. The mean maternal age was 33.1 years (SD 4.6); 97.8% were married. University-level education was reported by 51.0% of mothers and 53.7% of fathers. Most households had an annual income of 6 to

Future plans

Longitudinal follow-up will continue until the children reach age 15. Future analyses will examine associations between environmental exposures and allergic, developmental, endocrine/metabolic and obesity-related outcomes.

Patient preference survey for attributes of locally advanced or metastatic urothelial carcinoma treatment in Japan: a discrete-choice experiment

Por: Kitamura · H. · Uchida · H. · Tanaka · Y. · Akiyama · T. · Morishita · A. · Yakushiji · A. · Sakurai · M.
Objective

To investigate treatment preferences of Japanese patients with locally advanced or metastatic urothelial carcinoma (la/mUC).

Design

A discrete-choice experiment survey methodology was used to elicit patient preferences for attributes of la/mUC treatment, including adverse events (nausea/vomiting, neuropathy, alopecia and maculopapular rash), hospital stay requirements for treatment administration and overall survival. A multinomial logistic regression model was used to estimate treatment preferences. Coefficients of the model were then used to calculate the relative importance of each treatment attribute.

Setting and participants

Participants were recruited through healthcare facilities with urology departments across Japan.

Results

The study included 109 patients (72.5% male; mean (SD) age, 71.3 (8.9) years). Patients preferred treatments that minimised adverse events that could affect their daily activities, had a more favourable survival profile and did not require hospital stays for administration. Neuropathy emerged as the most important attribute to patients when making treatment decisions (relative attribute importance (RAI), 27.7%), followed by nausea/vomiting (RAI, 27.3%), maculopapular rash (RAI, 16.5%), hospital stay requirements (RAI, 12.1%), alopecia (RAI, 8.2%) and overall survival (RAI, 8.1%). Findings were similar across various subgroup analyses, though patients who were chemotherapy-experienced prioritised avoidance of neuropathy and nausea/vomiting more highly than those who were chemotherapy-naïve.

Conclusions

In this study, Japanese patients with la/mUC were more concerned about reduced quality of life due to adverse events than extending survival by 6 months. Patients, clinicians and other members of the care team need to communicate frequently and candidly about a patient’s well-being.

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.

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