Radical antegrade modular pancreatosplenectomy (RAMPS) is an isolation procedure in pancreatosplenectomy for pancreatic body/tail cancer. Connective tissues around the bifurcation of the celiac axis are dissected, followed by median-to-left retroperitoneal dissection. This procedure has the potential to isolate blood and lymphatic flow to the area of the pancreatic body/tail and the spleen to be excised. This is achieved by division of the inflow artery, transection of the pancreas, and then division of the outflow vein in the early phases of surgery. In cases of pancreatic ductal adenocarcinoma (PDAC), the procedure has been shown to decrease intraoperative blood loss and increase R0 resection rate by complete clearance of the lymph nodes. This trial investigates whether the isolation procedure can prolong the survival of patients with pancreatic ductal adenocarcinoma who undergo distal pancreatosplenectomy (DPS) compared with those that undergo the conventional approach. Patients with PDAC scheduled to undergo DPS are randomized before surgery to undergo either a conventional procedure (arm A) or to undergo the isolation procedure (arm B). In arm A, the pancreatic body, tail, and spleen are mobilized, followed by removal of the regional lymph nodes. The splenic vein is transected at the end of the procedure. The timing of division of the splenic artery (SA) is not restricted. In arm B, regional lymph nodes are dissected, then we transect the root of the SA, the pancreas, then the splenic vein. At the end of the procedure, the pancreatic body/tail and spleen are mobilized and removed. In total, 100 patients from multiple Japanese high-volume centers will be randomized. The primary endpoint is 2-year recurrence-free survival by intention-to-treat analysis. Secondary endpoints include intraoperative blood loss, R0 resection rate, and overall survival. If this trial shows that the isolation procedures can improve survival with a similar R0 rate and with a similar number of lymph node dissections to the conventional procedure, the isolation procedure is expected to become a standard procedure during DPS for PDAC. Conversely, if there were no significant differences in endpoints between the groups, it would demonstrate justification of either procedure from surgical and oncological points of view. UMIN Clinical Trials Registry UMIN000041381 . Registered on 10 August 2020. ClinicalTrials.gov NCT04600063 . Registered on 22 October 2020.

中文翻译：

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远端胰腺切除术期间的隔离程序与常规程序（ISOP-DP 试验）：随机对照试验的研究方案

根治性顺行模块化胰脾切除术 (RAMPS) 是胰体/尾癌胰脾切除术中的一种隔离程序。解剖腹腔轴分叉周围的结缔组织，然后进行中位至左腹膜后解剖。该程序有可能将血液和淋巴流分离到胰腺体/尾部和要切除的脾脏区域。这是通过分割流入动脉，横断胰腺，然后在手术早期分割流出静脉来实现的。在胰腺导管腺癌 (PDAC) 的情况下，该手术已被证明可以通过完全清除淋巴结来减少术中失血并提高 R0 切除率。本试验研究与接受传统方法的患者相比，隔离程序是否可以延长接受远端胰脾切除术 (DPS) 的胰腺导管腺癌患者的生存期。计划接受 DPS 的 PDAC 患者在手术前被随机分配接受常规手术（A 组）或接受隔离手术（B 组）。在 A 臂中，胰体、尾部和脾脏被调动，然后切除区域淋巴结。脾静脉在手术结束时被横断。脾动脉 (SA) 的分裂时间不受限制。在 B 组，解剖区域淋巴结，然后我们横切 SA 根部、胰腺，然后是脾静脉。在程序结束时，胰体/尾部和脾脏被调动和移除。总共将随机分配来自多个日本高容量中心的 100 名患者。主要终点是意向治疗分析的 2 年无复发生存期。次要终点包括术中失血量、R0 切除率和总生存期。如果该试验表明隔离程序可以以与传统程序相似的 R0 率和相似数量的淋巴结清扫术提高生存率，则隔离程序有望成为 PDAC DPS 期间的标准程序。相反，如果各组之间的终点没有显着差异，则从外科和肿瘤学的角度来看，这将证明任一程序的合理性。UMIN 临床试验注册 UMIN000041381。2020 年 8 月 10 日注册。ClinicalTrials.gov NCT04600063。于 2020 年 10 月 22 日注册。