{
  "abstract": "Background A novel airway balloon cryoablation (ABC) system using liquid nitrogen as cryogen was developed for bronchoscopic intervention in malignant central airway obstruction (MCAO). This study aimed to evaluate the efficacy and safety of this system.Methods This was a prospective, randomised, controlled, non-inferiority study that enrolled MCAO patients at 15 sites in China. Patients were assigned to the ABC group and the ERBOKRYOCA Cryosurgical (EC) system group in a 1:1 ratio. Airway tumour debulking with multimodality was permitted before cryoablation. The primary outcome was the airway patency rate after 6 weeks of intervention with a non-inferiority margin of −10%. Secondary outcomes included modified Medical Research Council (mMRC) Dyspnoea Scale and Karnofsky Performance Scale (KPS) assessment, and the duration of cryoablation.Results 198 patients were randomised. After 6 weeks of intervention, the airway patency rate was 78.49% in the ABC group and 60.92% in the EC group, showing that the difference was over the non-inferiority margin of −10% at 17.58% (95% CI 4.35% to 30.80%), p<0.001. The mMRC and KPS scores were significantly improved after 3 and 6 weeks in both groups, with no difference. The duration of cryoablation was shortened remarkably in the ABC group (378.29±399.54 s vs 624.93±443.72 s, p<0.001). The prevalence of bleeding was similar in the two groups, without life-threatening events.Conclusions The ABC system provided non-inferior and subsequent superior effect in airway patency rate compared with traditional carbon dioxide-driven cryoprobe in MCAO. This study supports this novel system as an alternative to cryoablation via bronchoscope for MCAO patients.Trial registration number ChiCTR2100042051.",
  "authors": [
    {
      "affiliations": [
        "Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China"
      ],
      "name": "Jie Liu"
    },
    {
      "affiliations": [
        "Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China"
      ],
      "name": "Chun Li"
    },
    {
      "affiliations": [
        "Endoscopy Center, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China"
      ],
      "name": "Ye Gu"
    },
    {
      "affiliations": [
        "Respiratory and Critical Care Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Yu Chen"
    },
    {
      "affiliations": [
        "Respiratory and Critical Care Medicine, The Second Affiliated Hospital of Air Force Medical University, Xi’an, Shaanxi, China"
      ],
      "name": "Faguang Jin"
    },
    {
      "affiliations": [
        "Pulmonary and Critical Care Medicine, Xianyang Central Hospital, Xianyang, Shaanxi, China"
      ],
      "name": "Yan Dang"
    },
    {
      "affiliations": [
        "Department of Pulmonary and Critical Care Medicine, Regional Medical Center for National Institute of Respiratory Diseases, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China"
      ],
      "name": "Enguo Chen"
    },
    {
      "affiliations": [
        "Department of Respiratory and Critical Care Medicine, Changhai Hospital, Shanghai, China"
      ],
      "name": "Yu-Chao Dong"
    },
    {
      "affiliations": [
        "Respiratory Medicine, Shanghai Tenth People’s Hospital, Shanghai, China"
      ],
      "name": "Changhui Wang"
    },
    {
      "affiliations": [
        "Respiratory and Critical Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, China"
      ],
      "name": "Chao Cao"
    },
    {
      "affiliations": [
        "Department of Pulmonary and Critical Care Medicine, Huazhong University of Science and Technology, Central Hospital of Wuhan, Tongji Medical College, Wuhan, Hubei, China"
      ],
      "name": "Yi Hu"
    },
    {
      "affiliations": [
        "Respiratory and Critical Care Medicine, Emergency General Hospital, Beijing, China"
      ],
      "name": "Yunzhi Zhou"
    },
    {
      "affiliations": [
        "Department of Respiratory Diseases, Nanchang University Second Affiliated Hospital, Nanchang, Jiangxi, China"
      ],
      "name": "Xiaoqun Ye"
    },
    {
      "affiliations": [
        "Pulmonary and Critical Care Medicine, Shanghai East Hospital, Shanghai, China"
      ],
      "name": "Qiang Li"
    },
    {
      "affiliations": [
        "Respiratory and Critical Care Medicine, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China"
      ],
      "name": "Hui Zhao"
    },
    {
      "affiliations": [
        "Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Chongqing Medical University, Chongqing, Sichuan, China"
      ],
      "name": "Shuliang Guo"
    },
    {
      "affiliations": [
        "Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China"
      ],
      "name": "Maosong Ye"
    },
    {
      "affiliations": [
        "Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China"
      ],
      "name": "Yuanlin Song"
    },
    {
      "affiliations": [
        "Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China",
        "Respiratory Medicine, Taikang Xianlin Drum Tower Hospital, Nanjing, China"
      ],
      "name": "Xin Zhang"
    },
    {
      "affiliations": [
        "Respiratory and Critical Care Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Shiyue Li"
    }
  ],
  "title": "Efficacy and safety of novel airway balloon cryoablation system for malignant central airway obstruction: a prospective, multicentre, randomised, non-inferiority study",
  "uid": "94267190-9c31-5fbb-85be-a8ef9d23d081"
}