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

Jiabin Jin, Yusheng Shi, Mengmin Chen, Jianfeng Qian, Kai Qin, Zhen Wang, Wei Chen, Weiwei Jin, Fengchun Lu, Zheyong Li, Zehua Wu, Li Jian, Bing Han, Xiao Liang, Chuandong Sun, Zheng Wu, Yiping Mou, Xiaoyu Yin, Heguang Huang, Hao Chen, Georgios Gemenetzis, Xiaxing Deng, Chenghong Peng, Baiyong Shen, Jiabin Jin, Yusheng Shi, Mengmin Chen, Jianfeng Qian, Kai Qin, Zhen Wang, Wei Chen, Weiwei Jin, Fengchun Lu, Zheyong Li, Zehua Wu, Li Jian, Bing Han, Xiao Liang, Chuandong Sun, Zheng Wu, Yiping Mou, Xiaoyu Yin, Heguang Huang, Hao Chen, Georgios Gemenetzis, Xiaxing Deng, Chenghong Peng, Baiyong Shen

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.gov NCT04400357 . Registered on May 22, 2020.

Keywords: Minimally invasive; Outcomes; Pancreatic cancer; Pancreatoduodenectomy; Recurrence; Robot-assisted; Robotic; Survival; Whipple.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
PORTAL trial flowchart: patient inclusion and randomization, arms design, and statistical analysis. BMI, body mass index; PDAC, pancreatic adenocarcinoma; ITT, intention-to-treat; PP, per-protocol
Fig. 2
Fig. 2
a Illustration of patient blinding in the postoperative setting; all wound dressings and drain sites are identical in patients who undergo both open and robotic pancreatoduodenectomy. b Illustration of trocar placement in robotic pancreatoduodenectomy; 1–3, robotic ports. C, camera port, A1––A3: assisting laparoscopic ports (utilized on individual patients basis)
Fig. 3
Fig. 3
Timeline diagram of the studied primary and secondary outcomes. EQ-5D-5L, Quality of Life Questionnaire; POD, postoperative day; PDAC, pancreatic adenocarcinoma

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