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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.

Multifaceted analysis of presenteeism: contributions of pain, psychological factors and daily functioning - a cross-sectional study in Japan

Por: Yoshino · A. · Ushio · K. · Nakamura · R. · Shiota · S. · Katagiri · T. · Nishihara · K. · Moriwaki · K. · Anno · K. · Mikami · Y. · Tsutsumi · Y.
Objective

Presenteeism, defined as reduced work efficiency due to health issues despite attending work, accounts for a substantial proportion of labour productivity loss. Although pain significantly impacts presenteeism, the relationship between pain and presenteeism remains poorly understood due to the multifaceted nature of pain, encompassing psychosocial factors and daily functioning. This study aimed to identify which of these factors are significantly associated with presenteeism among employees.

Design

Cross-sectional study using self-administered questionnaires and generalised additive model analysis.

Setting

Multiple workplaces (including a university and hospitals) in Japan.

Participants

Employed individuals (n=212, age range: 20–65 years; 59 males and 153 females) participated. They were recruited through workplace bulletin boards, email announcements and direct invitations. Participants with and without chronic pain were included.

Primary and secondary outcome measures

Participants completed self-report measures, including the Health and Work Performance Questionnaire (HPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Pain Catastrophising Scale (PCS), Beck Depression Inventory-second edition (BDI-II), State-Trait Anxiety Inventory (STAI) and WHO Disability Assessment Schedule 2.0 (WHODAS 2.0).

Results

The results indicated that absolute HPQ was significantly associated with BDI-II scores (F=4.51, p=0.035). On the other hand, relative HPQ was influenced by SF-MPQ (F=3.76, p=0.005), PCS (F=4.16, p=0.014), STAI (F=5.62, p=0.019) and limited daily activities (F=13.25, p=0.00035).

Conclusions

These findings suggest that presenteeism is multifactorial, with pain, psychosocial factors and daily functioning playing critical roles. Moreover, the impact of depression on presenteeism differs from that of pain and anxiety. Therefore, tailored intervention approaches may be required for each factor, ultimately improving workplace productivity.

Trial registration number

This study was preregistered at UMIN-CTR (UMIN000054797).

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