{
  "abstract": "Introduction Pancreaticoduodenectomy (PD) is the preferred surgical approach for resectable periampullary carcinomas. Non-pancreatic periampullary carcinomas (NPPC) demonstrate distinct biological behaviours and are generally less aggressive than pancreatic cancer. Despite over three decades of advancements, the role of laparoscopic PD (LPD) remains debated. Few studies have directly compared LPD and open PD (OPD) while accounting for tumour invasiveness, and the data specifically evaluating LPD vs OPD for NPPC are limited. Randomised controlled trials are necessary to determine whether therapeutic outcomes differ between LPD and OPD in NPPC patients.Methods and analysis The TJDBPS14 trial is a prospective, randomised controlled, open-label, multicentre non-inferiority study with a parallel-group design. All participating surgeons have performed at least 104 LPD and OPD procedures. A total of 212 selected patients diagnosed with NPPC and eligible for PD will be randomly assigned to either LPD or OPD. The primary outcome is postoperative hospital stay, with secondary outcomes including 1-year survival rate, perioperative outcomes, incidence of perioperative complications, short-term outcomes and quality of life. The hypothesis is that the postoperative hospital stay for the LPD group will not exceed that of the OPD group.Ethics and dissemination This study was approved by the Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, with independent third-party monitoring. The results of the trial will be presented at international conferences and published in peer-reviewed journals.Trial registration number NCT05788029. Registered on 30 November 2022.",
  "authors": [
    {
      "affiliations": [
        "Division of Hepato-Pancreato-Biliary Surgery, Huazhong University of Science and Technology Tongji Medical College Tongji Hospital, Wuhan, Hubei, China"
      ],
      "name": "Shizhen Li"
    },
    {
      "affiliations": [
        "Division of Hepato-Pancreato-Biliary Surgery, Huazhong University of Science and Technology Tongji Medical College Tongji Hospital, Wuhan, Hubei, China"
      ],
      "name": "Shutao Pan"
    },
    {
      "affiliations": [
        "Division of Hepato-Pancreato-Biliary Surgery, Huazhong University of Science and Technology Tongji Medical College Tongji Hospital, Wuhan, Hubei, China"
      ],
      "name": "Min Wang"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Army Medical University, Chongqing, China"
      ],
      "name": "Xiaobing Huang"
    },
    {
      "affiliations": [
        "Department of General Surgery, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China"
      ],
      "name": "Wenxing Zhao"
    },
    {
      "affiliations": [
        "Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China"
      ],
      "name": "Xianjun Yu"
    },
    {
      "affiliations": [
        "Department of Hepatopancreatobiliary Surgery, Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China"
      ],
      "name": "Xuemin Chen"
    },
    {
      "affiliations": [
        "Department of Pancreatic and Biliary Surgery, First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China"
      ],
      "name": "Hua Chen"
    },
    {
      "affiliations": [
        "Department of General Surgery, Shanxi Cancer Hospital, Taiyuan, Shanxi, China"
      ],
      "name": "Xueyi Dang"
    },
    {
      "affiliations": [
        "Department of Hepatopancreatobiliary Surgery, The First Affiliated Hospital of University of South China Clinical Medicine Research Center, Hengyang, Hunan, China"
      ],
      "name": "Guodong Chen"
    },
    {
      "affiliations": [
        "Department of Pancreatic Surgery, General Surgery, Shandong University Cheeloo College of Medicine, Jinan, Shandong, China"
      ],
      "name": "Lei Wang"
    },
    {
      "affiliations": [
        "Department of General Surgery, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China"
      ],
      "name": "Weide An"
    },
    {
      "affiliations": [
        "Division of Hepatobiliopancreatic surgery, Southern Medical University Nanfang Hospital, Guangzhou, China"
      ],
      "name": "Qifan Zhang"
    },
    {
      "affiliations": [
        "Department of Pancreatic Carcinoma, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China"
      ],
      "name": "Song Gao"
    },
    {
      "affiliations": [
        "Institute of Hepatopancreatobiliary Surgery, Chongqing General Hospital, Chongqing, China"
      ],
      "name": "Shixiang Guo"
    },
    {
      "affiliations": [
        "Division of Hepato-Pancreato-Biliary Surgery, Huazhong University of Science and Technology Tongji Medical College Tongji Hospital, Wuhan, Hubei, China"
      ],
      "name": "Tingting Qin"
    },
    {
      "affiliations": [
        "Division of Hepato-Pancreato-Biliary Surgery, Huazhong University of Science and Technology Tongji Medical College Tongji Hospital, Wuhan, Hubei, China"
      ],
      "name": "Hang Zhang"
    },
    {
      "affiliations": [
        "Division of Hepato-Pancreato-Biliary Surgery, Huazhong University of Science and Technology Tongji Medical College Tongji Hospital, Wuhan, Hubei, China"
      ],
      "name": "Renyi Qin"
    }
  ],
  "title": "Laparoscopic versus open pancreaticoduodenectomy for non-pancreatic periampullary adenocarcinomas: study protocol for a multicentre randomised controlled trial in China",
  "uid": "60110d7e-369b-5a91-905f-af59f6346593"
}