Robotic Versus Open Pancreatoduodenectomy in the PORTAL Trial

Key Takeaways

• Robotic pancreatoduodenectomy met the prespecified noninferiority margin for postoperative functional recovery and was associated with earlier recovery than open surgery.
• Overall postoperative morbidity, 90-day mortality and readmission, and pathology outcomes were broadly similar between groups.
• Robotic surgery took longer at 300 versus 270 minutes, had a 3.0% conversion rate, and cost more, in the setting of high-volume centres with credentialled surgeons.

In the PORTAL phase 3 trial, robotic pancreatoduodenectomy met the prespecified noninferiority margin for postoperative functional recovery across seven high-volume Chinese centers. Recovery was faster with robotics, with an RMET within 40 days of 12.1 days versus 16.0 days after open surgery, a difference of -3.9 days. The randomized comparison enrolled adults with resectable pancreatic or periampullary disease treated in tertiary pancreatic units. Short-term safety and pathology outcomes were broadly similar between groups, while hospital admission costs were higher with the robotic approach.

This multicenter, single masked, phase 3 non-inferiority randomized controlled trial ran across seven tertiary high-volume pancreatic centers in China from 15 June 2020 to 28 November 2024. Investigators enrolled 268 adults with resectable pancreatic or periampullary disease and randomized them 1:1 to robotic pancreatoduodenectomy (142) or open pancreatoduodenectomy (126). Fourteen randomized participants did not undergo surgery, so the modified intention-to-treat analysis included 132 robotic and 122 open cases managed with enhanced recovery pathways. Functional recovery required pain control without parenteral analgesia, at least 50% oral intake without intravenous fluids, independent mobilization, and no active intra-abdominal infection. RMET within 40 days summarized the primary endpoint, keeping the comparison focused on early postoperative recovery rather than long-term oncologic outcomes.

Noninferiority in the modified intention-to-treat analysis was also supported in per-protocol and as-treated analyses. Beyond the primary recovery measure, postoperative length of stay was 13 days with robotic surgery and 16 days with open surgery. Median index length of stay was 20.0 versus 22.0 days, in the same direction across hospital stay measures. EQ-5D values were reported at baseline and at one, three, and six months, but the clearest differences were around earlier functional recovery and shorter hospitalization.

Robotic surgery had a longer operative time, at 300 versus 270 minutes, while estimated blood loss was similar between groups. Overall postoperative morbidity was 31.1% (41/132) with robotic surgery and 36.1% (44/122) with open surgery. Complications of Clavien-Dindo grade II or higher occurred in 23.5% versus 34.4%, and 90-day mortality was 0.8% (1) versus 2.5% (3). Readmission within 90 days was similar at 7.6% and 6.6%, and conversion from robotic to open surgery occurred in 3.0% (4/132). Clinically relevant pancreatic fistula, delayed gastric emptying, post-pancreatectomy hemorrhage, bile leak, chyle leak, surgical site infection, and two reoperations per group were also reported, without a major separation in short-term safety.

Pathology outcomes were similar, with R0 resection rates of 100.0% (95/95) after robotic surgery and 98.8% (83/84) after open surgery. Median harvested lymph nodes were 21 versus 17, median positive lymph nodes were 0 versus 0, and tumor size was also similar. Median total hospital admission costs including readmission were ¥130,905 versus ¥108,071, a difference of ¥22,834. The authors of the report linked broader implementation to high-volume centers, credentialled surgeons beyond learning-curve thresholds, procedural volume, and platform acquisition and maintenance costs. They also noted that formal cost-effectiveness analysis and indirect societal costs were beyond scope, so the trial informs short-term comparisons within experienced centers rather than long-term benefit.