{
  "abstract": "Background Lumen-apposing metal stents (LAMSs) are increasingly used for the endoscopic management of pancreatic fluid collections (PFCs), including walled-off necrosis (WON) and pancreatic pseudocysts (PCs).Objective To evaluate the nationwide impact of implementing an LAMS (approved in Japan in 2018) on clinical outcomes in real-world settings.Design Using a nationwide inpatient database, we identified 5885 patients who underwent endoscopic ultrasound (EUS)-guided treatment for PFCs at 550 hospitals between 2010 and 2023. We examined the association between treatment period (pre-LAMS vs post-LAMS implementation) and clinical outcomes. Multivariable logistic and linear regression analyses were performed to estimate ORs and coefficients, respectively. Findings were validated using a multi-institutional clinical cohort (n=618) from specialty hospitals with more detailed clinical parameters with data collection during the same period.Results In the pre-LAMS period, 3787 cases were treated exclusively with plastic stents. After 2018, LAMS use stabilised at around 50% among 2098 cases treated between 2019 and 2023. Compared with the pre-LAMS period, patients treated during the post-LAMS period had a higher risk of bleeding with LAMS (adjusted OR, 1.81; 95% CI: 1.55 to 2.13), but not with plastic stents (adjusted OR, 0.96; 95% CI: 0.74 to 1.26). Rates of rescue surgery, in-hospital mortality and length of stay did not differ significantly (p>0.12). The post-LAMS period was associated with increased total costs (adjusted coefficient, US$2813; 95% CI: 1503 to 4122). In analyses stratified by PFC types (WON vs PC), the association of the post-LAMS period with bleeding risk appeared to be stronger for PCs than WON (p interaction=0.015) and WON patients had a shorter length of stay and lower total costs in the post-LAMS period (pinteraction<0.001). In the validation cohort, the elevated bleeding risk with LAMS was confirmed (adjusted OR, 1.59; 95% CI: 0.86 to 2.95, vs pre-LAMS period), though not statistically significant.Conclusions The implementation of LAMS was not associated with improved key clinical outcomes but was linked to a higher risk of bleeding and increased healthcare costs. These findings do not support the routine use of LAMS for EUS-guided treatment of all PFCs in standard clinical practice but may restrict it to WON cases with clear indications.",
  "authors": [
    {
      "affiliations": [
        "Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan",
        "Department of Hepato-Biliary-Pancreatic Medicine, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan"
      ],
      "name": "Tsuyoshi Hamada"
    },
    {
      "affiliations": [
        "Cancer Prevention Center, Chiba Cancer Center Research Institute, Chiba, Japan"
      ],
      "name": "Nobuaki Michihata"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan"
      ],
      "name": "Tomotaka Saito"
    },
    {
      "affiliations": [
        "Department of Health Services Research, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan"
      ],
      "name": "Yuya Kimura"
    },
    {
      "affiliations": [
        "First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan"
      ],
      "name": "Takuji Iwashita"
    },
    {
      "affiliations": [
        "Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan"
      ],
      "name": "Hiroki Matsui"
    },
    {
      "affiliations": [
        "Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University, Hyogo, Japan"
      ],
      "name": "Hideyuki Shiomi"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan"
      ],
      "name": "Mamoru Takenaka"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan"
      ],
      "name": "Keisuke Iwata"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu, Japan"
      ],
      "name": "Akinori Maruta"
    },
    {
      "affiliations": [
        "Divison of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Hyogo, Japan"
      ],
      "name": "Atsuhiro Masuda"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan"
      ],
      "name": "Saburo Matsubara"
    },
    {
      "affiliations": [
        "Department of Health Policy and Informatics, Graduate School of Medicine, Institute of Science Tokyo, Tokyo, Japan"
      ],
      "name": "Kiyohide Fushimi"
    },
    {
      "affiliations": [
        "Third Department of Internal Medicine, University of Toyama, Toyama, Japan"
      ],
      "name": "Ichiro Yasuda"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan"
      ],
      "name": "Hiroyuki Isayama"
    },
    {
      "affiliations": [
        "Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan"
      ],
      "name": "Hideo Yasunaga"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan",
        "Department of Internal Medicine, Institute of Gastroenterology, Tokyo Women’s Medical University, Tokyo, Japan"
      ],
      "name": "Yousuke Nakai"
    },
    {
      "affiliations": [],
      "name": "the WONDERFUL study group in Japan and collaborators"
    }
  ],
  "title": "Real-world impact of implementing lumen-apposing metal stents for pancreatic fluid collections: a nationwide Japanese study",
  "uid": "621875e0-5d06-55d3-9726-31e06d69c946"
}