麻豆传媒

Performed by highly experienced surgeons, robot-assisted pancreatoduodenectomy for pancreatic head or periampullary tumors proved feasible and safe and showed modest improvements in short-term outcomes compared with open surgery, an open-label randomized trial in China found.

In the study's modified intent-to-treat population, robotic surgery significantly reduced postoperative hospital length of stay compared with open surgery (median 11 vs 13.5 days, P=0.029), according to Rong Liu, MD, PhD, of the First Medical Center of Chinese People's Liberation Army General Hospital in Beijing, and colleagues.

In addition, robotic surgery was associated with shorter operating times (245 vs 298 minutes, P=0.0013) as well as reduced blood loss (75 vs 150 mL, P<0.0001), Liu and colleagues reported in .

This is the first multicenter, head-to-head trial showing that robotic pancreatoduodenectomy can shorten length of stay over open pancreatoduodenectomy, the researchers noted, adding that postoperative length of stay "is not only a single indicator, but a comprehensive representation of postoperative functional recovery and clinical benefit."

The shorter postoperative stays in the robotic pancreatoduodenectomy group "was not at the expense of increased readmission and mortality rates," said Liu and co-authors.

Over 90 days of follow-up, six of the 81 patients (7%) in the robotic-surgery group and five of the 80 patients (6%) in the open-surgery group required readmission, including for intra-abdominal hemorrhage (one in each group), vomiting (two in the robotic surgery group and one in the open surgery group), electrolyte disturbance (one in each group), and fever (two in each group).

The overall incidence of postoperative complications of grade 3 or higher was similar between groups (22% vs 23.4%, respectively), as was the 90-day mortality rate, with one in-hospital death in each group.

Pathology outcomes between groups were also similar, according to Liu and colleagues, including tumor size, tumor type, differentiation, the number of lymph nodes retrieved, and positive nodes.

In a , Elisa Bannone, MD, of Istituto Ospedaliero Fondazione Poliambulanza in Brescia, Italy, and Giovanni Marchegiani, MD, PhD, of the University of Padua in Italy, said the trial "shows that RPD [robotic pancreatoduodenectomy] is ready for mainstream use by experienced clinicians and centers, affirming its similar short-term outcomes compared with OPD [open pancreatoduodenectomy] in selected cases."

But Bannone and Marchegiani cautioned that despite the comparable pathology outcomes, "we should acknowledge that the [randomized controlled trial] did not have the statistical power to delineate oncological outcomes."

"Subsequent investigations should give priority to these outcomes to robustly validate the robotic approach and practitioners conducting RPD should maintain a comprehensive registry for meticulous outcome tracking," they wrote.

The randomized trial was conducted at three high-volume hospitals in China. Five surgeons from these centers who passed the learning curve for robotic pancreatoduodenectomy (more than 40 procedures) and open pancreatoduodenectomy (more than 60 procedures) conducted the surgeries.

Overall, 164 patients (median age of about 60 years, 57% male) were randomly assigned to robotic or open pancreatoduodenectomy. Patients had resectable benign, premalignant, or malignant tumors in the pancreatic head or periampullary region, and were considered suitable for either operation type. Patients with distant metastases were excluded.

Liu and colleagues acknowledged that generalizability of the results may be limited since the study was conducted in high-volume centers by surgeons with substantial experience and because only 3% of the patients in the study had obesity.

They also noted that the clinical benefit of robotic pancreatoduodenectomy needs to be clarified considering the added cost associated with robot-assisted surgeries.

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