The effect of minimally invasive or open radical antegrade modular pancreatosplenectomy on pancreatic cancer: A multicenter randomized clinical trial protocol

Menghua Dai; Hanyu Zhang; Yinmo Yang; Dianrong Xiu; Bing Peng; Bei Sun; Feng Cao; Zheng Wu; Lei Wang; Chunhui Yuan; Hua Chen; Zheng Wang; Xiaodong Tian; Hangyan Wang; Wenjing Liu; Jianwei Xu; Qiaofei Liu; Yupei Zhao

doi:10.3389/fonc.2022.965508

The effect of minimally invasive or open radical antegrade modular pancreatosplenectomy on pancreatic cancer: A multicenter randomized clinical trial protocol

Menghua Dai
, Hanyu Zhang
, Yinmo Yang
, Dianrong Xiu
, Bing Peng
, Bei Sun
, Feng Cao
, Zheng Wu
, Lei Wang
, Chunhui Yuan
, Hua Chen
, Zheng Wang
, Xiaodong Tian
, Hangyan Wang
, Wenjing Liu
, Jianwei Xu
, Qiaofei Liu
, Yupei Zhao

Chinese Academy of Medical Sciences
Peking University
Sichuan University
The First Affiliated Hospital of Harbin Medical University
Capital Medical University
The First Affiliated Hospital of Xi’an Jiaotong University
Qilu Hospital of Shandong University

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

Abstract

Background: Radical antegrade modular pancreatosplenectomy (RAMPS) has been proven to improve R0 resection and lymph harvest in treating patients with distal pancreatic cancer. The development of minimally invasive surgery has advantages in postoperative recovery. Therefore, minimally invasive (MI-) RAMPS may combine the advantages of both benefits to improve survival. Nevertheless, evidence to validate the safety and efficacy of MI-RAMPS is limited. Method/Design: The MIRROR trial will be the first multicenter prospective randomized clinical trial to investigate the outcome of MI-RAMPS. The hypothesis is that MI-RAMPS is superior in postoperative recovery. The primary outcome is the length of postoperative stay. Based on the hypothesis and primary outcome, the sample size is 250 patients (125 participants in each group). The trial will investigate factors related to surgical safety, short-term outcome, pathological assessment, and survival as secondary outcomes. Conclusion: This study will offer a relatively higher level of evidence to further illustrate the accessibility and benefits of MI-RAMPS for the treatment of distal pancreatic cancer. Clinical Trial Registration: Clinicaltrials.gov, NCT03770559.

Original language	English
Article number	965508
Journal	Frontiers in Oncology
Volume	12
DOIs	https://doi.org/10.3389/fonc.2022.965508
State	Published - 15 Sep 2022
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

clinical trial
design
length of stay
minimally invasive surgery
pancreatic cancer
protocol
radical antegrade modular pancreatosplenectomy

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10.3389/fonc.2022.965508

Cite this

Dai, M., Zhang, H., Yang, Y., Xiu, D., Peng, B., Sun, B., Cao, F., Wu, Z., Wang, L., Yuan, C., Chen, H., Wang, Z., Tian, X., Wang, H., Liu, W., Xu, J., Liu, Q., & Zhao, Y. (2022). The effect of minimally invasive or open radical antegrade modular pancreatosplenectomy on pancreatic cancer: A multicenter randomized clinical trial protocol. Frontiers in Oncology, 12, Article 965508. https://doi.org/10.3389/fonc.2022.965508

@article{9332814431cb48fab904f8ae06e5276e,

title = "The effect of minimally invasive or open radical antegrade modular pancreatosplenectomy on pancreatic cancer: A multicenter randomized clinical trial protocol",

abstract = "Background: Radical antegrade modular pancreatosplenectomy (RAMPS) has been proven to improve R0 resection and lymph harvest in treating patients with distal pancreatic cancer. The development of minimally invasive surgery has advantages in postoperative recovery. Therefore, minimally invasive (MI-) RAMPS may combine the advantages of both benefits to improve survival. Nevertheless, evidence to validate the safety and efficacy of MI-RAMPS is limited. Method/Design: The MIRROR trial will be the first multicenter prospective randomized clinical trial to investigate the outcome of MI-RAMPS. The hypothesis is that MI-RAMPS is superior in postoperative recovery. The primary outcome is the length of postoperative stay. Based on the hypothesis and primary outcome, the sample size is 250 patients (125 participants in each group). The trial will investigate factors related to surgical safety, short-term outcome, pathological assessment, and survival as secondary outcomes. Conclusion: This study will offer a relatively higher level of evidence to further illustrate the accessibility and benefits of MI-RAMPS for the treatment of distal pancreatic cancer. Clinical Trial Registration: Clinicaltrials.gov, NCT03770559.",

keywords = "clinical trial, design, length of stay, minimally invasive surgery, pancreatic cancer, protocol, radical antegrade modular pancreatosplenectomy",

author = "Menghua Dai and Hanyu Zhang and Yinmo Yang and Dianrong Xiu and Bing Peng and Bei Sun and Feng Cao and Zheng Wu and Lei Wang and Chunhui Yuan and Hua Chen and Zheng Wang and Xiaodong Tian and Hangyan Wang and Wenjing Liu and Jianwei Xu and Qiaofei Liu and Yupei Zhao",

note = "Publisher Copyright: Copyright {\textcopyright} 2022 Dai, Zhang, Yang, Xiu, Peng, Sun, Cao, Wu, Wang, Yuan, Chen, Wang, Tian, Wang, Liu, Xu, Liu, Zhao and MIRROR study group.",

year = "2022",

month = sep,

day = "15",

doi = "10.3389/fonc.2022.965508",

language = "英语",

volume = "12",

journal = "Frontiers in Oncology",

issn = "2234-943X",

publisher = "Frontiers Media SA",

}

Dai, M, Zhang, H, Yang, Y, Xiu, D, Peng, B, Sun, B, Cao, F, Wu, Z, Wang, L, Yuan, C, Chen, H, Wang, Z, Tian, X, Wang, H, Liu, W, Xu, J, Liu, Q & Zhao, Y 2022, 'The effect of minimally invasive or open radical antegrade modular pancreatosplenectomy on pancreatic cancer: A multicenter randomized clinical trial protocol', Frontiers in Oncology, vol. 12, 965508. https://doi.org/10.3389/fonc.2022.965508

TY - JOUR

T1 - The effect of minimally invasive or open radical antegrade modular pancreatosplenectomy on pancreatic cancer

T2 - A multicenter randomized clinical trial protocol

AU - Dai, Menghua

AU - Zhang, Hanyu

AU - Yang, Yinmo

AU - Xiu, Dianrong

AU - Peng, Bing

AU - Sun, Bei

AU - Cao, Feng

AU - Wu, Zheng

AU - Wang, Lei

AU - Yuan, Chunhui

AU - Chen, Hua

AU - Wang, Zheng

AU - Tian, Xiaodong

AU - Wang, Hangyan

AU - Liu, Wenjing

AU - Xu, Jianwei

AU - Liu, Qiaofei

AU - Zhao, Yupei

PY - 2022/9/15

Y1 - 2022/9/15

N2 - Background: Radical antegrade modular pancreatosplenectomy (RAMPS) has been proven to improve R0 resection and lymph harvest in treating patients with distal pancreatic cancer. The development of minimally invasive surgery has advantages in postoperative recovery. Therefore, minimally invasive (MI-) RAMPS may combine the advantages of both benefits to improve survival. Nevertheless, evidence to validate the safety and efficacy of MI-RAMPS is limited. Method/Design: The MIRROR trial will be the first multicenter prospective randomized clinical trial to investigate the outcome of MI-RAMPS. The hypothesis is that MI-RAMPS is superior in postoperative recovery. The primary outcome is the length of postoperative stay. Based on the hypothesis and primary outcome, the sample size is 250 patients (125 participants in each group). The trial will investigate factors related to surgical safety, short-term outcome, pathological assessment, and survival as secondary outcomes. Conclusion: This study will offer a relatively higher level of evidence to further illustrate the accessibility and benefits of MI-RAMPS for the treatment of distal pancreatic cancer. Clinical Trial Registration: Clinicaltrials.gov, NCT03770559.

AB - Background: Radical antegrade modular pancreatosplenectomy (RAMPS) has been proven to improve R0 resection and lymph harvest in treating patients with distal pancreatic cancer. The development of minimally invasive surgery has advantages in postoperative recovery. Therefore, minimally invasive (MI-) RAMPS may combine the advantages of both benefits to improve survival. Nevertheless, evidence to validate the safety and efficacy of MI-RAMPS is limited. Method/Design: The MIRROR trial will be the first multicenter prospective randomized clinical trial to investigate the outcome of MI-RAMPS. The hypothesis is that MI-RAMPS is superior in postoperative recovery. The primary outcome is the length of postoperative stay. Based on the hypothesis and primary outcome, the sample size is 250 patients (125 participants in each group). The trial will investigate factors related to surgical safety, short-term outcome, pathological assessment, and survival as secondary outcomes. Conclusion: This study will offer a relatively higher level of evidence to further illustrate the accessibility and benefits of MI-RAMPS for the treatment of distal pancreatic cancer. Clinical Trial Registration: Clinicaltrials.gov, NCT03770559.

KW - clinical trial

KW - design

KW - length of stay

KW - minimally invasive surgery

KW - pancreatic cancer

KW - protocol

KW - radical antegrade modular pancreatosplenectomy

UR - https://www.scopus.com/pages/publications/85139052540

U2 - 10.3389/fonc.2022.965508

DO - 10.3389/fonc.2022.965508

M3 - 文章

AN - SCOPUS:85139052540

SN - 2234-943X

VL - 12

JO - Frontiers in Oncology

JF - Frontiers in Oncology

M1 - 965508

ER -

The effect of minimally invasive or open radical antegrade modular pancreatosplenectomy on pancreatic cancer: A multicenter randomized clinical trial protocol

Abstract

UN SDGs

Keywords

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