PORTAL
Description
We hypothesised that postoperative functional recovery after robotic pancreatoduodenectomy (RPD) would be non-inferior to that after open pancreatoduodenectomy (OPD), without compromising pathological outcomes and safety. We conducted a multicentre, patient-blinded, phase III, non-inferiority randomised controlled trial to evaluate the effectiveness and safety of RPD. The primary endpoint was time from surgery to postoperative functional recovery. Secondary outcomes reported in this study included operative metrics, pathological parameters, length of stay, postoperative morbidity, and hospitalisation costs. Between 28 September 2020 and 28 November 2024, 268 patients were enrolled from 6 sites in China and randomly assigned to RPD (n=142) or OPD (n=126). The PORTAL trial showed that, in high-volume centres with credentialled surgeons, RPD met the prespecified non-inferiority margin for time to postoperative functional recovery, with comparable pathological outcomes and the overall burden of postoperative complications. The dataset includes baseline patient characteristics, randomised treatment allocation, time to postoperative functional recovery within 90 days after surgery, operative metrics, pathological parameters, EQ-5D utility index scores at baseline and 30, 90, and 180 days, length of stay, postoperative morbidity, and hospitalisation costs.
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These data were generated from the PORTAL trial, a multicentre, phase III, patient-blinded randomised controlled trial comparing robotic pancreatoduodenectomy with open pancreatoduodenectomy in credentialled high-volume centres. Eligible patients had less complex, resectable pancreatic head or periampullary lesions and met the prespecified inclusion and exclusion criteria. Patients were randomly assigned to robotic or open pancreatoduodenectomy according to a prespecified randomisation scheme. Data were collected prospectively according to the trial protocol and structured case report forms. The dataset includes baseline demographic and clinical characteristics, preoperative diagnosis and disease-related variables, operative details, postoperative recovery assessments, postoperative complications and adverse events, pathology outcomes, EQ-5D utility index scores, hospitalization cost, and follow-up data. The primary endpoint was time from surgery to postoperative functional recovery.The final analysis datasets were prepared after data cleaning and database lock, and analyses were conducted according to the prespecified statistical analysis plan using validated statistical software.
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- Intuitive Surgical (United States)Sunnyvale