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临床试验/NCT05939063
NCT05939063招募中不适用

Laparoscopic Radical Antegrade Modular Pancreatosplenectomy Versus Laparoscopic Distal Pancreatosplecnectomy in Selected Left-sided Pancreatic Cancer: a Multicenter Randomized Controlled Clinical Trial

Fudan University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
R0 transection margin rate

研究概览

简要总结

This multicenter randomized controlled clinical trial proposed the criteria for selecting patients with early-stage left-sided pancreatic cancer and aimed to compare the perioperative and oncological outcomes of patients within the criteria who underwent laparoscopic radical antegrade modular pancreatosplenectomy versus laparoscopic distal pancreatosplenectomy.

详细描述

Although prospective comparative studies are lacking, laparoscopic distal pancreatosplenectomy (LDP) was considered to be feasible, safe, and oncologically equivalent for treating pancreatic ductal adenocarcinoma (PDAC). However, the extent of posterior resection and the oncological safety of achieving complete N1 lymph node resection in LDP remain uncertain. Strasberg proposed radical antegrade modular pancreatosplenectomy (RAMPS) for the treatment of resectable left-sided PDAC and confirmed that this technique can achieve negative margins and satisfactory survival. Given the oncological equivalence of laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) and its advantages in short-term outcomes, several studies have assessed the feasibility of LRAMPS as the standard treatment for resectable left-sided PDAC. However, previous studies on LRAMPS have mostly included tumors staged T2 and above, and there is currently no research on the routine use of LRAMPS for early-stage tumors. We proposed the criteria for selecting patients with early-stage left-sided PDAC: (1) diameter ≤ 4 cm; (2) located ≥ 1 cm from the celiac trunk; (3) didn't invade the fascial layer behind the pancreas. This multicenter open-label randomized controlled clinical trial aims to compare the perioperative and oncological outcomes of patients within the criteria who underwent LRAMPS versus LDP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically diagnosed as resectable left-sided pancreatic cancer before surgery.
  • Imaging tumor diameter ≤ 4 cm.
  • Located ≥ 1cm from the celiac trunk.
  • Tumor didn't invade the fascial layer behind the pancreas.
  • Be able to comply with research protocol.
  • Voluntary participation and signed informed consent.

排除标准

  • Received neoadjuvant therapy.
  • Presence of liver or other distant metastasis.
  • Multifocal or recurrent disease.
  • History of other malignancies.
  • Simultaneously participating in other clinical trials.

结局指标

主要结局

R0 transection margin rate

时间窗: From the date of surgery to 1 month after surgery.

R0 transection margin rate diagnosed by postoperative pathological examination.

Lymph node positive rate

时间窗: From the date of surgery to 1 month after surgery.

Lymph node positive rate diagnosed by postoperative pathological examination.

R0 retroperitoneal margin rate

时间窗: From the date of surgery to 1 month after surgery.

R0 retroperitoneal margin rate diagnosed by postoperative pathological examination.

次要结局

  • Recurrence-free survival (RFS)(Through study completion, an average of 3 year.)
  • Perioperative complication rate(Within 90 days after surgery.)
  • Life quality satisfaction evaluated according to EORTC C30 scale(Through study completion, an average of 3 year.)
  • Overall survival (OS)(Through study completion, an average of 3 year.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xian-Jun Yu

President of Fudan University Shanghai Cancer Center

Fudan University

研究点 (1)

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