{
  "abstract": "Abstract Objective To determine whether robotic pancreatoduodenectomy (RPD) is non-inferior to open pancreatoduodenectomy (OPD) in terms of postoperative functional recovery, without compromising safety or oncological quality.Design Multicentre, single masked, phase 3, non-inferiority randomised controlled trial.Setting Seven tertiary high volume pancreatic centres in China, 15 June 2020 to 28 November 2024.Participants 268 adults with resectable pancreatic or periampullary disease.Interventions Participants were randomised to receive standardised RPD (n=142) or OPD (n=126), with enhanced recovery pathways.Main outcome measures The primary outcome was time from surgery to postoperative functional recovery, defined as adequate pain control without parenteral analgesia, ≥50% oral intake without intravenous fluids, independent mobilisation, and absence of active intra-abdominal infection. The restricted mean event time (RMET) within 40 days was a summary for time from surgery to postoperative functional recovery. Secondary outcomes included operative metrics, disease related outcomes, length of stay, postoperative morbidity, including complications of Clavien-Dindo grade II or higher (defined as complications requiring drug treatment or more intensive intervention), and hospital admission costs.Results Overall, 254 of 268 randomly assigned participants (mean age 62 years; 172 (64.2%) men) underwent surgery, completed follow-up, and were included in the modified intention-to-treat population; 14 did not undergo surgery. In the modified intention-to-treat population, the RMET was 12.1 days (95% confidence interval (CI) 11.2 to 13.1) in the RPD group and 16.0 days (14.5 to 17.5) in the OPD group (difference -3.9 days, 95% CI -5.6 to -2.2; P<0.001). Operative time was longer in the RPD group (300 minutes (interquartile range (IQR) 240-360 minutes) versus 270 (210-300) minutes in the OPD group, P<0.001) but postoperative length of stay was shorter in the RPD group (13 (IQR 11-16) days v 16 (13-20) days, P<0.001). Overall postoperative morbidity was 31.1% (41/132) in the RPD group versus 36.1% (44/122) in the OPD group and incidence of any complications of Clavien-Dindo grade II or higher was 23.5% (31/132) versus 34.4% (42/122), respectively. 90 day mortality was 0.8% (1) in the RPD group and 2.5% (3) in the OPD group. Median total costs of hospital admission (including readmission cost) were higher in the RPD group than in the OPD group (¥130 905 (£14 369; $19 351; €16 628) (IQR ¥114 853-¥152 547) v ¥108 071 (¥92 134-¥128 035), difference ¥22 834 (95% CI ¥16 744 to ¥30 522); P<0.001).Conclusions In high volume centres with credentialled surgeons, RPD met the non-inferiority margin for time from surgery to postoperative functional recovery, with comparable disease related outcomes and overall burden from postoperative complications. To generate wider system level efficiency gains, the implementation of RPD should take account of institutional expertise, procedural volume, acquisition of robotic surgical platforms and maintenance costs, and the potential for shorter hospital stay.Trial registration ClinicalTrials.gov NCT04400357.",
  "authors": [
    {
      "affiliations": [
        "Department of General Surgery, Pancreatic Disease Centre, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China",
        "Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine, Qionghai, Hainan, China"
      ],
      "name": "Jiabin Jin"
    },
    {
      "affiliations": [
        "Department of General Surgery, Pancreatic Disease Centre, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Kai Qin"
    },
    {
      "affiliations": [
        "Department of Surgery, Ninewells Hospital and Medical School, Dundee, Scotland, UK"
      ],
      "name": "Georgios Gemenetzis"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shanxi Province, China",
        "Xi’an Jiaotong University, Pancreatic Disease Centre, Xi’an, Shanxi Province, China"
      ],
      "name": "Zheng Wang"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Surgery, ChangHai Hospital, Naval Medical University, Shanghai, China"
      ],
      "name": "Chenxi Zheng"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shanxi Province, China",
        "Xi’an Jiaotong University, Pancreatic Disease Centre, Xi’an, Shanxi Province, China"
      ],
      "name": "Wei Li"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Surgery, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China"
      ],
      "name": "Zehua Wu"
    },
    {
      "affiliations": [
        "Department of General Surgery, Pancreatic Disease Centre, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Yusheng Shi"
    },
    {
      "affiliations": [
        "Department of General Surgery, Pancreatic Disease Centre, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Mengmin Chen"
    },
    {
      "affiliations": [
        "Department of General Surgery, Pancreatic Disease Centre, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Jianfeng Qian"
    },
    {
      "affiliations": [
        "Department of General Surgery, Pancreatic Disease Centre, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Yuanchi Weng"
    },
    {
      "affiliations": [
        "Department of Pancreaticobiliary Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China"
      ],
      "name": "Wei Chen"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang Province, China"
      ],
      "name": "Weiwei Jin"
    },
    {
      "affiliations": [
        "Department of General Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China"
      ],
      "name": "Renan Jin"
    },
    {
      "affiliations": [
        "Clinical Research Centre, Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Jian Li"
    },
    {
      "affiliations": [
        "Top-Alliance Clinical Research Centre, Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Leshan Liu"
    },
    {
      "affiliations": [
        "Division of Psychiatry, University College London, London, UK",
        "Department of Epidemiology and Public Health, University College London, London, UK"
      ],
      "name": "Yuntao Chen"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Surgery, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China"
      ],
      "name": "Bing Han"
    },
    {
      "affiliations": [
        "Department of General Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China"
      ],
      "name": "Xiao Liang"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Surgery, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China"
      ],
      "name": "Chuandong Sun"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shanxi Province, China",
        "Xi’an Jiaotong University, Pancreatic Disease Centre, Xi’an, Shanxi Province, China"
      ],
      "name": "Zheng Wu"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang Province, China"
      ],
      "name": "Yiping Mou"
    },
    {
      "affiliations": [
        "Department of Pancreaticobiliary Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China"
      ],
      "name": "Xiaoyu Yin"
    },
    {
      "affiliations": [
        "Department of General Surgery, Pancreatic Disease Centre, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Xiaxing Deng"
    },
    {
      "affiliations": [
        "Department of General Surgery, Pancreatic Disease Centre, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Chenghong Peng"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Surgery, ChangHai Hospital, Naval Medical University, Shanghai, China"
      ],
      "name": "Tianlin He"
    },
    {
      "affiliations": [
        "Department of Biostatistics, Institute of Clinical Medicine, Shanghai Jiao-Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Yanyan Song"
    },
    {
      "affiliations": [
        "Department of General Surgery, Pancreatic Disease Centre, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Baiyong Shen"
    }
  ],
  "title": "Robotic versus Open Pancreatoduodenectomy (PORTAL): multicentre, single masked, phase 3, non-inferiority randomised controlled trial",
  "uid": "b228a27c-dbae-5491-88e7-35615d46e734"
}