Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.
Trials. 2023 Aug 17;24(1):541. doi: 10.1186/s13063-023-07456-0.
Pancreatic 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 safety METHODS: The 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.
The 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 cancer Trial registration Chinese Clinical Trial Registry ChiCTR2100053844; pre-results. Registered on December 1, 2021.
胰腺导管腺癌（PDAC）是一种高度侵袭性的恶性肿瘤。根治性手术切除是唯一可能治愈的方法。越来越多的人认为，根治性顺行模块化胰脾切除术（RAMPS）可能有益于胰腺体尾部肿瘤患者。为此，提出了中国胰腺癌研究组（CSPAC）-3 试验，旨在比较 RAMPS 和标准逆行胰脾切除术（SRPS）对患者生存和术前安全性的影响。
这项随机对照试验将是多中心的、双臂的、结局盲法和意向治疗分析。将招募 300 名可切除的胰腺体尾部腺癌患者，并随机分为 RAMPS 或 SRPS 组。如果没有严重并发症，术后 4-6 周将根据初始方案推荐辅助化疗。采用优效性试验检验 RAMPS 改善生存结局的假设。主要结局是总生存（OS）。次要结局包括无复发生存（RFS）、R0 切除率、采集的淋巴结数量、术后并发症和生活质量评分。
过去十年中，RAMPS 的应用有所增加。据报道，RAMPS 在提高 R0 切除率和淋巴结检出率方面优于 SRPS。然而，尽管有这些优势，但关于 RAMPS 在生存方面的优越性的高水平文献却很少，这需要进行研究。为了解决这个问题，CSPAC 发起了第一项前瞻性、随机 III 期对照临床试验，旨在探索改善左侧胰腺癌患者预后和 OS 的最佳手术策略。
中国临床试验注册中心 ChiCTR2100053844；预注册于 2021 年 12 月 1 日。
