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

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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

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-021-05939-6.

Related collections

Most cited references 28

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The lack of consensus on how to define and grade adverse postoperative events has greatly hampered the evaluation of surgical procedures. A new classification of complications, initiated in 1992, was updated 5 years ago. It is based on the type of therapy needed to correct the complication. The principle of the classification was to be simple, reproducible, flexible, and applicable irrespective of the cultural background. The aim of the current study was to critically evaluate this classification from the perspective of its use in the literature, by assessing interobserver variability in grading complex complication scenarios and to correlate the classification grades with patients', nurses', and doctors' perception. Reports from the literature using the classification system were systematically analyzed. Next, 11 scenarios illustrating difficult cases were prepared to develop a consensus on how to rank the various complications. Third, 7 centers from different continents, having routinely used the classification, independently assessed the 11 scenarios. An agreement analysis was performed to test the accuracy and reliability of the classification. Finally, the perception of the severity was tested in patients, nurses, and physicians by presenting 30 scenarios, each illustrating a specific grade of complication. We noted a dramatic increase in the use of the classification in many fields of surgery. About half of the studies used the contracted form, whereas the rest used the full range of grading. Two-thirds of the publications avoided subjective terms such as minor or major complications. The study of 11 difficult cases among various centers revealed a high degree of agreement in identifying and ranking complications (89% agreement), and enabled a better definition of unclear situations. Each grade of complications significantly correlated with the perception by patients, nurses, and physicians (P < 0.05, Kruskal-Wallis test). This 5-year evaluation provides strong evidence that the classification is valid and applicable worldwide in many fields of surgery. No modification in the general principle of classification is warranted in view of the use in ongoing publications and trials. Subjective, inaccurate, or confusing terms such as "minor or major" should be removed from the surgical literature.

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Among patients with metastatic pancreatic cancer, combination chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) leads to longer overall survival than gemcitabine therapy. We compared the efficacy and safety of a modified FOLFIRINOX regimen with gemcitabine as adjuvant therapy in patients with resected pancreatic cancer.

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Abe Fingerhut, CHRISTOS DERVENIS, Dirk Gouma … (2007)

Delayed gastric emptying (DGE) is one of the most common complications after pancreatic resection. In the literature, the reported incidence of DGE after pancreatic surgery varies considerably between different surgical centers, primarily because an internationally accepted consensus definition of DGE is not available. Several surgical centers use a different definition of DGE. Hence, a valid comparison of different study reports and operative techniques is not possible. After a literature review on DGE after pancreatic resection, the International Study Group of Pancreatic Surgery (ISGPS) developed an objective and generally applicable definition with grades of DGE based primarily on severity and clinical impact. DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A, B, and C) were defined based on the impact on the clinical course and on postoperative management. The proposed definition, which includes a clinical grading of DGE, should allow objective and accurate comparison of the results of future clinical trials and will facilitate the objective evaluation of novel interventions and surgical modalities in the field of pancreatic surgery.

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Author and article information

Contributors

Georgios Gemenetzis:

ORCID: http://orcid.org/0000-0002-0549-1369

georgios.gemenetzis@glasgow.ac.uk

Xiaxing Deng: kejiadxx@hotmail.com

Chenghong Peng: chhpeng@yeah.net

Baiyong Shen: shenby@shsmu.edu.cn

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 27 December 2021

Publication date PMC-release: 27 December 2021

Publication date Collection: 2021

Volume: 22

Electronic Location Identifier: 954

Affiliations

[1 ]GRID grid.16821.3c, ISNI 0000 0004 0368 8293, Department of Pancreatic Surgery, Ruijin Hospital, , Shanghai Jiao Tong University School of Medicine, ; Shanghai, China

[2 ]GRID grid.452438.c, ISNI 0000 0004 1760 8119, Department of Hepatobiliary Surgery, , The First Affiliated Hospital of Xi’an Jiaotong University, ; Xi’an, Shanxi Province China

[3 ]GRID grid.12981.33, ISNI 0000 0001 2360 039X, Department of Pancreaticobiliary Surgery, The First Affiliated Hospital, , Sun Yat-sen University, ; Guangzhou, Guangdong Province China

[4 ]GRID grid.417401.7, ISNI 0000 0004 1798 6507, Department of Gastroenterology and Pancreatic Surgery, , Zhejiang Provincial People’s Hospital, ; Hangzhou, Zhejiang Province China

[5 ]GRID grid.411176.4, ISNI 0000 0004 1758 0478, Department of General Surgery, , Fujian Medical University Union Hospital, ; Fuzhou, Fujian Province China

[6 ]GRID grid.13402.34, ISNI 0000 0004 1759 700X, Department of General Surgery, Sir Run Run Shaw Hospital, , Zhejiang University School of Medicine, ; Hangzhou, Zhejiang Province China

[7 ]GRID grid.412521.1, ISNI 0000 0004 1769 1119, Department of Hepatobiliary and Pancreatic Surgery, , The Affiliated Hospital of Qingdao University, ; Qingdao, Shandong Province China

[8 ]GRID grid.16821.3c, ISNI 0000 0004 0368 8293, Clinical Research Center, , Shanghai Jiao Tong University School of Medicine, ; Shanghai, China

[9 ]GRID grid.418716.d, ISNI 0000 0001 0709 1919, Department of Hepatopancreatobiliary and Transplant Surgery, , Royal Infirmary Edinburgh, ; Edinburgh, UK

[10 ]GRID grid.411714.6, ISNI 0000 0000 9825 7840, Department of Pancreatobiliary Surgery, , Glasgow Royal Infirmary, ; Glasgow, UK

Author information

Georgios Gemenetzis http://orcid.org/0000-0002-0549-1369

Article

Publisher ID: 5939

DOI: 10.1186/s13063-021-05939-6

PMC ID: 8711152

PubMed ID: 34961558

SO-VID: ba5ba382-9b3a-42dc-8924-d41f6be3b20d

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 16 May 2021

Date accepted : 15 December 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100010477, Intuitive Surgical;

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: robotic,robot-assisted,minimally invasive,pancreatoduodenectomy,whipple,pancreatic cancer,outcomes,recurrence,survival

Data availability:

ScienceOpen disciplines: Medicine

Keywords: robotic, robot-assisted, minimally invasive, pancreatoduodenectomy, whipple, pancreatic cancer, outcomes, recurrence, survival

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

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Abstract

Background

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Trial registration

Supplementary Information

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CHAIN Network Collection

Most cited references 28

The Clavien-Dindo classification of surgical complications: five-year experience.

FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer

Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS).

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