Abstract
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
Highlights
Pancreatoduodenectomy is a complex and challenging procedure that requires meticulous tissue dissection and proficient suturing skills
The PORTAL trial is designed to assess the feasibility and safety of robotic pancreatoduodenectomy (RPD) compared to open pancreatoduodenectomy (OPD), in terms of functional recovery as described previously
The comparison/control group of OPD was selected because it is the standard of surgical practice and has a proven safety record when performed in highvolume centers
Summary
Pancreatoduodenectomy is a complex and challenging procedure that requires meticulous tissue dissection and proficient suturing skills. It is a sophisticated operation that requires proficient surgical skills, both for the dissection of the tumor from the adjacent vascular structures and for the restoration of gastrointestinal tract continuity with the performance of the pancreatic, biliary, and gastric anastomosis. This level of surgical complexity may result in significant postoperative morbidity, and data suggest that surgeon experience [2] and hospital volume [3] are critical for the achievement of favorable outcomes in pancreatic surgery. The significant costs of the robotic platform and the lack of robust evidence to demonstrate meaningful benefit have raised concerns in the surgical community regarding its generalized acceptance [14]
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