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

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

JOURNAL=Frontiers in Oncology

VOLUME=12

YEAR=2022

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.965508

DOI=10.3389/fonc.2022.965508

ISSN=2234-943X

ABSTRACT=<sec><title>Background</title><p>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.</p></sec><sec><title>Method/Design</title><p>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.</p></sec><sec><title>Conclusion</title><p>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.</p></sec><sec><title>Clinical Trial Registration</title><p><uri xlink:href="http://Clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">Clinicaltrials.gov</uri>, NCT03770559.</p></sec>