Radical antegrade modular pancreatosplenectomy (RAMPS) versus standard retrograde pancreatosplenectomy (SRPS) for resectable body and tail pancreatic adenocarcinoma: protocol of a multicenter, prospective, randomized phase III control trial (CSPAC-3)

Trials

Study Protocol

Qingcai Meng¹  Bo Zhang¹  Wei Wang¹  Jin Xu¹  Miaoyan Wei¹  Si Shi¹  Jialin Li¹  Jiang Liu¹  Chen Liang¹  Hang Xu¹  Jie Hua¹  Xianjun Yu¹ 

[1] Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, 200032, Shanghai, China;Department of Oncology, Shanghai Medical College, Fudan University, 200032, Shanghai, China;

关键词: Distal pancreatectomy;    Clinical trials;    Pancreatic cancer;    Pancreatic surgery;    Radical antegrade modular pancreatosplenectomy;   

DOI  :  10.1186/s13063-023-07456-0

 received in 2022-12-21, accepted in 2023-06-13,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPancreatic ductal adenocarcinoma (PDAC) is a highly aggressive malignancy. Radical surgical resection offers the only potential cure. There is increasing agreement that radical antegrade modular pancreatosplenectomy (RAMPS) may benefit patients with tumors in the body and tail of the pancreas. To address this, the Chinese Study Group for Pancreatic Cancer (CSPAC)-3 trial is proposed to compare the effect of RAMPS and standard retrograde pancreatosplenectomy (SRPS) on patient survival and preoperative safetyMethodsThe randomized controlled trial will be multicenter and two-armed with blinded outcomes and intention-to-treat analysis. Three hundred patients with resectable body and tail pancreatic adenocarcinoma will be enrolled and randomly assigned to RAMPS or SRPS. Adjuvant chemotherapy based on an initial regimen will be recommended 4–6 weeks after surgery if no serious complication occurs. The hypothesis that RAMPS improves survival outcomes compared with SRPS will be tested using a superiority trial. The primary outcome will be overall survival (OS). Secondary outcomes will include recurrence-free survival (RFS), R0 resection rate, the number of harvested lymph nodes, postoperative complications, and quality of life scores.DiscussionThe use of RAMPS has increased over the past decade. It is reported that RAMPS is superior to SRPS in improving both the rate of R0 resection and lymph node yield. Despite these advantages, however, there is little high-level documentation of the superiority of RAMPS in terms of survival and this needs to be investigated. To address this issue, CSPAC has instigated the first prospective, randomized phase III control trials, aiming to explore the optimal surgical strategy for improving the prognosis and OS of patients with left-sided pancreatic cancerTrial registrationChinese Clinical Trial Registry ChiCTR2100053844; pre-results. Registered on December 1, 2021.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

Fig. 5