Robotic versus Open Pancreatoduodenectomy for Pancreatic and Periampullary Tumors (PORTAL): a study protocol for a multicenter phase III non-inferiority randomized controlled trial

Trials

Li Jian¹  Yiping Mou²  Weiwei Jin²  Fengchun Lu³  Heguang Huang³  Xiao Liang⁴  Zheyong Li⁴  Zheng Wu⁵  Zhen Wang⁵  Chuandong Sun⁶  Bing Han⁶  Zehua Wu⁶  Jiabin Jin⁷  Xiaxing Deng⁷  Hao Chen⁷  Jianfeng Qian⁷  Chenghong Peng⁷  Baiyong Shen⁷  Mengmin Chen⁷  Kai Qin⁷  Yusheng Shi⁷  Georgios Gemenetzis⁸  Wei Chen⁹  Xiaoyu Yin⁹ 

[1] Clinical Research Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China;Department of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang Province, China;Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China;Department of General Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China;Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shanxi Province, China;Department of Hepatobiliary and Pancreatic Surgery, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China;Department of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China;Department of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China;Department of Hepatopancreatobiliary and Transplant Surgery, Royal Infirmary Edinburgh, Edinburgh, UK;Department of Pancreatobiliary Surgery, Glasgow Royal Infirmary, Glasgow, UK;Department of Pancreaticobiliary Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China;

关键词: Robotic;    Robot-assisted;    Minimally invasive;    Pancreatoduodenectomy;    Whipple;    Pancreatic cancer;    Outcomes;    Recurrence;    Survival;   

DOI  :  10.1186/s13063-021-05939-6

来源: Springer

【 摘 要 】

BackgroundPancreatoduodenectomy is a complex and challenging procedure that requires meticulous tissue dissection and proficient suturing skills. Minimally invasive surgery with the utilization of robotic platforms has demonstrated advantages in perioperative patient outcomes in retrospective studies. The development of robotic pancreatoduodenectomy (RPD) in specific has progressed significantly, since first reported in 2003, and high-volume centers in pancreatic surgery are reporting large patient series with improved pain management and reduced length of stay. However, prospective studies to assess objectively the feasibility and safety of RPD compared to open pancreatoduodenectomy (OPD) are currently lacking.Methods/designThe PORTAL trial is a multicenter randomized controlled, patient-blinded, parallel-group, phase III non-inferiority trial performed in seven high-volume centers for pancreatic and robotic surgery in China (> 20 RPD and > 100 OPD annually in each participating center). The trial is designed to enroll and randomly assign 244 patients with an indication for elective pancreatoduodenectomy for malignant periampullary and pancreatic lesions, as well as premalignant and symptomatic benign periampullary and pancreatic disease. The primary outcome is time to functional recovery postoperatively, measured in days. Secondary outcomes include postoperative morbidity and mortality, as well as perioperative costs. A sub-cohort of 128 patients with pancreatic adenocarcinoma (PDAC) will also be compared to assess the percentage of patients who undergo postoperative adjuvant chemotherapy within 8 weeks, in each arm. Secondary outcomes in this cohort will include patterns of disease recurrence, recurrence-free survival, and overall survival.DiscussionThe PORTAL trial is designed to assess the feasibility and safety of RPD compared to OPD, in terms of functional recovery as described previously. Additionally, this trial will explore whether RPD allows increased access to postoperative adjuvant chemotherapy, in a sub-cohort of patients with PDAC.Trial registrationClinicalTrials.govNCT04400357. Registered on May 22, 2020

【 授权许可】

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