{
  "abstract": "Introduction Flexible ureteroscopy has advanced modern stone management; however, lower pole renal stones remain a challenge due to suboptimal ureteroscope deflection and navigation using conventional flexible and navigable suction ureteral access sheaths (FANS). The SCULPT trial is designed to assess whether the novel steerable FANS—which enables active controlled deflection—can improve the success rate of lower pole access during flexible ureteroscopy.Methods and analysis This multicentre, prospective, single-blinded, randomised controlled superiority trial will recruit 400 adult patients (aged 18–75 years) with solitary lower pole renal stones ≤2 cm diagnosed by CT from 20 high-volume urological centres in China. Participants will be randomised 1:1 to undergo flexible ureteroscopy with either steerable or conventional FANS. The primary outcome is the success rate of navigating into the lower pole calyx (defined as successful direct stone visualisation, laser lithotripsy and aspiration without adjunct use). Secondary outcomes include immediate and 1 month stone-free rates, operative time, complication profiles (graded by Clavien–Dindo), instrument damage rates, quality-of-life assessments and cost analysis. Statistical analysis will be performed using appropriate tests for continuous and categorical data, with their significance set by prespecified superiority margins.Ethics and dissemination The study protocol has been designed in accordance with the Declaration of Helsinki and ICH-GCP guidelines. Ethical approval was centrally granted by the Institutional Review Board of The First Affiliated Hospital of Guangzhou Medical University and adopted by all participating centres following local feasibility review. The trial results will be disseminated via peer-reviewed publication and presentation at international conferences.Trial registration number NCT06898216.",
  "authors": [
    {
      "affiliations": [
        "Department of Surgery, SH Ho Urology Centre, The Chinese University of Hong Kong, Hong Kong, China"
      ],
      "name": "Steffi Kar Kei Yuen, Steffi"
    },
    {
      "affiliations": [
        "Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China"
      ],
      "name": "Shusheng Liu"
    },
    {
      "affiliations": [
        "Department of Urology, Ng Teng Fong General Hospital, Singapore"
      ],
      "name": "Vineet Gauhar"
    },
    {
      "affiliations": [
        "Department of Urology, the third Medical Center, PLA General Hospital, Beijing, China"
      ],
      "name": "Haixing Mai"
    },
    {
      "affiliations": [
        "Department of Urology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China"
      ],
      "name": "Weiyang He"
    },
    {
      "affiliations": [
        "Department of Urology, Peking University People’s Hospital, Beijing, China"
      ],
      "name": "Hao Hu"
    },
    {
      "affiliations": [
        "Department of Urology, The Second Affiliated Hospital of Kunming Medical University, Kunming, China"
      ],
      "name": "Changxing Ke"
    },
    {
      "affiliations": [
        "Department of Urology, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China"
      ],
      "name": "Yinbo Dai"
    },
    {
      "affiliations": [
        "Department of Urology, Henan Provincial People’s Hospital, Zhengzhou, China"
      ],
      "name": "Lei Shan"
    },
    {
      "affiliations": [
        "Department of Urology, Nanfang Hospital, Southern Medical University, Guangzhou, China"
      ],
      "name": "Yaodong Jiang"
    },
    {
      "affiliations": [
        "Department of Urology, Wuhan NO.1 Hospital, Wuhan, China"
      ],
      "name": "Jingdong Yuan"
    },
    {
      "affiliations": [
        "Department of Urology, The Tenth Affiliated Hospital, Southern Medical University (Dongguan People's Hospital), Dongguan, China"
      ],
      "name": "Zhengguo Cao"
    },
    {
      "affiliations": [
        "Department of Urology, Changzhou No.2 People’s Hospital, Changzhou, Jiangsu, China"
      ],
      "name": "Li Zuo"
    },
    {
      "affiliations": [
        "Department of Urology, Dongguan Tungwah Hospital, Dongguan, China"
      ],
      "name": "Chunting Yang"
    },
    {
      "affiliations": [
        "Department of Urology, Panzhihua Central Hospital, Panzhihua, China"
      ],
      "name": "Bing Bai"
    },
    {
      "affiliations": [
        "Department of Urology, Yan’an Hospital of Kunming City, Kunming, China"
      ],
      "name": "Xiaofang Bi"
    },
    {
      "affiliations": [
        "Department of Urology, NO.1 People's Hospital of Dali City, Dali, China"
      ],
      "name": "Hengtai Zhao"
    },
    {
      "affiliations": [
        "Department of Urology, Huadu District People’s Hospital of Guangzhou, Guangzhou, China"
      ],
      "name": "Ming Xi"
    },
    {
      "affiliations": [
        "Department of Urology, Dongguan Kanghua Hospital, Dongguan, China"
      ],
      "name": "Ning Ding"
    },
    {
      "affiliations": [
        "Department of Urology, Jiangmen Central Hospital, Jiangmen, China"
      ],
      "name": "Shuo Deng"
    },
    {
      "affiliations": [
        "Department of Urology, Shaoyang Central Hospital, Shaoyang, China"
      ],
      "name": "Shan Tang"
    },
    {
      "affiliations": [
        "Department of Urology, the Affiliated Qingyuan Hospital (Qingyuan People’s Hospital), Guangzhou Medical University, Qingyuan, China"
      ],
      "name": "Jianwen Zeng"
    },
    {
      "affiliations": [
        "Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China",
        "Department of Urology, Singapore General Hospital, Singapore"
      ],
      "name": "Jingzeng Du"
    },
    {
      "affiliations": [
        "Department of Urology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China"
      ],
      "name": "Wenqi Wu"
    },
    {
      "affiliations": [
        "School of Public Health, Guangzhou Medical University, Guangzhou, China"
      ],
      "name": "Jinxiang Ma"
    },
    {
      "affiliations": [
        "Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China"
      ],
      "name": "Wen Zhong"
    },
    {
      "affiliations": [
        "Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China"
      ],
      "name": "Zhijian Zhao"
    },
    {
      "affiliations": [
        "Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China"
      ],
      "name": "Yongda Liu"
    },
    {
      "affiliations": [
        "International School of Medicine, Istanbul Medipol University, Istanbul, Turkey",
        "Bashkir State Medical University, Ufa, Russia"
      ],
      "name": "Jean de la Rosette"
    },
    {
      "affiliations": [
        "Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China"
      ],
      "name": "Guohua Zeng"
    },
    {
      "affiliations": [
        "Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China"
      ],
      "name": "Wei Zhu"
    }
  ],
  "title": "Steerable versus Conventional flexible and navigable suction ureteral access sheath (FANS) flexible Ureteroscopy for Lower Pole stones Treatment: study protocol for a multicentre, randomised superiority trial (SCULPT trial)",
  "uid": "adaec323-55dc-568b-acc6-607322941c41"
}