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

Jin, J. et al. (2021) Robotic versus Open Pancreatoduodenectomy for Pancreatic and Periampullary Tumors (PORTAL): a study protocol for a multicenter phase III non-inferiority randomized controlled trial. Trials, 22, 954. (doi: 10.1186/s13063-021-05939-6) (PMID:34961558) (PMCID:PMC8711152)

Abstract

Abstract: Background: Pancreatoduodenectomy 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/design: The 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. Discussion: The 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 registration: ClinicalTrials.govNCT04400357. Registered on May 22, 2020

• Item Type: Articles
• Additional Information: Funding for this trial was provided by the Interdisciplinary Program of Shanghai Jiao Tong University (YG2019QNB26) and the Medical Engineering Cross Foundation of Shanghai Jiao Tong University (grant No. ZH2018ZDA01). Additional financial support was provided by Intuitive Surgical (Sunnyvale, CA, USA).
• Keywords: Robotic, robot-assisted, minimally invasive, pancreatoduodenectomy, whipple, pancreatic cancer, outcomes, recurrence, survival.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Gemenetzis, Mr Georgios
• Authors: Jin, J., Shi, Y., Chen, M., Qian, J., Qin, K., Wang, Z., Chen, W., Jin, W., Lu, F., Li, Z., Wu, Z., Jian, L., Han, B., Liang, X., Sun, C., Wu, Z., Mou, Y., Yin, X., Huang, H., Chen, H., Gemenetzis, G., Deng, X., Peng, C., and Shen, B.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: Trials
• Publisher: BioMed Central
• ISSN: 1745-6215
• ISSN (Online): 1745-6215
• Copyright Holders: Copyright © 2021 The Authors
• First Published: First published in Trials 22: 954
• Publisher Policy: Reproduced under a Creative Commons License