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

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机构: [1]Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China. [2]Department of General Surgery, Peking University First Hospital, Beijing, China. [3]Department of General Surgery, Peking University Third Hospital, Beijing, China. [4]Department of Pancreatic Surgery, West China Hospital, Sichuan University, Chengdu, China. [5]Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, China. [6]Department of General Surgery, Xuan Wu Hospital, Capital Medical University, Beijing, China. [7]Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [8]Department of Pancreatic Surgery, General Surgery, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.
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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.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.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.Clinicaltrials.gov, NCT03770559.Copyright © 2022 Dai, Zhang, Yang, Xiu, Peng, Sun, Cao, Wu, Wang, Yuan, Chen, Wang, Tian, Wang, Liu, Xu, Liu, Zhao and MIRROR study group.

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出版当年[2021]版:
大类 | 3 区 医学
小类 | 3 区 肿瘤学
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大类 | 3 区 医学
小类 | 3 区 肿瘤学
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Q2 ONCOLOGY
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Q2 ONCOLOGY

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第一作者机构: [1]Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
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